M. Alexander Otto, PA, MMS

TOPLINE:

Transcatheter arterial chemoembolization (TACE), a standard treatment for liver metastases from colorectal cancer, shows promise for treating locally advanced rectal tumors.

METHODOLOGY:

• The combination of neoadjuvant chemoradiotherapy, total mesorectal excision, and postoperative adjuvant chemotherapy is the current standard of care for locally advanced rectal cancer. But with pathological complete response rates of only 10%-15% and more than 30% of patients developing distant metastases within 3 years, outcomes remain suboptimal.
• Chinese investigators took a step to improve the situation, applying TACE — a standard treatment for colorectal liver metastases — to rectal tumors, dubbing the approach transcatheter rectal arterial chemoembolization (TRACE).
• As in TACE, TRACE uses precisely injected chemotherapeutic and vaso-occlusive agents to shut down blood flow to tumors, starving them of oxygen and nutrients.
• The research team tried the approach in 111 patients with stage II or III rectal tumors and performance status scores of 0-1.
• TRACE was delivered with oxaliplatin and followed by radiotherapy and S1 chemotherapy (tegafur, gimeracil, and potassium oteracil). Total mesorectal excisions were performed 4-8 weeks later, followed by mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) or CAPOX (oxaliplatin and capecitabine) chemotherapy for 4-6 months.

TAKEAWAY:

• Overall, 20.7% of patients undergoing TRACE had a pathological complete response, and almost half (48.65%) had a major pathological response.
• Nearly 62% of patients were disease-free at 5 years, and almost 75% were alive at 5 years.
• No serious surgical complications occurred, but 21.6% of patients had postoperative complications. Overall, about 26% of patients (29 of 111) had grade 3/4 toxicities.

IN PRACTICE:

“The addition of transcatheter rectal arterial chemoembolisation to the neoadjuvant therapy can improve the pathological remission rate and prognosis in patients with locally advanced rectal cancer, without increasing the incidence of preoperative adverse events and postoperative complications,” the researchers concluded. “Given its promising effectiveness and safe profile, incorporating TRACE into the standard treatment strategy for patients with [locally advanced rectal cancer] should be considered.”

SOURCE:

The work, led by W. Yang of the Army Medical University in Chongqing, China, was published in Clinical Oncology.

LIMITATIONS:

The study was performed at a single center with no control arm in a Chinese population.

DISCLOSURES:

The work was funded by the Third Military Medical University in China. The investigators had no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Transcatheter arterial chemoembolization (TACE), a standard treatment for liver metastases from colorectal cancer, shows promise for treating locally advanced rectal tumors.

METHODOLOGY:

• The combination of neoadjuvant chemoradiotherapy, total mesorectal excision, and postoperative adjuvant chemotherapy is the current standard of care for locally advanced rectal cancer. But with pathological complete response rates of only 10%-15% and more than 30% of patients developing distant metastases within 3 years, outcomes remain suboptimal.
• Chinese investigators took a step to improve the situation, applying TACE — a standard treatment for colorectal liver metastases — to rectal tumors, dubbing the approach transcatheter rectal arterial chemoembolization (TRACE).
• As in TACE, TRACE uses precisely injected chemotherapeutic and vaso-occlusive agents to shut down blood flow to tumors, starving them of oxygen and nutrients.
• The research team tried the approach in 111 patients with stage II or III rectal tumors and performance status scores of 0-1.
• TRACE was delivered with oxaliplatin and followed by radiotherapy and S1 chemotherapy (tegafur, gimeracil, and potassium oteracil). Total mesorectal excisions were performed 4-8 weeks later, followed by mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) or CAPOX (oxaliplatin and capecitabine) chemotherapy for 4-6 months.

TAKEAWAY:

• Overall, 20.7% of patients undergoing TRACE had a pathological complete response, and almost half (48.65%) had a major pathological response.
• Nearly 62% of patients were disease-free at 5 years, and almost 75% were alive at 5 years.
• No serious surgical complications occurred, but 21.6% of patients had postoperative complications. Overall, about 26% of patients (29 of 111) had grade 3/4 toxicities.

IN PRACTICE:

“The addition of transcatheter rectal arterial chemoembolisation to the neoadjuvant therapy can improve the pathological remission rate and prognosis in patients with locally advanced rectal cancer, without increasing the incidence of preoperative adverse events and postoperative complications,” the researchers concluded. “Given its promising effectiveness and safe profile, incorporating TRACE into the standard treatment strategy for patients with [locally advanced rectal cancer] should be considered.”

SOURCE:

The work, led by W. Yang of the Army Medical University in Chongqing, China, was published in Clinical Oncology.

LIMITATIONS:

The study was performed at a single center with no control arm in a Chinese population.

DISCLOSURES:

The work was funded by the Third Military Medical University in China. The investigators had no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Transcatheter arterial chemoembolization (TACE), a standard treatment for liver metastases from colorectal cancer, shows promise for treating locally advanced rectal tumors.

METHODOLOGY:

• The combination of neoadjuvant chemoradiotherapy, total mesorectal excision, and postoperative adjuvant chemotherapy is the current standard of care for locally advanced rectal cancer. But with pathological complete response rates of only 10%-15% and more than 30% of patients developing distant metastases within 3 years, outcomes remain suboptimal.
• Chinese investigators took a step to improve the situation, applying TACE — a standard treatment for colorectal liver metastases — to rectal tumors, dubbing the approach transcatheter rectal arterial chemoembolization (TRACE).
• As in TACE, TRACE uses precisely injected chemotherapeutic and vaso-occlusive agents to shut down blood flow to tumors, starving them of oxygen and nutrients.
• The research team tried the approach in 111 patients with stage II or III rectal tumors and performance status scores of 0-1.
• TRACE was delivered with oxaliplatin and followed by radiotherapy and S1 chemotherapy (tegafur, gimeracil, and potassium oteracil). Total mesorectal excisions were performed 4-8 weeks later, followed by mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) or CAPOX (oxaliplatin and capecitabine) chemotherapy for 4-6 months.

TAKEAWAY:

• Overall, 20.7% of patients undergoing TRACE had a pathological complete response, and almost half (48.65%) had a major pathological response.
• Nearly 62% of patients were disease-free at 5 years, and almost 75% were alive at 5 years.
• No serious surgical complications occurred, but 21.6% of patients had postoperative complications. Overall, about 26% of patients (29 of 111) had grade 3/4 toxicities.

IN PRACTICE:

“The addition of transcatheter rectal arterial chemoembolisation to the neoadjuvant therapy can improve the pathological remission rate and prognosis in patients with locally advanced rectal cancer, without increasing the incidence of preoperative adverse events and postoperative complications,” the researchers concluded. “Given its promising effectiveness and safe profile, incorporating TRACE into the standard treatment strategy for patients with [locally advanced rectal cancer] should be considered.”

SOURCE:

The work, led by W. Yang of the Army Medical University in Chongqing, China, was published in Clinical Oncology.

