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ELCC: NSCLC mutation testing highlights ctDNA’s limitations
GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.
“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.
Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.
The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.
The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.
On Twitter @mitchelzoler
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| Mitchel L. Zoler/Frontline Medical News Dr. Egbert F. Smit |
The ASSESS study is the largest evaluation of using ctDNA to test the status of a lung tumor for the presence of a mutation in the gene for the epidermal growth factor receptor. It also gives us insight into the feasibility and effectiveness of using this approach in routine practice, outside of a rigorously designed trial. The result was that mutation testing using plasma specimens to obtain circulating tumor DNA was generally doable but resulted in low sensitivity and a low positive predictive value.
The low sensitivity seen overall in ASSESS likely resulted from the multiple testing reagents, commercially available testing kits, and in-house techniques used by individual laboratories in this international study done in diverse settings. Some of the tests for epidermal growth factor receptor (EGFR) mutations are quite sensitive, and others less so. The specific testing method used matters quite a lot. The heterogeneity of methods used in ASSESS reflects the diversity of what usually happens in real-world practice.
Based on the sensitivity limitations, I currently see using ctDNA to test for EGFR mutations only when this is the only option for mutation assessment because a conventional biopsy of the primary tumor failed to provide enough DNA for EGFR mutation testing. Although it is hard to find specific numbers on how often this situation arises in current practice, it seems to happen roughly 10%-30% of the time. So, for about one-fifth of patients with newly diagnosed or recurrent stage III or IV lung cancer EGFR mutation assessment using ctDNA will be necessary.
The data from ASSESS and other studies show that when ctDNA testing identifies an EGFR mutation you can rely on its accuracy. The problem is when ctDNA testing fails to identify an EGFR mutation. In those situations you need to be cautious as you can’t rely on a negative result as being a true negative. I would also be cautious about using ctDNA testing to follow lung cancer patients, as the clinical importance of finding new EGFR alleles appearing in the patient’s blood over time is not yet clear. We need more studies that follow these patients and changes in their EGFR ctDNA over time to determine the clinical relevance of these changes.
The results from ASSESS add to the existing body of evidence that ctDNA testing to find EGFR mutations is feasible in a real-world setting.
Dr. Egbert F. Smit is a professor of pulmonary medicine at the VU University Medical Center in Amsterdam.He had no relevant disclosures. He made these comments in an interview and as the designated discussant for the ASSESS study at the meeting.
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| Mitchel L. Zoler/Frontline Medical News Dr. Egbert F. Smit |
The ASSESS study is the largest evaluation of using ctDNA to test the status of a lung tumor for the presence of a mutation in the gene for the epidermal growth factor receptor. It also gives us insight into the feasibility and effectiveness of using this approach in routine practice, outside of a rigorously designed trial. The result was that mutation testing using plasma specimens to obtain circulating tumor DNA was generally doable but resulted in low sensitivity and a low positive predictive value.
The low sensitivity seen overall in ASSESS likely resulted from the multiple testing reagents, commercially available testing kits, and in-house techniques used by individual laboratories in this international study done in diverse settings. Some of the tests for epidermal growth factor receptor (EGFR) mutations are quite sensitive, and others less so. The specific testing method used matters quite a lot. The heterogeneity of methods used in ASSESS reflects the diversity of what usually happens in real-world practice.
Based on the sensitivity limitations, I currently see using ctDNA to test for EGFR mutations only when this is the only option for mutation assessment because a conventional biopsy of the primary tumor failed to provide enough DNA for EGFR mutation testing. Although it is hard to find specific numbers on how often this situation arises in current practice, it seems to happen roughly 10%-30% of the time. So, for about one-fifth of patients with newly diagnosed or recurrent stage III or IV lung cancer EGFR mutation assessment using ctDNA will be necessary.
The data from ASSESS and other studies show that when ctDNA testing identifies an EGFR mutation you can rely on its accuracy. The problem is when ctDNA testing fails to identify an EGFR mutation. In those situations you need to be cautious as you can’t rely on a negative result as being a true negative. I would also be cautious about using ctDNA testing to follow lung cancer patients, as the clinical importance of finding new EGFR alleles appearing in the patient’s blood over time is not yet clear. We need more studies that follow these patients and changes in their EGFR ctDNA over time to determine the clinical relevance of these changes.
