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Study underscores aggressive approach to inflammatory breast cancer

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Wed, 01/04/2023 - 16:47

Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.

Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.

Dr. Kelly Rosso
Trimodality therapy at MD Anderson is defined as neoadjuvant chemotherapy and targeted systemic therapies followed by aggressive surgical resection to negative surgical margins and specific radiotherapy, Dr. Rosso said.

Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.

“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”

In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.

Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.

“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”

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On Twitter @denisefulton

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Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.

Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.

Dr. Kelly Rosso
Trimodality therapy at MD Anderson is defined as neoadjuvant chemotherapy and targeted systemic therapies followed by aggressive surgical resection to negative surgical margins and specific radiotherapy, Dr. Rosso said.

Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.

“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”

In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.

Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.

“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”

[email protected]

On Twitter @denisefulton

Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.

Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.

Dr. Kelly Rosso
Trimodality therapy at MD Anderson is defined as neoadjuvant chemotherapy and targeted systemic therapies followed by aggressive surgical resection to negative surgical margins and specific radiotherapy, Dr. Rosso said.

Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.

“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”

In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.

Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.

“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”

[email protected]

On Twitter @denisefulton

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Key clinical point: Trimodality therapy is the correct approach for nonmetastatic inflammatory breast cancer.

Major finding: Locoregional recurrence occurred in 4 out of 114 women with inflammatory breast cancer treated with trimodality therapy.

Data source: A prospective database of 277 women diagnosed with inflammatory breast cancer between 2007 and 2015.

Disclosures: The study was unsponsored. Dr. Rosso disclosed no relevant conflicts of interest.

Risk of recurrence outweighs risk of contralateral breast cancer for DCIS patients

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LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.

“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”

Dr. Megan Miller
In a database review of 2,759 DCIS patients, Dr. Miller and associates found the incidence rate of CBC was 2.8% and 5.6% after 5 and 10 years, respectively, compared with 7.8% and 14.3% for the rate of ipsilateral breast tumor recurrence (IBTR). All patients had undergone breast conserving surgery between 1978-2011, with a median follow up time of 6.8 years.

The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.

Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).

More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.

“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”

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LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.

“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”

Dr. Megan Miller
In a database review of 2,759 DCIS patients, Dr. Miller and associates found the incidence rate of CBC was 2.8% and 5.6% after 5 and 10 years, respectively, compared with 7.8% and 14.3% for the rate of ipsilateral breast tumor recurrence (IBTR). All patients had undergone breast conserving surgery between 1978-2011, with a median follow up time of 6.8 years.

The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.

Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).

More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.

“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”

 

LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.

“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”

Dr. Megan Miller
In a database review of 2,759 DCIS patients, Dr. Miller and associates found the incidence rate of CBC was 2.8% and 5.6% after 5 and 10 years, respectively, compared with 7.8% and 14.3% for the rate of ipsilateral breast tumor recurrence (IBTR). All patients had undergone breast conserving surgery between 1978-2011, with a median follow up time of 6.8 years.

The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.

Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).

More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.

“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”

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Key clinical point: In treating DCIS, the focus should be on risk factors and appropriate therapy for the diseased breast, not the opposite breast.

Major finding: Among 2,759 patients, incidence rate of contralateral breast cancer was 2.8% and 5.6% over 5 and 10 years, respectively, while risk of ipsilateral breast tumor recurrence was 7.8% and 14.3% over 5 and 10 years, respectively.

Data source: Study of 2,759 DCIS patients who underwent breast conserving surgery between 1978-2011, who were followed for a median of 6.8 years.

Disclosures: The investigators reported no relevant disclosures.

VIDEO: Study confirms uneven access to liver cancer treatment at VA hospitals

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Wed, 05/26/2021 - 13:52

 

Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).

Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.

Source: American Gastroenterological Association

 

“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”

Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).

After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).

Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.

Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.

“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”

The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
 

Body

 

The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.


First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.


Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.


Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.

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The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.


First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.


Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.


Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.

Body

 

The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.


First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.


Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.


Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.

 

Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).

Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.

Source: American Gastroenterological Association

 

“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”

Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).

After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).

Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.

Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.

“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”

The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
 

 

Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).

Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.

Source: American Gastroenterological Association

 

“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”

Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).

After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).

Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.

Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.

“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”

The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
 

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Key clinical point: Undertreatment of hepatocellular carcinoma was common within the Veterans Affairs system, and varied by geographic region.

