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Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer unfit for cisplatin-based chemotherapy: Phase II--results of EORTC Study 30986
Journal of Clinical Oncology, 10/05/09

Santis MD et al. – Both combinations are active in this group of unfit patients. However, patients with PS 2 and GFR less than 60 mL/min do not benefit from combination CHT. Alternative treatment modalities should be sought in this subgroup of poor-risk patients

Methods

CHT-naïve patients
Measurable disease and impaired renal function (30 mL/min < glomerular filtration rate [GFR] < 60 mL/min) and/or performance status (PS) 2 were randomly assigned to receive either GC (gemcitabine 1,000 mg/m2 on days 1 and 8 and carboplatin area under serum concentration-time curve [AUC] 4.5) for 21 days or M-CAVI (methotrexate 30 mg/m2 on days 1, 15, and 22; carboplatin AUC 4.5 on day 1; and vinblastine 3 mg/m2 on days 1, 15, and 22) for 28 days
End points of response and SAT evaluated with respect to treatment group, renal function, PS, and Bajorin risk groups

Results

Three of 178 patients ineligible or did not start treatment
Overall response rates 42% (37 of 88) for GC and 30% (26 of 87) for M-CAVI
Patients with PS 2 and GFR less than 60 mL/min and patients in Bajorin risk group 2 showed response rate of only 26% and 20% and an SAT rate of 26% and 25%

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