LIMITATIONS:

The study was performed at a single center with no control arm in a Chinese population.

DISCLOSURES:

The work was funded by the Third Military Medical University in China. The investigators had no conflicts of interest.

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

Although treatment of advanced gastroesophageal cancer is increasingly dependent on biomarkers, only about 40% of patients are tested.

For patients to fully benefit from the latest targeted therapies, biomarker testing needs to improve, explained Yelena Janjigian, MD, chief of gastrointestinal oncology at the Memorial Sloan Kettering Cancer Center in New York City.

“The biomarker revolution in this disease has been quite remarkable in the last 10 years, so it’s very important to routinely test for these biomarkers,” Dr. Janjigian said in a presentation at the 2024 ASCO Gastrointestinal Cancers Symposium.

Dr. Janjigian suspected that inertia and logistics are the main reasons biomarker testing rates have lagged. “Even at tertiary cancer centers like ours, we fall short,” she said. For practices that don’t see many patients with gastroesophageal cancer, the rates are probably worse.

Biomarker testing, however, is readily available, Dr. Janjigian said, and overall, it’s about “being obsessive about doing it and following up on it and training your staff.”

As for how to prioritize biomarker testing for treatment selection, Dr. Janjigian provided her top three picks.

Microsatellite instability (MSI) is the most important biomarker, followed by human epidermal growth factor receptor 2 (HER2) as well as tumors expressing programmed death–ligand 1 (PD-L1) with a combined positive score (CPS) of 5 or higher.

Claudin 18.2 testing is “a great newcomer” worth mentioning as well, she noted. Claudin 18.2 is “very druggable,” and several claudin-targeting drugs are currently being assessed, including zolbetuximab.

MSI testing earned the top spot for Dr. Janjigian given the overall survival results from the CHECKMATE 649 trial.

The trial, which Dr. Janjigian led, assessed treatment with first-line nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy alone in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Median overall survival among the small subset of patients with high MSI who received nivolumab plus chemotherapy (n = 23) was more than three times longer than that among those who received chemotherapy alone (n = 21) — 38.7 months vs 12.3 months. Median overall survival was not reached in patients with high MSI who received nivolumab plus ipilimumab at the trial’s 36-month follow-up.

Dr. Janjigian’s case for a PD-L1 CPS of 5 or higher also came, in part, from the CHECKMATE 649 trial. In a subgroup analysis, patients with a CPS of 5 or higher receiving nivolumab plus chemotherapy had a significantly higher median overall survival of 14.4 months vs 11.1 months with chemotherapy alone.

Dr. Janjigian made the case for HER2 testing based on outcomes from the KEYNOTE 811 trial.

This trial, also led by Dr. Janjigian, randomized HER2-positive patients with unresectable advanced gastroesophageal junction adenocarcinoma irrespective of PDL-1 status to pembrolizumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy alone.

Past studies have reported that targeting HER2 by itself is not a good idea, Dr. Janjigian said, but this trial demonstrated that dual PD-L1/HER2 blockade improves survival outcomes.

Median overall survival in HER2-positive patients with a PD-L1 CPS of 1 or more was 20.0 months vs 15.7 months (hazard ratio [HR], 0.81; 95% CI, 0.67-0.98) compared with 20.0 vs 16.8 months in the overall cohort (HR, 0.84; 95% CI, 0.70-1.01). However, patients with PD-L1 CPS below 1 showed limited benefit from pembrolizumab (HR, 1.41 for overall survival; 95% CI, 0.90-2.20).

To take advantage of the benefit, HER2 testing is “critical,” Dr. Janjigian said.

Overall, when it comes to targeted therapy for advanced disease, the evolution has been rapid. But “we are not done yet,” she said. “We need to be smarter about patient selection” by using biomarker testing.

Dr. Janjigian reported a range of industry ties, including travel expenses, honoraria, and research funding from nivolumab maker Bristol Myers Squibb and Merck, the maker of pembrolizumab. She also advises both companies.

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

Although treatment of advanced gastroesophageal cancer is increasingly dependent on biomarkers, only about 40% of patients are tested.

For patients to fully benefit from the latest targeted therapies, biomarker testing needs to improve, explained Yelena Janjigian, MD, chief of gastrointestinal oncology at the Memorial Sloan Kettering Cancer Center in New York City.

“The biomarker revolution in this disease has been quite remarkable in the last 10 years, so it’s very important to routinely test for these biomarkers,” Dr. Janjigian said in a presentation at the 2024 ASCO Gastrointestinal Cancers Symposium.

Dr. Janjigian suspected that inertia and logistics are the main reasons biomarker testing rates have lagged. “Even at tertiary cancer centers like ours, we fall short,” she said. For practices that don’t see many patients with gastroesophageal cancer, the rates are probably worse.

Biomarker testing, however, is readily available, Dr. Janjigian said, and overall, it’s about “being obsessive about doing it and following up on it and training your staff.”

As for how to prioritize biomarker testing for treatment selection, Dr. Janjigian provided her top three picks.

Microsatellite instability (MSI) is the most important biomarker, followed by human epidermal growth factor receptor 2 (HER2) as well as tumors expressing programmed death–ligand 1 (PD-L1) with a combined positive score (CPS) of 5 or higher.

Claudin 18.2 testing is “a great newcomer” worth mentioning as well, she noted. Claudin 18.2 is “very druggable,” and several claudin-targeting drugs are currently being assessed, including zolbetuximab.

MSI testing earned the top spot for Dr. Janjigian given the overall survival results from the CHECKMATE 649 trial.

The trial, which Dr. Janjigian led, assessed treatment with first-line nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy alone in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Median overall survival among the small subset of patients with high MSI who received nivolumab plus chemotherapy (n = 23) was more than three times longer than that among those who received chemotherapy alone (n = 21) — 38.7 months vs 12.3 months. Median overall survival was not reached in patients with high MSI who received nivolumab plus ipilimumab at the trial’s 36-month follow-up.

Dr. Janjigian’s case for a PD-L1 CPS of 5 or higher also came, in part, from the CHECKMATE 649 trial. In a subgroup analysis, patients with a CPS of 5 or higher receiving nivolumab plus chemotherapy had a significantly higher median overall survival of 14.4 months vs 11.1 months with chemotherapy alone.

Dr. Janjigian made the case for HER2 testing based on outcomes from the KEYNOTE 811 trial.

This trial, also led by Dr. Janjigian, randomized HER2-positive patients with unresectable advanced gastroesophageal junction adenocarcinoma irrespective of PDL-1 status to pembrolizumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy alone.

Past studies have reported that targeting HER2 by itself is not a good idea, Dr. Janjigian said, but this trial demonstrated that dual PD-L1/HER2 blockade improves survival outcomes.

