User login
Study aims to determine prognostic factors for subset of thyroid cancer patients
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm may be candidates for a “watch and wait” approach before initiating treatment with sorafenib.
Major finding: Baseline or disease-related variables found to be prognostic factors for progression-free survival in placebo patients and in all patients when adjusted for sorafenib treatment included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia versus Europe and North America.
Data source: An analysis of 417 patients from the randomized, controlled, double-blind, phase III DECISION trial.
Disclosures: Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
Adding cisplatin to docetaxel monotherapy provides no benefit for elderly with NSCLC
There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced non–small cell lung cancer.
Major finding: Overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49).
Data source: Randomized phase III Japanese trial of 276 elderly patients with stage III, stage IV, or recurrent non–small cell lung cancer (Intergroup Trial JCOG0803/WJOG4307L).
Disclosures: Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
Genetic test predicts 10-year risk of DCIS recurrence
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
AT SABCS 2014
Key clinical point: A genetic assay can accurately predict the 10-year risk of local recurrence in women with ductal carcinoma in situ.
Major finding: Women with the highest risk as graded by Oncotype DCIS Score were 68% more likely to develop recurrence than were those in the lowest risk group.
Data source: The retrospective validation study comprised 257 women with DCIS who were treated with breast-conserving surgery alone.
Disclosures:Funding was provided by the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
VIDEO: What was the most interesting thing you learned at the meeting?
SAN ANTONIO – Our reporter Michele Sullivan asked selected attendees at the San Antonio Breast Cancer Symposium to identify the most interesting or practice-changing study presented at the meeting. The answer was the same across the board - the Suppression of Ovarian Function Trial (SOFT), which showed that selective ovarian suppression reduces disease recurrence in women with early breast cancer.
In our video interview clinicians respond to the implications of the data in their practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Our reporter Michele Sullivan asked selected attendees at the San Antonio Breast Cancer Symposium to identify the most interesting or practice-changing study presented at the meeting. The answer was the same across the board - the Suppression of Ovarian Function Trial (SOFT), which showed that selective ovarian suppression reduces disease recurrence in women with early breast cancer.
In our video interview clinicians respond to the implications of the data in their practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Our reporter Michele Sullivan asked selected attendees at the San Antonio Breast Cancer Symposium to identify the most interesting or practice-changing study presented at the meeting. The answer was the same across the board - the Suppression of Ovarian Function Trial (SOFT), which showed that selective ovarian suppression reduces disease recurrence in women with early breast cancer.
In our video interview clinicians respond to the implications of the data in their practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SABCS 2014
VIDEO: Multidisciplinary panel addresses role of anesthesia, analgesics in patient outcomes
SAN ANTONIO – A panel that included a breast surgeon, a medical oncologist, and a patient advocate met at the San Antonio Breast Cancer Symposium to discuss emerging research on the link between anesthesia and cancer recurrence. The issue was first raised following publication of a retrospective study in 2006, which showed a 40% reduction in recurrence in women given a type of regional anesthesia, with general anesthesia, rather than general anesthesia and postoperative morphine anesthesia during primary breast cancer surgery.
Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, moderated the discussion with Dr. Juan Cata, assistant professor in the department of anesthesiology and perioperative medicine at the University of Texas MD Anderson Cancer Center, Dr. Susan Love, breast surgeon, and president and medical director of the Dr. Susan Love Research Foundation, and Musa Mayer, author and patient advocate.
The panel addressed the impact of surgery alone, anesthesia during surgery, and perioperative analgesics on patients’ immune functioning and ultimately disease outcomes. The state of the evidence in breast cancer and other tumor types, and an ongoing prospective trial with breast cancer patients, were also discussed.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @nikolaideslaura
SAN ANTONIO – A panel that included a breast surgeon, a medical oncologist, and a patient advocate met at the San Antonio Breast Cancer Symposium to discuss emerging research on the link between anesthesia and cancer recurrence. The issue was first raised following publication of a retrospective study in 2006, which showed a 40% reduction in recurrence in women given a type of regional anesthesia, with general anesthesia, rather than general anesthesia and postoperative morphine anesthesia during primary breast cancer surgery.
Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, moderated the discussion with Dr. Juan Cata, assistant professor in the department of anesthesiology and perioperative medicine at the University of Texas MD Anderson Cancer Center, Dr. Susan Love, breast surgeon, and president and medical director of the Dr. Susan Love Research Foundation, and Musa Mayer, author and patient advocate.
The panel addressed the impact of surgery alone, anesthesia during surgery, and perioperative analgesics on patients’ immune functioning and ultimately disease outcomes. The state of the evidence in breast cancer and other tumor types, and an ongoing prospective trial with breast cancer patients, were also discussed.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @nikolaideslaura
SAN ANTONIO – A panel that included a breast surgeon, a medical oncologist, and a patient advocate met at the San Antonio Breast Cancer Symposium to discuss emerging research on the link between anesthesia and cancer recurrence. The issue was first raised following publication of a retrospective study in 2006, which showed a 40% reduction in recurrence in women given a type of regional anesthesia, with general anesthesia, rather than general anesthesia and postoperative morphine anesthesia during primary breast cancer surgery.
Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, moderated the discussion with Dr. Juan Cata, assistant professor in the department of anesthesiology and perioperative medicine at the University of Texas MD Anderson Cancer Center, Dr. Susan Love, breast surgeon, and president and medical director of the Dr. Susan Love Research Foundation, and Musa Mayer, author and patient advocate.
The panel addressed the impact of surgery alone, anesthesia during surgery, and perioperative analgesics on patients’ immune functioning and ultimately disease outcomes. The state of the evidence in breast cancer and other tumor types, and an ongoing prospective trial with breast cancer patients, were also discussed.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @nikolaideslaura
AT SABCS 2014
Ultrasound bests elastography for specificity of thyroid cancer diagnosis
CORONADO, CALIF.– Compared with elastography, ultrasound predictors of malignancy were more specific for presurgical diagnosis and in differentiating between benign and malignant thyroid nodules, results from a pooled analysis showed.
“Elastography is controversial,” Dr. Parisha Bhatia said in an interview during the annual meeting of the American Thyroid Association. “Some studies have reported that it has better sensitivity and specificity, compared with conventional ultrasound, but others have found it not to be helpful.”
