De Santis M., Bachner M., Cerveny M., Kametriser G., Steininger T., Königsberg R., Schratter-Sehn A., Sedlmayer F., Dittrich C.
Annals of Oncology 2014 25:9 (1789-1794) Article Number mdu209
Background: We conducted a phase I trial of gemcitabine (gem) with concurrent radiotherapy in patients with muscleinvasive bladder cancer (BC) ineligible for surgery or cisplatin or refusing organ loss. Patients and methods: Patients with urothelial cancer, cT2-T4, cN0-1, M0, ineligible for surgery due to local tumor extension, PS, age or co-morbidities or who refused surgery were included. After maximal transurethral resection, the treatment schedule included: twice-weekly i.v. infusion of gem [dose levels (DL) 1-6: 20, 27, 30, 33, 50 and 40 mg/m2, respectively] for 30 min and concurrent radiotherapy (RT) to the bladder with 55.5 Gy. The primary end point was to determine the maximum-tolerated dose (MTD) and the dose recommended (RD) for further studies of this gem schedule. The secondary end point was late toxicity. The MTD was defined by dose-limiting toxicity (DLT) in 2 or more of 6 patients, discontinuation of RT and/or gem for > 1 week in 2 or more of 6 patients due to grade (G) 3/4 acute and/or late toxicity in more than 2 of 18 patients…(ver más)