Median overall survival in HER2-positive patients with a PD-L1 CPS of 1 or more was 20.0 months vs 15.7 months (hazard ratio [HR], 0.81; 95% CI, 0.67-0.98) compared with 20.0 vs 16.8 months in the overall cohort (HR, 0.84; 95% CI, 0.70-1.01). However, patients with PD-L1 CPS below 1 showed limited benefit from pembrolizumab (HR, 1.41 for overall survival; 95% CI, 0.90-2.20).

To take advantage of the benefit, HER2 testing is “critical,” Dr. Janjigian said.

Overall, when it comes to targeted therapy for advanced disease, the evolution has been rapid. But “we are not done yet,” she said. “We need to be smarter about patient selection” by using biomarker testing.

Dr. Janjigian reported a range of industry ties, including travel expenses, honoraria, and research funding from nivolumab maker Bristol Myers Squibb and Merck, the maker of pembrolizumab. She also advises both companies.

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

Although treatment of advanced gastroesophageal cancer is increasingly dependent on biomarkers, only about 40% of patients are tested.

For patients to fully benefit from the latest targeted therapies, biomarker testing needs to improve, explained Yelena Janjigian, MD, chief of gastrointestinal oncology at the Memorial Sloan Kettering Cancer Center in New York City.

“The biomarker revolution in this disease has been quite remarkable in the last 10 years, so it’s very important to routinely test for these biomarkers,” Dr. Janjigian said in a presentation at the 2024 ASCO Gastrointestinal Cancers Symposium.

Dr. Janjigian suspected that inertia and logistics are the main reasons biomarker testing rates have lagged. “Even at tertiary cancer centers like ours, we fall short,” she said. For practices that don’t see many patients with gastroesophageal cancer, the rates are probably worse.

Biomarker testing, however, is readily available, Dr. Janjigian said, and overall, it’s about “being obsessive about doing it and following up on it and training your staff.”

As for how to prioritize biomarker testing for treatment selection, Dr. Janjigian provided her top three picks.

Microsatellite instability (MSI) is the most important biomarker, followed by human epidermal growth factor receptor 2 (HER2) as well as tumors expressing programmed death–ligand 1 (PD-L1) with a combined positive score (CPS) of 5 or higher.

Claudin 18.2 testing is “a great newcomer” worth mentioning as well, she noted. Claudin 18.2 is “very druggable,” and several claudin-targeting drugs are currently being assessed, including zolbetuximab.

MSI testing earned the top spot for Dr. Janjigian given the overall survival results from the CHECKMATE 649 trial.

The trial, which Dr. Janjigian led, assessed treatment with first-line nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy alone in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Median overall survival among the small subset of patients with high MSI who received nivolumab plus chemotherapy (n = 23) was more than three times longer than that among those who received chemotherapy alone (n = 21) — 38.7 months vs 12.3 months. Median overall survival was not reached in patients with high MSI who received nivolumab plus ipilimumab at the trial’s 36-month follow-up.

Dr. Janjigian’s case for a PD-L1 CPS of 5 or higher also came, in part, from the CHECKMATE 649 trial. In a subgroup analysis, patients with a CPS of 5 or higher receiving nivolumab plus chemotherapy had a significantly higher median overall survival of 14.4 months vs 11.1 months with chemotherapy alone.

Dr. Janjigian made the case for HER2 testing based on outcomes from the KEYNOTE 811 trial.

This trial, also led by Dr. Janjigian, randomized HER2-positive patients with unresectable advanced gastroesophageal junction adenocarcinoma irrespective of PDL-1 status to pembrolizumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy alone.

Past studies have reported that targeting HER2 by itself is not a good idea, Dr. Janjigian said, but this trial demonstrated that dual PD-L1/HER2 blockade improves survival outcomes.

Median overall survival in HER2-positive patients with a PD-L1 CPS of 1 or more was 20.0 months vs 15.7 months (hazard ratio [HR], 0.81; 95% CI, 0.67-0.98) compared with 20.0 vs 16.8 months in the overall cohort (HR, 0.84; 95% CI, 0.70-1.01). However, patients with PD-L1 CPS below 1 showed limited benefit from pembrolizumab (HR, 1.41 for overall survival; 95% CI, 0.90-2.20).

To take advantage of the benefit, HER2 testing is “critical,” Dr. Janjigian said.

Overall, when it comes to targeted therapy for advanced disease, the evolution has been rapid. But “we are not done yet,” she said. “We need to be smarter about patient selection” by using biomarker testing.

Dr. Janjigian reported a range of industry ties, including travel expenses, honoraria, and research funding from nivolumab maker Bristol Myers Squibb and Merck, the maker of pembrolizumab. She also advises both companies.

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

Renewed interest in hepatic arterial chemotherapy infusion pumps may be on the horizon, given promising overall survival findings in patients with advanced, unresectable cholangiocarcinoma.

Dutch investigators reported a 3-year overall survival of 33% in patients with advanced, unresectable cholangiocarcinoma confined to the liver who received the infusion chemotherapy vs 3% in historical controls treated with standard systemic gemcitabine/cisplatin.

The response with the pump is “clearly superior” to systemic treatment, said investigator Bas Groot Koerkamp, MD, who presented the findings at the ASCO Gastrointestinal Cancers Symposium.

“I do share the enthusiasm of my colleagues about immunotherapy and targeted treatments for intrahepatic cholangiocarcinoma,” said Dr. Koerkamp, a hepato-pancreato-biliary surgeon at Erasmus University Medical Center, Rotterdam, the Netherlands. But “none of these treatments has shown a 3-year overall survival of one in three with advanced disease.”

The hepatic arterial infusion pump, a hockey puck-sized device that essentially bathes liver tumors in floxuridine for about 2 weeks, is not a new technology. The pump has been around since at least the 1990s, developed largely at Memorial Sloan Kettering Cancer Center, New York City, where Dr. Koerkamp trained.

Three previous small studies in cholangiocarcinoma reported outcomes similar to Dr. Koerkamp’s. Despite the strong survival outcomes, uptake of these pumps has lagged.

A key reason is likely the lack of phase 3 trials evaluating the technology, Laleh Melstrom, MD, chief of surgical oncology at City of Hope, outside of Los Angeles, Duarte, California, told this news organization.

Dr. Melstrom, who moderated Dr. Koerkamp’s presentation, also noted that using the pump requires special attention to bilirubin levels to prevent biliary toxicity and knowledge of pump placement.

The pump, placed subcutaneously on one side of the lower abdomen, is connected to a side branch of the hepatic artery and then filled with the chemotherapy agent floxuridine. Delivering floxuridine directly to the hepatic artery increases liver lesion exposure 200-fold over systemic delivery. The pump needs to be refilled after 2 weeks.

“It’s not difficult to place the pump, even doing it robotically,” which was how it was placed in over 40% of patients in the study, Dr. Koerkamp said.

As for biliary toxicity, only one patient in the current study developed biliary sclerosis, which was easily handled with a stent. “You just put in a stent and continue,” Dr. Koerkamp said.

The current single-arm phase 2 study included 50 patients implanted with the hepatic pump at three centers in the Netherlands. All patients had advanced, unresectable cholangiocarcinoma confined to the liver.

