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Lookup NU author(s): Dr James Roberts
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Purpose: Gemcitabine plus cisplatin (OC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic transitional-cell carcinoma (TCC) of the urothelium. Patients and Methods: Patients with stage IV TCC and no prior systemic chemotherapy were randomized to OC (gemcitabine 1,000 mg/m(2) days 1, 8, and 15; cisplatin 70 mg/m(2) day 2) or standard MVAC every 28 days for a maximum of six cycles. Results: Four hundred five patients were randomized (GC, n = 203; MVAC, n = 202). The groups were well-balanced with respect to prognostic factors. Overall survival was similar on both arms (hazards ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; P =.75), as were time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30), time to treatment failure (HR, 0.89: 95% CI, 0.72 to 1.10), and response rate (GC, 49%; MVAC, 46%). More OC patients completed six cycles of therapy, with fewer dose adjustments. The toxic death rate was 1% on the GC arm and 3% on the MVAC arm. More GC than MVAC patients had grade 3/4 anemia (27% v 18%, respectively) and thrombocytopenia (57% v 21%, respectively). On both arms, the RBC transfusion rate was 13 Of 100 cycles and grade 3/4 hemorrhage or hematuria was 2%; the platelet transfusion rate war four patients per 100 cycles and two patients per 100 cycles on GC and MVAC, respectively. More MVAC patients, compared with GC patients, had grade 3/4 neutropenia (82% v 71%, respectively), neutropenic fever (14% v 2%, respectively), neutropenic sepsis (12% v 1%, respectively), and grade 3/4 mucositis (22% v 1%, respectively) and alapecia (55% v 11%, respectively). Quality of life was maintained during treatment on both arms; however, more patients on GC fared better regarding weight, performance status, and fatigue. Conclusion: GC provides a similar survival advantage to MVAC with a better safety profile and tolerability. This better-risk benefit ratio should change the standard of care for patients with locally advanced and metastatic TCC from MVAC to OC. (C) 2000 by American Society of Clinical Oncology.
Author(s): von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Rovira PS, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Oncology
Year: 2000
Volume: 17
Issue: 17
Pages: 3068-3077
ISSN (print): 0732-183X
ISSN (electronic): 1527-7755
Publisher: American Society of Clinical Oncology
URL: http://jco.ascopubs.org/content/18/17/3068.full.pdf
