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• W2241325899 abstract "4592 Background: Pemetrexed (P) and gemcitabine (G) have demonstrated broad single-agent activity in many solid tumors, including bladder cancer. The study objectives were to determine response rate (RR), progression-free survival, overall survival (OS), and safety and toxicity of the combination of P/G in patients (pts) with locally advanced or metastatic bladder cancer who have not received prior chemotherapy. Methods: G 1250 mg/m2 was administered over 30-minute iv on days 1 and 8, and P 500 mg/m2 over 10-minute iv on day 8 after G, q21days. Pts received supplementation of folic acid, vitamin B12, and dexamethasone in relation to treatment with P. Results: The 62 enrolled pts comprised the intent to treat (ITT) population. Of the 62 pts, 49 (7 female, 42 male) with a median age of 66 years (range, 38–81) were qualified for efficacy analyses per predefined protocol criteria. Their median WHO PS was 1, and 59% had visceral metastases. A median of 4 cycles (range, 1–9) was given, for a total of 191 cycles. There were 20 dose reductions (9 P, 11 G), 51 dose delays (31 P, 20 G), and 4 dose omissions (2 P, 2 G). Overall RR was 26.5% (95% CI, 14.2%–38.9%) with 3 CR and 10 PR. With a 33% censoring rate, the median OS was 10.1 months (95% CI, 7.7–14.0 months). Further data collection and analyses including efficacy analyses of the 13 non-evaluable pts in the ITT population are ongoing. 60 pts qualified for safety analyses. CTC grade 3/4 hematologic toxicities included anemia (13.3%), thrombocytopenia (10.0%), neutropenia (36.7%), febrile neutropenia (18.3%), and neutropenic sepsis (3.3%). Grade 3/4 nonhematologic toxicities included elevated AST (4.0%) and ALT (8.4%), fatigue (8.4%), stomatitis (4.0%), skin toxicity (2.2%), and dyspnea (8.3%). There was one toxic death. Conclusions: The P/G combination is an active treatment with a predictable and manageable safety profile in this bladder cancer population wherein the majority had poor prognostic factors. However, with the current dosing and schedule, it is not obvious that the combination is superior to single-agent G, as similar results may have been obtained by G alone. The final data on efficacy and safety will be presented at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly" @default.
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• W2241325899 date "2005-06-01" @default.
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• W2241325899 title "A phase II trial of pemetrexed plus gemcitabine as first-line treatment for locally advanced or metastatic transitional cell carcinoma of the urothelium" @default.
• W2241325899 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.4592" @default.
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