In an effort to compare the efficacy of elastography and ultrasound in determining benign and malignant thyroid nodules, and to determine if elastography has a complementary role to fine needle aspiration (FNA), Dr. Bhatia and her associates searched Embase and PubMed databases for articles involving more than 50 nodules using specimen histology as the reference standard. They discovered 14 prospective studies and organized them into one of two groups. Group 1 included nodules with FNA cytology–proven “benign/malignant” result. Group 2 included nodules with FNA cytology as “intermediate.” The elasticity score was compared with ultrasound features such as taller than wide, irregular margins, internal vascularity, calcification, and absence of halo to determine validity measures and likelihood ratios.
Dr. Bhatia, an endocrine surgeon at Tulane University, New Orleans, reported on findings from 2,732 nodules in the pooled analysis. Of these, 64% were benign, 25% were malignant, and 11% were indeterminate.
In group 1, elastography showed a sensitivity of 75%, a specificity of 80%, a positive predictive value (PPV) of 61%, a negative predictive value (NPV) of 89%, and a likelihood ratio of 5.7, with a higher predictive value for nodules smaller than 1 cm in diameter (PPV of 79% and NPV of 83%). The strongest ultrasound-related predictor of malignancies was “taller than wide” (a specificity of 92%, a NPV of 51%, yet a sensitivity of only 24%), followed by irregular margins (a specificity of 91%, sensitivity of 48%, and a PPV of 64%). Combination of elastography and ultrasound had the highest sensitivity (96%) and NPV (96%), yet lower specificity (46%) and PPV (46%).
In group 2, elastography yielded a higher sensitivity (90%) and NPV (92%), while ultrasound features were highly specific, with the highest values for “taller than wide” shape (85%) in these thyroid nodules.
“Ultrasound predictors of malignancy prove to be more specific for presurgical diagnosis and differentiation of benign and malignant thyroid nodules,” the researchers wrote in their abstract. “When used as an adjunct, the higher sensitivity and NPV of combination of both the techniques can lead to better selection of candidates for FNA.”
Dr. Bhatia acknowledged certain limitations of the study, including the fact that the pooled data contained little information on indeterminate thyroid nodules. She reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF.– Compared with elastography, ultrasound predictors of malignancy were more specific for presurgical diagnosis and in differentiating between benign and malignant thyroid nodules, results from a pooled analysis showed.
“Elastography is controversial,” Dr. Parisha Bhatia said in an interview during the annual meeting of the American Thyroid Association. “Some studies have reported that it has better sensitivity and specificity, compared with conventional ultrasound, but others have found it not to be helpful.”
In an effort to compare the efficacy of elastography and ultrasound in determining benign and malignant thyroid nodules, and to determine if elastography has a complementary role to fine needle aspiration (FNA), Dr. Bhatia and her associates searched Embase and PubMed databases for articles involving more than 50 nodules using specimen histology as the reference standard. They discovered 14 prospective studies and organized them into one of two groups. Group 1 included nodules with FNA cytology–proven “benign/malignant” result. Group 2 included nodules with FNA cytology as “intermediate.” The elasticity score was compared with ultrasound features such as taller than wide, irregular margins, internal vascularity, calcification, and absence of halo to determine validity measures and likelihood ratios.
Dr. Bhatia, an endocrine surgeon at Tulane University, New Orleans, reported on findings from 2,732 nodules in the pooled analysis. Of these, 64% were benign, 25% were malignant, and 11% were indeterminate.
In group 1, elastography showed a sensitivity of 75%, a specificity of 80%, a positive predictive value (PPV) of 61%, a negative predictive value (NPV) of 89%, and a likelihood ratio of 5.7, with a higher predictive value for nodules smaller than 1 cm in diameter (PPV of 79% and NPV of 83%). The strongest ultrasound-related predictor of malignancies was “taller than wide” (a specificity of 92%, a NPV of 51%, yet a sensitivity of only 24%), followed by irregular margins (a specificity of 91%, sensitivity of 48%, and a PPV of 64%). Combination of elastography and ultrasound had the highest sensitivity (96%) and NPV (96%), yet lower specificity (46%) and PPV (46%).
In group 2, elastography yielded a higher sensitivity (90%) and NPV (92%), while ultrasound features were highly specific, with the highest values for “taller than wide” shape (85%) in these thyroid nodules.
“Ultrasound predictors of malignancy prove to be more specific for presurgical diagnosis and differentiation of benign and malignant thyroid nodules,” the researchers wrote in their abstract. “When used as an adjunct, the higher sensitivity and NPV of combination of both the techniques can lead to better selection of candidates for FNA.”
Dr. Bhatia acknowledged certain limitations of the study, including the fact that the pooled data contained little information on indeterminate thyroid nodules. She reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF.– Compared with elastography, ultrasound predictors of malignancy were more specific for presurgical diagnosis and in differentiating between benign and malignant thyroid nodules, results from a pooled analysis showed.
“Elastography is controversial,” Dr. Parisha Bhatia said in an interview during the annual meeting of the American Thyroid Association. “Some studies have reported that it has better sensitivity and specificity, compared with conventional ultrasound, but others have found it not to be helpful.”
In an effort to compare the efficacy of elastography and ultrasound in determining benign and malignant thyroid nodules, and to determine if elastography has a complementary role to fine needle aspiration (FNA), Dr. Bhatia and her associates searched Embase and PubMed databases for articles involving more than 50 nodules using specimen histology as the reference standard. They discovered 14 prospective studies and organized them into one of two groups. Group 1 included nodules with FNA cytology–proven “benign/malignant” result. Group 2 included nodules with FNA cytology as “intermediate.” The elasticity score was compared with ultrasound features such as taller than wide, irregular margins, internal vascularity, calcification, and absence of halo to determine validity measures and likelihood ratios.
Dr. Bhatia, an endocrine surgeon at Tulane University, New Orleans, reported on findings from 2,732 nodules in the pooled analysis. Of these, 64% were benign, 25% were malignant, and 11% were indeterminate.
