BACKGROUNDNeoadjuvant chemotherapy for patients with muscle‐invasive bladder carcinoma is given to treat micrometastases and to preserve the bladder. The objective of this study was to evaluate the possibility of bladder preservation in patients with muscle‐invasive bladder carcinoma who were treated with neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (M‐VAC) chemotherapy.METHODSOne hundred four consecutive patients with T2–T4,N0,M0 transitional cell carcinoma of the bladder were treated with 3 cycles of neoadjuvant M‐VAC chemotherapy. After clinical restaging, 52 patients underwent transurethral resection of the bladder (TURB) alone, 13 patients underwent partial cystectomy, and 39 patients underwent radical cystectomy.RESULTSThe median survival for the entire group was 7.49 years (95% confidence interval, 4.86–10.0 years). Forty‐nine patients (49%) were T0 at the time of TURB after receiving M‐VAC. Thirty‐one of 52 patients (60%) who received chemotherapy and underwent TURB alone were alive at a median follow‐up of 56 + months (range, 10–160 + months): Twenty‐three patients (44%) in that TURB group maintained an intact bladder. Of 13 responding patients with monofocal lesions who underwent partial cystectomy, only 1 patient required salvage cystectomy, and survival generally was good. The 5‐year survival rate for this group was 69%. With a long median follow‐up of 88 + months (range, 16–158 months), 4 patients (31%) were alive with a functioning bladder. In the radical cystectomy group, the median follow‐up was 45 months (range, 4–172 + months), and 15 of 39 patients (38%) patients remained alive. In 77 patients who had their tumors down‐staged to T0 or superficial disease, the median follow‐up was 63 months (range, 4–172 + months), and the 5‐year rate survival was 69%. This is in contrast to a 5‐year survival rate of only 26% in 27 patients who failed to respond and had a status ≥ T2 after receiving chemotherapy (median follow‐up, 31 months; range, 7–156 + months). The median survival for 27 elderly patients (age ≥ 70 years; median age, 73 years; range, 70–82 years) was 90 months (7.5 years). For elderly patients who underwent TURB and partial cystectomy, the 5‐year survival rate was 67% with a 109‐month (9‐year) median survival; 47% of patients preserved their bladders intact. The median follow‐up of the living elderly patients was 61 months (range, 20–120 + months).CONCLUSIONSBladder sparing in selected patients on the basis of response to neoadjuvant chemotherapy is a feasible approach that should be confirmed in prospective, randomized trials. Selected elderly patients are candidates for this approach. Cancer 2003;97:1644–52. © 2003 American Cancer Society.DOI 10.1002/cncr.11232