Major finding: Only 25% of Barcelona Clinic Liver Cancer stage 0/A patients received potentially curative therapies. Those in the mid-South were significantly less likely to receive active treatment than were those in the Northeast (HR, 0.62; 95% CI, 0.44-0.85). In an adjusted model, treatment at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; P less than .001).

Data source: A national, retrospective cohort study of all 3,988 patients who were diagnosed with hepatocellular carcinoma between 2008 and 2010 and received care through Veterans Affairs.

Disclosures: The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.

ASBS annual meeting to explore treatment controversies

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ACS Surgery News will be in Las Vegas this week at the annual meeting of the American Society of Breast Surgeons reporting on the latest in multidisciplinary management of benign and not-so-benign breast disease. Our reporters will cover controversies in neoadjuvant therapy, including managing axilla and skipping surgery with biopsy proven pathological complete response (pCR), as well as the use of axillary ultrasound on a clinically negative axilla, and what to do for in situ carcinoma and borderline cases. Coverage will also include the latest updates in high-risk and genetic predisposition, breast cancer subtypes, lymphedema, and recurrent and metastatic breast cancer, and guidance for coding and reimbursement.

Highly anticipated presentations include:

• Many Women are Choosing Unnecessarily Radical Surgeries for Early-Stage Cancer

• Debunking the Myth of Lymphedema Risk

• Aggressive Inflammatory Breast Cancer Treatment Yields Low Local/Regional Recurrence

Our team will provide daily coverage, beginning Thursday, April 27.

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ACS Surgery News will be in Las Vegas this week at the annual meeting of the American Society of Breast Surgeons reporting on the latest in multidisciplinary management of benign and not-so-benign breast disease. Our reporters will cover controversies in neoadjuvant therapy, including managing axilla and skipping surgery with biopsy proven pathological complete response (pCR), as well as the use of axillary ultrasound on a clinically negative axilla, and what to do for in situ carcinoma and borderline cases. Coverage will also include the latest updates in high-risk and genetic predisposition, breast cancer subtypes, lymphedema, and recurrent and metastatic breast cancer, and guidance for coding and reimbursement.

Highly anticipated presentations include:

• Many Women are Choosing Unnecessarily Radical Surgeries for Early-Stage Cancer

• Debunking the Myth of Lymphedema Risk

• Aggressive Inflammatory Breast Cancer Treatment Yields Low Local/Regional Recurrence

Our team will provide daily coverage, beginning Thursday, April 27.

 

ACS Surgery News will be in Las Vegas this week at the annual meeting of the American Society of Breast Surgeons reporting on the latest in multidisciplinary management of benign and not-so-benign breast disease. Our reporters will cover controversies in neoadjuvant therapy, including managing axilla and skipping surgery with biopsy proven pathological complete response (pCR), as well as the use of axillary ultrasound on a clinically negative axilla, and what to do for in situ carcinoma and borderline cases. Coverage will also include the latest updates in high-risk and genetic predisposition, breast cancer subtypes, lymphedema, and recurrent and metastatic breast cancer, and guidance for coding and reimbursement.

Highly anticipated presentations include:

• Many Women are Choosing Unnecessarily Radical Surgeries for Early-Stage Cancer

• Debunking the Myth of Lymphedema Risk

• Aggressive Inflammatory Breast Cancer Treatment Yields Low Local/Regional Recurrence

Our team will provide daily coverage, beginning Thursday, April 27.

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Proceed cautiously with liver cancer resection in elderly patients

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– A decision to proceed with major hepatectomy in patients 75 and older with perihilar cholangiocarcinoma should be made on a case-by-case basis following strict selection, Thuy Tran, MD, said, based on a study of 210 patients.

“As the U.S. population ages, an increasing number of elderly patients are being evaluated for resection of GI malignancies,” Dr. Tran said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

“Advanced age has been regarded as contraindication to resection for complex hepatobiliary malignancies,” she explained, with concerns that “it may be too risky, and the survival benefit is limited in elderly populations. However, the oncologic benefit of aggressive surgical strategies in perihilar cholangiocarcinoma remains a subject of debate.”

Dr. Tran and her colleagues identified patients who underwent curative resection for perihilar cholangiocarcinoma (CCA) in the U.S. Extrahepatic Biliary Malignancy Consortium database. They compared outcomes of those younger than 75 years versus patients 75 years and older. A total of 59% of the cohort were men, 20% were 75 years and older, and the median age was 66 years.

CCA is a rare and aggressive malignancy, often presenting with obstructive jaundice, said Dr. Tran, a postdoctoral research fellow in general surgery at Stanford (Calif.) University.