In group 1, elastography showed a sensitivity of 75%, a specificity of 80%, a positive predictive value (PPV) of 61%, a negative predictive value (NPV) of 89%, and a likelihood ratio of 5.7, with a higher predictive value for nodules smaller than 1 cm in diameter (PPV of 79% and NPV of 83%). The strongest ultrasound-related predictor of malignancies was “taller than wide” (a specificity of 92%, a NPV of 51%, yet a sensitivity of only 24%), followed by irregular margins (a specificity of 91%, sensitivity of 48%, and a PPV of 64%). Combination of elastography and ultrasound had the highest sensitivity (96%) and NPV (96%), yet lower specificity (46%) and PPV (46%).
In group 2, elastography yielded a higher sensitivity (90%) and NPV (92%), while ultrasound features were highly specific, with the highest values for “taller than wide” shape (85%) in these thyroid nodules.
“Ultrasound predictors of malignancy prove to be more specific for presurgical diagnosis and differentiation of benign and malignant thyroid nodules,” the researchers wrote in their abstract. “When used as an adjunct, the higher sensitivity and NPV of combination of both the techniques can lead to better selection of candidates for FNA.”
Dr. Bhatia acknowledged certain limitations of the study, including the fact that the pooled data contained little information on indeterminate thyroid nodules. She reported having no financial disclosures.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Ultrasound is more specific than elastography in helping clinicians make a presurgical diagnosis of thyroid cancer.
Major finding: Compared with elastography, ultrasound was more specific in presurgical diagnosis and in differentiating between benign and malignant thyroid nodules (specificity of 92% vs. 80%, respectively).
Data source: A pooled analysis of 14 prospective studies involving findings from 2,732 thyroid nodules.
Disclosures: Dr. Bhatia reported having no financial disclosures.
Regional lymph node mets not a risk factor for death in adrenocortical carcinoma
SAN FRANCISCO– Positive regional lymph nodes are not an independent risk factor for death from adrenocortical carcinoma, finds a cohort study presented at the annual clinical congress of the American College of Surgeons.
“High tumor grade and distant metastasis were the only independent prognostic factors,” reported lead researcher Dr. Kun-Tai Hsu, a surgical resident formerly with the University of Wisconsin–Madison and currently at Michigan State University in East Lansing.
“While regional lymph node metastasis was not associated with worse outcome, it was associated with local tumor invasion. More importantly, regional lymph node status and local tumor invasion had equivalent impact on disease-specific mortality, but lymph node status was not a marker for local tumor invasion,” he added.
Using the Surveillance, Epidemiology, and End Results (SEER) database, the researchers analyzed data for 1,202 adults who underwent surgery for unilateral adrenocortical carcinoma between 1973 and 2010. A total of 10% had regional lymph node metastases, as ascertained by sampling, imaging, or both.
Median survival was 46 months for the cohort overall, and the 5-year rate of disease-specific mortality was 55%, Dr. Hsu reported. Patients with regional lymph node metastases had higher significantly disease-specific mortality in unadjusted analyses but not in adjusted analysis. However, high tumor grade and distant metastases were both strong independent risk factors (hazard ratios, 2.37 and 2.87).
Patients were more likely to have regional lymph node metastases if they had local invasion. When peers having neither of these factors were the comparator, risk was elevated for patients with only positive lymph nodes (HR, 9.9) and for patients with only local invasion (HR, 6.7), and most for patients having both factors (HR, 18.0).
“The effect appears to be additive rather than a true interaction,” commented Dr. Hsu, who disclosed that he had no conflicts of interest relevant to the research. “Therefore, there was no synergistic interaction between local tumor invasion and regional lymph node metastases: these two disease factors equally predict disease-specific mortality and are not simply a marker of one another.”
“We are aware that there are several limitations of the SEER database,” he acknowledged. “Nevertheless, given the rare nature of adrenocortical carcinoma, SEER provided enough data to have the statistical power and objectivity not available from single-institution studies.”
In an interview, session comoderator Dr. Amelia C. Grover of the Department of Surgery’s division of surgical oncology, Virginia Commonwealth University in Richmond, said that the findings reinforce earlier research on this cancer. “The problem is, adrenocortical carcinoma is such a uncommon disease, it makes drawing a large enough group difficult. So the SEER database was a great resource,” she agreed. “However, because of its limitations, it makes it hard to draw any significant conclusions, again stressing that for these unusual endocrine neoplasms, it’s really great to have collaborative efforts from multiple institutions in driving that research forward and collecting that data so that we can better care for those patients.”
SAN FRANCISCO– Positive regional lymph nodes are not an independent risk factor for death from adrenocortical carcinoma, finds a cohort study presented at the annual clinical congress of the American College of Surgeons.
“High tumor grade and distant metastasis were the only independent prognostic factors,” reported lead researcher Dr. Kun-Tai Hsu, a surgical resident formerly with the University of Wisconsin–Madison and currently at Michigan State University in East Lansing.
“While regional lymph node metastasis was not associated with worse outcome, it was associated with local tumor invasion. More importantly, regional lymph node status and local tumor invasion had equivalent impact on disease-specific mortality, but lymph node status was not a marker for local tumor invasion,” he added.
Using the Surveillance, Epidemiology, and End Results (SEER) database, the researchers analyzed data for 1,202 adults who underwent surgery for unilateral adrenocortical carcinoma between 1973 and 2010. A total of 10% had regional lymph node metastases, as ascertained by sampling, imaging, or both.
Median survival was 46 months for the cohort overall, and the 5-year rate of disease-specific mortality was 55%, Dr. Hsu reported. Patients with regional lymph node metastases had higher significantly disease-specific mortality in unadjusted analyses but not in adjusted analysis. However, high tumor grade and distant metastases were both strong independent risk factors (hazard ratios, 2.37 and 2.87).
Patients were more likely to have regional lymph node metastases if they had local invasion. When peers having neither of these factors were the comparator, risk was elevated for patients with only positive lymph nodes (HR, 9.9) and for patients with only local invasion (HR, 6.7), and most for patients having both factors (HR, 18.0).
“The effect appears to be additive rather than a true interaction,” commented Dr. Hsu, who disclosed that he had no conflicts of interest relevant to the research. “Therefore, there was no synergistic interaction between local tumor invasion and regional lymph node metastases: these two disease factors equally predict disease-specific mortality and are not simply a marker of one another.”
