Postmus P E, Giaccone G, Debruyne C, Sahmoud T, Splinter T A, van Zandwijk N
Department of Pulmonary Diseases, Free University Hospital, Amsterdam, The Netherlands.
Semin Oncol. 1996 Oct;23(5 Suppl 12):10-3.
Toxicity and response rates are evaluated in a randomized phase II study comparing paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)/cisplatin with teniposide/cisplatin in the treatment of non-small cell lung cancer to decide whether this study should continue as a phase III trial. A response was seen in 26% (10 of 38) of the patients receiving teniposide/cisplatin and in 40% (14 of 35) of those receiving paclitaxel/cisplatin. Overall, evidence of toxicity was more severe in the cisplatin/teniposide group, especially with regard to myelotoxicity. Grade 4 neutropenia was seen in 66% of patients receiving teniposide compared with 29% of those treated with paclitaxel/cisplatin. The study is to continue as a phase III trial, with 150 patients expected to participate in each treatment group.
在一项随机II期研究中评估了毒性和缓解率,该研究比较了紫杉醇(泰素;百时美施贵宝公司,新泽西州普林斯顿)/顺铂与替尼泊苷/顺铂治疗非小细胞肺癌的疗效,以决定该研究是否应继续作为III期试验。接受替尼泊苷/顺铂治疗的患者中有26%(38例中的10例)出现缓解,接受紫杉醇/顺铂治疗的患者中有40%(35例中的14例)出现缓解。总体而言,顺铂/替尼泊苷组的毒性证据更为严重,尤其是在骨髓毒性方面。接受替尼泊苷治疗的患者中有66%出现4级中性粒细胞减少,而接受紫杉醇/顺铂治疗的患者中这一比例为29%。该研究将继续作为III期试验,预计每个治疗组有150名患者参与。