Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer:: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study
Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer:: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study
复制标题
DOI：
10.1200/jco.2005.03.070
复制
发表时间：
2005-09-01
影响因子：
45.3
通讯作者：
Pérol, M
中科院分区：
文献类型：
--
作者：
Fournel, P;Robinet, G;Pérol, M
目的 我们进行了一项 III 期研究，以比较同步与序贯放疗 (RT) 和化疗 (CT) 治疗对不可切除的 III 期非小细胞肺癌 (NSCLC) 的生存影响。 患者和方法 患者被随机分配到两个治疗组之一。在序贯组中，患者在第 1、29 和 57 天接受顺铂 (120 mg/m(2)) 诱导 CT，从第 1 天到第 78 天接受长春瑞滨 (30 mg/m(2)/周) 诱导 CT，随后接受 33 次剂量 66 Gy 的胸部放疗（每次 2 Gy，每周 5 次）。在并行组中，从第1天开始进行相同的RT，并进行两个并行周期的顺铂20 mg/m(2)/d和依托泊苷50 mg/m(2)/d（第1至5天和第29至33天）；然后患者在第 78 天和第 106 天接受顺铂 80 mg/m(2) 巩固治疗，并在第 78 天到 127 天接受长春瑞滨 30 mg/m2/周。 结果 205 名患者被随机分配。两组的预处理特征非常平衡。序贯组中有 6 人中毒死亡，同时组有 10 人中毒死亡。序贯组的中位生存期为 14.5 个月，同步组的中位生存期为 16.3 个月（对数秩检验 P=0.24）。同时治疗组的两年、三年和四年生存率（分别为 39%、25% 和 21%）优于序贯治疗组（分别为 26%、19% 和 14%）。同步组的食管毒性发生率显着高于序贯组（32% V 3%）。 结论 虽然没有统计学意义，但观察到中位、2、3、4 年生存率的临床重要差异，有利于同步放化疗的趋势表明同步放化疗是局部晚期 NSCLC 患者的最佳策略。
Purpose We conducted a phase III study to compare the survival impact of concurrent versus sequential treatment with radiotherapy (RT) and chemotherapy (CT) in unresectable stage III non-small-cell lung cancer (NSCLC).Patients and Methods Patients were randomly assigned to one of the two treatment arms. In the sequential arm, patients received induction CT with cisplatin (120 mg/m(2)) on days 1, 29, and 57, and vinorelbine (30 mg/m(2)/wk) from day 1 to day 78, followed by thoracic RT at a dose of 66 Gy in 33 fractions (2 Gy per fraction and 5 fractions per week). In the concurrent arm, the same RT was started on day 1 with two concurrent cycles of cisplatin 20 mg/m(2)/d and etoposide 50 mg/m(2)/d (days 1 to 5 and days 29 to 33); patients then received consolidation therapy with cisplatin 80 mg/m(2) on days 78 and 106 and vinorelbine 30 mg/m2/wk from days 78 to 127.Results Two hundred five patients were randomly assigned. Pretreatment characteristics were well balanced between the two arms. There were six toxic deaths in the sequential arm and 10 in the concurrent arm. Median survival was 14.5 months in the sequential arm and 16.3 months in the concurrent arm (log-rank test P=.24). Two-, 3-, and 4-year survival rates were better in the concurrent arm (39%, 25%, and 21%, respectively) than in the sequential arm (26%, 19%, and 14%, respectively). Esophageal toxicity was significantly more frequent in the concurrent arm than in the sequential arm (32% V 3%).Conclusion Although not statistically significant, clinically important differences in the median, 2-, 3-, and 4-year survival rates were observed, with a trend in favor of concurrent chemoradiation suggesting that is the optimal strategy for patients with locally advanced NSCLC.