“We are aware that there are several limitations of the SEER database,” he acknowledged. “Nevertheless, given the rare nature of adrenocortical carcinoma, SEER provided enough data to have the statistical power and objectivity not available from single-institution studies.”
In an interview, session comoderator Dr. Amelia C. Grover of the Department of Surgery’s division of surgical oncology, Virginia Commonwealth University in Richmond, said that the findings reinforce earlier research on this cancer. “The problem is, adrenocortical carcinoma is such a uncommon disease, it makes drawing a large enough group difficult. So the SEER database was a great resource,” she agreed. “However, because of its limitations, it makes it hard to draw any significant conclusions, again stressing that for these unusual endocrine neoplasms, it’s really great to have collaborative efforts from multiple institutions in driving that research forward and collecting that data so that we can better care for those patients.”
SAN FRANCISCO– Positive regional lymph nodes are not an independent risk factor for death from adrenocortical carcinoma, finds a cohort study presented at the annual clinical congress of the American College of Surgeons.
“High tumor grade and distant metastasis were the only independent prognostic factors,” reported lead researcher Dr. Kun-Tai Hsu, a surgical resident formerly with the University of Wisconsin–Madison and currently at Michigan State University in East Lansing.
“While regional lymph node metastasis was not associated with worse outcome, it was associated with local tumor invasion. More importantly, regional lymph node status and local tumor invasion had equivalent impact on disease-specific mortality, but lymph node status was not a marker for local tumor invasion,” he added.
Using the Surveillance, Epidemiology, and End Results (SEER) database, the researchers analyzed data for 1,202 adults who underwent surgery for unilateral adrenocortical carcinoma between 1973 and 2010. A total of 10% had regional lymph node metastases, as ascertained by sampling, imaging, or both.
Median survival was 46 months for the cohort overall, and the 5-year rate of disease-specific mortality was 55%, Dr. Hsu reported. Patients with regional lymph node metastases had higher significantly disease-specific mortality in unadjusted analyses but not in adjusted analysis. However, high tumor grade and distant metastases were both strong independent risk factors (hazard ratios, 2.37 and 2.87).
Patients were more likely to have regional lymph node metastases if they had local invasion. When peers having neither of these factors were the comparator, risk was elevated for patients with only positive lymph nodes (HR, 9.9) and for patients with only local invasion (HR, 6.7), and most for patients having both factors (HR, 18.0).
“The effect appears to be additive rather than a true interaction,” commented Dr. Hsu, who disclosed that he had no conflicts of interest relevant to the research. “Therefore, there was no synergistic interaction between local tumor invasion and regional lymph node metastases: these two disease factors equally predict disease-specific mortality and are not simply a marker of one another.”
“We are aware that there are several limitations of the SEER database,” he acknowledged. “Nevertheless, given the rare nature of adrenocortical carcinoma, SEER provided enough data to have the statistical power and objectivity not available from single-institution studies.”
In an interview, session comoderator Dr. Amelia C. Grover of the Department of Surgery’s division of surgical oncology, Virginia Commonwealth University in Richmond, said that the findings reinforce earlier research on this cancer. “The problem is, adrenocortical carcinoma is such a uncommon disease, it makes drawing a large enough group difficult. So the SEER database was a great resource,” she agreed. “However, because of its limitations, it makes it hard to draw any significant conclusions, again stressing that for these unusual endocrine neoplasms, it’s really great to have collaborative efforts from multiple institutions in driving that research forward and collecting that data so that we can better care for those patients.”
AT THE ACS CLINICAL CONGRESS
Key clinical point: Regional lymph node metastasis does not independently predict disease-specific mortality.
Major finding: Patients with involved regional nodes were not more likely to die from their cancer after other factors were taken in account.
Data source: A retrospective cohort study of 1,202 adults who had surgery for unilateral adrenocortical carcinoma.
Disclosures: Dr. Hsu disclosed that he had no relevant conflicts of interest.
Sentinel lymph node mapping effective for staging early endometrial cancer
MELBOURNE – Staging endometrial cancer using sentinel lymph node mapping reduces side effects for patients, and enables selection of lymph nodes for pathology that are more likely to have disease in them, an investigator reported at the biennial meeting of the International Gynecologic Cancer Society.
The procedure results in fewer lymph nodes being removed – usually two to three on each side, and no more than ten – which meant less side effects such as lymphedema, and potentially avoided the need for pelvic lymphadenectomy said Dr. Nadeem Abu-Rustum, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York.
“One, you are removing fewer lymph nodes so there’s less radicality in surgery and less side effects; two, it makes the operating time faster, and three, you give the pathologist fewer lymph nodes but they can work on them in more depth to try to find low-volume metastases,” Dr. Abu-Rustum said in an interview.
“It’s a win-win situation for the patient.”
Dr. Abu-Rustum and colleagues at Memorial Sloan-Kettering have developed a sentinel lymph node mapping algorithm for stage I cervical or endometrial cancers.
“It is applicable for any women who has endometrial cancer where the surgeon feels that the cancer is contained, and you need staging information,” he said.
However he stressed it was not applicable in patients with obvious metastases or with abnormal lymph nodes.
“This is for normal-appearing lymph nodes, clinical stage I, and the algorithm checklist really protects you because it will exclude those patients [with abnormal lymph nodes].”
While there was ongoing debate about where to inject the dye to best identify the sentinel node, Dr. Abu-Rustum told the conference that he and his colleagues believed injecting into the cervix at the three o’clock and nine o’clock positions was the most reasonable option.
He also commented on the different dyes used, saying that while methylene blue or lymphazurin had been the traditional choice – with or without technetium-99 – the near-infrared fluorescing indocyanine green and use of a laser significantly improved accuracy of the procedure.
“Now you’re able to increase the chance of finding the lymph node from 80% to almost 100%, and finding it on the right and the left was 60%, now it’s 80%,” he said.
In another presentation, a speaker reported an overall sentinel lymph node detection rate of 92%, and a 74% rate of bilateral detection, using a combination of methylene blue, technetium-99, and indocyanine green, in 100 patients who underwent sentinel lymph node mapping for endometrial cancer.
Among the 10 patients in the prospective study who had metastatic disease, 9 had a positive sentinel lymph node. The sentinel node was found to be the only positive node in 66% of these patients, suggesting that this was the most clinically relevant node. There was one case of a false negative for a sentinel lymph node, reported Dr. Jeffrey How, obstetrics and gynecology resident at the McGill University Health Centre, Montreal.
