Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial.
Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial.
复制标题
DOI：
10.1016/s0140-6736(09)60737-6
复制
发表时间：
2009-08-01
期刊：
影响因子：
168.9
通讯作者：
Cox, James D.
中科院分区：
文献类型：
--
作者：
Albain, Kathy S.;Swann, R. Suzanne;Rusch, Valerie W.;Turrisi, Andrew T., III;Shepherd, Frances A.;Smith, Colum;Chen, Yuhchyau;Livingston, Robert B.;Feins, Richard H.;Gandara, David R.;Fry, Willard A.;Darling, Gail;Johnson, David H.;Green, Mark R.;Miller, Robert C.;Ley, Joanne;Sause, Willliam T.;Cox, James D.
同步化疗加放疗（chemoRT）是IIIA（N2）期非小细胞肺癌（NSCLC）的标准治疗，NSCLC是一种常见疾病。II期研究证实了化疗后切除的可行性，生存率令人鼓舞。这项III期试验比较了两种方法。T1- 3 pN 2 M0期NSCLC患者在诱导化疗RT（2个周期的顺铂和依托泊苷[PE]，同时接受45戈伊RT）前随机分组。如果没有进展，则第1组接受切除术，第2组继续接受不间断RT至61戈伊。给予另外两个周期的PE。主要终点为总生存期（OS）。396例符合条件的患者的无进展生存期在第1组中上级：中位数12.8个月vs 10.5个月，p=0.017，风险比（HR）0.77（0.62，0.96）; 5年22.4% vs 11.1%。中位OS分别为23.6个月和22.2个月，p=0.24，HR 0.87（0.70，1.10）。5年生存率分别为第1组27.2%和第2组20.3%;比值比0.63（0.36，1.10，p=0.10）。开胸术时N 0状态预测中位OS为33.5个月（5年，41.8%）。化疗的主要毒副反应为中性粒细胞减少和食管炎。第1组16例（7.9%）患者发生治疗相关死亡，其中14例为肺切除术后;第2组4例（2.1%）患者发生治疗相关死亡。一项探索性分析显示，接受肺叶切除术的患者与仅接受化疗RT的匹配队列相比，OS有所改善，但接受肺切除术的患者（匹配相似）的OS没有改善。化疗后，尽管PFS有所改善，但手术没有显著的生存优势。化学RT+确定性RT和化学RT后切除（最好是肺叶切除术）都是IIIA期（N2）NSCLC患者的选择。
Concurrent chemotherapy plus radiation therapy (chemoRT) is the standard treatment for stage IIIA(N2) non-small cell lung cancer (NSCLC), a common disease entity. Phase II studies demonstrated feasibility of resection after chemoRT with encouraging survival rates. This phase III trial compared both approaches. Patients with stage T1-3pN2M0 NSCLC were randomized before induction chemoRT (2 cycles of cisplatin and etoposide [PE] concurrent with 45 Gy RT). If no progression, arm 1 underwent resection, and arm 2 continued RT uninterrupted to 61 Gy. Two additional cycles of PE were given. The primary endpoint was overall survival (OS). Progression-free survival for 396 eligible patients was superior in arm 1: median 12.8 versus 10.5 months, p=0.017, hazard ratio (HR) 0.77 (0.62,0.96); 5-yr 22.4% versus 11.1%. Median OS was 23.6 versus 22.2 months, p=0.24, HR 0.87 (0.70,1.10). Five-year survivals were arm 1, 27.2% and arm 2, 20.3%; odds ratio 0.63 (0.36,1.10, p=0.10). N0 status at thoracotomy predicted median OS of 33.5 months (5-year, 41.8%). Major chemoRT toxicities were neutropenia and esophagitis. Treatment-related death occurred in 16 (7.9%) patients on arm 1, of which 14 were post-pneumonectomy; and in 4 (2.1%) on arm 2. An exploratory analysis showed improved OS for patients who underwent lobectomy versus a matched cohort on chemoRT alone, but not for those undergoing pneumonectomy (matched similarly). There was no significant survival advantage to surgery after chemoRT, despite improved PFS. Both chemoRT with definitive RT and chemoRT followed by resection (preferably lobectomy) are options for patients with stage IIIA(N2) NSCLC.