Preoperative characteristics were similar in the groups, except that cardiac morbidity was higher in the older cohort. In addition, pathology characteristics did not differ significantly between age groups, including tumor stage, nodal status, grade, size, and margin status.

The in-hospital mortality was double for the older patients, 15% versus 8%, despite the similarities, Dr. Tran said. “This supports the notion that it is more difficult to salvage older patients when they run into a complication,” she added.

Postoperative morbidity was also higher in older patients, 78% versus 68%, but did not reach statistical significance (P = .34).

The 90-day mortality rate was 22% in patients 75 years and older, compared with 10% in younger patients, a nonsignificant difference (P = .09).

Five-year survival was 15% in the older cohort and 22% for the younger patients (P = .003). There was a “more significant drop in the survival curves in the older age group, but then they get closer,” Dr. Tran said. The disease-specific survival did not differ significantly at 46 months versus 37 months, respectively.

Advanced-stage cancer and elevated CA 19-9 tumor marker levels were independent predictors of survival in a multivariate analysis, but age was not. Higher body mass index was associated with a higher perioperative mortality in older patients, but sex, cardiac morbidity, and ASA status were not. Dr. Tran said, “Lower BMI may be a useful tool to select elderly patients,” she noted.

“Elderly patients have double the mortality following major hepatectomy for perihilar cholangiocarcinoma,” Dr. Tran said. “However, the long-term, cancer-specific outcome appears similar to that of younger patients.” Physiologically robust older patients may be better candidates for surgery, she suggested.

Of the six patients who died in the 75 and older group, two patients died from liver failure, one from sepsis, one intraoperatively, one from unknown causes, and one died who required reoperation for postop bleeding, Dr. Tran said. “We did not find patients dying from MI or pneumonia, probably due to the small number of patients.”

Dr. Tran said that 2.5% of the older group and 5% of the younger group received neoadjuvant chemotherapy, which was not a statistically significant difference.

A meeting attendee asked if left versus right hepatectomy made a difference, and why the researchers chose 75 years as the cutoff age between younger and older groups.

“Left vs. right laterality does not seem to make an impact in terms of survival,” Dr. Tran said. “The median age was 66 years, and we used the upper limit of standard deviation, which was 75.”

Dr. Tran had no relevant financial disclosures.

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– A decision to proceed with major hepatectomy in patients 75 and older with perihilar cholangiocarcinoma should be made on a case-by-case basis following strict selection, Thuy Tran, MD, said, based on a study of 210 patients.

“As the U.S. population ages, an increasing number of elderly patients are being evaluated for resection of GI malignancies,” Dr. Tran said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

“Advanced age has been regarded as contraindication to resection for complex hepatobiliary malignancies,” she explained, with concerns that “it may be too risky, and the survival benefit is limited in elderly populations. However, the oncologic benefit of aggressive surgical strategies in perihilar cholangiocarcinoma remains a subject of debate.”

Dr. Tran and her colleagues identified patients who underwent curative resection for perihilar cholangiocarcinoma (CCA) in the U.S. Extrahepatic Biliary Malignancy Consortium database. They compared outcomes of those younger than 75 years versus patients 75 years and older. A total of 59% of the cohort were men, 20% were 75 years and older, and the median age was 66 years.

CCA is a rare and aggressive malignancy, often presenting with obstructive jaundice, said Dr. Tran, a postdoctoral research fellow in general surgery at Stanford (Calif.) University.

Preoperative characteristics were similar in the groups, except that cardiac morbidity was higher in the older cohort. In addition, pathology characteristics did not differ significantly between age groups, including tumor stage, nodal status, grade, size, and margin status.

The in-hospital mortality was double for the older patients, 15% versus 8%, despite the similarities, Dr. Tran said. “This supports the notion that it is more difficult to salvage older patients when they run into a complication,” she added.

Postoperative morbidity was also higher in older patients, 78% versus 68%, but did not reach statistical significance (P = .34).

The 90-day mortality rate was 22% in patients 75 years and older, compared with 10% in younger patients, a nonsignificant difference (P = .09).

Five-year survival was 15% in the older cohort and 22% for the younger patients (P = .003). There was a “more significant drop in the survival curves in the older age group, but then they get closer,” Dr. Tran said. The disease-specific survival did not differ significantly at 46 months versus 37 months, respectively.

Advanced-stage cancer and elevated CA 19-9 tumor marker levels were independent predictors of survival in a multivariate analysis, but age was not. Higher body mass index was associated with a higher perioperative mortality in older patients, but sex, cardiac morbidity, and ASA status were not. Dr. Tran said, “Lower BMI may be a useful tool to select elderly patients,” she noted.

