User login
Enhanced recovery led to fewer complications for major oncologic procedures
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
REPORTING FROM SSO 2018
Key clinical point: Enhanced recovery protocol implementation is feasible in major oncologic surgery.
Major finding: Complication rates were 21.9% for enhanced recovery protocol versus 33.9% for traditional postoperative protocol.
Study details: Analysis of 3,256 oncology operations in an institutional ACS NSQIP database performed from 2011 to 2016.
Disclosures: Dr. Marcus and her coauthors reported having no financial disclosures.
Source: Marcus RK et al. SSO 2018, Abstract 21
Gene strong predictor of metastasis in melanoma
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
REPORTING FROM SSO 2018
Key clinical point: The CXCL1 gene may predict metastatic risk in primary melanoma.
Major findings: CXCL1 overexpression yielded 50% 5-year survival, almost half that of underexpression.
Study details: Gene analysis of samples from 37 patients with nonmetastatic primary melanoma who had surgical removal of primary lesion with median follow-up of 38 months.
Disclosures: Dr. Erdrich and her coauthors reported having no financial disclosures.
Source: Erdrich J et al. SSO 2018, Abstract 82.
Extracapsular spread predicts survival in SLN+ melanoma
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
REPORTING FROM SSO 2018
Key clinical point: Extracapsular spread (ECS) may be a reliable biomarker of survival in stage III melanoma.
Major finding: ECS status was an indicator of progression-free survival (hazard ratio 2.4; P less than .0001) in micrometastatic disease.
Study details: Retrospective cohort study of 515 patients who had micro- or macrometastatic lymphadenopathy at two U.K. centers from 2000 to 2017.
Disclosures: Dr. Lo and coauthors reported having no financial disclosures.
Source: Lo M et al. SSO 2018 Abstract 70.
Study finds gaps in bundled colectomy payments
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
REPORTING FROM SSO 2018
Key clinical point: Medicare payment methodology does not truly reflect episode costs for colectomy.
Major finding: Colectomy charges were higher for benign disease than for cancer.
Study details: Retrospective cohort study of 10,928 patients in a national Medicare database who had colon surgery during 2011-2014.
Disclosures: The investigators had no financial relationships to disclose. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
Source: Huges BD. SSO 2018.
Surgery after immunotherapy effective in advanced melanoma
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
REPORTING FROM SSO 2018
Key clinical point: Surgery after immunotherapy can achieve good outcomes in advanced melanoma.
Major findings: Complete resection achieved an estimated 5-year overall survival of 75%.
Study details: Analysis of a cohort of 237 patients from a prospectively maintained institutional melanoma database who had surgery after immunotherapy for unresectable stage III and IV melanoma during 2003-2017.
Disclosures: Dr. Bello reported having no financial disclosures. Some coauthors reported financial relationships with various pharmaceutical companies.
Source: Bello DM et al. SSO 2018, Abstract 5.
Can cN0 and pCR limit axillary surgery in some breast cancer patients?
CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.
Alison U. Barron, MD, breast surgery oncology fellow at Mayo, presented the results. “In patients with HER2+ breast cancer and TNBC who are clinically node negative (cN0) and achieve a breast pathological complete response, this data supports omitting axillary surgery in clinical trials assessing no surgery after neoadjuvant chemotherapy (NAC),” she said. “In patients who present with clinically positive node [cN1] disease with a breast pathological complete response, surgical staging of the axilla is still recommended.”
“Response rates to NAC have increased,” Dr. Barron said. She cited previous reports that showed response rates ranging from 9%-13% for anthracyclines to 19%-26% with the addition of taxanes, and to 60%-70% with the addition of trastuzumab and pertuzumab in HER2+ disease. “Furthermore, we know that tumor biology affects response rates, with TNBC and HER2+ disease having the highest rates of pathologic complete response,” she said.
“In the current era when we frequently operate on patients, we find no residual cancer in the tissue at the time of surgery,” Dr. Barron said. “The question arises as to whether we can limit surgery in patients with a pathological complete response.” While imaging has limited ability to reliably detect pCR with 100% specificity, she noted that recent trials have shown the potential of tumor-bed biopsy to identify pCR in patients after NAC (Ann Surg. Published online Oct. 23, 2017. doi: 10.1097/SLA.0000000000002573; JAMA Surg. 2017;152(7):665-70).
