Effect of preoperative chemoradiation in addition to preoperative chemotherapy:: a randomised trial in stage III non-small-cell lung cancer
Effect of preoperative chemoradiation in addition to preoperative chemotherapy:: a randomised trial in stage III non-small-cell lung cancer
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DOI：
10.1016/s1470-2045(08)70156-6
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发表时间：
2008-07-01
期刊：
影响因子：
51.1
通讯作者：
Semik, Michael
中科院分区：
文献类型：
--
作者：
Thomas, Michael;Ruebe, Christian;Semik, Michael
背景：术前化疗可提高适合切除的III期非小细胞肺癌（NSCLC）患者的生存率。我们的目的是评估额外的影响，术前放化疗对肿瘤切除，病理反应，和生存在这些patients.Methods之间1995年10月1日，2003年7月1日，患者与第IIIA-IIIB期非小细胞肺癌和侵袭性纵隔评估从26个参与机构的德国肺癌合作组（GLCCG）被随机分配到两个治疗组之一。干预组给予顺铂和足叶乙甙3个周期，放疗后每日2次，同时给予卡铂和长春地辛，最后手术切除（切缘阳性或不能切除者继续每日2次放疗）。对照组给予顺铂、足叶乙甙3个周期治疗，手术治疗后行放疗。主要终点是随机化后符合治疗条件的患者的中位无进展生存期（PFS）。随机化后有资格接受治疗的患者的次要终点是总生存期（OS）和接受手术的患者比例。肿瘤切除患者的次要终点是切缘阴性的比例、完全切除的比例、组织病理学缓解的比例和纵隔分期下调的比例。此外，对不适合切除的患者和接受切除的患者的其他亚组进行了PFS和OS方面的探索性（未预先指定）事后分析。该试验在ClinicalTrials.gov网站上注册，编号NCT 00176137。34例患者不符合入选标准，被排除。在524例合格患者中，介入组264例中的142例（54%）和对照组260例中的154例（59%）接受了手术; 264例中的98例（37%）和260例中的84例（32%）接受了完全切除。在完全切除的患者中，纵隔分期降低的患者比例（98例中45例[46%]和84例中24例[29%]，p=0.02）和病理反应的患者比例（98例中59例[60%]和84例中17例[20%]，p
Background Preoperative chemotherapy improves survival in patients with stage III non-small-cell lung cancer (NSCLC) amenable to resection. We aimed to assess the additional effect of preoperative chemoradiation on tumour resection, pathological response, and survival in these patients.Methods Between Oct 1, 1995, and July 1, 2003, patients with stage IIIA-IIIB NSCLC and invasive mediastinal assessment from 26 participating institutions of the German Lung Cancer Cooperative Group (GLCCG) were randomly assigned to one of two treatment groups. The intervention group were scheduled to receive three cycles of cisplatin and etoposide, followed by twice-daily radiation with concurrent carboplatin and vindesine, and then surgical resection (those with positive resection margins or unresectable disease were offered further twice-daily radiotherapy). The control group were scheduled to receive three cycles of cisplatin and etoposide, followed by surgery, and then further radiotherapy. The primary endpoint was median progression-free survival (PFS) in patients eligible for treatment after randomisation. Secondary endpoints in patients eligible for treatment after randomisation were overall survival (OS) and the proportion of patients undergoing surgery. Secondary endpoints in patients with tumour resection were the proportion with negative resection margins, the proportion with complete resection, the proportion with histopathological response, and the proportion with mediastinal downstaging. Additionally, exploratory (not prespecified) post-hoc analyses in terms of PFS and OS were done on patients not amenable to resection and on further subgroups of patients undergoing resection. Analyses were by intention to treat. This trial is registered on the ClinicalTrials.gov website, number NCT 00176137.Findings 558 patients were randomly assigned. 34 patients did not meet inclusion criteria and were excluded. Of 524 eligible patients, 142 of 264 (54%) in the interventional group and 154 of 260 (59%) in the control group underwent surgery; 98 of 264 (37%) and 84 of 260 (32%) underwent complete resection. In patients with complete resection, the proportion of those with mediastinal downstaging (45 of 98 [46%] and 24 of 84 [29%], p=0.02) and pathological response (59 of 98 [60%] and 17 of 84 [20%], p