“Elderly patients have double the mortality following major hepatectomy for perihilar cholangiocarcinoma,” Dr. Tran said. “However, the long-term, cancer-specific outcome appears similar to that of younger patients.” Physiologically robust older patients may be better candidates for surgery, she suggested.

Of the six patients who died in the 75 and older group, two patients died from liver failure, one from sepsis, one intraoperatively, one from unknown causes, and one died who required reoperation for postop bleeding, Dr. Tran said. “We did not find patients dying from MI or pneumonia, probably due to the small number of patients.”

Dr. Tran said that 2.5% of the older group and 5% of the younger group received neoadjuvant chemotherapy, which was not a statistically significant difference.

A meeting attendee asked if left versus right hepatectomy made a difference, and why the researchers chose 75 years as the cutoff age between younger and older groups.

“Left vs. right laterality does not seem to make an impact in terms of survival,” Dr. Tran said. “The median age was 66 years, and we used the upper limit of standard deviation, which was 75.”

Dr. Tran had no relevant financial disclosures.

 

– A decision to proceed with major hepatectomy in patients 75 and older with perihilar cholangiocarcinoma should be made on a case-by-case basis following strict selection, Thuy Tran, MD, said, based on a study of 210 patients.

“As the U.S. population ages, an increasing number of elderly patients are being evaluated for resection of GI malignancies,” Dr. Tran said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

“Advanced age has been regarded as contraindication to resection for complex hepatobiliary malignancies,” she explained, with concerns that “it may be too risky, and the survival benefit is limited in elderly populations. However, the oncologic benefit of aggressive surgical strategies in perihilar cholangiocarcinoma remains a subject of debate.”

Dr. Tran and her colleagues identified patients who underwent curative resection for perihilar cholangiocarcinoma (CCA) in the U.S. Extrahepatic Biliary Malignancy Consortium database. They compared outcomes of those younger than 75 years versus patients 75 years and older. A total of 59% of the cohort were men, 20% were 75 years and older, and the median age was 66 years.

CCA is a rare and aggressive malignancy, often presenting with obstructive jaundice, said Dr. Tran, a postdoctoral research fellow in general surgery at Stanford (Calif.) University.

Preoperative characteristics were similar in the groups, except that cardiac morbidity was higher in the older cohort. In addition, pathology characteristics did not differ significantly between age groups, including tumor stage, nodal status, grade, size, and margin status.

The in-hospital mortality was double for the older patients, 15% versus 8%, despite the similarities, Dr. Tran said. “This supports the notion that it is more difficult to salvage older patients when they run into a complication,” she added.

Postoperative morbidity was also higher in older patients, 78% versus 68%, but did not reach statistical significance (P = .34).

The 90-day mortality rate was 22% in patients 75 years and older, compared with 10% in younger patients, a nonsignificant difference (P = .09).

Five-year survival was 15% in the older cohort and 22% for the younger patients (P = .003). There was a “more significant drop in the survival curves in the older age group, but then they get closer,” Dr. Tran said. The disease-specific survival did not differ significantly at 46 months versus 37 months, respectively.

Advanced-stage cancer and elevated CA 19-9 tumor marker levels were independent predictors of survival in a multivariate analysis, but age was not. Higher body mass index was associated with a higher perioperative mortality in older patients, but sex, cardiac morbidity, and ASA status were not. Dr. Tran said, “Lower BMI may be a useful tool to select elderly patients,” she noted.

“Elderly patients have double the mortality following major hepatectomy for perihilar cholangiocarcinoma,” Dr. Tran said. “However, the long-term, cancer-specific outcome appears similar to that of younger patients.” Physiologically robust older patients may be better candidates for surgery, she suggested.

Of the six patients who died in the 75 and older group, two patients died from liver failure, one from sepsis, one intraoperatively, one from unknown causes, and one died who required reoperation for postop bleeding, Dr. Tran said. “We did not find patients dying from MI or pneumonia, probably due to the small number of patients.”

Dr. Tran said that 2.5% of the older group and 5% of the younger group received neoadjuvant chemotherapy, which was not a statistically significant difference.

A meeting attendee asked if left versus right hepatectomy made a difference, and why the researchers chose 75 years as the cutoff age between younger and older groups.

“Left vs. right laterality does not seem to make an impact in terms of survival,” Dr. Tran said. “The median age was 66 years, and we used the upper limit of standard deviation, which was 75.”

