Annals of Oncology 12:929-935, 2001
© 2001 European Society for Medical Oncology
research-article |
A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer
1CRC Institute for Cancer Studies, University of Birmingham Birmingham, United Kingdom
2Queen Elizabeth Hospital, Edgbaston Birmingham, United Kingdom
Dr Nicholas James CRC Institute for Cancer Studies University of Birmingham Edgbaston Birmingham B15 2TA UK E-mail n.d.james{at}bham.ac.uk
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—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 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%); 14: 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.
bladder cancer, chemoradiation, organ preservation