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The Food and Drug Administration has acknowledged reports of squamous cell carcinoma (SCC) of the breast as well as lymphomas associated with postmastectomy breast implants.

Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.

The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.

Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.

SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.” 

The results were published in a research letter in JAMA Surgery.

Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.

Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.

Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.

Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).

The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.

Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has acknowledged reports of squamous cell carcinoma (SCC) of the breast as well as lymphomas associated with postmastectomy breast implants.

Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.

The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.

Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.

SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.” 

The results were published in a research letter in JAMA Surgery.

Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.

Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.

Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.

Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).

The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.

Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has acknowledged reports of squamous cell carcinoma (SCC) of the breast as well as lymphomas associated with postmastectomy breast implants.

Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.

The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.

Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.

SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.” 

The results were published in a research letter in JAMA Surgery.

Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.

Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.

Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.

Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).

The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.

Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
 

A version of this article first appeared on Medscape.com.

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

A version of this article first appeared on Medscape.com.

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

A version of this article first appeared on Medscape.com.

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

A version of this article first appeared on Medscape.com.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.

Timing of a switch to treatment from gefitinib to osimertinib based on molecular progression led to an earlier switch than timing based on conventional measures in a new study of 100 adults with epidermal growth factor (EGFR)–mutant non–small cell lung cancer (NSCLC).

Previous studies have suggested that molecular progression of disease in patients with EGFR-mutant NSCLC, as measured by sequential plasma EGFR T790M, may precede radiological progression, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

However, the impact of these measures on timing of treatment changes and patient outcomes has not been examined, wrote Jordi Remon, MD, of Paris (France)–Saclay University and colleagues, in Annals of Oncology.

The European Organization for Research Treatment and Cancer Lung Cancer Group designed a phase 2 clinical trial known as APPLE to evaluate the use of sequential plasma EGFR T790M and determine the optimal sequencing for gefitinib and osimertinib in patients with EGFR-mutant NSCLC.

The researchers reported results from two randomized arms of the APPLE trial. In arm B, 52 patients received gefitinib until emergence of circulating tumor DNA (ctDNA) EGFR T790M mutation, based on the cobas EGFR test v2 (a real-time PCR test), or progression of disease based on Response Evaluation Criteria in Solid Tumors (RECIST). In arm C, 51 patients received gefitinib until disease progression based on RECIST. Both arms then switched to osimertinib. Patients randomized to a third arm (arm A) received osimertinib upfront until progression of disease based on RECIST, and they were not included in the current study.

The primary endpoint was progression-free survival (PFS) while receiving osimertinib at 18 months in patients who were originally randomized to gefitinib, then switched to osimertinib at the emergence of circulating tumor DNA. Secondary endpoints included PFS, overall response rate, overall survival, and brain PFS.

Patients entered the study between November 2017 and February 2020. A total of 75% and 65% of those in arms B and C, respectively, were female, approximately 65% had the mutation EGFR Del19, and approximately one-third had baseline brain metastases. In arm B, 17% of patients switched to osimertinib based on the emergence of ctDNA T790M mutation before progressive disease based on RECIST. The median time to molecular disease progression was 266 days.

More patients in arm B met the primary endpoint of PFS while receiving osimertinib at 18 months (67.2%) than in arm C (53.5%), after a median follow-up of 30 months.

As for secondary endpoints, the median PFS in the two arms was 22.0 months and 20.2 months, respectively. Median overall survival was 42.8 months in arm C and was not reached in arm B. The median brain PFS was 24.4 months for arm B and 21.4 months for arm C.

The benefits seen in the osimertinib patients may be due in part to the timing of the switch to correspond with molecular or radiological disease progression, the researchers wrote in their discussion.

In the future, more research is needed to determine whether molecular monitoring may impact patients’ outcomes, compared with monitoring based on radiological progression, they said.

The findings were limited by several factors, mainly the rapid evolution in the treatment landscape of EGFR-mutant NSCLC, the researchers noted.

Osimertinib is currently considered the preferred first-line treatment by most physicians, they said. “The APPLE trial is the first prospective study supporting the role of dynamic adaptive strategies based on ctDNA monitoring in patients with EGFR-mutant advanced NSCLC.”