The National Cancer Database data the Mayo researchers analyzed yielded an overall breast pCR of 29%. “When broken down by tumor subtype, we saw significantly higher rates of breast pCR in patients with HER2+ disease (42%, n = 3,107) and TNBC (35%, n = 2,469), compared with patients with hormone-receptor positive (HR+)/HER2-negative disease (12%, n = 1,020),” she said.
When the analysis looked specifically at patients who were clinically node negative at presentation and had a pCR, the rates of positive lymph nodes at the time of surgery were 1.6% in HER2+ patients and 1.7% in TNBC disease, Dr. Barron said. “If there was residual disease in the breast, the nodal positivity rate was significantly higher, at 18% in HER2+ and 12% in TNBC,” she added. In those who were clinical N1, the breast pCR rates were similar – 41% in HER2+ and 35% in TNBC – but nodal positivity rates were significantly higher, at 13% and 14%, respectively.
The HR+/HER2- group had significantly lower rates of pCR: 12% in the cN0 and 13% in the cN1 subgroups. This subgroup also had higher nodal positivity rates – in the cN0 subgroup, 4% in those with a breast pCR and 34% in those with residual disease in the breast, and in the cN1 subgroup, 30% and 83%, respectively.
When the investigators looked at the extent of nodal burden in cN0 patients with breast pCR, they found the rate of N2 and N3 disease was near zero across all biologic subtypes. “In patients who were cN1 at presentation and achieved a breast pCR but had residual axillary disease, the majority had N1 disease with only 1.5%-4% having four or more positive lymph nodes,” Dr. Barron said.
In the discussion, session moderator Carla Fisher, MD, of Indiana University, Indianapolis, said, “While we might not be ready for prime time to not evaluate the lymph nodes of these patients, this study does speak to the importance of establishing N0 and N1 prior to NAC.” In reply to her question about how Mayo routinely evaluates node status prior to NAC, Dr. Barron noted that Mayo performs routine axillary ultrasound. However, the NCDB data does not specify what imaging was done. This is thought to vary across the centers in the NCDB, Dr. Barron said.
Noted Dr. Boughey, “The findings from this study provide data that can be used moving forward for planning future clinical trials.” She also said that these findings do not alter the current standard of care; that still calls for breast and nodal surgery after NAC. However, the ongoing NRG-BR005 phase II clinical trial is assessing the accuracy of tumor-bed biopsy in these situations (ClinicalTrials.gov Identifier: NCT03188393). “The results from that trial will help inform future trials evaluating eliminating breast surgery in patients with an excellent response to NAC,” Dr. Boughey said. “Those patients could also potentially avoid axillary surgery based on the data we have now.”
Dr. Barron and Dr. Boughey and coauthors reported having no financial disclosures.
SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.
CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.
Alison U. Barron, MD, breast surgery oncology fellow at Mayo, presented the results. “In patients with HER2+ breast cancer and TNBC who are clinically node negative (cN0) and achieve a breast pathological complete response, this data supports omitting axillary surgery in clinical trials assessing no surgery after neoadjuvant chemotherapy (NAC),” she said. “In patients who present with clinically positive node [cN1] disease with a breast pathological complete response, surgical staging of the axilla is still recommended.”
“Response rates to NAC have increased,” Dr. Barron said. She cited previous reports that showed response rates ranging from 9%-13% for anthracyclines to 19%-26% with the addition of taxanes, and to 60%-70% with the addition of trastuzumab and pertuzumab in HER2+ disease. “Furthermore, we know that tumor biology affects response rates, with TNBC and HER2+ disease having the highest rates of pathologic complete response,” she said.
“In the current era when we frequently operate on patients, we find no residual cancer in the tissue at the time of surgery,” Dr. Barron said. “The question arises as to whether we can limit surgery in patients with a pathological complete response.” While imaging has limited ability to reliably detect pCR with 100% specificity, she noted that recent trials have shown the potential of tumor-bed biopsy to identify pCR in patients after NAC (Ann Surg. Published online Oct. 23, 2017. doi: 10.1097/SLA.0000000000002573; JAMA Surg. 2017;152(7):665-70).
The National Cancer Database data the Mayo researchers analyzed yielded an overall breast pCR of 29%. “When broken down by tumor subtype, we saw significantly higher rates of breast pCR in patients with HER2+ disease (42%, n = 3,107) and TNBC (35%, n = 2,469), compared with patients with hormone-receptor positive (HR+)/HER2-negative disease (12%, n = 1,020),” she said.