Dr. Tran had no relevant financial disclosures.

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Key clinical point: Patients 75 years and older undergoing hepatectomy for perihilar cholangiocarcinoma trended toward higher mortality but experienced cancer-specific outcomes similar to younger patients.

Major finding: 90-day mortality was 22% in patients 75 years and older versus 10% in younger patients (nonsignificant, P = .09).

Data source: Retrospective database study of 210 people who had curative intent resection for perihilar cholangiocarcinoma.

Disclosures: Dr. Tran had no relevant financial disclosures.

Neoadjuvant therapy timing may impact pancreatic cancer outcomes

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– In patients with pancreatic cancer, an interval of 8 weeks between receiving neoadjuvant chemoradiation and surgical resection may improve resection margins, according to findings presented at the annual Society of Surgical Oncology Cancer Symposium.

The delay in resection did not negatively impact outcomes, and there was a modest improvement in overall survival among patients who had an 8-10 week interval between treatments.

“Attention should be focused on the treatment interval to time of resection in prospective studies,” said lead study author Raphael J. Louie, MD, of Dartmouth (N.H.) Hitchcock Norris Cotton Cancer Center.

Dr. Louie explained that for patients with pancreatic adenocarcinoma who receive neoadjuvant chemoradiation, it is unclear how long the optimal interval should be between therapy completion and surgical resection.

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“Recent studies have suggested an improved tumor response with a longer interval from chemoradiation and surgical resection in rectal cancer,” he said.

For this study, Dr. Louie and his colleagues sought to determine the optimal interval between neoadjuvant therapy and surgery to maximize response and oncologic outcomes.

“We hypothesized that there may be benefit to a delay,” he said.

The retrospective analysis included 637 patients who had been diagnosed with pancreatic adenocarcinoma at the Norris Cotton Cancer Center, and who had completed neoadjuvant chemoradiation and underwent R0 surgical resection between Jan. 1, 2004, and Dec. 31, 2015.

Of this group, 195 patients had metastatic disease, 28 underwent upfront surgical exploration, and 94 were lost to follow-up or had a poor performance status and were not included in the final analysis.

The cohort was grouped according to time from chemoradiation completion to surgery: 6-8 weeks, 8-10 weeks, and more than 10 weeks.

A total of 320 patients received neoadjuvant chemoradiation and 288 completed the full course. Of this group, 128 were evaluable by pathologic review.

Among patients with a 6- to 8-week interval, 61% had an R0 resection margin. This percentage rose to 72% for those who had an 8- to 10-week interval, and in similar fashion, 70% for those who had a 10- to 13-week interval (P = .6)

However, there was no statistical difference when the three groups were compared collectively.

Of 26 patients who were resected within 6-8 weeks of chemoradiation, 11% achieved a complete response (CR), 27% had a partial response (PR), and 61% had recurrence for an average disease-free survival of 20 months.

In the group (n = 58) of patients who were resected within 8-10 weeks, 7% had CR, 71% had PR, and 62% had recurrence, for an average disease-free survival of 17 months. Finally, the 44 patients who were resected within 10-13 weeks had similar outcomes; 5% had CR, 61% had PR, and 61% of patients had recurrence for an average disease-free survival of 14 months.

Dr. Louie noted that even though they observed improved PR in the 8- to 10-week group, there was no statistical significance in disease-free survival (P = .71) or overall survival (P = .19).

“Allowing more time from neoadjuvant therapy completion to surgical resection may improve the pathologic response,” said Dr. Louie. “Larger studies are needed to determine if the time interval to surgical resection has oncologic benefit for these patients.”

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– In patients with pancreatic cancer, an interval of 8 weeks between receiving neoadjuvant chemoradiation and surgical resection may improve resection margins, according to findings presented at the annual Society of Surgical Oncology Cancer Symposium.

The delay in resection did not negatively impact outcomes, and there was a modest improvement in overall survival among patients who had an 8-10 week interval between treatments.

“Attention should be focused on the treatment interval to time of resection in prospective studies,” said lead study author Raphael J. Louie, MD, of Dartmouth (N.H.) Hitchcock Norris Cotton Cancer Center.

Dr. Louie explained that for patients with pancreatic adenocarcinoma who receive neoadjuvant chemoradiation, it is unclear how long the optimal interval should be between therapy completion and surgical resection.

decade3d/Thinkstock
“Recent studies have suggested an improved tumor response with a longer interval from chemoradiation and surgical resection in rectal cancer,” he said.

