Phase III Study Comparing Second- and Third-Generation Regimens With Concurrent Thoracic Radiotherapy in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer: West Japan Thoracic Oncology Group WJTOG0105
Phase III Study Comparing Second- and Third-Generation Regimens With Concurrent Thoracic Radiotherapy in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer: West Japan Thoracic Oncology Group WJTOG0105
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DOI：
10.1200/jco.2009.24.5050
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发表时间：
2010-08-10
影响因子：
45.3
通讯作者：
Fukuoka, Masahiro
中科院分区：
文献类型：
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作者：
Yamamoto, Nobuyuki;Nakagawa, Kazuhiko;Fukuoka, Masahiro
目的：对不能切除的III期非小细胞肺癌(NSCLC)患者进行同期胸腔放疗(TRT)的III期试验，比较第三代和第二代化疗的疗效。患者接受以下治疗：A(对照组)，4周期丝裂霉素(8 mg/m(2)，第1天)/长春新碱(3 mg/m(2)，第1、8天)/顺铂(80 mg/m(2)，第1天)加TRT 60Gy1周；B组，每周伊立替康20 mg/m(2)/卡铂(AUC)(血药浓度-时间曲线下面积[AUC]2)，疗程6周，TRT 60GY，然后伊立替康(50 mg/m2，第1、8天)/卡铂(AUC 5，第1天)；C组：每周紫杉醇(40 mg/m2)/卡铂(AUC2)+TRT 60Gy6周，然后用紫杉醇(200 mg/m2，第1天)/卡铂(AUC5，第1天)2个疗程。结果A、B、C三组中位生存期分别为20.5、19.8、22.0个月，5年生存率分别为17.5%、17.8%、19.8%。尽管治疗组的总体存活率没有明显差异，但试验组的总体存活率并未达到非劣势。A组3~4级中性粒细胞减少症、发热中性粒细胞减少症和胃肠道疾病的发生率显著高于B组和C组(P<；.001)。化疗中断在B组比A组和C组更常见。结论C组疗效相当，且在三组中表现出更有利的毒副作用。ARM C应被视为局部晚期不能切除的非小细胞肺癌的标准治疗方案。J Clin Oncol28：3739-3745。(C)2010年美国临床肿瘤学会
PurposeThis phase III trial of concurrent thoracic radiotherapy (TRT) was conducted to compare third-generation chemotherapy with second-generation chemotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC).Patients and MethodsEligible patients received the following treatments: A (control), four cycles of mitomycin (8 mg/m(2) on day 1)/vindesine (3 mg/m(2) on days 1, 8)/cisplatin (80 mg/m(2) on day 1) plus TRT 60 Gy (treatment break for 1 week); B, weekly irinotecan (20 mg/m(2))/carboplatin (area under the plasma concentration-time curve [AUC] 2) for 6 weeks plus TRT 60 Gy, followed by two courses of irinotecan (50 mg/m2 on days1, 8)/carboplatin (AUC 5 on day1); C, weekly paclitaxel (40 mg/m2)/carboplatin (AUC 2) for 6 weeks plus TRT 60 Gy, followed by two courses of paclitaxel (200 mg/m2 on day1)/carboplatin (AUC 5 on day 1).ResultsThe median survival time and 5-year survival rates were 20.5, 19.8, and 22.0 months and 17.5%, 17.8%, and 19.8% in arms A, B, and C, respectively. Although no significant differences in overall survival were apparent among the treatment arms, noninferiority of the experimental arms was not achieved. The incidences of grade 3 to 4 neutropenia, febrile neutropenia, and gastrointestinal disorder were significantly higher in arm A than in arm B or C (P < .001). Chemotherapy interruptions were more common in arm B than in arm A or C.ConclusionArm C was equally efficacious and exhibited a more favorable toxicity profile among three arms. Arm C should be considered a standard regimen in the management of locally advanced unresectable NSCLC. J Clin Oncol 28: 3739-3745. (C) 2010 by American Society of Clinical Oncology