Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3–pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial

摘要: Summary Background Patients with muscle-invasive urothelial carcinoma of the bladder have poor survival after cystectomy. The EORTC 30994 trial aimed to compare immediate versus deferred cisplatin-based combination chemotherapy radical cystectomy in patients pT3–pT4 or N+ M0 bladder. Methods This intergroup, open-label, randomised, phase 3 recruited from hospitals across Europe and Canada. Eligible had histologically proven bladder, disease node positive (pN1–3) bilateral lymphadenectomy, no evidence any microscopic residual disease. Within 90 days cystectomy, were centrally randomly assigned (1:1) by minimisation either adjuvant (four cycles gemcitabine plus cisplatin, high-dose methotrexate, vinblastine, doxorubicin, cisplatin [high-dose MVAC], MVAC) six at relapse, stratification for institution, pT category, lymph status according number nodes dissected. Neither nor investigators masked. Overall was primary endpoint; all analyses intention treat. closed recruitment 284 planned 660 patients. is registered ClinicalTrials.gov, NCT00028756. Findings From April 29, 2002, Aug 14, 2008, (141 treatment 143 treatment), followed up until data cutoff 21, 2013. After a median follow-up 7·0 years (IQR 5·2–8·7), 66 (47%) 141 group died compared 82 (57%) group. No significant improvement overall noted when (adjusted HR 0·78, 95% CI 0·56–1·08; p=0·13). Immediate significantly prolonged progression-free (HR 0·54, 0·4–0·73, p Interpretation Our did not show lymphadenectomy carcinoma. However, limited power, it possible that some subgroups might still benefit chemotherapy. An updated individual patient meta-analysis biomarker research are needed further elucidate potential Funding Lilly, Canadian Cancer Society Research.