The results from ASSESS add to the existing body of evidence that ctDNA testing to find EGFR mutations is feasible in a real-world setting.
Dr. Egbert F. Smit is a professor of pulmonary medicine at the VU University Medical Center in Amsterdam.He had no relevant disclosures. He made these comments in an interview and as the designated discussant for the ASSESS study at the meeting.
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| Mitchel L. Zoler/Frontline Medical News Dr. Egbert F. Smit |
The ASSESS study is the largest evaluation of using ctDNA to test the status of a lung tumor for the presence of a mutation in the gene for the epidermal growth factor receptor. It also gives us insight into the feasibility and effectiveness of using this approach in routine practice, outside of a rigorously designed trial. The result was that mutation testing using plasma specimens to obtain circulating tumor DNA was generally doable but resulted in low sensitivity and a low positive predictive value.
The low sensitivity seen overall in ASSESS likely resulted from the multiple testing reagents, commercially available testing kits, and in-house techniques used by individual laboratories in this international study done in diverse settings. Some of the tests for epidermal growth factor receptor (EGFR) mutations are quite sensitive, and others less so. The specific testing method used matters quite a lot. The heterogeneity of methods used in ASSESS reflects the diversity of what usually happens in real-world practice.
Based on the sensitivity limitations, I currently see using ctDNA to test for EGFR mutations only when this is the only option for mutation assessment because a conventional biopsy of the primary tumor failed to provide enough DNA for EGFR mutation testing. Although it is hard to find specific numbers on how often this situation arises in current practice, it seems to happen roughly 10%-30% of the time. So, for about one-fifth of patients with newly diagnosed or recurrent stage III or IV lung cancer EGFR mutation assessment using ctDNA will be necessary.
The data from ASSESS and other studies show that when ctDNA testing identifies an EGFR mutation you can rely on its accuracy. The problem is when ctDNA testing fails to identify an EGFR mutation. In those situations you need to be cautious as you can’t rely on a negative result as being a true negative. I would also be cautious about using ctDNA testing to follow lung cancer patients, as the clinical importance of finding new EGFR alleles appearing in the patient’s blood over time is not yet clear. We need more studies that follow these patients and changes in their EGFR ctDNA over time to determine the clinical relevance of these changes.
The results from ASSESS add to the existing body of evidence that ctDNA testing to find EGFR mutations is feasible in a real-world setting.
Dr. Egbert F. Smit is a professor of pulmonary medicine at the VU University Medical Center in Amsterdam.He had no relevant disclosures. He made these comments in an interview and as the designated discussant for the ASSESS study at the meeting.
GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.
“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.
Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.
The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.
The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.
On Twitter @mitchelzoler
GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.
“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.
Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.
The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.
The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.
On Twitter @mitchelzoler
AT ELCC 2015
Key clinical point: In a real-world setting genetic tests that used ctDNA to find treatment-determining mutations in patients with advanced lung cancer were generally less sensitive than genetic tests using biopsy material from the primary tumor.
Major finding: Mutation assessment results from ctDNA and biopsy DNA showed concordance in 89% of specimen pairs tested.
Data source: Prospective study with paired test results from 1,162 patients treated in seven European countries or in Japan.
Disclosures: The ASSESS study was funded by AstraZeneca. Dr. Reck has been a speaker and consultant to AstraZeneca and seven other companies.
Oophorectomy improves survival after breast cancer in BRCA1 carriers
Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.
In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).
Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.
“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).
The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.
Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.
Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).
Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”
Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.
In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).
Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.
“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).
The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.
Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.
Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).
Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”
Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.
In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).
Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.
“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).
The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.
Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.
Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).
Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”
FROM JAMA ONCOLOGY
Key clinical point: Oophorectomy significantly improved the prognosis of women with breast cancer and a BRCA1 mutation.
Major finding: The adjusted hazard ratio for breast cancer mortality in women with a BRCA1 mutation who had breast cancer and a subsequent oophorectomy was 0.38 (95% CI, 0.19-0.077; P = .007).
Data source: The retrospective cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and breast cancer diagnosed from 1975 to 2008.
