Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III…
By H. Maase, S. W. Hansen, J. Roberts, L. Dogliotti, T. Oliver, M. J. Moore, I. Bodrogi, P. Albers, A. Knuth, C. Lippert and 8 more. Journal of Clinical Oncology, 2000
2,153 citations recorded by the source corpus.
PURPOSE Gemcitabine plus cisplatin (GC) 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 GC (gemcitabine 1,000 mg/m2 days 1, 8 and 15; cisplatin 70 mg/m2 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 GC 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 was 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 alopecia (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 GC.
Subfields: Surgery
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Citations in the corpus
- Cellular pharmacology of gemcitabine. (2006, background): “Today gemcitabine is indicated as a single agent in the treatment of patients with metastatic pancreatic cancer [2] and in combination chemotherapy in non-small cell lung cancer [3], bladder cancer [4] and breast cancer [5].”
- Treatment of muscle-invasive and metastatic bladder cancer: update of the EAU guidelines. (2011, background): “The lower toxicity of GC, however, has resulted in GC increasingly becoming a new standard regimen [75].”
- Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. (2012, result): “This is in line with the experience for patients who are eligible for cisplatin therapy in whom GC was found to be less toxic than methotrexate/vinblastine/doxorubicin/cisplatin (MVAC).(23) However, in view of the results of several single-arm phase II studies,(15,24) it remains uncertain to what ex”
- Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. (2006, background): “Eligibility Criteria The details of the study have been reported in detail in this journal.(6) In summary, eligible patients had measurable or assessable, histologically proven, locally advanced (T4b, N2, or N3) or metastatic (M1) TCC of the urothelium.”