The study was supported by AstraZeneca. Lead author Dr. Remon had no financial conflicts to disclose. Corresponding author Dr. Dziadziuszko disclosed honoraria for consultancy or lectures from AstraZeneca, Roche, Novartis, MSD, Takeda, Pfizer, Amgen, and Bristol-Myers Squibb.

Timing of a switch to treatment from gefitinib to osimertinib based on molecular progression led to an earlier switch than timing based on conventional measures in a new study of 100 adults with epidermal growth factor (EGFR)–mutant non–small cell lung cancer (NSCLC).

Previous studies have suggested that molecular progression of disease in patients with EGFR-mutant NSCLC, as measured by sequential plasma EGFR T790M, may precede radiological progression, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

However, the impact of these measures on timing of treatment changes and patient outcomes has not been examined, wrote Jordi Remon, MD, of Paris (France)–Saclay University and colleagues, in Annals of Oncology.

The European Organization for Research Treatment and Cancer Lung Cancer Group designed a phase 2 clinical trial known as APPLE to evaluate the use of sequential plasma EGFR T790M and determine the optimal sequencing for gefitinib and osimertinib in patients with EGFR-mutant NSCLC.

The researchers reported results from two randomized arms of the APPLE trial. In arm B, 52 patients received gefitinib until emergence of circulating tumor DNA (ctDNA) EGFR T790M mutation, based on the cobas EGFR test v2 (a real-time PCR test), or progression of disease based on Response Evaluation Criteria in Solid Tumors (RECIST). In arm C, 51 patients received gefitinib until disease progression based on RECIST. Both arms then switched to osimertinib. Patients randomized to a third arm (arm A) received osimertinib upfront until progression of disease based on RECIST, and they were not included in the current study.

The primary endpoint was progression-free survival (PFS) while receiving osimertinib at 18 months in patients who were originally randomized to gefitinib, then switched to osimertinib at the emergence of circulating tumor DNA. Secondary endpoints included PFS, overall response rate, overall survival, and brain PFS.

Patients entered the study between November 2017 and February 2020. A total of 75% and 65% of those in arms B and C, respectively, were female, approximately 65% had the mutation EGFR Del19, and approximately one-third had baseline brain metastases. In arm B, 17% of patients switched to osimertinib based on the emergence of ctDNA T790M mutation before progressive disease based on RECIST. The median time to molecular disease progression was 266 days.

More patients in arm B met the primary endpoint of PFS while receiving osimertinib at 18 months (67.2%) than in arm C (53.5%), after a median follow-up of 30 months.

As for secondary endpoints, the median PFS in the two arms was 22.0 months and 20.2 months, respectively. Median overall survival was 42.8 months in arm C and was not reached in arm B. The median brain PFS was 24.4 months for arm B and 21.4 months for arm C.

The benefits seen in the osimertinib patients may be due in part to the timing of the switch to correspond with molecular or radiological disease progression, the researchers wrote in their discussion.

In the future, more research is needed to determine whether molecular monitoring may impact patients’ outcomes, compared with monitoring based on radiological progression, they said.

The findings were limited by several factors, mainly the rapid evolution in the treatment landscape of EGFR-mutant NSCLC, the researchers noted.

Osimertinib is currently considered the preferred first-line treatment by most physicians, they said. “The APPLE trial is the first prospective study supporting the role of dynamic adaptive strategies based on ctDNA monitoring in patients with EGFR-mutant advanced NSCLC.”

The study was supported by AstraZeneca. Lead author Dr. Remon had no financial conflicts to disclose. Corresponding author Dr. Dziadziuszko disclosed honoraria for consultancy or lectures from AstraZeneca, Roche, Novartis, MSD, Takeda, Pfizer, Amgen, and Bristol-Myers Squibb.

Timing of a switch to treatment from gefitinib to osimertinib based on molecular progression led to an earlier switch than timing based on conventional measures in a new study of 100 adults with epidermal growth factor (EGFR)–mutant non–small cell lung cancer (NSCLC).

Previous studies have suggested that molecular progression of disease in patients with EGFR-mutant NSCLC, as measured by sequential plasma EGFR T790M, may precede radiological progression, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

However, the impact of these measures on timing of treatment changes and patient outcomes has not been examined, wrote Jordi Remon, MD, of Paris (France)–Saclay University and colleagues, in Annals of Oncology.