The addition of indocyanine green increased the precision of in vivo detection of sentinel lymph nodes, aiding detection of the highest-yield lymph nodes for pathology, he said.
No conflicts of interest were declared.
MELBOURNE – Staging endometrial cancer using sentinel lymph node mapping reduces side effects for patients, and enables selection of lymph nodes for pathology that are more likely to have disease in them, an investigator reported at the biennial meeting of the International Gynecologic Cancer Society.
The procedure results in fewer lymph nodes being removed – usually two to three on each side, and no more than ten – which meant less side effects such as lymphedema, and potentially avoided the need for pelvic lymphadenectomy said Dr. Nadeem Abu-Rustum, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York.
“One, you are removing fewer lymph nodes so there’s less radicality in surgery and less side effects; two, it makes the operating time faster, and three, you give the pathologist fewer lymph nodes but they can work on them in more depth to try to find low-volume metastases,” Dr. Abu-Rustum said in an interview.
“It’s a win-win situation for the patient.”
Dr. Abu-Rustum and colleagues at Memorial Sloan-Kettering have developed a sentinel lymph node mapping algorithm for stage I cervical or endometrial cancers.
“It is applicable for any women who has endometrial cancer where the surgeon feels that the cancer is contained, and you need staging information,” he said.
However he stressed it was not applicable in patients with obvious metastases or with abnormal lymph nodes.
“This is for normal-appearing lymph nodes, clinical stage I, and the algorithm checklist really protects you because it will exclude those patients [with abnormal lymph nodes].”
While there was ongoing debate about where to inject the dye to best identify the sentinel node, Dr. Abu-Rustum told the conference that he and his colleagues believed injecting into the cervix at the three o’clock and nine o’clock positions was the most reasonable option.
He also commented on the different dyes used, saying that while methylene blue or lymphazurin had been the traditional choice – with or without technetium-99 – the near-infrared fluorescing indocyanine green and use of a laser significantly improved accuracy of the procedure.
“Now you’re able to increase the chance of finding the lymph node from 80% to almost 100%, and finding it on the right and the left was 60%, now it’s 80%,” he said.
In another presentation, a speaker reported an overall sentinel lymph node detection rate of 92%, and a 74% rate of bilateral detection, using a combination of methylene blue, technetium-99, and indocyanine green, in 100 patients who underwent sentinel lymph node mapping for endometrial cancer.
Among the 10 patients in the prospective study who had metastatic disease, 9 had a positive sentinel lymph node. The sentinel node was found to be the only positive node in 66% of these patients, suggesting that this was the most clinically relevant node. There was one case of a false negative for a sentinel lymph node, reported Dr. Jeffrey How, obstetrics and gynecology resident at the McGill University Health Centre, Montreal.
The addition of indocyanine green increased the precision of in vivo detection of sentinel lymph nodes, aiding detection of the highest-yield lymph nodes for pathology, he said.
No conflicts of interest were declared.
MELBOURNE – Staging endometrial cancer using sentinel lymph node mapping reduces side effects for patients, and enables selection of lymph nodes for pathology that are more likely to have disease in them, an investigator reported at the biennial meeting of the International Gynecologic Cancer Society.
The procedure results in fewer lymph nodes being removed – usually two to three on each side, and no more than ten – which meant less side effects such as lymphedema, and potentially avoided the need for pelvic lymphadenectomy said Dr. Nadeem Abu-Rustum, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York.
“One, you are removing fewer lymph nodes so there’s less radicality in surgery and less side effects; two, it makes the operating time faster, and three, you give the pathologist fewer lymph nodes but they can work on them in more depth to try to find low-volume metastases,” Dr. Abu-Rustum said in an interview.
“It’s a win-win situation for the patient.”
Dr. Abu-Rustum and colleagues at Memorial Sloan-Kettering have developed a sentinel lymph node mapping algorithm for stage I cervical or endometrial cancers.
“It is applicable for any women who has endometrial cancer where the surgeon feels that the cancer is contained, and you need staging information,” he said.
However he stressed it was not applicable in patients with obvious metastases or with abnormal lymph nodes.
“This is for normal-appearing lymph nodes, clinical stage I, and the algorithm checklist really protects you because it will exclude those patients [with abnormal lymph nodes].”
While there was ongoing debate about where to inject the dye to best identify the sentinel node, Dr. Abu-Rustum told the conference that he and his colleagues believed injecting into the cervix at the three o’clock and nine o’clock positions was the most reasonable option.
He also commented on the different dyes used, saying that while methylene blue or lymphazurin had been the traditional choice – with or without technetium-99 – the near-infrared fluorescing indocyanine green and use of a laser significantly improved accuracy of the procedure.
“Now you’re able to increase the chance of finding the lymph node from 80% to almost 100%, and finding it on the right and the left was 60%, now it’s 80%,” he said.
In another presentation, a speaker reported an overall sentinel lymph node detection rate of 92%, and a 74% rate of bilateral detection, using a combination of methylene blue, technetium-99, and indocyanine green, in 100 patients who underwent sentinel lymph node mapping for endometrial cancer.
Among the 10 patients in the prospective study who had metastatic disease, 9 had a positive sentinel lymph node. The sentinel node was found to be the only positive node in 66% of these patients, suggesting that this was the most clinically relevant node. There was one case of a false negative for a sentinel lymph node, reported Dr. Jeffrey How, obstetrics and gynecology resident at the McGill University Health Centre, Montreal.
The addition of indocyanine green increased the precision of in vivo detection of sentinel lymph nodes, aiding detection of the highest-yield lymph nodes for pathology, he said.
No conflicts of interest were declared.
AT IGCS 2014
Radioactive iodine may boost survival in papillary thyroid cancer
CORONADO, CALIF. – The use of radioactive iodine in patients with papillary thyroid cancer showed a small but statistically significant survival benefit for all tumor size categories, a long-term analysis of national data suggested.
“The incidence of papillary thyroid carcinoma is rapidly rising, but the survival advantage of radioactive iodine ablation has not been confirmed,” Dr. Paritosh Suman said at the annual meeting of the American Thyroid Association.
