A phase I-II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer

Background: The management of locally advanced bladder cancer remains contr oversial with poor local control with radiotherapy alone. Synchronous chemo therapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2-T4a N0/NX M0 bladder cancer were ent ered into this single centre phase I-II study. Patients received radiothera py to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was gi ven with Mitomycin C 12 mg/m(2) day 1 and 5-fluorouracil 500 mg/m(2)/24 hou rs weeks one and four of radiotherapy for five or seven days on each occasi on. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58-79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); T4: 9 (29 %); TCC grade 2: 8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis . Ten of thirty-one had a GFR < 50 ml/min. Toxicity was mild to moderate wi th the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Patholo gical complete response rate at three months was 74% (5-day regimen) and 50 % (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with a cceptable toxicity in poor prognosis patients. A randomised trial is being launched.