Sequential Administration Of Cisplatin (C), Gemcitabine (G) And Docetaxel (D), As First-Line Treatment In Patients With Advanced Transitional Cell Carcinoma (Tcc) Of The Urothelial Tract: A Multicenter Phase Ii Study

14574 Background: The GC combination has become a standard of care for advanced TCC. D has demonstrated broad single agent activity in many solid tumors including bladder cancer. We evaluated the safety and the activity of their sequential administration in patients (pts) with locally advanced or metastatic TCC who have not received prior chemotherapy. Methods: Chemotherapy-naïve pts with histologically proven locally advanced or metastatic TCC were enrolled. G 1100 mg/m2 was administered over 30-minutes IV on days 1 and 15, C 80 mg/m2 on day 1 with the adequate hydration and D 80 mg/m2 over 1 h on day 15. Results: From 4/2004–12/2005, 26 pts (25 male, 1 female), median age 65.5 years (range, 48–75), (PS 0/1/2: 16/8/2) were enrolled onto the study. The majority (19pts, 73.1%) had metastatic disease. A median of 4 cycles (range 1–9) was given for a total of 113 cycles. There were 12 delayed cycles due to toxicity and 15 dose reductions. Three (16.7%) complete responses (CRs) and 6 (33.3%) partial responses (PRs) [2 of them were converted to CR with additional surgery] were observed in 18 evaluable pts [overall RR of 50%; 95% CI 26.9%-3.1%]. The median time to progression was 7.9, and the months while median survival has not yet reached. The 1-year survival is 68.86%. Gr III-IV hematologic toxicity included neutropenia (61.5%), febrile neutropenia (11.5%), anemia (7.7%) and thrombocytopenia (7.6%). Non hematologic toxicity was mild (grade III vomiting and diarrhea in 7.7% and 3.8% of the pts, respectively). There was no neutropenic sepsis or toxic death. Conclusions: The sequential administration of cisplatin, gemcitabine and docetaxel is an active treatment for pts with advanced TCC. Toxicity is not manageable and this regimen warrants further investigation. No significant financial relationships to disclose.