To investigate the effect of radioactive iodine (RAI) on papillary thyroid cancer mortality, Dr. Suman and his associates identified 108,565 patients from the National Cancer Data Base who were diagnosed with papillary thyroid cancer and underwent total or near total thyroidectomy between 1998 and 2006.
The investigators classified tumors into one of four groups by diameter size: 10 mm or less, 11-20 mm, 21-40 mm, and greater than 40 mm. The study researchers used Cox regression analysis to quantify the effect of radioactive iodine, adjusting for clinicopathologic, demographic, and socioeconomic variables. A total of 52% of the patients were older than 45 years, 77% were female, and 54% received RAI.
Factors predicting the use of RAI were being male, having positive margins, having cervical lymph node involvement, and having a tumor size greater than 4 cm in diameter, said Dr. Suman, an endocrinology surgery fellow at North Shore University Health System in Evanston, Ill. The 10-year overall survival rate was 90% in those who received RAI, compared with 87.4% among those who did not, for a small but statistically significant survival advantage (P < .0001).
Among patients who received RAI, the 10-year survival advantage by diameter of tumor was 3.4% for those with tumors 10 mm or less; 2.8% with 11-20 mm; 3.3% with 21-40 mm, and 5.7% with greater than 40 mm.
Age also played a factor, with a 10-year survival advantage of 0.5% for those aged 18-35 years; 1.5% for those aged 36-45 years; 0.9% for those aged 46-55 years; 0.6% for those aged 56-65 years; and 2.1% for those older than 65 years. Both men and women who received RAI had a statistically significant survival advantage at 10 years (3.9% and 1.6%, respectively).
When the researchers assessed the 10-year survival advantage by lymph node category of patients who received RAI, the rates were 2.9% for N-0, 4.2% for N-1, 5.2% for N-1A, and 5.8% for N-1B. By margin status, the 10-year survival advantage was 3.1% for negative margins, 3.6% for positive margins, 3.5% for microscopic margins, and 8.8% for gross margins.
In an analysis of all patients with very low-risk, low-risk, and high-risk papillary thyroid carcinoma according to ATA guidelines for the use of RAI, the study authors found a 10-year survival advantage of RAI in each of the three categories.
Among patients with very low-risk papillary thyroid carcinoma, the rate of 10-year survival was 92.2% among those who received RAI, compared with 89% among those who did not (hazard ratio, 0.74). Similar associations were observed in those with low-risk carcinoma (91.8% vs. 89%; HR, 0.80) and in those with high-risk carcinoma (86.2% vs. 79.2%; HR, 0.71).
“RAI is associated with a statistically significant but small overall survival advantage for most patients,” Dr. Suman said. “High-risk patients, defined by large tumor size, lymph node involvement, and gross margins, achieve the greatest benefit with RAI ablation.”
Dr. Suman reported having no relevant financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – The use of radioactive iodine in patients with papillary thyroid cancer showed a small but statistically significant survival benefit for all tumor size categories, a long-term analysis of national data suggested.
“The incidence of papillary thyroid carcinoma is rapidly rising, but the survival advantage of radioactive iodine ablation has not been confirmed,” Dr. Paritosh Suman said at the annual meeting of the American Thyroid Association.
To investigate the effect of radioactive iodine (RAI) on papillary thyroid cancer mortality, Dr. Suman and his associates identified 108,565 patients from the National Cancer Data Base who were diagnosed with papillary thyroid cancer and underwent total or near total thyroidectomy between 1998 and 2006.
The investigators classified tumors into one of four groups by diameter size: 10 mm or less, 11-20 mm, 21-40 mm, and greater than 40 mm. The study researchers used Cox regression analysis to quantify the effect of radioactive iodine, adjusting for clinicopathologic, demographic, and socioeconomic variables. A total of 52% of the patients were older than 45 years, 77% were female, and 54% received RAI.
Factors predicting the use of RAI were being male, having positive margins, having cervical lymph node involvement, and having a tumor size greater than 4 cm in diameter, said Dr. Suman, an endocrinology surgery fellow at North Shore University Health System in Evanston, Ill. The 10-year overall survival rate was 90% in those who received RAI, compared with 87.4% among those who did not, for a small but statistically significant survival advantage (P < .0001).
Among patients who received RAI, the 10-year survival advantage by diameter of tumor was 3.4% for those with tumors 10 mm or less; 2.8% with 11-20 mm; 3.3% with 21-40 mm, and 5.7% with greater than 40 mm.
Age also played a factor, with a 10-year survival advantage of 0.5% for those aged 18-35 years; 1.5% for those aged 36-45 years; 0.9% for those aged 46-55 years; 0.6% for those aged 56-65 years; and 2.1% for those older than 65 years. Both men and women who received RAI had a statistically significant survival advantage at 10 years (3.9% and 1.6%, respectively).
When the researchers assessed the 10-year survival advantage by lymph node category of patients who received RAI, the rates were 2.9% for N-0, 4.2% for N-1, 5.2% for N-1A, and 5.8% for N-1B. By margin status, the 10-year survival advantage was 3.1% for negative margins, 3.6% for positive margins, 3.5% for microscopic margins, and 8.8% for gross margins.
In an analysis of all patients with very low-risk, low-risk, and high-risk papillary thyroid carcinoma according to ATA guidelines for the use of RAI, the study authors found a 10-year survival advantage of RAI in each of the three categories.
Among patients with very low-risk papillary thyroid carcinoma, the rate of 10-year survival was 92.2% among those who received RAI, compared with 89% among those who did not (hazard ratio, 0.74). Similar associations were observed in those with low-risk carcinoma (91.8% vs. 89%; HR, 0.80) and in those with high-risk carcinoma (86.2% vs. 79.2%; HR, 0.71).
“RAI is associated with a statistically significant but small overall survival advantage for most patients,” Dr. Suman said. “High-risk patients, defined by large tumor size, lymph node involvement, and gross margins, achieve the greatest benefit with RAI ablation.”
Dr. Suman reported having no relevant financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – The use of radioactive iodine in patients with papillary thyroid cancer showed a small but statistically significant survival benefit for all tumor size categories, a long-term analysis of national data suggested.