Ultimately, 48 of 50 patients received treatment after one patient died of unrelated causes and another had an arterial dissection.

Overall, 38 received gemcitabine/cisplatin concurrently, and the remaining had the pump treatment alone, having already received the systemic combination. Most (84%) received at least four cycles of chemotherapy infusion.

Almost half of patients (46%) had a partial response to treatment, and 88% exhibited disease control at 6 months. Four patients who responded underwent a liver resection, one of whom had a complete pathologic response.

Median overall survival was 22 months vs 12 months in historical controls. One-year median overall survival was 80% in the treatment group vs 47% in controls, and 3-year median overall survival was 33% in the pump group vs 3% in controls.

An audience member noted that similar results have been reported for transarterial Yttrium-90 radioembolization, another and newer option to treat intrahepatic cholangiocarcinoma.

“The Y90 results are quite impressive,” Dr. Koerkamp said, adding that he’d like to see a head-to-head comparison.

“The main advantage of the pump is that it treats the entire liver,” as opposed to one lesion at a time, “so if you have 10 lesions [the pump] makes a lot more sense,” he said.

There is “definitely a movement” to “reinvigorate” the hepatic artery infusion pump approach, Dr. Melstrom said.

The study was funded by the Dutch Cancer Society. Dr. Koerkamp disclosed research funding from Tricumed, a maker of implantable infusion pumps. Dr. Melstrom didn’t have any disclosures.

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

Renewed interest in hepatic arterial chemotherapy infusion pumps may be on the horizon, given promising overall survival findings in patients with advanced, unresectable cholangiocarcinoma.

Dutch investigators reported a 3-year overall survival of 33% in patients with advanced, unresectable cholangiocarcinoma confined to the liver who received the infusion chemotherapy vs 3% in historical controls treated with standard systemic gemcitabine/cisplatin.

The response with the pump is “clearly superior” to systemic treatment, said investigator Bas Groot Koerkamp, MD, who presented the findings at the ASCO Gastrointestinal Cancers Symposium.

“I do share the enthusiasm of my colleagues about immunotherapy and targeted treatments for intrahepatic cholangiocarcinoma,” said Dr. Koerkamp, a hepato-pancreato-biliary surgeon at Erasmus University Medical Center, Rotterdam, the Netherlands. But “none of these treatments has shown a 3-year overall survival of one in three with advanced disease.”

The hepatic arterial infusion pump, a hockey puck-sized device that essentially bathes liver tumors in floxuridine for about 2 weeks, is not a new technology. The pump has been around since at least the 1990s, developed largely at Memorial Sloan Kettering Cancer Center, New York City, where Dr. Koerkamp trained.

Three previous small studies in cholangiocarcinoma reported outcomes similar to Dr. Koerkamp’s. Despite the strong survival outcomes, uptake of these pumps has lagged.

A key reason is likely the lack of phase 3 trials evaluating the technology, Laleh Melstrom, MD, chief of surgical oncology at City of Hope, outside of Los Angeles, Duarte, California, told this news organization.

Dr. Melstrom, who moderated Dr. Koerkamp’s presentation, also noted that using the pump requires special attention to bilirubin levels to prevent biliary toxicity and knowledge of pump placement.

The pump, placed subcutaneously on one side of the lower abdomen, is connected to a side branch of the hepatic artery and then filled with the chemotherapy agent floxuridine. Delivering floxuridine directly to the hepatic artery increases liver lesion exposure 200-fold over systemic delivery. The pump needs to be refilled after 2 weeks.

“It’s not difficult to place the pump, even doing it robotically,” which was how it was placed in over 40% of patients in the study, Dr. Koerkamp said.

As for biliary toxicity, only one patient in the current study developed biliary sclerosis, which was easily handled with a stent. “You just put in a stent and continue,” Dr. Koerkamp said.

The current single-arm phase 2 study included 50 patients implanted with the hepatic pump at three centers in the Netherlands. All patients had advanced, unresectable cholangiocarcinoma confined to the liver.

Ultimately, 48 of 50 patients received treatment after one patient died of unrelated causes and another had an arterial dissection.

Overall, 38 received gemcitabine/cisplatin concurrently, and the remaining had the pump treatment alone, having already received the systemic combination. Most (84%) received at least four cycles of chemotherapy infusion.

Almost half of patients (46%) had a partial response to treatment, and 88% exhibited disease control at 6 months. Four patients who responded underwent a liver resection, one of whom had a complete pathologic response.

Median overall survival was 22 months vs 12 months in historical controls. One-year median overall survival was 80% in the treatment group vs 47% in controls, and 3-year median overall survival was 33% in the pump group vs 3% in controls.

An audience member noted that similar results have been reported for transarterial Yttrium-90 radioembolization, another and newer option to treat intrahepatic cholangiocarcinoma.

“The Y90 results are quite impressive,” Dr. Koerkamp said, adding that he’d like to see a head-to-head comparison.

“The main advantage of the pump is that it treats the entire liver,” as opposed to one lesion at a time, “so if you have 10 lesions [the pump] makes a lot more sense,” he said.

There is “definitely a movement” to “reinvigorate” the hepatic artery infusion pump approach, Dr. Melstrom said.

The study was funded by the Dutch Cancer Society. Dr. Koerkamp disclosed research funding from Tricumed, a maker of implantable infusion pumps. Dr. Melstrom didn’t have any disclosures.

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

Renewed interest in hepatic arterial chemotherapy infusion pumps may be on the horizon, given promising overall survival findings in patients with advanced, unresectable cholangiocarcinoma.

Dutch investigators reported a 3-year overall survival of 33% in patients with advanced, unresectable cholangiocarcinoma confined to the liver who received the infusion chemotherapy vs 3% in historical controls treated with standard systemic gemcitabine/cisplatin.

The response with the pump is “clearly superior” to systemic treatment, said investigator Bas Groot Koerkamp, MD, who presented the findings at the ASCO Gastrointestinal Cancers Symposium.

“I do share the enthusiasm of my colleagues about immunotherapy and targeted treatments for intrahepatic cholangiocarcinoma,” said Dr. Koerkamp, a hepato-pancreato-biliary surgeon at Erasmus University Medical Center, Rotterdam, the Netherlands. But “none of these treatments has shown a 3-year overall survival of one in three with advanced disease.”

The hepatic arterial infusion pump, a hockey puck-sized device that essentially bathes liver tumors in floxuridine for about 2 weeks, is not a new technology. The pump has been around since at least the 1990s, developed largely at Memorial Sloan Kettering Cancer Center, New York City, where Dr. Koerkamp trained.

Three previous small studies in cholangiocarcinoma reported outcomes similar to Dr. Koerkamp’s. Despite the strong survival outcomes, uptake of these pumps has lagged.

A key reason is likely the lack of phase 3 trials evaluating the technology, Laleh Melstrom, MD, chief of surgical oncology at City of Hope, outside of Los Angeles, Duarte, California, told this news organization.

