[Treatment of infiltrating cancer of the bladder with cisplatin, fluorouracil, and concurrent radiotherapy: results of a pilot study].

PURPOSE

Pilot study to assess treatment feasibility and results of a 2-drug chemotherapy (CT) regimen administered concurrently with radiotherapy (RT) for muscle-invasive bladder cancer.

MATERIALS AND METHODS

Fourty-six patients were included into a prospective study from December 1992 to April 1996. The median age was 66 years. Thirty-seven percent of the patients had T3B-T4 tumors, and 46% had benefited from prior macroscopically complete transurethral resection (TUR). Pelvic irradiation consisted of 50.4 Gy in 28 fractions over 39 days. Concurrent CT consisting of cisplatin (80 mg/m2/d1) and 5-fluorouracil (800 mg/m2/d2 to 5) by continuous infusions (5-FU) was delivered during the first and fifth weeks of radiation therapy. Twenty-three patients received two additional courses of adjuvant CT with cisplatin, methotrexate and vinblastin (MCV).

RESULTS

The median follow-up was 38 months. The feasibility of concurrent CT-RT was excellent: 96% of the patients completed radiotherapy and 100% of them received the two courses of P-FU. The acute toxicity was mild: no hematological toxicity or renal toxicity over grade II, 4 cases of bowel or rectal reversible grade III toxicity and 2 cases of reversible grade III cystitis. A complete response was achieved in 30 out of the 42 evaluable patients (65.2%). Nine patients received an immediate salvage treatment (3 TUR, 3 additional radiotherapy and 3 cystectomies). Ten patients had local failure. Projected 3-year locoregional control was 49% for the 46 patients. Projected overall 3-year survival was 53%. Functional results were good for disease-free patients with preserved bladder: 1 grade I, 3 grade II, and no grade III cystitis.

CONCLUSION

Concurrent 2-drug chemoradiotherapy with cisplatin and 5-fluorouracil is feasible without major toxicity and offers a potentially curative and conservative treatment for patients with localized muscle-invasive bladder cancer.