Disclosures: Dr. Kelly Metcalfe reported having no disclosures. The research was funded by the Canadian Breast Cancer Foundation.
Sentinel node mapping adequately detects nodal spread of endometrial cancer
CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.
“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.
“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.
Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.
They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.
Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.
Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.
Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)
With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).
“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”
“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”
In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.
In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.
In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.
“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”
CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.
“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.
“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.
Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.
They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.
Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.
Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.
Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)
With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).
“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”
“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”
In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.
In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.
In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.
“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”
CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.
“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.
“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.
Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.
They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.
Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.
Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.
Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)
With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).
“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”
“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”
In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.
In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.
In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.
“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: SLN mapping performs similarly to LND for detecting stage IIIC disease in women with endometrial cancer.
Major finding: SLN mapping had a higher detection rate of stage IIIC1 disease in low-risk disease (4.8% vs. 1.8%) and a similar detection rate of stage IIIC disease overall in intermediate- and high-risk disease.
Data source: Two retrospective cohort studies of 1,135 women with low-risk endometrial cancer and 412 women with intermediate- or high-risk endometrial cancer.
Disclosures: Dr. Eriksson disclosed that she had no relevant conflicts of interest. Dr. Ducie disclosed that she had no relevant conflicts of interest.
SCORPION: Interval debulking is safer in advanced ovarian cancer
CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).
The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.
“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.
“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”
The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”
Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.
“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.
The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.
Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.
On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).
Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.
In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.
The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).
CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).
The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.
“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.
“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”
The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”
Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.
“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.
The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.
Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.
On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).
Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.
In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.
The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).
CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).
The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.
“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.
“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”
The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”
Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.
“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.
The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.
Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.
On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).
Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.
In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.
The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Complications were much less common with interval debulking than with primary debulking.
Major finding: The odds of major perioperative morbidity were 19.3 times higher with primary debulking than with neoadjuvant chemotherapy followed by interval debulking.
Data source: Interim results of a randomized phase III trial among 110 patients with ovarian cancer and a high tumor load.
Disclosures: Dr. Fagotti disclosed that she had no relevant conflicts of interest.
Model accurately spots low-risk endometrial cancer
CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.
The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.
“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.
“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”
Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”
The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.
In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.
The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.
Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.
On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.
In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.
The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.
The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.
CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.
The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.
“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.
“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”
Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”
The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.
In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.
The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.
Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.
On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.
In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.
The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.
The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.
CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.
The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.
“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.
“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”
Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”
The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.
In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.
The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.
Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.
On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.
In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.
The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.
The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: A preoperative risk model may help identify women with endometrial cancer who can skip lymphadenectomy.
Major finding: The model had a negative predictive value of 97%.
Data source: A prospective cohort study of 529 Asian women with endometrial cancer.
Disclosures: Dr. Kang disclosed that he had no relevant conflicts of interest.
Rectal preservation feasible after cancer clinical remission
HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.
That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.
Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.
“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.
Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.
They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.
Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).
Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).
Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.
As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.
There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.
Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.
The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.
HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.
That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.
Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.
“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.
Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.
They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.
Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).
Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).
Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.
As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.
There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.
Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.
The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.
HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.
That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.
Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.
“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.
Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.
They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.
Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).
Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).
Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.
As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.
There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.
Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.
The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.
Key clinical point: Patients with complete clinical response after neoadjuvant chemotherapy for rectal cancer may be able to be safely followed with nonoperative management.
Major finding: There were no significant differences at 4 years in either disease-specific or overall survival among patients with rectal cancer managed conservatively or with total mesorectal excision.
Data source: Review of prospectively collected data on 145 patients with locally advanced rectal cancer.
Disclosures: The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.
Neoadjuvant therapy facilitates breast conservation
HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.
“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.
A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.
The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.
Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.
Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.
Factors to consider when selecting neoadjuvant chemotherapy include:
• Tumor size.
• Lymph node status.
• Estrogen, progesterone, and/or HER2 status.
• Treatment sensitivity (as measured by Ki-67 or other markers).
• Pathologic complete response rates.
Chemo for HR-positive?
“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.
Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.
HER2-positive disease
For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study
Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.
Triple negative disease
Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.
Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.
HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.
“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.
A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.
The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.
Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.
Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.
Factors to consider when selecting neoadjuvant chemotherapy include:
• Tumor size.
• Lymph node status.
