Service de Pneumologie, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France.
Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.
Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSCLC) in fit, non-elderly adults, but monotherapy is recommended for patients older than 70 years. We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC.
In this multicentre, open-label, phase 3, randomised trial we recruited patients aged 70-89 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0-2. Patients received either four cycles (3 weeks on treatment, 1 week off treatment) of carboplatin (on day 1) plus paclitaxel (on days 1, 8, and 15) or five cycles (2 weeks on treatment, 1 week off treatment) of vinorelbine or gemcitabine monotherapy. Randomisation was done centrally with the minimisation method. The primary endpoint was overall survival, and analysis was done by intention to treat. This trial is registered, number NCT00298415.
451 patients were enrolled. 226 were randomly assigned monotherapy and 225 doublet chemotherapy. Median age was 77 years and median follow-up was 30.3 months (range 8.6-45.2). Median overall survival was 10.3 months for doublet chemotherapy and 6.2 months for monotherapy (hazard ratio 0.64, 95% CI 0.52-0.78; p<0.0001); 1-year survival was 44.5% (95% CI 37.9-50.9) and 25.4% (19.9-31.3), respectively. Toxic effects were more frequent in the doublet chemotherapy group than in the monotherapy group (most frequent, decreased neutrophil count (108 [48.4%] vs 28 [12.4%]; asthenia 23 [10.3%] vs 13 [5.8%]).
Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. We feel that the current treatment paradigm for these patients should be reconsidered.
Intergroupe Francophone de Cancérologie Thoracique, Institut National du Cancer.
铂类双联化疗被推荐用于治疗身体状况良好、非老年的晚期非小细胞肺癌（NSCLC）患者，但对于 70 岁以上的患者推荐使用单药治疗。我们比较了含铂类双联化疗方案与老年晚期 NSCLC 患者的单药治疗。
在这项多中心、开放标签、3 期、随机试验中，我们招募了年龄在 70-89 岁、局部晚期或转移性 NSCLC 和世界卫生组织（WHO）体能状态评分为 0-2 的患者。患者接受了 4 个周期（治疗 3 周，休息 1 周）的卡铂（第 1 天）加紫杉醇（第 1、8 和 15 天）或 5 个周期（治疗 2 周，休息 1 周）的长春瑞滨或吉西他滨单药治疗。采用中央最小化方法进行随机分组。主要终点是总生存期，分析采用意向治疗。该试验已注册，编号为 NCT00298415。
共纳入 451 例患者。226 例患者被随机分配至单药治疗组，225 例患者被分配至双联化疗组。中位年龄为 77 岁，中位随访时间为 30.3 个月（范围 8.6-45.2）。双联化疗组的中位总生存期为 10.3 个月，单药治疗组为 6.2 个月（风险比 0.64，95%CI 0.52-0.78；p<0.0001）；1 年生存率分别为 44.5%（95%CI 37.9-50.9）和 25.4%（19.9-31.3）。与单药治疗组相比，双联化疗组的毒性反应更常见（最常见的是中性粒细胞减少（108[48.4%]比 28[12.4%]）和乏力（23[10.3%]比 13[5.8%]）。
尽管毒性反应增加，但与长春瑞滨或吉西他滨单药治疗相比，含铂类双联化疗可使老年 NSCLC 患者的生存获益。我们认为目前对这些患者的治疗模式应重新考虑。
法国胸科癌症协作组、法国国家癌症研究所。
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