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Adjuvant chemotherapy improves survival in patients with locally advanced bladder cancer who did not receive the neoadjuvant chemotherapy that is currently advocated by some experts, according to a report published online Jan. 18 in Journal of Clinical Oncology.
Two large randomized clinical trials and one meta-analysis demonstrated a survival advantage for patients who received neoadjuvant cisplatin-based chemotherapy, but three subsequent trials attempting to confirm those results were unable to do so: all three were terminated early because of poor accrual of study participants. At present, 1%-15% of eligible U.S. patients with muscle-invasive bladder cancer receive neoadjuvant chemotherapy. Clinicians favor adjuvant chemotherapy instead, “likely because of theoretic concerns regarding delaying potentially curative surgery and the ability to base treatment decisions on more precise pathologic, rather than clinical, staging,” said Dr. Matthew D. Galsky of Tisch Cancer Institute, Mount Sinai, N.Y., and his associates.
To further examine this issue, they analyzed information in the National Cancer Database, a registry that collects deidentified patient-level data from more than 1,500 U.S. hospitals with accredited cancer programs, which represents approximately 70% of all newly diagnosed cases across the country. For this observational study, the investigators focused on 5,653 patients who underwent radical cystectomy for urothelial bladder cancer during a 3-year period and who were found to have pathologic T3-4 and/or nodal involvement at surgery. A total of 1,293 patients (23%) then received multiagent chemotherapy while the remainder received no chemotherapy. All the patients were followed for a median of 7 years.
Compared with patients who did not receive adjuvant chemotherapy, those who did tended to be younger, have a higher income, have fewer comorbidities, and have positive surgical margins. The data were adjusted to account for these and other differences between the two study groups by using propensity-score matching.
Five-year overall survival was 37.0% with adjuvant chemotherapy and 29.1% without it, a significant difference favoring the treatment. In a further analysis, chemotherapy was associated with improved overall survival with an HR of 0.70. This survival benefit was strong across all subgroups of patients regardless of patient age, performance status, lymph node status, and a variety of other factors, and it remained robust in sensitivity analyses, Dr. Galsky and his associates said (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.64.1076).
These findings “provide important information for facilitating treatment decisions.” Neoadjuvant chemotherapy followed by cystectomy remains the preferred approach, but for patients who don’t receive that, postcystectomy chemotherapy may still improve survival, they said.
Galsky et al. provide compelling evidence to support adjuvant chemotherapy for advanced bladder cancer, and their data will likely make the recommendation for the treatment more emphatic.
However, there are a few caveats. The data do not provide specifics about the chemotherapy these patients received: Was it cisplatin based? What was the number of doses given, and what was the dose intensity? There also is no information about recurrences or subsequent salvage therapies in the control group. And although the investigators took great care to control for imbalances between the two study groups, the possibility that these factors may have affected the final outcomes cannot be ruled out completely.
Dr. Sumanta K. Pal is a medical oncologist at the City of Hope Comprehensive Cancer Center, Duarte, Calif. He reported ties to Novartis, Medivation, Astellas Pharma, Pfizer, Novartis, AVEO Pharmaceuticals, Myriad Pharmaceuticals, and Genentech. Dr. Pal and his associates made these remarks in an editorial (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.65.4368).
Galsky et al. provide compelling evidence to support adjuvant chemotherapy for advanced bladder cancer, and their data will likely make the recommendation for the treatment more emphatic.
However, there are a few caveats. The data do not provide specifics about the chemotherapy these patients received: Was it cisplatin based? What was the number of doses given, and what was the dose intensity? There also is no information about recurrences or subsequent salvage therapies in the control group. And although the investigators took great care to control for imbalances between the two study groups, the possibility that these factors may have affected the final outcomes cannot be ruled out completely.
Dr. Sumanta K. Pal is a medical oncologist at the City of Hope Comprehensive Cancer Center, Duarte, Calif. He reported ties to Novartis, Medivation, Astellas Pharma, Pfizer, Novartis, AVEO Pharmaceuticals, Myriad Pharmaceuticals, and Genentech. Dr. Pal and his associates made these remarks in an editorial (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.65.4368).
Galsky et al. provide compelling evidence to support adjuvant chemotherapy for advanced bladder cancer, and their data will likely make the recommendation for the treatment more emphatic.
However, there are a few caveats. The data do not provide specifics about the chemotherapy these patients received: Was it cisplatin based? What was the number of doses given, and what was the dose intensity? There also is no information about recurrences or subsequent salvage therapies in the control group. And although the investigators took great care to control for imbalances between the two study groups, the possibility that these factors may have affected the final outcomes cannot be ruled out completely.
Dr. Sumanta K. Pal is a medical oncologist at the City of Hope Comprehensive Cancer Center, Duarte, Calif. He reported ties to Novartis, Medivation, Astellas Pharma, Pfizer, Novartis, AVEO Pharmaceuticals, Myriad Pharmaceuticals, and Genentech. Dr. Pal and his associates made these remarks in an editorial (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.65.4368).
Adjuvant chemotherapy improves survival in patients with locally advanced bladder cancer who did not receive the neoadjuvant chemotherapy that is currently advocated by some experts, according to a report published online Jan. 18 in Journal of Clinical Oncology.