When the analysis looked specifically at patients who were clinically node negative at presentation and had a pCR, the rates of positive lymph nodes at the time of surgery were 1.6% in HER2+ patients and 1.7% in TNBC disease, Dr. Barron said. “If there was residual disease in the breast, the nodal positivity rate was significantly higher, at 18% in HER2+ and 12% in TNBC,” she added. In those who were clinical N1, the breast pCR rates were similar – 41% in HER2+ and 35% in TNBC – but nodal positivity rates were significantly higher, at 13% and 14%, respectively.
The HR+/HER2- group had significantly lower rates of pCR: 12% in the cN0 and 13% in the cN1 subgroups. This subgroup also had higher nodal positivity rates – in the cN0 subgroup, 4% in those with a breast pCR and 34% in those with residual disease in the breast, and in the cN1 subgroup, 30% and 83%, respectively.
When the investigators looked at the extent of nodal burden in cN0 patients with breast pCR, they found the rate of N2 and N3 disease was near zero across all biologic subtypes. “In patients who were cN1 at presentation and achieved a breast pCR but had residual axillary disease, the majority had N1 disease with only 1.5%-4% having four or more positive lymph nodes,” Dr. Barron said.
In the discussion, session moderator Carla Fisher, MD, of Indiana University, Indianapolis, said, “While we might not be ready for prime time to not evaluate the lymph nodes of these patients, this study does speak to the importance of establishing N0 and N1 prior to NAC.” In reply to her question about how Mayo routinely evaluates node status prior to NAC, Dr. Barron noted that Mayo performs routine axillary ultrasound. However, the NCDB data does not specify what imaging was done. This is thought to vary across the centers in the NCDB, Dr. Barron said.
Noted Dr. Boughey, “The findings from this study provide data that can be used moving forward for planning future clinical trials.” She also said that these findings do not alter the current standard of care; that still calls for breast and nodal surgery after NAC. However, the ongoing NRG-BR005 phase II clinical trial is assessing the accuracy of tumor-bed biopsy in these situations (ClinicalTrials.gov Identifier: NCT03188393). “The results from that trial will help inform future trials evaluating eliminating breast surgery in patients with an excellent response to NAC,” Dr. Boughey said. “Those patients could also potentially avoid axillary surgery based on the data we have now.”
Dr. Barron and Dr. Boughey and coauthors reported having no financial disclosures.
SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.
CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.
Alison U. Barron, MD, breast surgery oncology fellow at Mayo, presented the results. “In patients with HER2+ breast cancer and TNBC who are clinically node negative (cN0) and achieve a breast pathological complete response, this data supports omitting axillary surgery in clinical trials assessing no surgery after neoadjuvant chemotherapy (NAC),” she said. “In patients who present with clinically positive node [cN1] disease with a breast pathological complete response, surgical staging of the axilla is still recommended.”
“Response rates to NAC have increased,” Dr. Barron said. She cited previous reports that showed response rates ranging from 9%-13% for anthracyclines to 19%-26% with the addition of taxanes, and to 60%-70% with the addition of trastuzumab and pertuzumab in HER2+ disease. “Furthermore, we know that tumor biology affects response rates, with TNBC and HER2+ disease having the highest rates of pathologic complete response,” she said.
“In the current era when we frequently operate on patients, we find no residual cancer in the tissue at the time of surgery,” Dr. Barron said. “The question arises as to whether we can limit surgery in patients with a pathological complete response.” While imaging has limited ability to reliably detect pCR with 100% specificity, she noted that recent trials have shown the potential of tumor-bed biopsy to identify pCR in patients after NAC (Ann Surg. Published online Oct. 23, 2017. doi: 10.1097/SLA.0000000000002573; JAMA Surg. 2017;152(7):665-70).
The National Cancer Database data the Mayo researchers analyzed yielded an overall breast pCR of 29%. “When broken down by tumor subtype, we saw significantly higher rates of breast pCR in patients with HER2+ disease (42%, n = 3,107) and TNBC (35%, n = 2,469), compared with patients with hormone-receptor positive (HR+)/HER2-negative disease (12%, n = 1,020),” she said.
