1155 A phase III trial of neoadjuvant chemotherapy (NCT) in patients (PTS) with invasive bladder cancer (IBC). Preliminary results: NCT improves pathological complete response rate

Introduction As we reported previously (Eur J Cancer 1991;27(SI2): 107; Ann Oncol 1994;5(S8):66) treatment with CBDCA, MTX and VBL is as effective as M-VAC in advanced bladder cancer with long-term survival and can be safely given in an outpatient basis and in pts with impaired renal function. We designed a multicentric study, randomizing pts to receive NCT followed by cistectomy (branch A) or cistectomy alone (branch B). We present the results of pts treated in one institution. Patients and methods The inclusion criteria were transitional IBC T3b–4aN0M0, T2–3aN0M0 with obstructive uropathy or presence of diffuse Tis, and creatinine 2 and VBL 4 mg/m 2 (d + 1, +8) and CBDCA 350 mg/m 2 (d +2); 3 cycles, every 4 weeks. All surgical specimens were reviewed by one pathologist*.The minimum follow-up was 2 years. Sixty-six pts were analyzed: 33 pts in branch A, 33 pts in branch B. Results Postoperatory mortality was 3%. Response rates were: pCR and pPR 20% and 23% in branch A, and 3% and 12% in branch B. The pCR differences (17%, Cl 2–32%) and the pCR + pPR differences (28%, Cl 7–50%) were statistically significant with p  Conclusions It's the first time that NCT in IBC has demonstrated more pathological responses than the transuretral resection alone. More pts and more trials are needed to confirm these results. The absence of survival differences could be due to chemotherapy selection of pts with a good prognosis in branch A.