SWOG-8710 — Neoadjuvant Chemotherapy plus Cystectomy Compared with Cystectomy Alone for Locally Advanced Bladder Cancer

Phase 3 · 2003 · Bladder Cancer

Design

Randomized intergroup phase 3 trial comparing three cycles of neoadjuvant M-VAC chemotherapy followed by radical cystectomy versus radical cystectomy alone.

Population

Patients with locally advanced muscle-invasive bladder cancer (clinical stage T2 to T4a) with no evidence of metastasis.

Primary Endpoint

Overall survival

Key Result

Median survival was 77 months with neoadjuvant M-VAC versus 46 months with cystectomy alone, with a trend toward improved survival (HR ~0.75; P=0.06 two-sided), and pathologic complete response (pT0) in 38% versus 15%.

Guideline Impact

Basis for NCCN/AUA/EAU recommendation of neoadjuvant cisplatin-based chemotherapy in muscle-invasive bladder cancer