• Estrogen, progesterone, and/or HER2 status.
• Treatment sensitivity (as measured by Ki-67 or other markers).
• Pathologic complete response rates.
Chemo for HR-positive?
“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.
Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.
HER2-positive disease
For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study
Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.
Triple negative disease
Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.
Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.
HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.
“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.
A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.
The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.
Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.
Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.
Factors to consider when selecting neoadjuvant chemotherapy include:
• Tumor size.
• Lymph node status.
• Estrogen, progesterone, and/or HER2 status.
• Treatment sensitivity (as measured by Ki-67 or other markers).
• Pathologic complete response rates.
Chemo for HR-positive?
“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.
Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.
HER2-positive disease
For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study
Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.
Triple negative disease
Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.
Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.
New melanoma therapies may break the bank
HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.
Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.
“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.
Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.
Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.
But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.
Increased survival, higher costs
Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.
The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).
The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.
The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.
Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.
In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.
Dr. Gershenwald disclosed serving on a Merck advisory board.
HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.
Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.
“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.
Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.
Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.
But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.
Increased survival, higher costs
Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.
The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).
The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.
The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.
Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.
In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.
Dr. Gershenwald disclosed serving on a Merck advisory board.
HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.
Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.
“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.
Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.
Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.
But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.
Increased survival, higher costs
Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.
The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).
The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.
The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.
Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.
In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.
Dr. Gershenwald disclosed serving on a Merck advisory board.
AT SSO 2015
Key clinical point: Immunotherapies and targeted agents for metastatic melanoma are effective but very costly.
Major finding: The incremental cost-effectiveness ratio for vemurafenib, compared with dacarbazine, was nearly $354,993 per quality-adjusted life-year gained.
Data source: A review of data on the efficacy and costs of therapy for metastatic malignant melanoma.
Disclosures: Dr. Gershenwald disclosed serving on a Merck advisory board.
Clinical doc improvement ups income, quality
HOUSTON – Results of a pilot program suggest that a surgeon-led Clinical Documentation Improvement (CDI) program can improve the accuracy of diagnostic coding, validate the quality of care delivered, and help ensure that hospitals are fairly compensated for the complexity of care they provide.
A comparison of outcomes of cases from four surgical oncologists from the periods before and after implementation of a CDI suggested that the actual case mix index (CMI) was 9% higher than the original charts indicated, a change that would translate into a more than $700,000 increase in reimbursement, said Dr. Keith Gray from the University of Tennessee Medical Center in Knoxville.
“CDI is low-hanging fruit in the era of pay for quality and dwindling hospital margins. Physicians and hospitals can benefit, and surgical oncologists are the natural physicians in the hospital to lead this process, “ Dr. Gray said at the Society of Surgical Oncology 2015 Cancer Symposium.
CDI programs are collaborative efforts between clinicians and health information management professionals, designed to document the quality of care the institution delivers through improved diagnostic coding, he explained.
The benefits of CDI include more accurate reflection of the severity of illness of patients, better sharing of data among caregivers, optimizing of claims processing, and a stronger bottom line.
“We all think we have the sickest patients in the country, and that’s why our results don’t match up. Clinical documentation is an opportunity for you to prove that,” he said.
In the study, a physician extender trained in CDI audited and update all inpatient diagnoses made by four surgical oncologists in a hospital-based practice from November 2012 through May 2013. The diagnoses were listed as being present on admission or recorded during the inpatient stay.
The investigators looked at data on the CMI, average mortality risk, and average severity of illness for 489 patients treated during the study period. These data were compared with a control set from 482 patients treated from March 2011 through October 2012, the period immediately prior to the implementation of the CDI.
The authors found that with the clinical documentation program in place, the CMI, risk of mortality estimates, and severity of illness index all increased.
The practice’s mean CMI, for example, increased from 2.38 to 2.59 (P < .001), a 9% relative increase. Dr. Gray noted that every 0.1 change in CMI represents a $700/patient difference in reimbursement. Therefore, the change would translate into a $718,830 relative increase in reimbursement.
Similarly, the severity of illness index, based on patient comorbidities, age, procedures, and principal diagnosis also increased, from a mean of 2.32 for controls to 2.54 during the study period, translating into a 9.5% increase (P < .001).