For this study, Dr. Louie and his colleagues sought to determine the optimal interval between neoadjuvant therapy and surgery to maximize response and oncologic outcomes.

“We hypothesized that there may be benefit to a delay,” he said.

The retrospective analysis included 637 patients who had been diagnosed with pancreatic adenocarcinoma at the Norris Cotton Cancer Center, and who had completed neoadjuvant chemoradiation and underwent R0 surgical resection between Jan. 1, 2004, and Dec. 31, 2015.

Of this group, 195 patients had metastatic disease, 28 underwent upfront surgical exploration, and 94 were lost to follow-up or had a poor performance status and were not included in the final analysis.

The cohort was grouped according to time from chemoradiation completion to surgery: 6-8 weeks, 8-10 weeks, and more than 10 weeks.

A total of 320 patients received neoadjuvant chemoradiation and 288 completed the full course. Of this group, 128 were evaluable by pathologic review.

Among patients with a 6- to 8-week interval, 61% had an R0 resection margin. This percentage rose to 72% for those who had an 8- to 10-week interval, and in similar fashion, 70% for those who had a 10- to 13-week interval (P = .6)

However, there was no statistical difference when the three groups were compared collectively.

Of 26 patients who were resected within 6-8 weeks of chemoradiation, 11% achieved a complete response (CR), 27% had a partial response (PR), and 61% had recurrence for an average disease-free survival of 20 months.

In the group (n = 58) of patients who were resected within 8-10 weeks, 7% had CR, 71% had PR, and 62% had recurrence, for an average disease-free survival of 17 months. Finally, the 44 patients who were resected within 10-13 weeks had similar outcomes; 5% had CR, 61% had PR, and 61% of patients had recurrence for an average disease-free survival of 14 months.

Dr. Louie noted that even though they observed improved PR in the 8- to 10-week group, there was no statistical significance in disease-free survival (P = .71) or overall survival (P = .19).

“Allowing more time from neoadjuvant therapy completion to surgical resection may improve the pathologic response,” said Dr. Louie. “Larger studies are needed to determine if the time interval to surgical resection has oncologic benefit for these patients.”

 

– In patients with pancreatic cancer, an interval of 8 weeks between receiving neoadjuvant chemoradiation and surgical resection may improve resection margins, according to findings presented at the annual Society of Surgical Oncology Cancer Symposium.

The delay in resection did not negatively impact outcomes, and there was a modest improvement in overall survival among patients who had an 8-10 week interval between treatments.

“Attention should be focused on the treatment interval to time of resection in prospective studies,” said lead study author Raphael J. Louie, MD, of Dartmouth (N.H.) Hitchcock Norris Cotton Cancer Center.

Dr. Louie explained that for patients with pancreatic adenocarcinoma who receive neoadjuvant chemoradiation, it is unclear how long the optimal interval should be between therapy completion and surgical resection.

decade3d/Thinkstock
“Recent studies have suggested an improved tumor response with a longer interval from chemoradiation and surgical resection in rectal cancer,” he said.

For this study, Dr. Louie and his colleagues sought to determine the optimal interval between neoadjuvant therapy and surgery to maximize response and oncologic outcomes.

“We hypothesized that there may be benefit to a delay,” he said.

The retrospective analysis included 637 patients who had been diagnosed with pancreatic adenocarcinoma at the Norris Cotton Cancer Center, and who had completed neoadjuvant chemoradiation and underwent R0 surgical resection between Jan. 1, 2004, and Dec. 31, 2015.

Of this group, 195 patients had metastatic disease, 28 underwent upfront surgical exploration, and 94 were lost to follow-up or had a poor performance status and were not included in the final analysis.

The cohort was grouped according to time from chemoradiation completion to surgery: 6-8 weeks, 8-10 weeks, and more than 10 weeks.

A total of 320 patients received neoadjuvant chemoradiation and 288 completed the full course. Of this group, 128 were evaluable by pathologic review.

Among patients with a 6- to 8-week interval, 61% had an R0 resection margin. This percentage rose to 72% for those who had an 8- to 10-week interval, and in similar fashion, 70% for those who had a 10- to 13-week interval (P = .6)

However, there was no statistical difference when the three groups were compared collectively.

Of 26 patients who were resected within 6-8 weeks of chemoradiation, 11% achieved a complete response (CR), 27% had a partial response (PR), and 61% had recurrence for an average disease-free survival of 20 months.