Dr. Melstrom, who moderated Dr. Koerkamp’s presentation, also noted that using the pump requires special attention to bilirubin levels to prevent biliary toxicity and knowledge of pump placement.

The pump, placed subcutaneously on one side of the lower abdomen, is connected to a side branch of the hepatic artery and then filled with the chemotherapy agent floxuridine. Delivering floxuridine directly to the hepatic artery increases liver lesion exposure 200-fold over systemic delivery. The pump needs to be refilled after 2 weeks.

“It’s not difficult to place the pump, even doing it robotically,” which was how it was placed in over 40% of patients in the study, Dr. Koerkamp said.

As for biliary toxicity, only one patient in the current study developed biliary sclerosis, which was easily handled with a stent. “You just put in a stent and continue,” Dr. Koerkamp said.

The current single-arm phase 2 study included 50 patients implanted with the hepatic pump at three centers in the Netherlands. All patients had advanced, unresectable cholangiocarcinoma confined to the liver.

Ultimately, 48 of 50 patients received treatment after one patient died of unrelated causes and another had an arterial dissection.

Overall, 38 received gemcitabine/cisplatin concurrently, and the remaining had the pump treatment alone, having already received the systemic combination. Most (84%) received at least four cycles of chemotherapy infusion.

Almost half of patients (46%) had a partial response to treatment, and 88% exhibited disease control at 6 months. Four patients who responded underwent a liver resection, one of whom had a complete pathologic response.

Median overall survival was 22 months vs 12 months in historical controls. One-year median overall survival was 80% in the treatment group vs 47% in controls, and 3-year median overall survival was 33% in the pump group vs 3% in controls.

An audience member noted that similar results have been reported for transarterial Yttrium-90 radioembolization, another and newer option to treat intrahepatic cholangiocarcinoma.

“The Y90 results are quite impressive,” Dr. Koerkamp said, adding that he’d like to see a head-to-head comparison.

“The main advantage of the pump is that it treats the entire liver,” as opposed to one lesion at a time, “so if you have 10 lesions [the pump] makes a lot more sense,” he said.

There is “definitely a movement” to “reinvigorate” the hepatic artery infusion pump approach, Dr. Melstrom said.

The study was funded by the Dutch Cancer Society. Dr. Koerkamp disclosed research funding from Tricumed, a maker of implantable infusion pumps. Dr. Melstrom didn’t have any disclosures.

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

SAN FRANCISCO — The immunotherapy combination nivolumab plus ipilimumab rivals chemotherapy as well as pembrolizumab monotherapy in the first-line treatment of metastatic colorectal cancer (CRC), new data indicated.

Findings from the CHECKMATE-8HW trial revealed that first-line nivolumab plus ipilimumab led to a significant improvement in progression-free survival (PFS) compared with chemotherapy among patients with metastatic CRC.

More specifically, at 2 years, PFS was 72% among patients with microsatellite instability–high (MSI-H) or deficient mismatch repair (dMMR) randomized to the immunotherapy combination compared with just 14% among those randomized to chemotherapy with or without targeted therapy.

The magnitude of the benefit was unexpected, especially considering patients received only four cycles of the immunotherapy combination in the trial. “It’s a good surprise,” said lead investigator Thierry Andre, MD, who presented the findings at the 2024 ASCO Gastrointestinal Cancers Symposium.

The findings indicate that nivolumab plus ipilimumab should really be “a new standard,” said Andre, a medical oncologist at Sorbonne University, Paris.

The combination as well as nivolumab alone has received US Food and Drug Administration’s (FDA’s) approval to treat MSI-H or dMMR metastatic CRC in the second line, following chemotherapy failure.

The FDA also approved pembrolizumab as first-line monotherapy for this CRC indication in 2020. The KEYNOTE-177 trial, which led to the pembrolizumab approval, reported a 2-year PFS of 48% among patients receiving the monotherapy. Andre was the lead investigator on KEYNOTE-177.

To compare PFS results for pembrolizumab and nivolumab alone, the CHECKMATE-8HW trial included a nivolumab monotherapy arm, but these results are pending, as are the overall survival findings, Andre said.

Overall, CHECKMATE-8HW must be taken into context with KEYNOTE-177, and “we need a little bit more trial data” for oncologists to decide between the two options, said Neil Newman, MD, a radiation oncologist at the University of Texas Health Science Center, San Antonio, Texas, who co-moderated Dr. Andre’s presentation.

Andre noted, however, that if the nivolumab and pembrolizumab monotherapy results are similar, most patients will likely receive the nivolumab/ipilimumab combination, given the improved PFS outcomes.

In CHECKMATE-8HW, patients were randomized to three regimens. The 202 patients in the combination arm received nivolumab 240 mg plus ipilimumab 1 mg/kg every 3 weeks for four doses, followed by nivolumab 480 mg every 4 weeks. The 101 patients in the chemotherapy group received investigator’s choice of mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab. And the nivolumab monotherapy arm received nivolumab 240 mg every 2 weeks for six doses, followed by nivolumab 480 mg every 4 weeks.

Treatment continued until disease progression or unacceptable toxicity over a maximum of 2 years. The median duration of treatment was 13.5 months in the nivolumab/ipilimumab arm vs 4 months in the chemotherapy arm.

PFS curves started to separate between nivolumab/ipilimumab and chemotherapy at about 3 months.

Patients receiving the combination exhibited a 79% reduction in the risk for disease progression or death at 2 years (72% vs 14%; hazard ratio, 0.21; P < .0001). The median PFS was not reached with the combination vs 5.9 months with chemotherapy. The PFS benefit of nivolumab/ipilimumab held across various subgroups, including patients with KRAS or NRAS mutations and baseline lung, liver, or peritoneal metastases.

The incidence of grade 3/4 treatment-related adverse events was 23% with nivolumab/ipilimumab vs 48% in the chemotherapy arm. The most common grade 3/4 events with nivolumab/ipilimumab were diarrhea/colitis (5%), adrenal insufficiency (4%), hepatitis (3%), and inflammation of the pituitary gland (3%).

Two treatment-related deaths occurred in the combination arm — one from pneumonitis and the second from myocarditis — and none occurred in the chemotherapy arm.

Mark A. Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, was impressed with the CHECKMATE-8HW findings. The data are shaping up to make nivolumab/ipilimumab “the next great step in metastatic CRC management beyond KEYNOTE-177,” Dr. Lewis said.

Dr. Lewis noted that the new trial makes it “imperative” to standardize testing for immunotherapy candidacy upfront. “It is completely unacceptable for any patient with metastatic CRC to not have their MMR/MSI status assessed,” he said. “Much as no oncologist would dare treat breast cancer without testing ER, PR, HER2 status, biomarkers cannot be a later-line afterthought in stage IV CRC.”

Drugmaker Bristol-Myers Squibb told this news organization that the company will be seeking a first-line indication for the combination, and anticipates approval early next year or possibly sooner, if the FDA grants a priority review.