“The incidence of papillary thyroid carcinoma is rapidly rising, but the survival advantage of radioactive iodine ablation has not been confirmed,” Dr. Paritosh Suman said at the annual meeting of the American Thyroid Association.
To investigate the effect of radioactive iodine (RAI) on papillary thyroid cancer mortality, Dr. Suman and his associates identified 108,565 patients from the National Cancer Data Base who were diagnosed with papillary thyroid cancer and underwent total or near total thyroidectomy between 1998 and 2006.
The investigators classified tumors into one of four groups by diameter size: 10 mm or less, 11-20 mm, 21-40 mm, and greater than 40 mm. The study researchers used Cox regression analysis to quantify the effect of radioactive iodine, adjusting for clinicopathologic, demographic, and socioeconomic variables. A total of 52% of the patients were older than 45 years, 77% were female, and 54% received RAI.
Factors predicting the use of RAI were being male, having positive margins, having cervical lymph node involvement, and having a tumor size greater than 4 cm in diameter, said Dr. Suman, an endocrinology surgery fellow at North Shore University Health System in Evanston, Ill. The 10-year overall survival rate was 90% in those who received RAI, compared with 87.4% among those who did not, for a small but statistically significant survival advantage (P < .0001).
Among patients who received RAI, the 10-year survival advantage by diameter of tumor was 3.4% for those with tumors 10 mm or less; 2.8% with 11-20 mm; 3.3% with 21-40 mm, and 5.7% with greater than 40 mm.
Age also played a factor, with a 10-year survival advantage of 0.5% for those aged 18-35 years; 1.5% for those aged 36-45 years; 0.9% for those aged 46-55 years; 0.6% for those aged 56-65 years; and 2.1% for those older than 65 years. Both men and women who received RAI had a statistically significant survival advantage at 10 years (3.9% and 1.6%, respectively).
When the researchers assessed the 10-year survival advantage by lymph node category of patients who received RAI, the rates were 2.9% for N-0, 4.2% for N-1, 5.2% for N-1A, and 5.8% for N-1B. By margin status, the 10-year survival advantage was 3.1% for negative margins, 3.6% for positive margins, 3.5% for microscopic margins, and 8.8% for gross margins.
In an analysis of all patients with very low-risk, low-risk, and high-risk papillary thyroid carcinoma according to ATA guidelines for the use of RAI, the study authors found a 10-year survival advantage of RAI in each of the three categories.
Among patients with very low-risk papillary thyroid carcinoma, the rate of 10-year survival was 92.2% among those who received RAI, compared with 89% among those who did not (hazard ratio, 0.74). Similar associations were observed in those with low-risk carcinoma (91.8% vs. 89%; HR, 0.80) and in those with high-risk carcinoma (86.2% vs. 79.2%; HR, 0.71).
“RAI is associated with a statistically significant but small overall survival advantage for most patients,” Dr. Suman said. “High-risk patients, defined by large tumor size, lymph node involvement, and gross margins, achieve the greatest benefit with RAI ablation.”
Dr. Suman reported having no relevant financial disclosures.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: The use of radioactive iodine is associated with a small but statistically significant increase in overall survival in most patients with papillary thyroid carcinoma.
Major finding: The 10-year overall survival rate was 90% in patients who received RAI, compared with 87.4% among those who did not, a small but statistically significant difference (P < .0001).
Data source: An analysis of 108,565 patients from the National Cancer Data Base who were diagnosed with papillary thyroid cancer and underwent total or near total thyroidectomy between 1998 and 2006.
Disclosures: Dr. Suman reported having no relevant financial disclosures.
Palliative tumor removal extends survival
Palliative resection of the primary tumor actually extends survival in patients with metastatic colorectal adenocarcinoma, according to a report published online Nov. 4 in Annals of Surgery.
In what the investigators described as the first population-based study to assess trends in cancer-specific and overall survival among U.S. patients who did or did not undergo palliative removal of the primary tumor, the resection consistently conferred statistically significant and clinically meaningful survival benefits among 37,793 patients treated during a 12-year period.
“There is a heated debate in the medical and surgical oncology community regarding whether or not an asymptomatic primary tumor should be removed in patients with unresectable, synchronous cancer metastases,” wrote Dr. Ignazio Tarantino of the department of surgery, Kantonsspital St. Gallen (Switzerland) and the department of general, abdominal, and transplant surgery, University of Heidelberg (Germany) and his associates.
Current National Comprehensive Cancer Network guidelines recommend against palliative surgery in this setting, primarily because of evidence that leaving the primary tumor in situ seldom leads to life-threatening complications such as bleeding or bowel obstruction, while resection can cause complications and is not strictly necessary in terminally ill patients. But given these new findings of a significant survival benefit, “the dogma that [such tumors] never should be resected ... must be questioned,” the investigators wrote.
Dr. Tarantino and his associates analyzed Surveillance, Epidemiology, and End Results (SEER) data for 23,004 patients (60.9% of the total study population) who underwent primary tumor resection and 14,789 (39.1%) who did not. The percentage of patients who had the surgery steadily declined throughout the study period.
Palliative removal of the primary tumor was a significant protective factor for overall survival (HR of death, 0.49) and for cancer-specific survival (HR of cancer death, 0.49) in both the primary data analysis and a proportional hazard regression analysis.
Patients undergoing resection tended to be younger and healthier than those who did not have the procedure, so the researchers performed a propensity-score matching analysis to account for baseline differences between the two study groups. After adjustment for numerous potential confounders, palliative primary tumor resection continued to exert a significant protective effect for overall and cancer-specific survival, with HRs of 0.40 and 0.39, respectively. The survival benefit also persisted, with identical hazard ratios, in two further sensitivity analyses of the data, Dr. Tarantino and his associates noted (Ann. Surg. 2014 Nov. 4 [doi: 10.1097/SLA.0000000000000860]).
The mechanism by which palliative resection imparts a survival benefit is not yet known, they added.
Major advances in systemic treatment of metastatic colorectal cancer were achieved during the study period, and survival improved accordingly across both groups of patients over time. “Because of the improvement in systemic treatment, we anticipated that the differences in survival between the subsets of patients who did and who did not undergo palliative primary tumor resection would decrease over time. However – against our a priori hypothesis – our analysis demonstrates the contrary,” the investigators noted.