In the group (n = 58) of patients who were resected within 8-10 weeks, 7% had CR, 71% had PR, and 62% had recurrence, for an average disease-free survival of 17 months. Finally, the 44 patients who were resected within 10-13 weeks had similar outcomes; 5% had CR, 61% had PR, and 61% of patients had recurrence for an average disease-free survival of 14 months.

Dr. Louie noted that even though they observed improved PR in the 8- to 10-week group, there was no statistical significance in disease-free survival (P = .71) or overall survival (P = .19).

“Allowing more time from neoadjuvant therapy completion to surgical resection may improve the pathologic response,” said Dr. Louie. “Larger studies are needed to determine if the time interval to surgical resection has oncologic benefit for these patients.”

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Key clinical point: A longer interval between neoadjuvant therapy and surgical resection could improve some outcomes in pancreatic cancer.

Major finding: Resection after 8 weeks may improve resection margins and may provide a modest improvement in survival for some patients.

Data source: Retrospective cohort study of 128 evaluable patients with biopsy-proven pancreatic adenocarcinoma who received neoadjuvant chemoradiation.

Disclosures: Dr. Louie has no disclosures.

Debulking called reasonable for unresectable liver cancer

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Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

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Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

 

Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

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Key clinical point: Surgical resection for neuroendocrine liver metastases offers the best chance for long-term survival, and debulking may be an option for patients for whom resection is not feasible.

Major finding: The 10-year overall survival was 77% in the curative intent surgery group, compared with 41% among the debulking patients.

Data source: A retrospective database study of 629 people with neuroendocrine liver metastases.

Disclosures: Dr. Bagante and Dr. Lee had no relevant financial disclosures.

NET can benefit breast cancer patients with delayed surgery

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Wed, 01/04/2023 - 16:48

 

SEATTLE – A short course of neoadjuvant therapy could be considered in breast cancer patients with expected delays to resection, while they are awaiting surgery, according to study findings presented at the annual Society of Surgical Oncology Cancer Symposium.

More than half of breast cancer patients who undergo surgical resection as the initial modality will experience delays to surgery of more than 4 weeks. Of this group, more than half of patients receive shorter than standard courses of neoadjuvant therapy (NET), and the patients most likely to benefit were those older than 50 years, with ductal tumors, and the effect was seen in all T stages.

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“Multimodal therapy in breast cancer has led to improvements in outcomes, and standard NET regimens lasting greater than 12 weeks have improved the rates of breast conservation in randomized, controlled trials,” said study lead author James P. De Andrade, MD, from the University of Iowa, Iowa City.

Recent reports show that NET is increasing. However, Dr. De Andrade pointed out, delays in receiving surgery remain a problem in breast cancer treatment and are associated with worse overall and cancer specific survival.

“Off-label use of NET is sometimes used in patients undergoing surgical delays,” he said.

NET use for 3 months has been associated with decreasing the size of tumors in patients with hormone receptor–positive (HR+) invasive breast cancer and allowing for breast conservation therapy. While short-term NET is sometimes used in women who are experiencing delay to surgery, the incidence and efficacy of this regimen remains undefined.

In the current study, Dr. De Andrade and his colleagues sought to answer three clinical questions:

• How long are patients with operable breast cancer waiting to undergo surgery?

• What is the pattern of use of short-course NET?

• What are the effects of short-course NET on outcomes?

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SEATTLE – A short course of neoadjuvant therapy could be considered in breast cancer patients with expected delays to resection, while they are awaiting surgery, according to study findings presented at the annual Society of Surgical Oncology Cancer Symposium.

More than half of breast cancer patients who undergo surgical resection as the initial modality will experience delays to surgery of more than 4 weeks. Of this group, more than half of patients receive shorter than standard courses of neoadjuvant therapy (NET), and the patients most likely to benefit were those older than 50 years, with ductal tumors, and the effect was seen in all T stages.

chemotherapy hand
©BluePlanetEarth/thinkstockphotos.com
chemotherapy
“Multimodal therapy in breast cancer has led to improvements in outcomes, and standard NET regimens lasting greater than 12 weeks have improved the rates of breast conservation in randomized, controlled trials,” said study lead author James P. De Andrade, MD, from the University of Iowa, Iowa City.

Recent reports show that NET is increasing. However, Dr. De Andrade pointed out, delays in receiving surgery remain a problem in breast cancer treatment and are associated with worse overall and cancer specific survival.

“Off-label use of NET is sometimes used in patients undergoing surgical delays,” he said.