The work was funded by Bristol-Myers Squibb and the ONO Pharmaceutical Company. Dr. Andre had numerous industry ties, including being a consultant for both BMS and Merck. He also reported honoraria from both companies. Dr. Newman and Dr. Lewis didn’t have any disclosures.

A version of this article appeared on Medscape.com.

SAN FRANCISCO — The immunotherapy combination nivolumab plus ipilimumab rivals chemotherapy as well as pembrolizumab monotherapy in the first-line treatment of metastatic colorectal cancer (CRC), new data indicated.

Findings from the CHECKMATE-8HW trial revealed that first-line nivolumab plus ipilimumab led to a significant improvement in progression-free survival (PFS) compared with chemotherapy among patients with metastatic CRC.

More specifically, at 2 years, PFS was 72% among patients with microsatellite instability–high (MSI-H) or deficient mismatch repair (dMMR) randomized to the immunotherapy combination compared with just 14% among those randomized to chemotherapy with or without targeted therapy.

The magnitude of the benefit was unexpected, especially considering patients received only four cycles of the immunotherapy combination in the trial. “It’s a good surprise,” said lead investigator Thierry Andre, MD, who presented the findings at the 2024 ASCO Gastrointestinal Cancers Symposium.

The findings indicate that nivolumab plus ipilimumab should really be “a new standard,” said Andre, a medical oncologist at Sorbonne University, Paris.

The combination as well as nivolumab alone has received US Food and Drug Administration’s (FDA’s) approval to treat MSI-H or dMMR metastatic CRC in the second line, following chemotherapy failure.

The FDA also approved pembrolizumab as first-line monotherapy for this CRC indication in 2020. The KEYNOTE-177 trial, which led to the pembrolizumab approval, reported a 2-year PFS of 48% among patients receiving the monotherapy. Andre was the lead investigator on KEYNOTE-177.

To compare PFS results for pembrolizumab and nivolumab alone, the CHECKMATE-8HW trial included a nivolumab monotherapy arm, but these results are pending, as are the overall survival findings, Andre said.

Overall, CHECKMATE-8HW must be taken into context with KEYNOTE-177, and “we need a little bit more trial data” for oncologists to decide between the two options, said Neil Newman, MD, a radiation oncologist at the University of Texas Health Science Center, San Antonio, Texas, who co-moderated Dr. Andre’s presentation.

Andre noted, however, that if the nivolumab and pembrolizumab monotherapy results are similar, most patients will likely receive the nivolumab/ipilimumab combination, given the improved PFS outcomes.

In CHECKMATE-8HW, patients were randomized to three regimens. The 202 patients in the combination arm received nivolumab 240 mg plus ipilimumab 1 mg/kg every 3 weeks for four doses, followed by nivolumab 480 mg every 4 weeks. The 101 patients in the chemotherapy group received investigator’s choice of mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab. And the nivolumab monotherapy arm received nivolumab 240 mg every 2 weeks for six doses, followed by nivolumab 480 mg every 4 weeks.

Treatment continued until disease progression or unacceptable toxicity over a maximum of 2 years. The median duration of treatment was 13.5 months in the nivolumab/ipilimumab arm vs 4 months in the chemotherapy arm.

PFS curves started to separate between nivolumab/ipilimumab and chemotherapy at about 3 months.

Patients receiving the combination exhibited a 79% reduction in the risk for disease progression or death at 2 years (72% vs 14%; hazard ratio, 0.21; P < .0001). The median PFS was not reached with the combination vs 5.9 months with chemotherapy. The PFS benefit of nivolumab/ipilimumab held across various subgroups, including patients with KRAS or NRAS mutations and baseline lung, liver, or peritoneal metastases.

The incidence of grade 3/4 treatment-related adverse events was 23% with nivolumab/ipilimumab vs 48% in the chemotherapy arm. The most common grade 3/4 events with nivolumab/ipilimumab were diarrhea/colitis (5%), adrenal insufficiency (4%), hepatitis (3%), and inflammation of the pituitary gland (3%).

Two treatment-related deaths occurred in the combination arm — one from pneumonitis and the second from myocarditis — and none occurred in the chemotherapy arm.

Mark A. Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, was impressed with the CHECKMATE-8HW findings. The data are shaping up to make nivolumab/ipilimumab “the next great step in metastatic CRC management beyond KEYNOTE-177,” Dr. Lewis said.

Dr. Lewis noted that the new trial makes it “imperative” to standardize testing for immunotherapy candidacy upfront. “It is completely unacceptable for any patient with metastatic CRC to not have their MMR/MSI status assessed,” he said. “Much as no oncologist would dare treat breast cancer without testing ER, PR, HER2 status, biomarkers cannot be a later-line afterthought in stage IV CRC.”

Drugmaker Bristol-Myers Squibb told this news organization that the company will be seeking a first-line indication for the combination, and anticipates approval early next year or possibly sooner, if the FDA grants a priority review.

The work was funded by Bristol-Myers Squibb and the ONO Pharmaceutical Company. Dr. Andre had numerous industry ties, including being a consultant for both BMS and Merck. He also reported honoraria from both companies. Dr. Newman and Dr. Lewis didn’t have any disclosures.

A version of this article appeared on Medscape.com.

SAN FRANCISCO — The immunotherapy combination nivolumab plus ipilimumab rivals chemotherapy as well as pembrolizumab monotherapy in the first-line treatment of metastatic colorectal cancer (CRC), new data indicated.

Findings from the CHECKMATE-8HW trial revealed that first-line nivolumab plus ipilimumab led to a significant improvement in progression-free survival (PFS) compared with chemotherapy among patients with metastatic CRC.

More specifically, at 2 years, PFS was 72% among patients with microsatellite instability–high (MSI-H) or deficient mismatch repair (dMMR) randomized to the immunotherapy combination compared with just 14% among those randomized to chemotherapy with or without targeted therapy.

The magnitude of the benefit was unexpected, especially considering patients received only four cycles of the immunotherapy combination in the trial. “It’s a good surprise,” said lead investigator Thierry Andre, MD, who presented the findings at the 2024 ASCO Gastrointestinal Cancers Symposium.

The findings indicate that nivolumab plus ipilimumab should really be “a new standard,” said Andre, a medical oncologist at Sorbonne University, Paris.

The combination as well as nivolumab alone has received US Food and Drug Administration’s (FDA’s) approval to treat MSI-H or dMMR metastatic CRC in the second line, following chemotherapy failure.

The FDA also approved pembrolizumab as first-line monotherapy for this CRC indication in 2020. The KEYNOTE-177 trial, which led to the pembrolizumab approval, reported a 2-year PFS of 48% among patients receiving the monotherapy. Andre was the lead investigator on KEYNOTE-177.

To compare PFS results for pembrolizumab and nivolumab alone, the CHECKMATE-8HW trial included a nivolumab monotherapy arm, but these results are pending, as are the overall survival findings, Andre said.

