Safety and Resource Utilization by Non-small Cell Lung Cancer Histology Results from the Randomized Phase III Study of Pemetrexed Plus Cisplatin versus Gemcitabine Plus Cisplatin in Chemonaive Patients with Advanced Non-small Cell Lung Cancer
Safety and Resource Utilization by Non-small Cell Lung Cancer Histology Results from the Randomized Phase III Study of Pemetrexed Plus Cisplatin versus Gemcitabine Plus Cisplatin in Chemonaive Patients with Advanced Non-small Cell Lung Cancer
复制标题
DOI：
10.1097/jto.0b013e3181eaf30f
复制
发表时间：
2010-10-01
影响因子：
20.4
通讯作者：
Paz-Ares, Luis
中科院分区：
文献类型：
--
作者：
Novello, Silvia;Pimentel, Francisco Luis;Paz-Ares, Luis
简介：一项针对晚期非小细胞肺癌的大型、随机、III期研究的预先设定分析显示，与吉西他滨/顺铂相比，培美曲塞/顺铂治疗的非鳞状细胞癌患者的生存期显著改善。选定的3/4级毒性和资源利用有利于培美曲塞在总体人群中，但详细的安全性结果，组织学尚未reported.Methods：治疗的患者被纳入本分析的安全性组织学。在每个周期，评估不良事件，并记录合并用药、输血和住院情况。措施进行了总结，组织学和比较武器与Fisher的精确test.Results：分析时，鳞状和非鳞状组织学，安全性和资源利用率为每个治疗组的总体人群的。所选毒性不因组织学而异。伴随药物的使用和住院治疗也非常相似的模式中观察到的整体population.Conclusions：虽然以前的疗效分析显示了显着的培美曲塞治疗非鳞状细胞癌患者的优势，本分析的结果表明，安全性和资源利用不因组织学而异，并与整体人群一致。无论组织学如何，接受培美曲塞/顺铂治疗的患者的安全性和资源利用是可预测的、可重现的，并且与培美曲塞已确立的有利安全性特征一致。
Introduction: A prespecified analysis of the large, randomized, phase III study in advanced non-small cell lung cancer showed significant improvement in survival for nonsquamous patients treated with pemetrexed/cisplatin versus gemcitabine/cisplatin. Selected grade 3/4 toxicities and resource utilization favored pemetrexed in the overall population, but detailed safety results by histology have not been reported.Methods: Treated patients were included in this analysis of safety by histology. At each cycle, adverse events were assessed, and concomitant medications, transfusions, and hospitalizations were recorded. Measures were summarized by histology and compared between arms with Fisher's exact test.Results: When analyzed by squamous and nonsquamous histology, safety and resource utilization for each treatment arm paralleled those of the overall population. Selected toxicities did not vary by histology. Concomitant medication use and hospitalizations were also very similar to the patterns observed in the overall population.Conclusions: Although previous efficacy analyses showed a significant pemetrexed treatment advantage for nonsquamous patients, results of this analysis indicate that safety and resource utilization do not vary by histology and are consistent with the overall population. The safety and resource utilization of patients treated with pemetrexed/cisplatin are predictable, reproducible, and consistent with the established favorable safety profile of pemetrexed, regardless of histology.