Two large randomized clinical trials and one meta-analysis demonstrated a survival advantage for patients who received neoadjuvant cisplatin-based chemotherapy, but three subsequent trials attempting to confirm those results were unable to do so: all three were terminated early because of poor accrual of study participants. At present, 1%-15% of eligible U.S. patients with muscle-invasive bladder cancer receive neoadjuvant chemotherapy. Clinicians favor adjuvant chemotherapy instead, “likely because of theoretic concerns regarding delaying potentially curative surgery and the ability to base treatment decisions on more precise pathologic, rather than clinical, staging,” said Dr. Matthew D. Galsky of Tisch Cancer Institute, Mount Sinai, N.Y., and his associates.
To further examine this issue, they analyzed information in the National Cancer Database, a registry that collects deidentified patient-level data from more than 1,500 U.S. hospitals with accredited cancer programs, which represents approximately 70% of all newly diagnosed cases across the country. For this observational study, the investigators focused on 5,653 patients who underwent radical cystectomy for urothelial bladder cancer during a 3-year period and who were found to have pathologic T3-4 and/or nodal involvement at surgery. A total of 1,293 patients (23%) then received multiagent chemotherapy while the remainder received no chemotherapy. All the patients were followed for a median of 7 years.
Compared with patients who did not receive adjuvant chemotherapy, those who did tended to be younger, have a higher income, have fewer comorbidities, and have positive surgical margins. The data were adjusted to account for these and other differences between the two study groups by using propensity-score matching.
Five-year overall survival was 37.0% with adjuvant chemotherapy and 29.1% without it, a significant difference favoring the treatment. In a further analysis, chemotherapy was associated with improved overall survival with an HR of 0.70. This survival benefit was strong across all subgroups of patients regardless of patient age, performance status, lymph node status, and a variety of other factors, and it remained robust in sensitivity analyses, Dr. Galsky and his associates said (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.64.1076).
These findings “provide important information for facilitating treatment decisions.” Neoadjuvant chemotherapy followed by cystectomy remains the preferred approach, but for patients who don’t receive that, postcystectomy chemotherapy may still improve survival, they said.
Adjuvant chemotherapy improves survival in patients with locally advanced bladder cancer who did not receive the neoadjuvant chemotherapy that is currently advocated by some experts, according to a report published online Jan. 18 in Journal of Clinical Oncology.
Two large randomized clinical trials and one meta-analysis demonstrated a survival advantage for patients who received neoadjuvant cisplatin-based chemotherapy, but three subsequent trials attempting to confirm those results were unable to do so: all three were terminated early because of poor accrual of study participants. At present, 1%-15% of eligible U.S. patients with muscle-invasive bladder cancer receive neoadjuvant chemotherapy. Clinicians favor adjuvant chemotherapy instead, “likely because of theoretic concerns regarding delaying potentially curative surgery and the ability to base treatment decisions on more precise pathologic, rather than clinical, staging,” said Dr. Matthew D. Galsky of Tisch Cancer Institute, Mount Sinai, N.Y., and his associates.
To further examine this issue, they analyzed information in the National Cancer Database, a registry that collects deidentified patient-level data from more than 1,500 U.S. hospitals with accredited cancer programs, which represents approximately 70% of all newly diagnosed cases across the country. For this observational study, the investigators focused on 5,653 patients who underwent radical cystectomy for urothelial bladder cancer during a 3-year period and who were found to have pathologic T3-4 and/or nodal involvement at surgery. A total of 1,293 patients (23%) then received multiagent chemotherapy while the remainder received no chemotherapy. All the patients were followed for a median of 7 years.
Compared with patients who did not receive adjuvant chemotherapy, those who did tended to be younger, have a higher income, have fewer comorbidities, and have positive surgical margins. The data were adjusted to account for these and other differences between the two study groups by using propensity-score matching.
Five-year overall survival was 37.0% with adjuvant chemotherapy and 29.1% without it, a significant difference favoring the treatment. In a further analysis, chemotherapy was associated with improved overall survival with an HR of 0.70. This survival benefit was strong across all subgroups of patients regardless of patient age, performance status, lymph node status, and a variety of other factors, and it remained robust in sensitivity analyses, Dr. Galsky and his associates said (J Clin Oncol. 2016 Jan. 18. doi:10.1200/JCO.2015.64.1076).
These findings “provide important information for facilitating treatment decisions.” Neoadjuvant chemotherapy followed by cystectomy remains the preferred approach, but for patients who don’t receive that, postcystectomy chemotherapy may still improve survival, they said.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Adjuvant chemotherapy improves survival in patients with locally advanced bladder cancer who did not receive the neoadjuvant chemotherapy that is currently advocated.
Major finding: Five-year overall survival was 37.0% with adjuvant chemotherapy and 29.1% without it.
Data source: A propensity-matched observational cohort study involving 5,653 cases in a national cancer database followed for approximately 7 years.
Disclosures: This study was supported by a Clinical and Translational Science KL2 Faculty Scholars Award. Dr. Galsky reported ties to Dual Therapeutics, BioMotive, Janssen Oncology, Dendreon, Merck, GlaxoSmithKline, Eli Lilly, Astellas Pharma, Genentech, Novartis, and Bristol-Myers Squibb.