Overall, CHECKMATE-8HW must be taken into context with KEYNOTE-177, and “we need a little bit more trial data” for oncologists to decide between the two options, said Neil Newman, MD, a radiation oncologist at the University of Texas Health Science Center, San Antonio, Texas, who co-moderated Dr. Andre’s presentation.

Andre noted, however, that if the nivolumab and pembrolizumab monotherapy results are similar, most patients will likely receive the nivolumab/ipilimumab combination, given the improved PFS outcomes.

In CHECKMATE-8HW, patients were randomized to three regimens. The 202 patients in the combination arm received nivolumab 240 mg plus ipilimumab 1 mg/kg every 3 weeks for four doses, followed by nivolumab 480 mg every 4 weeks. The 101 patients in the chemotherapy group received investigator’s choice of mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab. And the nivolumab monotherapy arm received nivolumab 240 mg every 2 weeks for six doses, followed by nivolumab 480 mg every 4 weeks.

Treatment continued until disease progression or unacceptable toxicity over a maximum of 2 years. The median duration of treatment was 13.5 months in the nivolumab/ipilimumab arm vs 4 months in the chemotherapy arm.

PFS curves started to separate between nivolumab/ipilimumab and chemotherapy at about 3 months.

Patients receiving the combination exhibited a 79% reduction in the risk for disease progression or death at 2 years (72% vs 14%; hazard ratio, 0.21; P < .0001). The median PFS was not reached with the combination vs 5.9 months with chemotherapy. The PFS benefit of nivolumab/ipilimumab held across various subgroups, including patients with KRAS or NRAS mutations and baseline lung, liver, or peritoneal metastases.

The incidence of grade 3/4 treatment-related adverse events was 23% with nivolumab/ipilimumab vs 48% in the chemotherapy arm. The most common grade 3/4 events with nivolumab/ipilimumab were diarrhea/colitis (5%), adrenal insufficiency (4%), hepatitis (3%), and inflammation of the pituitary gland (3%).

Two treatment-related deaths occurred in the combination arm — one from pneumonitis and the second from myocarditis — and none occurred in the chemotherapy arm.

Mark A. Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, was impressed with the CHECKMATE-8HW findings. The data are shaping up to make nivolumab/ipilimumab “the next great step in metastatic CRC management beyond KEYNOTE-177,” Dr. Lewis said.

Dr. Lewis noted that the new trial makes it “imperative” to standardize testing for immunotherapy candidacy upfront. “It is completely unacceptable for any patient with metastatic CRC to not have their MMR/MSI status assessed,” he said. “Much as no oncologist would dare treat breast cancer without testing ER, PR, HER2 status, biomarkers cannot be a later-line afterthought in stage IV CRC.”

Drugmaker Bristol-Myers Squibb told this news organization that the company will be seeking a first-line indication for the combination, and anticipates approval early next year or possibly sooner, if the FDA grants a priority review.

The work was funded by Bristol-Myers Squibb and the ONO Pharmaceutical Company. Dr. Andre had numerous industry ties, including being a consultant for both BMS and Merck. He also reported honoraria from both companies. Dr. Newman and Dr. Lewis didn’t have any disclosures.

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release. 

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release. 

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release. 

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

SAN ANTONIO — New research provides some reassuring news for young women hoping to become pregnant after a diagnosis of BRCA-mutated breast cancer.

As with other breast cancers, we can now say to BRCA carriers: “Don’t worry. You can get pregnant. You’ll be okay,” said Jame Abraham, MD, chair of Hematology & Medical Oncology at the Cleveland Clinic, who was not involved in the research. 

The analysis, presented at the San Antonio Breast Cancer Symposium, revealed no issue with women becoming pregnant and carrying a healthy baby to term and reported no sign of worse disease outcomes among BRCA carriers following diagnosis and treatment. 

“The final and most important conclusion from our study is that conceiving after proper breast cancer treatment and follow-up should not be contraindicated anymore in young BRCA carriers,” a message of particular importance for oncofertility counseling, lead investigator Matteo Lambertini, MD, a breast cancer oncologist at the University of Genova, Italy, said during his SABCS presentation. 

The study was published December 7 in JAMA to coincide with his presentation.

Although pregnancy after breast cancer is generally considered safe, limited data exist for BRCA carriers in particular, Dr. Lambertini said.

The current analysis represents the largest look into the matter to date. The study included 4732 young women from across the globe who had been diagnosed with stage I-III invasive breast cancer. These women, all BRCA carriers, were 40 years or younger (median age at diagnosis, 35 years).

The team compared outcomes between 659 patients who had at least one pregnancy over a median follow-up of almost 8 years with 4073 women who did not become pregnant. 

Dr. Lambertini and colleagues reported a median time of 3.5 years from breast cancer diagnosis to conception. Overall, about 1 in 5 young BRCA carriers (22%) conceived within 10 years after their breast cancer diagnosis. Of the 80% of patients with a completed pregnancy, 91% delivered at term and only 4 infants (0.9%) had documented congenital anomalies.

In short, “the rate of pregnancy, fetal, and obstetric complications was low and in line with the expectations in a population of women with similar age and no history of breast cancer,” Dr. Lambertini said. The team cautioned, however, that the data was extracted from oncology medical records, which might have underreported maternal and fetal outcomes. 

Disease-free survival was similar among women who became pregnant and those who did not after breast cancer (adjusted HR, 0.99; 95% CI, 0.81-1.20). 

When looking at the specific BRCA gene, differences did emerge. BRCA1 carriers had better disease-free survival after pregnancy (aHR, 0.80), while BRCA2 carriers appeared to have worse disease-free survival after pregnancy (aHR, 1.55). 

For reasons that remain unclear, the researchers also found that BRCA1 carriers who got pregnant had significantly better breast cancer-specific survival (aHR, 0.59; P < .01) and overall survival (aHR, 0.58; P < .01). These women tended to have HR-negative breast cancer, which the authors also found was associated with improved survival after pregnancy (aHR, 0.76).

It’s possible, the team posited, that hormone receptor status played a role in the observed survival benefit. It’s also possible that these women were healthier overall. 

The overall survival advantage, however, did not extend to BRCA2 carriers, who tended to have hormone receptor-positive disease. Hormone receptor-positive status did not appear to have a significant impact on survival (aHR, 1.30; 95% CI, 0.95-1.76).

“While the results appear reassuring for BRCA1 carriers, more caution is needed to counsel BRCA2 carriers, “ the investigators wrote.

The study was funded by the Italian Association for Cancer Research, Gilead, and others. Investigators had numerous ties to industry, including Dr. Lambertini, who is an adviser and speaker for Roche, Pfizer, Novartis, and others. The full list of disclosures can be found with the original article.

A version of this article appeared on Medscape.com.

SAN ANTONIO — New research provides some reassuring news for young women hoping to become pregnant after a diagnosis of BRCA-mutated breast cancer.