The European Organization for Research Treatment and Cancer Lung Cancer Group designed a phase 2 clinical trial known as APPLE to evaluate the use of sequential plasma EGFR T790M and determine the optimal sequencing for gefitinib and osimertinib in patients with EGFR-mutant NSCLC.

The researchers reported results from two randomized arms of the APPLE trial. In arm B, 52 patients received gefitinib until emergence of circulating tumor DNA (ctDNA) EGFR T790M mutation, based on the cobas EGFR test v2 (a real-time PCR test), or progression of disease based on Response Evaluation Criteria in Solid Tumors (RECIST). In arm C, 51 patients received gefitinib until disease progression based on RECIST. Both arms then switched to osimertinib. Patients randomized to a third arm (arm A) received osimertinib upfront until progression of disease based on RECIST, and they were not included in the current study.

The primary endpoint was progression-free survival (PFS) while receiving osimertinib at 18 months in patients who were originally randomized to gefitinib, then switched to osimertinib at the emergence of circulating tumor DNA. Secondary endpoints included PFS, overall response rate, overall survival, and brain PFS.

Patients entered the study between November 2017 and February 2020. A total of 75% and 65% of those in arms B and C, respectively, were female, approximately 65% had the mutation EGFR Del19, and approximately one-third had baseline brain metastases. In arm B, 17% of patients switched to osimertinib based on the emergence of ctDNA T790M mutation before progressive disease based on RECIST. The median time to molecular disease progression was 266 days.

More patients in arm B met the primary endpoint of PFS while receiving osimertinib at 18 months (67.2%) than in arm C (53.5%), after a median follow-up of 30 months.

As for secondary endpoints, the median PFS in the two arms was 22.0 months and 20.2 months, respectively. Median overall survival was 42.8 months in arm C and was not reached in arm B. The median brain PFS was 24.4 months for arm B and 21.4 months for arm C.

The benefits seen in the osimertinib patients may be due in part to the timing of the switch to correspond with molecular or radiological disease progression, the researchers wrote in their discussion.

In the future, more research is needed to determine whether molecular monitoring may impact patients’ outcomes, compared with monitoring based on radiological progression, they said.

The findings were limited by several factors, mainly the rapid evolution in the treatment landscape of EGFR-mutant NSCLC, the researchers noted.

Osimertinib is currently considered the preferred first-line treatment by most physicians, they said. “The APPLE trial is the first prospective study supporting the role of dynamic adaptive strategies based on ctDNA monitoring in patients with EGFR-mutant advanced NSCLC.”

The study was supported by AstraZeneca. Lead author Dr. Remon had no financial conflicts to disclose. Corresponding author Dr. Dziadziuszko disclosed honoraria for consultancy or lectures from AstraZeneca, Roche, Novartis, MSD, Takeda, Pfizer, Amgen, and Bristol-Myers Squibb.

The immunotherapy blinatumomab improves short-term outcomes when added to standard chemotherapy for infants with KMT2A-rearranged acute lymphoblastic leukemia (ALL), according to a report in the New England Journal of Medicine.

Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.

“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.

“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.

The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
 

Pediatric community responds

There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”

Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”

The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.

Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”

The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
 

Study details

Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.

The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m² per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.

Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.

Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.

There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.

There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.

Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.

The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.

The immunotherapy blinatumomab improves short-term outcomes when added to standard chemotherapy for infants with KMT2A-rearranged acute lymphoblastic leukemia (ALL), according to a report in the New England Journal of Medicine.

Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.

“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.

“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.

The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
 

Pediatric community responds

There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”

Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”

The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.

Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”

The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
 

Study details

Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.

The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m² per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.

Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.

Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.

There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.

There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.

Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.

The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.

The immunotherapy blinatumomab improves short-term outcomes when added to standard chemotherapy for infants with KMT2A-rearranged acute lymphoblastic leukemia (ALL), according to a report in the New England Journal of Medicine.

Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.

“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.

“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.

The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
 

Pediatric community responds

There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”

Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”

The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.

Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”

The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
 

Study details

Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.

The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m² per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.

Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.

Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.

There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.

There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.

Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.

The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

A version of this article first appeared on Medscape.com.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

A version of this article first appeared on Medscape.com.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

A version of this article first appeared on Medscape.com.