Adjuvant chemotherapy prolonged survival after radical nephroureterectomy by nearly a year, compared with observation alone, among patients with locally advanced or positive regional lymph node upper tract urothelial carcinoma, researchers reported.
After a median follow-up period of 49 months, median overall survival was 47 months with adjuvant chemotherapy and 36 months with observation alone (P less than .001), reported Thomas Seisen, MD, of Harvard Medical School, Boston, and his associates.
This analysis included 3,253 patients with pT3/T4 and/or pN+ upper tract urothelial carcinoma from the National Cancer Database. A total of 762 (23%) patients received adjuvant chemotherapy within 90 days after surgery, while 2,491 (77%) patients underwent observation only (J Clin Oncol. 2017 Jan 3. doi: 10.1200/JCO.2016.69.414).
Kaplan Meier analyses yielded 5-year adjusted overall survival rates of 44% and 36%, respectively. Adjuvant chemotherapy conferred a significant overall survival benefit in a Cox proportional hazards regression analysis (hazard ratio, 0.77; 95% confidence interval, 0.68 to 0.88), and the effect held up in tests designed to minimize selection bias – including propensity score adjustment (HR, 0.82; 0.73 to 0.93), stratification (HR, 0.84; 0.74 to 0.95), and matching (HR, 0.84; 0.75 to 0.95).
The effect persisted across subgroups stratified by age, gender, comorbidity burden, pathologic stage, and surgical margin status, and there was no significant variability in treatment effects, the researchers said. The findings are subject to “the usual biases related to the observational study design,” but pending level 1 evidence, they inform the management of patients with advanced upper tract urothelial carcinoma who undergo radical nephroureterectomy, the researchers concluded.
The work was supported by the Vattikuti Urology Institute, the Conquer Cancer Foundation of the American Society of Clinical Oncology, and the Prostate Cancer Foundation. Dr. Seisen had no relevant financial disclosures.