When the analysis looked specifically at patients who were clinically node negative at presentation and had a pCR, the rates of positive lymph nodes at the time of surgery were 1.6% in HER2+ patients and 1.7% in TNBC disease, Dr. Barron said. “If there was residual disease in the breast, the nodal positivity rate was significantly higher, at 18% in HER2+ and 12% in TNBC,” she added. In those who were clinical N1, the breast pCR rates were similar – 41% in HER2+ and 35% in TNBC – but nodal positivity rates were significantly higher, at 13% and 14%, respectively.
The HR+/HER2- group had significantly lower rates of pCR: 12% in the cN0 and 13% in the cN1 subgroups. This subgroup also had higher nodal positivity rates – in the cN0 subgroup, 4% in those with a breast pCR and 34% in those with residual disease in the breast, and in the cN1 subgroup, 30% and 83%, respectively.
When the investigators looked at the extent of nodal burden in cN0 patients with breast pCR, they found the rate of N2 and N3 disease was near zero across all biologic subtypes. “In patients who were cN1 at presentation and achieved a breast pCR but had residual axillary disease, the majority had N1 disease with only 1.5%-4% having four or more positive lymph nodes,” Dr. Barron said.
In the discussion, session moderator Carla Fisher, MD, of Indiana University, Indianapolis, said, “While we might not be ready for prime time to not evaluate the lymph nodes of these patients, this study does speak to the importance of establishing N0 and N1 prior to NAC.” In reply to her question about how Mayo routinely evaluates node status prior to NAC, Dr. Barron noted that Mayo performs routine axillary ultrasound. However, the NCDB data does not specify what imaging was done. This is thought to vary across the centers in the NCDB, Dr. Barron said.
Noted Dr. Boughey, “The findings from this study provide data that can be used moving forward for planning future clinical trials.” She also said that these findings do not alter the current standard of care; that still calls for breast and nodal surgery after NAC. However, the ongoing NRG-BR005 phase II clinical trial is assessing the accuracy of tumor-bed biopsy in these situations (ClinicalTrials.gov Identifier: NCT03188393). “The results from that trial will help inform future trials evaluating eliminating breast surgery in patients with an excellent response to NAC,” Dr. Boughey said. “Those patients could also potentially avoid axillary surgery based on the data we have now.”
Dr. Barron and Dr. Boughey and coauthors reported having no financial disclosures.
SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.
REPORTING FROM SSO 2018
Key clinical point: Neoadjuvant chemotherapy for certain breast cancers achieves low rates of nodal positivity.
Major finding: In clinically node-negative HER2+ and triple-negative disease, nodal positivity after NAC in patients that had breast pathological complete response was less than 2%.
Study details: Review of 22,695 patients in NCDB with clinical T1 or T2 disease from 2010 to 2014.
Disclosure: Dr. Barron and coauthors reported having no financial disclosures.
Source: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.
No increased complication risk with delaying resection for LARC
CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”
The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.
The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).
Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.
Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.
The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).
During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.
Dr. Roxburgh and coauthors reported having no financial disclosures.
SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.
CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”
The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.
The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).
Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.
Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.
The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).
During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.
Dr. Roxburgh and coauthors reported having no financial disclosures.
SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.
CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”
The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.
The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).
Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.
Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.
The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).
During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.
Dr. Roxburgh and coauthors reported having no financial disclosures.
SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.
REPORTING FROM SSO 2018
Key clinical point: Timing of surgery for rectal cancer within 12 weeks of neoadjuvant therapy does not influence complications.
Major finding: Complication rates in early and later surgery groups were 44% and 38%.
Study details: Institutional cohort of 607 patients who had rectal resection within 16 weeks of completing NT between June 2009 and March 2015.
Disclosure: Dr. Roxburgh and coauthors reported having no financial disclosures.
Source: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.
Accuracy of colon cancer lymph node sampling influenced by location
CHICAGO – Clinical guidelines recommend , but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.
Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.
The probability of achieving true nodal negativity when 12 lymph nodes were examined was 64% for left and 68% for right colon cancer in the trial group and 72% and 77% in the NCDB cohort, Dr. Dehal said.
The analysis also examined how many nodes would need to be sampled to achieve probabilities of 85%, 90% and 95% true nodal negativity. This analysis found the numbers were consistently lower for right- vs. left-sided disease, Dr. Dehal said. For example, in the trial cohort, 27 lymph nodes would need be sampled in right-sided disease to achieve 85% probability vs. 31 in left-sided. In the NCDB cohort, those numbers were 21 and 25, respectively.
