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

Autor: Syed A. Hussain, D. D. Moffitt, D. M. A. Wallace, D. R. Peake, Nicholas D. James, John Glaholm
Rok vydání: 2001
Předmět:
Zdroj: Annals of Oncology. 12:929-935
ISSN: 0923-7534
DOI: 10.1023/a:1011133820532
Popis: Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2 T4a N0/NX M0 bladder cancer were entered into this single centre phase I Il study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m 2 day I and 5-fluorouracil 500 mg/m 2 / 24 hours weeks one and four of radiotherapy for five or seven days on each occasion. 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 with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological 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 acceptable toxicity in poor prognosis patients. A randomised trial is being launched.
Databáze: OpenAIRE