No financial or material support was provided for this study. Dr. Tarantino and his associates reported having no financial disclosures.
Palliative resection of the primary tumor actually extends survival in patients with metastatic colorectal adenocarcinoma, according to a report published online Nov. 4 in Annals of Surgery.
In what the investigators described as the first population-based study to assess trends in cancer-specific and overall survival among U.S. patients who did or did not undergo palliative removal of the primary tumor, the resection consistently conferred statistically significant and clinically meaningful survival benefits among 37,793 patients treated during a 12-year period.
“There is a heated debate in the medical and surgical oncology community regarding whether or not an asymptomatic primary tumor should be removed in patients with unresectable, synchronous cancer metastases,” wrote Dr. Ignazio Tarantino of the department of surgery, Kantonsspital St. Gallen (Switzerland) and the department of general, abdominal, and transplant surgery, University of Heidelberg (Germany) and his associates.
Current National Comprehensive Cancer Network guidelines recommend against palliative surgery in this setting, primarily because of evidence that leaving the primary tumor in situ seldom leads to life-threatening complications such as bleeding or bowel obstruction, while resection can cause complications and is not strictly necessary in terminally ill patients. But given these new findings of a significant survival benefit, “the dogma that [such tumors] never should be resected ... must be questioned,” the investigators wrote.
Dr. Tarantino and his associates analyzed Surveillance, Epidemiology, and End Results (SEER) data for 23,004 patients (60.9% of the total study population) who underwent primary tumor resection and 14,789 (39.1%) who did not. The percentage of patients who had the surgery steadily declined throughout the study period.
Palliative removal of the primary tumor was a significant protective factor for overall survival (HR of death, 0.49) and for cancer-specific survival (HR of cancer death, 0.49) in both the primary data analysis and a proportional hazard regression analysis.
Patients undergoing resection tended to be younger and healthier than those who did not have the procedure, so the researchers performed a propensity-score matching analysis to account for baseline differences between the two study groups. After adjustment for numerous potential confounders, palliative primary tumor resection continued to exert a significant protective effect for overall and cancer-specific survival, with HRs of 0.40 and 0.39, respectively. The survival benefit also persisted, with identical hazard ratios, in two further sensitivity analyses of the data, Dr. Tarantino and his associates noted (Ann. Surg. 2014 Nov. 4 [doi: 10.1097/SLA.0000000000000860]).
The mechanism by which palliative resection imparts a survival benefit is not yet known, they added.
Major advances in systemic treatment of metastatic colorectal cancer were achieved during the study period, and survival improved accordingly across both groups of patients over time. “Because of the improvement in systemic treatment, we anticipated that the differences in survival between the subsets of patients who did and who did not undergo palliative primary tumor resection would decrease over time. However – against our a priori hypothesis – our analysis demonstrates the contrary,” the investigators noted.
No financial or material support was provided for this study. Dr. Tarantino and his associates reported having no financial disclosures.
Palliative resection of the primary tumor actually extends survival in patients with metastatic colorectal adenocarcinoma, according to a report published online Nov. 4 in Annals of Surgery.
In what the investigators described as the first population-based study to assess trends in cancer-specific and overall survival among U.S. patients who did or did not undergo palliative removal of the primary tumor, the resection consistently conferred statistically significant and clinically meaningful survival benefits among 37,793 patients treated during a 12-year period.
“There is a heated debate in the medical and surgical oncology community regarding whether or not an asymptomatic primary tumor should be removed in patients with unresectable, synchronous cancer metastases,” wrote Dr. Ignazio Tarantino of the department of surgery, Kantonsspital St. Gallen (Switzerland) and the department of general, abdominal, and transplant surgery, University of Heidelberg (Germany) and his associates.
Current National Comprehensive Cancer Network guidelines recommend against palliative surgery in this setting, primarily because of evidence that leaving the primary tumor in situ seldom leads to life-threatening complications such as bleeding or bowel obstruction, while resection can cause complications and is not strictly necessary in terminally ill patients. But given these new findings of a significant survival benefit, “the dogma that [such tumors] never should be resected ... must be questioned,” the investigators wrote.
Dr. Tarantino and his associates analyzed Surveillance, Epidemiology, and End Results (SEER) data for 23,004 patients (60.9% of the total study population) who underwent primary tumor resection and 14,789 (39.1%) who did not. The percentage of patients who had the surgery steadily declined throughout the study period.
Palliative removal of the primary tumor was a significant protective factor for overall survival (HR of death, 0.49) and for cancer-specific survival (HR of cancer death, 0.49) in both the primary data analysis and a proportional hazard regression analysis.
Patients undergoing resection tended to be younger and healthier than those who did not have the procedure, so the researchers performed a propensity-score matching analysis to account for baseline differences between the two study groups. After adjustment for numerous potential confounders, palliative primary tumor resection continued to exert a significant protective effect for overall and cancer-specific survival, with HRs of 0.40 and 0.39, respectively. The survival benefit also persisted, with identical hazard ratios, in two further sensitivity analyses of the data, Dr. Tarantino and his associates noted (Ann. Surg. 2014 Nov. 4 [doi: 10.1097/SLA.0000000000000860]).
The mechanism by which palliative resection imparts a survival benefit is not yet known, they added.
Major advances in systemic treatment of metastatic colorectal cancer were achieved during the study period, and survival improved accordingly across both groups of patients over time. “Because of the improvement in systemic treatment, we anticipated that the differences in survival between the subsets of patients who did and who did not undergo palliative primary tumor resection would decrease over time. However – against our a priori hypothesis – our analysis demonstrates the contrary,” the investigators noted.
No financial or material support was provided for this study. Dr. Tarantino and his associates reported having no financial disclosures.
Key clinical point: Palliative removal of the primary tumor extends survival in patients with metastatic colorectal cancer.
Major finding: Palliative resection of the primary tumor was a significant protective factor for overall survival (HR of death, 0.49) and for cancer-specific survival (HR of cancer death, 0.49) in both the primary data analysis and a proportional hazard regression analysis.
Data source: A population-based study of the duration of survival in 23,004 patients with metastatic colorectal cancer who had palliative removal of the primary tumor and 14,789 who did not during a 12-year period.
Disclosures: No financial or material support was provided for this study. Dr. Tarantino and his associates reported having no disclosures.