NET use for 3 months has been associated with decreasing the size of tumors in patients with hormone receptor–positive (HR+) invasive breast cancer and allowing for breast conservation therapy. While short-term NET is sometimes used in women who are experiencing delay to surgery, the incidence and efficacy of this regimen remains undefined.

In the current study, Dr. De Andrade and his colleagues sought to answer three clinical questions:

• How long are patients with operable breast cancer waiting to undergo surgery?

• What is the pattern of use of short-course NET?

• What are the effects of short-course NET on outcomes?

 

SEATTLE – A short course of neoadjuvant therapy could be considered in breast cancer patients with expected delays to resection, while they are awaiting surgery, according to study findings presented at the annual Society of Surgical Oncology Cancer Symposium.

More than half of breast cancer patients who undergo surgical resection as the initial modality will experience delays to surgery of more than 4 weeks. Of this group, more than half of patients receive shorter than standard courses of neoadjuvant therapy (NET), and the patients most likely to benefit were those older than 50 years, with ductal tumors, and the effect was seen in all T stages.

chemotherapy hand
©BluePlanetEarth/thinkstockphotos.com
chemotherapy
“Multimodal therapy in breast cancer has led to improvements in outcomes, and standard NET regimens lasting greater than 12 weeks have improved the rates of breast conservation in randomized, controlled trials,” said study lead author James P. De Andrade, MD, from the University of Iowa, Iowa City.

Recent reports show that NET is increasing. However, Dr. De Andrade pointed out, delays in receiving surgery remain a problem in breast cancer treatment and are associated with worse overall and cancer specific survival.

“Off-label use of NET is sometimes used in patients undergoing surgical delays,” he said.

NET use for 3 months has been associated with decreasing the size of tumors in patients with hormone receptor–positive (HR+) invasive breast cancer and allowing for breast conservation therapy. While short-term NET is sometimes used in women who are experiencing delay to surgery, the incidence and efficacy of this regimen remains undefined.

In the current study, Dr. De Andrade and his colleagues sought to answer three clinical questions:

• How long are patients with operable breast cancer waiting to undergo surgery?

• What is the pattern of use of short-course NET?

• What are the effects of short-course NET on outcomes?

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Key clinical point: Short-course neoadjuvant therapy is an option for breast cancer patients with expected delays to surgery.

Major finding: Use of neoadjuvant therapy was associated with downstaging from clinical stage to final pathology stage and reducing re-excision in breast conservation surgery.

Data source: The National Cancer Database was used to identify 530,009 patients.

Disclosures: Dr. De Andrade had no disclosures.

Transanal TME comparable to open, lap approaches to rectal cancer

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– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

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– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

 

– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

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Key clinical point: Transanal total mesorectal excision (TME) is a viable alternative to open or laparoscopic TME in cancers of the low and midrectum.

Major finding: Postoperative pathological staging showed complete remission in 16%, with pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Data source: Analysis of 187 patients prospectively enrolled in a standardized database who had transanal TME from November 2011 to June 2016 at a single center.

Disclosures: Dr. van Laarhoven reported having no financial disclosures.

Neoadjuvant chemoradiation may give transplant the edge over resection in biliary cancer

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– Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.

Comstock/Thinkstock
None of the resection patients in the meta-analysis received neoadjuvant therapy; all of the participants in two of the orthotopic liver transplantation studies, however, started with neoadjuvant chemoradiation. These patients experienced 59% and 82% 5-year survival rates, the longest reported among the nine studies in the meta-analysis.

“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”

The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).

Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.

Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.

“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.

In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.

Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.

In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.

Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.

Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.

Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.

“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”

“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”

The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.

Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.

Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.

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– Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.

Comstock/Thinkstock
None of the resection patients in the meta-analysis received neoadjuvant therapy; all of the participants in two of the orthotopic liver transplantation studies, however, started with neoadjuvant chemoradiation. These patients experienced 59% and 82% 5-year survival rates, the longest reported among the nine studies in the meta-analysis.

“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”

The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).

Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.

Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.

“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.

In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.

Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.

In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.

Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.

Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.

Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.

“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”

“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”

The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.

Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.

Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.

 

– Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.

Comstock/Thinkstock
None of the resection patients in the meta-analysis received neoadjuvant therapy; all of the participants in two of the orthotopic liver transplantation studies, however, started with neoadjuvant chemoradiation. These patients experienced 59% and 82% 5-year survival rates, the longest reported among the nine studies in the meta-analysis.

“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”

The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).

Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.

Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.

“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.

In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.

Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.

In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.

Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.

Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.

Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.

“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”

“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”

The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.

Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.

Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.

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