Risk of mortality estimates – the likelihood of in-hospital death based on comorbidities, age, procedures, and principal diagnosis – also increased, from a mean 1.88 to 2.07, a 10% increase (P < .001).
Although the CMI, risk of mortality, and severity of illness all increased during the study period, compared with the control period, the percentage of cases above the average length of stay, a measure of quality care, declined significantly, from 45.6% pre-CDI to 31.1% after CDI was implemented (P = .0001). Other measures of quality such as the observed to expected mortality ratio, length of stay ratio, and percentage of cases above the average cost also improved, but the changes were not statistically significant.
“CDI is relatively easy to implement with the resources that we have in place, and there’s minimal additional training to become efficient in this process,” Dr. Gray said.
The study was internally funded. Dr. Gray did not report potential conflicts of interest.
HOUSTON – Results of a pilot program suggest that a surgeon-led Clinical Documentation Improvement (CDI) program can improve the accuracy of diagnostic coding, validate the quality of care delivered, and help ensure that hospitals are fairly compensated for the complexity of care they provide.
A comparison of outcomes of cases from four surgical oncologists from the periods before and after implementation of a CDI suggested that the actual case mix index (CMI) was 9% higher than the original charts indicated, a change that would translate into a more than $700,000 increase in reimbursement, said Dr. Keith Gray from the University of Tennessee Medical Center in Knoxville.
“CDI is low-hanging fruit in the era of pay for quality and dwindling hospital margins. Physicians and hospitals can benefit, and surgical oncologists are the natural physicians in the hospital to lead this process, “ Dr. Gray said at the Society of Surgical Oncology 2015 Cancer Symposium.
CDI programs are collaborative efforts between clinicians and health information management professionals, designed to document the quality of care the institution delivers through improved diagnostic coding, he explained.
The benefits of CDI include more accurate reflection of the severity of illness of patients, better sharing of data among caregivers, optimizing of claims processing, and a stronger bottom line.
“We all think we have the sickest patients in the country, and that’s why our results don’t match up. Clinical documentation is an opportunity for you to prove that,” he said.
In the study, a physician extender trained in CDI audited and update all inpatient diagnoses made by four surgical oncologists in a hospital-based practice from November 2012 through May 2013. The diagnoses were listed as being present on admission or recorded during the inpatient stay.
The investigators looked at data on the CMI, average mortality risk, and average severity of illness for 489 patients treated during the study period. These data were compared with a control set from 482 patients treated from March 2011 through October 2012, the period immediately prior to the implementation of the CDI.
The authors found that with the clinical documentation program in place, the CMI, risk of mortality estimates, and severity of illness index all increased.
The practice’s mean CMI, for example, increased from 2.38 to 2.59 (P < .001), a 9% relative increase. Dr. Gray noted that every 0.1 change in CMI represents a $700/patient difference in reimbursement. Therefore, the change would translate into a $718,830 relative increase in reimbursement.
Similarly, the severity of illness index, based on patient comorbidities, age, procedures, and principal diagnosis also increased, from a mean of 2.32 for controls to 2.54 during the study period, translating into a 9.5% increase (P < .001).
Risk of mortality estimates – the likelihood of in-hospital death based on comorbidities, age, procedures, and principal diagnosis – also increased, from a mean 1.88 to 2.07, a 10% increase (P < .001).
Although the CMI, risk of mortality, and severity of illness all increased during the study period, compared with the control period, the percentage of cases above the average length of stay, a measure of quality care, declined significantly, from 45.6% pre-CDI to 31.1% after CDI was implemented (P = .0001). Other measures of quality such as the observed to expected mortality ratio, length of stay ratio, and percentage of cases above the average cost also improved, but the changes were not statistically significant.
“CDI is relatively easy to implement with the resources that we have in place, and there’s minimal additional training to become efficient in this process,” Dr. Gray said.
The study was internally funded. Dr. Gray did not report potential conflicts of interest.
HOUSTON – Results of a pilot program suggest that a surgeon-led Clinical Documentation Improvement (CDI) program can improve the accuracy of diagnostic coding, validate the quality of care delivered, and help ensure that hospitals are fairly compensated for the complexity of care they provide.
