培美曲塞
吉西他滨
医学
顺铂
内科学
肺癌
肿瘤科
化疗
发热性中性粒细胞减少症
养生
危险系数
临床研究阶段
中性粒细胞减少症
胃肠病学
置信区间
作者
Giorgio V. Scagliotti,Purvish Parikh,Joachim von Pawel,Bonne Biesma,Johan Vansteenkiste,Christian Manegold,Piotr Serwatowski,U. Gatzemeier,Raghunadharao Digumarti,Mauro Zukin,Jin S. Lee,Anders Mellemgaard,Keunchil Park,Shehkar Patil,Janusz Rolski,Tuncay Göksel,Filippo de Marinis,Lorinda Simms,Katherine P. Sugarman,David R. Gandara
标识
DOI:10.1200/jco.2007.15.0375
摘要
Purpose Cisplatin plus gemcitabine is a standard regimen for first-line treatment of advanced non–small-cell lung cancer (NSCLC). Phase II studies of pemetrexed plus platinum compounds have also shown activity in this setting. Patients and Methods This noninferiority, phase III, randomized study compared the overall survival between treatment arms using a fixed margin method (hazard ratio [HR] < 1.176) in 1,725 chemotherapy-naive patients with stage IIIB or IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Patients received cisplatin 75 mg/m 2 on day 1 and gemcitabine 1,250 mg/m 2 on days 1 and 8 (n = 863) or cisplatin 75 mg/m 2 and pemetrexed 500 mg/m 2 on day 1 (n = 862) every 3 weeks for up to six cycles. Results Overall survival for cisplatin/pemetrexed was noninferior to cisplatin/gemcitabine (median survival, 10.3 v 10.3 months, respectively; HR = 0.94; 95% CI, 0.84 to 1.05). Overall survival was statistically superior for cisplatin/pemetrexed versus cisplatin/gemcitabine in patients with adenocarcinoma (n = 847; 12.6 v 10.9 months, respectively) and large-cell carcinoma histology (n = 153; 10.4 v 6.7 months, respectively). In contrast, in patients with squamous cell histology, there was a significant improvement in survival with cisplatin/gemcitabine versus cisplatin/pemetrexed (n = 473; 10.8 v 9.4 months, respectively). For cisplatin/pemetrexed, rates of grade 3 or 4 neutropenia, anemia, and thrombocytopenia (P ≤ .001); febrile neutropenia (P = .002); and alopecia (P < .001) were significantly lower, whereas grade 3 or 4 nausea (P = .004) was more common. Conclusion In advanced NSCLC, cisplatin/pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. This is the first prospective phase III study in NSCLC to show survival differences based on histologic type.
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