التفاصيل البيبلوغرافية
| العنوان: |
Larotaxel with Cisplatin in the First-Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer: A Randomized, Active-Controlled, Phase III Trial (CILAB). |
| المؤلفون: |
Sternberg, Cora N., Skoneczna, Iwona A., Castellano, Daniel, Theodore, Christine, Blais, Normand, Voog, Eric, Bellmunt, Joaquim, Peters, Frank, Le-Guennec, Solenn, Cerbone, Linda, Risse, Marie-Laure, Machiels, Jean-Pascal |
| المصدر: |
Oncology; Nov2013, Vol. 85 Issue 4, p208-215, 8p, 6 Charts, 1 Graph |
| مصطلحات موضوعية: |
CANCER chemotherapy, CISPLATIN, ACADEMIC medical centers, BLADDER tumors, BLOOD testing, CONFIDENCE intervals, DRUG side effects, INFECTION, LONGITUDINAL method, MEDICAL cooperation, METASTASIS, PACLITAXEL, RESEARCH, RESEARCH funding, SAFETY, SURVIVAL, RANDOMIZED controlled trials, RELATIVE medical risk, PROPORTIONAL hazards models, DESCRIPTIVE statistics, KAPLAN-Meier estimator |
| مصطلحات جغرافية: |
EUROPE |
| مستخلص: |
Background: This open-label, randomized phase III trial evaluated larotaxel/cisplatin versus gemcitabine/cisplatin as first-line treatment for locally advanced (T4b) or metastatic urothelial tract or bladder cancer. Methods: Patients were randomized to larotaxel 50 mg/m2 with cisplatin 75 mg/m2 every 3 weeks (larotaxel/cisplatin) or gemcitabine 1,000 mg/m2 on days 1, 8, and 15 with cisplatin 70 mg/m2 on day 1 every 4 weeks (gemcitabine/cisplatin). The primary endpoint was overall survival (OS). Results: The trial was prematurely closed following the sponsor's decision to stop clinical development of larotaxel (n = 337 randomized). The larotaxel dose was reduced to 40 mg/m2 and cisplatin to 60 mg/m2 following a data monitoring committee safety review of the first 97 patients. At the time of analysis, the median OS was 13.7 months [95% confidence interval (CI) 11.2-17.1] with larotaxel/cisplatin and 14.3 months (95% CI 10.5 to not reached) with gemcitabine/cisplatin [hazard ratio (HR) 1.21; 95% CI 0.83-1.76; p = 0.33]. The median progression-free survival (PFS) was 5.6 months (95% CI 4.1-6.2) with larotaxel/cisplatin and 7.6 months (95% CI 6.6-9.1) with gemcitabine/cisplatin (HR 1.67; 95% CI 1.24-2.25). More myelosuppression was observed with gemcitabine/cisplatin. Conclusion: There was no difference in OS. Although the trial was closed prematurely, PFS appeared worse with larotaxel/cisplatin, suggesting that larotaxel/cisplatin does not improve outcomes versus cisplatin/gemcitabine. © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