A comparison of outcomes of cases from four surgical oncologists from the periods before and after implementation of a CDI suggested that the actual case mix index (CMI) was 9% higher than the original charts indicated, a change that would translate into a more than $700,000 increase in reimbursement, said Dr. Keith Gray from the University of Tennessee Medical Center in Knoxville.
“CDI is low-hanging fruit in the era of pay for quality and dwindling hospital margins. Physicians and hospitals can benefit, and surgical oncologists are the natural physicians in the hospital to lead this process, “ Dr. Gray said at the Society of Surgical Oncology 2015 Cancer Symposium.
CDI programs are collaborative efforts between clinicians and health information management professionals, designed to document the quality of care the institution delivers through improved diagnostic coding, he explained.
The benefits of CDI include more accurate reflection of the severity of illness of patients, better sharing of data among caregivers, optimizing of claims processing, and a stronger bottom line.
“We all think we have the sickest patients in the country, and that’s why our results don’t match up. Clinical documentation is an opportunity for you to prove that,” he said.
In the study, a physician extender trained in CDI audited and update all inpatient diagnoses made by four surgical oncologists in a hospital-based practice from November 2012 through May 2013. The diagnoses were listed as being present on admission or recorded during the inpatient stay.
The investigators looked at data on the CMI, average mortality risk, and average severity of illness for 489 patients treated during the study period. These data were compared with a control set from 482 patients treated from March 2011 through October 2012, the period immediately prior to the implementation of the CDI.
The authors found that with the clinical documentation program in place, the CMI, risk of mortality estimates, and severity of illness index all increased.
The practice’s mean CMI, for example, increased from 2.38 to 2.59 (P < .001), a 9% relative increase. Dr. Gray noted that every 0.1 change in CMI represents a $700/patient difference in reimbursement. Therefore, the change would translate into a $718,830 relative increase in reimbursement.
Similarly, the severity of illness index, based on patient comorbidities, age, procedures, and principal diagnosis also increased, from a mean of 2.32 for controls to 2.54 during the study period, translating into a 9.5% increase (P < .001).
Risk of mortality estimates – the likelihood of in-hospital death based on comorbidities, age, procedures, and principal diagnosis – also increased, from a mean 1.88 to 2.07, a 10% increase (P < .001).
Although the CMI, risk of mortality, and severity of illness all increased during the study period, compared with the control period, the percentage of cases above the average length of stay, a measure of quality care, declined significantly, from 45.6% pre-CDI to 31.1% after CDI was implemented (P = .0001). Other measures of quality such as the observed to expected mortality ratio, length of stay ratio, and percentage of cases above the average cost also improved, but the changes were not statistically significant.
“CDI is relatively easy to implement with the resources that we have in place, and there’s minimal additional training to become efficient in this process,” Dr. Gray said.
The study was internally funded. Dr. Gray did not report potential conflicts of interest.
AT SSO 2015
Key clinical point: A surgeon-led clinical documentation program can increase revenue by demonstrating case-mix severity.
Major finding: An audit of previous cases showed that proper documentation would yield $718,830 in additional reimbursements.
Data source: Pilot program and retrospective case audit involving cases of 489 patients and 482 controls.
Disclosures: The study was internally funded. Dr. Gray did not report potential conflicts of interest.
Risk scale predicts mortality after gastric cancer surgery
HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.
The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.
“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.
The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.
Weighing risks
Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.
She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.
They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.
They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.
They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.
The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.
The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.
The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.
The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.
The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.
Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.
HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.
The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.
“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.
The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.
Weighing risks
Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.
She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.
They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.
They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.
They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.
The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.
The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.
The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.
The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.
The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.
Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.
HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.
The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.
“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.
The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.
Weighing risks
Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.
She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.
They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.
They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.
They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.
The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.
The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.
The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.
The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.
The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.
Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.
AT SSO 2015
Key clinical point: The bedside risk scale can be used in patient counseling prior to surgery for gastric malignancies.
Major finding: Patients with scores of 0-5 had perioperative death rates of 1.3%-4.5%. Patients with higher scores had death rates ranging from 6.0% to 23.1%.
Data source: Review of retrospective data on 24,538 adults who underwent partial or total gastric resection for malignancies.
Disclosures: The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.