As with other breast cancers, we can now say to BRCA carriers: “Don’t worry. You can get pregnant. You’ll be okay,” said Jame Abraham, MD, chair of Hematology & Medical Oncology at the Cleveland Clinic, who was not involved in the research. 

The analysis, presented at the San Antonio Breast Cancer Symposium, revealed no issue with women becoming pregnant and carrying a healthy baby to term and reported no sign of worse disease outcomes among BRCA carriers following diagnosis and treatment. 

“The final and most important conclusion from our study is that conceiving after proper breast cancer treatment and follow-up should not be contraindicated anymore in young BRCA carriers,” a message of particular importance for oncofertility counseling, lead investigator Matteo Lambertini, MD, a breast cancer oncologist at the University of Genova, Italy, said during his SABCS presentation. 

The study was published December 7 in JAMA to coincide with his presentation.

Although pregnancy after breast cancer is generally considered safe, limited data exist for BRCA carriers in particular, Dr. Lambertini said.

The current analysis represents the largest look into the matter to date. The study included 4732 young women from across the globe who had been diagnosed with stage I-III invasive breast cancer. These women, all BRCA carriers, were 40 years or younger (median age at diagnosis, 35 years).

The team compared outcomes between 659 patients who had at least one pregnancy over a median follow-up of almost 8 years with 4073 women who did not become pregnant. 

Dr. Lambertini and colleagues reported a median time of 3.5 years from breast cancer diagnosis to conception. Overall, about 1 in 5 young BRCA carriers (22%) conceived within 10 years after their breast cancer diagnosis. Of the 80% of patients with a completed pregnancy, 91% delivered at term and only 4 infants (0.9%) had documented congenital anomalies.

In short, “the rate of pregnancy, fetal, and obstetric complications was low and in line with the expectations in a population of women with similar age and no history of breast cancer,” Dr. Lambertini said. The team cautioned, however, that the data was extracted from oncology medical records, which might have underreported maternal and fetal outcomes. 

Disease-free survival was similar among women who became pregnant and those who did not after breast cancer (adjusted HR, 0.99; 95% CI, 0.81-1.20). 

When looking at the specific BRCA gene, differences did emerge. BRCA1 carriers had better disease-free survival after pregnancy (aHR, 0.80), while BRCA2 carriers appeared to have worse disease-free survival after pregnancy (aHR, 1.55). 

For reasons that remain unclear, the researchers also found that BRCA1 carriers who got pregnant had significantly better breast cancer-specific survival (aHR, 0.59; P < .01) and overall survival (aHR, 0.58; P < .01). These women tended to have HR-negative breast cancer, which the authors also found was associated with improved survival after pregnancy (aHR, 0.76).

It’s possible, the team posited, that hormone receptor status played a role in the observed survival benefit. It’s also possible that these women were healthier overall. 

The overall survival advantage, however, did not extend to BRCA2 carriers, who tended to have hormone receptor-positive disease. Hormone receptor-positive status did not appear to have a significant impact on survival (aHR, 1.30; 95% CI, 0.95-1.76).

“While the results appear reassuring for BRCA1 carriers, more caution is needed to counsel BRCA2 carriers, “ the investigators wrote.

The study was funded by the Italian Association for Cancer Research, Gilead, and others. Investigators had numerous ties to industry, including Dr. Lambertini, who is an adviser and speaker for Roche, Pfizer, Novartis, and others. The full list of disclosures can be found with the original article.

A version of this article appeared on Medscape.com.

SAN ANTONIO — New research provides some reassuring news for young women hoping to become pregnant after a diagnosis of BRCA-mutated breast cancer.

As with other breast cancers, we can now say to BRCA carriers: “Don’t worry. You can get pregnant. You’ll be okay,” said Jame Abraham, MD, chair of Hematology & Medical Oncology at the Cleveland Clinic, who was not involved in the research. 

The analysis, presented at the San Antonio Breast Cancer Symposium, revealed no issue with women becoming pregnant and carrying a healthy baby to term and reported no sign of worse disease outcomes among BRCA carriers following diagnosis and treatment. 

“The final and most important conclusion from our study is that conceiving after proper breast cancer treatment and follow-up should not be contraindicated anymore in young BRCA carriers,” a message of particular importance for oncofertility counseling, lead investigator Matteo Lambertini, MD, a breast cancer oncologist at the University of Genova, Italy, said during his SABCS presentation. 

The study was published December 7 in JAMA to coincide with his presentation.

Although pregnancy after breast cancer is generally considered safe, limited data exist for BRCA carriers in particular, Dr. Lambertini said.

The current analysis represents the largest look into the matter to date. The study included 4732 young women from across the globe who had been diagnosed with stage I-III invasive breast cancer. These women, all BRCA carriers, were 40 years or younger (median age at diagnosis, 35 years).

The team compared outcomes between 659 patients who had at least one pregnancy over a median follow-up of almost 8 years with 4073 women who did not become pregnant. 

Dr. Lambertini and colleagues reported a median time of 3.5 years from breast cancer diagnosis to conception. Overall, about 1 in 5 young BRCA carriers (22%) conceived within 10 years after their breast cancer diagnosis. Of the 80% of patients with a completed pregnancy, 91% delivered at term and only 4 infants (0.9%) had documented congenital anomalies.

In short, “the rate of pregnancy, fetal, and obstetric complications was low and in line with the expectations in a population of women with similar age and no history of breast cancer,” Dr. Lambertini said. The team cautioned, however, that the data was extracted from oncology medical records, which might have underreported maternal and fetal outcomes. 

Disease-free survival was similar among women who became pregnant and those who did not after breast cancer (adjusted HR, 0.99; 95% CI, 0.81-1.20). 

When looking at the specific BRCA gene, differences did emerge. BRCA1 carriers had better disease-free survival after pregnancy (aHR, 0.80), while BRCA2 carriers appeared to have worse disease-free survival after pregnancy (aHR, 1.55). 

For reasons that remain unclear, the researchers also found that BRCA1 carriers who got pregnant had significantly better breast cancer-specific survival (aHR, 0.59; P < .01) and overall survival (aHR, 0.58; P < .01). These women tended to have HR-negative breast cancer, which the authors also found was associated with improved survival after pregnancy (aHR, 0.76).

It’s possible, the team posited, that hormone receptor status played a role in the observed survival benefit. It’s also possible that these women were healthier overall. 

The overall survival advantage, however, did not extend to BRCA2 carriers, who tended to have hormone receptor-positive disease. Hormone receptor-positive status did not appear to have a significant impact on survival (aHR, 1.30; 95% CI, 0.95-1.76).

“While the results appear reassuring for BRCA1 carriers, more caution is needed to counsel BRCA2 carriers, “ the investigators wrote.

The study was funded by the Italian Association for Cancer Research, Gilead, and others. Investigators had numerous ties to industry, including Dr. Lambertini, who is an adviser and speaker for Roche, Pfizer, Novartis, and others. The full list of disclosures can be found with the original article.

A version of this article appeared on Medscape.com.