“The current threshold for adequate nodal sampling does not reliably predict the true nodal negativity in this subgroup of patients,” Dr. Dehal said. “In both cohorts – the trial and NCDB – more lymph nodes are needed to predict the true nodal negativity in patients with left compared to right colon cancer.”
These findings may help to inform revisions to existing clinical guidelines, Dr. Dehal said.
“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”
Dr. Dehal and his coauthors reported having no financial disclosures.
SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.
*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type
CHICAGO – Clinical guidelines recommend , but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.
Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.
The probability of achieving true nodal negativity when 12 lymph nodes were examined was 64% for left and 68% for right colon cancer in the trial group and 72% and 77% in the NCDB cohort, Dr. Dehal said.
The analysis also examined how many nodes would need to be sampled to achieve probabilities of 85%, 90% and 95% true nodal negativity. This analysis found the numbers were consistently lower for right- vs. left-sided disease, Dr. Dehal said. For example, in the trial cohort, 27 lymph nodes would need be sampled in right-sided disease to achieve 85% probability vs. 31 in left-sided. In the NCDB cohort, those numbers were 21 and 25, respectively.
“The current threshold for adequate nodal sampling does not reliably predict the true nodal negativity in this subgroup of patients,” Dr. Dehal said. “In both cohorts – the trial and NCDB – more lymph nodes are needed to predict the true nodal negativity in patients with left compared to right colon cancer.”
These findings may help to inform revisions to existing clinical guidelines, Dr. Dehal said.
“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”
Dr. Dehal and his coauthors reported having no financial disclosures.
SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.
*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type
CHICAGO – Clinical guidelines recommend , but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.
Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.
The probability of achieving true nodal negativity when 12 lymph nodes were examined was 64% for left and 68% for right colon cancer in the trial group and 72% and 77% in the NCDB cohort, Dr. Dehal said.
The analysis also examined how many nodes would need to be sampled to achieve probabilities of 85%, 90% and 95% true nodal negativity. This analysis found the numbers were consistently lower for right- vs. left-sided disease, Dr. Dehal said. For example, in the trial cohort, 27 lymph nodes would need be sampled in right-sided disease to achieve 85% probability vs. 31 in left-sided. In the NCDB cohort, those numbers were 21 and 25, respectively.
“The current threshold for adequate nodal sampling does not reliably predict the true nodal negativity in this subgroup of patients,” Dr. Dehal said. “In both cohorts – the trial and NCDB – more lymph nodes are needed to predict the true nodal negativity in patients with left compared to right colon cancer.”
These findings may help to inform revisions to existing clinical guidelines, Dr. Dehal said.
“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”
Dr. Dehal and his coauthors reported having no financial disclosures.
SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.
*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type
REPORTING FROM SSO 2018
Key clinical point: Sidedness influences the number of lymph nodes needed to predict true nodal negativity in colon cancer.
Major finding: Probability of true nodal negativity when 12 lymph nodes were examined was 64% for left and 68% for right colon cancer.
Study details: Randomized, multicenter trial of ultrastaging in colon cancer in 370 patients and National Cancer Database sampling of 153,945 patients.
Disclosures: Dr. Dehal and his coauthors report having no financial disclosures.
Source: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.
Over one-third report financial burden from breast cancer treatment
CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.
“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.
Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.
Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.
Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”
She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.
Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.
Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.
The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.
Dr. Greenup and her study coauthors reported having no financial disclosures.
SOURCE: Greenup RA. SSO 2018, Abstract No. 24.
CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.
“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.
Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.
Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.
Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”
She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.
Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.
Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.
The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.
Dr. Greenup and her study coauthors reported having no financial disclosures.
SOURCE: Greenup RA. SSO 2018, Abstract No. 24.
CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.
“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.
Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.
Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.
Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”
She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.
Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.
Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.
The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.
Dr. Greenup and her study coauthors reported having no financial disclosures.
SOURCE: Greenup RA. SSO 2018, Abstract No. 24.
REPORTING FROM SSO 2018
Key clinical point: Treatment costs are important to many women with breast cancer, although most report not having cost discussions with their physicians.
Major finding: Despite the high levels of insurance coverage, 35% of study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.”
Study details: An 88-item survey completed by 654 adult women who had treatment for breast cancer.
Disclosures: Dr. Greenup and her coauthors reported having no financial disclosures.
Source: Greenup RA. SSO 2018, Abstract No. 24.