Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell lung cancer
Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell lung cancer
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DOI：
10.1093/jnci/djg059
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发表时间：
2003-10-01
影响因子：
10.3
通讯作者：
Tonato, M
中科院分区：
文献类型：
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作者：
Scagliotti, GV;Fossati, R;Tonato, M
背景：手术是 1 期、11 期或 IIIA 期非小细胞肺癌 (NSCLC) 患者的主要治疗方法。然而，单纯手术后NSCLC患者的长期生存率在很大程度上不能令人满意，辅助化疗对患者生存率的作用尚未确定。方法：1994年1月至1999年1月期间，1209名1、11或IIIA期NSCLC患者被随机分配接受丝裂霉素C（第1天8 Mg/m(2)）、长春地辛（第1和第8天3 Mg/m(2)）和顺铂（第1天100 Mg/m(2)），每3周接受三个周期（MVP组；n = 606）或完全切除后不治疗（对照组；n = 603）。随机化根据研究中心、肿瘤大小、淋巴结受累和进行放射治疗的意图进行分层。主要终点是总生存期，次要终点是无进展生存期和与辅助治疗相关的毒性。使用对数秩检验分析生存曲线。所有统计检验都是双面的。结果：中位随访时间为 64.5 个月后，两组患者的总生存期（风险比 = 0.96，95% 置信区间 = 0.81 至 1.13；P = 0.589）或无进展生存期（风险比 = 0.89，95% 置信区间 = 0.76 至 1.03；P = 0.128）无统计学显着差异。只有 69% 的患者接受了三个计划周期的 MVP。 MVP 组中 3 级和 4 级中性粒细胞减少症的发生率分别为 16% 和 12%。 MVP 组中 65% 的患者完成了放射治疗，对照组中 82% 的患者完成了放射治疗。在多变量分析中，只有疾病阶段和性别与生存相关。结论：这项随机试验未能前瞻性地证实辅助化疗在完全切除的 NSCLC 中具有统计学意义。鉴于本研究中使用的 MVP 方案的依从性较差，未来的研究应该探索更有效的治疗方法。
Background: Surgery is the primary treatment for patients with stage 1, 11, or IIIA non-small-cell lung cancer (NSCLC). However, long-term survival of NSCLC patients after surgery alone is largely unsatisfactory, and the role of adjuvant chemotherapy in patient survival has not yet been established. Methods: Between January 1994 and January 1999, 1209 patients with stage 1, 11, or IIIA NSCLC were randomly assigned to receive mitomycin C (8 Mg/m(2) on day 1), vindesine (3 Mg/m(2) on days I and 8), and cisplatin (100 Mg/m(2) on day 1) every 3 weeks for three cycles (MVP group; n = 606) or no treatment (control group; n = 603) after complete resection. Randomization was stratified by investigational center, tumor size, lymph-node involvement, and the intention to perform radiotherapy. The primary endpoint was overall survival and secondary endpoints were progression-free survival and toxicity associated with adjuvant treatment. Survival curves were analyzed using the log-rank test. All statistical tests were two-sided. Results: After a median follow-up time of 64.5 months, there was no statistically significant difference between the two patient groups in overall survival (hazard ratio = 0.96, 95% confidence interval = 0.81 to 1.13; P =.589) or progression-free survival (hazard ratio = 0.89, 95% confidence interval = 0.76 to 1.03; P =.128). Only 69% of patients received the three planned cycles of MVP. Grades 3 and 4 neutropenia occurred in 16% and 12%, respectively, of patients in the MVP arm. Radiotherapy was completed by 65% of patients in the MVP arm and by 82% of patients in the control group. In the multivariable analysis, only disease stage and sex were associated with survival. Conclusion: This randomized trial failed to prospectively confirm a statistically significant role for adjuvant chemotherapy in completely resected NSCLC. Given the poor compliance with the MVP regimen used in this study, future studies should explore more effective treatments.