Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer
Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer
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DOI：
10.1200/jco.2007.15.0375
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发表时间：
2008-07-20
影响因子：
45.3
通讯作者：
Gandara, David
中科院分区：
文献类型：
--
作者：
Scagliotti, Giorgio Vittorio;Parikh, Purvish;Gandara, David
目的顺铂联合吉西他滨是晚期非小细胞肺癌（NSCLC）一线治疗的标准方案。培美曲塞加铂类化合物的II期研究也显示出在这种情况下的活性。患者和方法这项非劣效性、III期、随机研究使用固定边界方法（风险比[HR] < 1.176）在1，725名未经化疗的IIIB或IV期非小细胞肺癌患者中比较了治疗组之间的总生存期，东部肿瘤协作组体能状态为0至1。患者接受顺铂75 mg/m2第1天和吉西他滨1，250 mg/m2第1和8天（n = 863）或顺铂75 mg/m2第1天和培美曲塞500 mg/m2第1天（n = 862），每3周一次，最多6个周期。（中位生存期，分别为10.3 v10.3个月; HR = 0.94; 95%CI，0.84 - 1.05）。在腺癌（n = 847;分别为12.6 vs10.9个月）和大细胞癌组织学类型（n = 153;分别为10.4 vs6.7个月）患者中，顺铂/培美曲塞的总生存期在统计学上上级顺铂/吉西他滨。相比之下，在鳞状细胞组织学患者中，顺铂/吉西他滨与顺铂/培美曲塞相比，生存期显著改善（n = 473;分别为10.8 v9.4个月）。对于顺铂/培美曲塞，3级或4级中性粒细胞减少、贫血和血小板减少的发生率（P
PurposeCisplatin 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 MethodsThis 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.ResultsOverall 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