Adjuvant Chemotherapy vs Observation After Neoadjuvant Therapy and Radical Cystectomy for Bladder Cancer
In an analysis reported in JAMA Oncology, Seisen et al found that adjuvant chemotherapy was associated with a survival benefit vs observation in patients with adverse prognostic features after neoadjuvant therapy and radical cystectomy for urothelial carcinoma of the bladder.
Study Details
The study involved National Cancer Database data from January 2006 to December 2012 on 788 patients with pT3/T4 or pN-positive disease, of whom 184 (23.4%) received cisplatin-based adjuvant therapy and 604 (76.6%) received observation after neoadjuvant chemotherapy and radical cystectomy. Patients had a mean age of 65.3 years, and 23.5% were female.
Multiple imputation was used for missing data, and inverse probability of treatment weighting (IPTW)–adjusted Kaplan-Meier and Cox proportional hazards regression analyses were performed with a 6-month conditional landmark to compare overall survival between the two groups.
Overall Survival
The 6-month conditional landmark IPTW-adjusted Kaplan-Meier curves showed that median overall survival was 29.9 months (interquartile range = 15.1–85.4 months) in the adjuvant therapy group vs 24.2 months (interquartile range = 12.9–58.9 months) in the observation group (P = .046). The 5-year IPTW-adjusted rates of overall survival were 36.8% vs 24.7%. The IPTW-adjusted Cox proportional hazards regression analysis showed a hazard ratio of 0.78 (P = .046) favoring adjuvant therapy. The benefit of adjuvant therapy was reduced significantly with increasing age, but no significant interaction of treatment effect was observed for sex (P = .82), Charlson comorbidity index (P = .51), pT/N stage (P = .95), or surgical margin status (P = .29).
The investigators concluded: “This study found that [adjuvant chemotherapy] after [neoadjuvant chemotherapy] and [radical cystectomy] may be associated with an [overall survival] benefit for patients with pT3/T4 and/or pN-positive urothelial carcinoma of the bladder]. The present findings should be considered as preliminary evidence to conduct a randomized clinical trial to address this association.”
Quoc-Dien Trinh, MD, of the Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, is the corresponding author of the JAMA Oncology article.
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