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新辅助放化疗治疗 IIIA-N2 期非小细胞肺癌是否可行?IFCT-0101 期临床试验的成熟结果。

Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial.

机构信息

Department of Radiotherapy-Oncology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Université Claude Bernard-Lyon 1, Lyon, France.

出版信息

Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.

DOI:10.1016/j.lungcan.2009.10.003
PMID:19879013
Abstract

Locally advanced non-small cell lung cancers share a risk of both local and systemic recurrence and justifies a therapeutic strategy combining focal and systemic treatment. In resectable stage IIIA-N2 tumors, peri-operative chemotherapy significantly increases survival rates. Chemoradiotherapy, which is the standard treatment of non-resectable locally advanced tumors, may have a role as an induction treatment to reduce locoregional recurrence rates. In the present phase II trial, we aimed at comparing standard induction chemotherapy (arm A: cisplatin and gemcitabine) with 2 different regimens of induction chemoradiotherapy (total dose: 46 Gy) including third-generation cytotoxic agents (arm B: cisplatin and vinorelbine; arm C: carboplatin and paclitaxel) in patients with resectable stage IIIA-N2 NSCLC, using feasibility of the whole strategy, including surgery, as a primary endpoint. A total of 46 patients were included. Response rate was significantly higher after induction chemoradiotherapy vs. chemotherapy (87% vs. 57%, p=0.049). A total of 44 patients underwent operation. The feasibility rate of the proposed therapeutic strategy was 89% for the whole cohort, 93% in arm A (induction chemotherapy with cisplatin and gemcitabine), 88% in arm B (induction chemoradiotherapy with cisplatin and vinorelbine), and 87% in arm C (induction chemoradiotherapy with carboplatin and paclitaxel) (p=0.857). Overall median, 1-year, and 3-year survival were 30 months, 87%, and 43%, respectively. Induction chemoradiotherapy with modern treatment regimens is highly feasible and may show promises in the current and future developments of multimodal therapeutic strategies in locally advanced NSCLC.

摘要

局部晚期非小细胞肺癌既有局部复发风险,也有全身复发风险,因此需要采用局部和全身治疗相结合的治疗策略。在可切除的 IIIA-N2 期肿瘤中,围手术期化疗显著提高了生存率。放化疗是不可切除的局部晚期肿瘤的标准治疗方法,可能作为诱导治疗以降低局部区域复发率。在目前的 II 期试验中,我们旨在比较标准诱导化疗(A 组:顺铂和吉西他滨)与 2 种不同的诱导放化疗方案(总剂量:46Gy),包括第三代细胞毒性药物(B 组:顺铂和长春瑞滨;C 组:卡铂和紫杉醇)在可切除的 IIIA-N2 NSCLC 患者中的疗效,将包括手术在内的整个策略的可行性作为主要终点。共纳入 46 例患者。诱导放化疗后缓解率明显高于化疗(87% vs. 57%,p=0.049)。共有 44 例患者接受了手术。整个队列的治疗策略可行性率为 89%,A 组(顺铂和吉西他滨诱导化疗)为 93%,B 组(顺铂和长春瑞滨诱导放化疗)为 88%,C 组(卡铂和紫杉醇诱导放化疗)为 87%(p=0.857)。总体中位、1 年和 3 年生存率分别为 30 个月、87%和 43%。含现代治疗方案的诱导放化疗具有高度可行性,可能在局部晚期 NSCLC 的多模式治疗策略的当前和未来发展中具有广阔前景。

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