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非小细胞肺癌患者的化疗:大肺癌试验的手术背景

Chemotherapy for patients with non-small cell lung cancer: the surgical setting of the Big Lung Trial.

作者信息

Waller D, Peake M D, Stephens R J, Gower N H, Milroy R, Parmar M K B, Rudd R M, Spiro S G

机构信息

Cancer Division, Medical Research Council Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK.

出版信息

Eur J Cardiothorac Surg. 2004 Jul;26(1):173-82. doi: 10.1016/j.ejcts.2004.03.041.

Abstract

OBJECTIVES

The non-small cell lung cancer (NSCLC) meta-analysis suggested a survival benefit for cisplatin-based chemotherapy when given in addition to surgery, radical radiotherapy or 'best supportive care'. However, it included many small trials and trials with differing eligibility criteria and chemotherapy regimens. The aim of the Big Lung Trial was therefore to run a large pragmatic trial to confirm the survival benefits seen in the meta-analysis.

METHODS

In the surgery setting, a total of 381 patients were randomised to chemotherapy (C, 192 patients) or no chemotherapy (NoC, 189 patients). C was three 3-weekly cycles of cisplatin/vindesine, mitomycin/ifosfamide/cisplatin, mitomycin/vinblastine/cisplatin or vinorelbine/cisplatin.

RESULTS

Chemotherapy was given before surgery in 3% of patients whilst 97% received adjuvant chemotherapy. Baseline characteristics were: median age 61 years, 69% male, 48% squamous cell, 93% WHO PS 0-1, 27% stage I, 38% stage II, and 34% stage III. Complete resection was achieved in approximately 95% of patients. In the C group, 13% received no chemotherapy, 21% one or two cycles, and 64% all three cycles of their prescribed chemotherapy (60% of the latter with no delays or modification). 30% had grade 3/4 toxicity, mainly haematological, nausea/vomiting and neutropenic fever, and six patients were reported as having a treatment-related death. 198 (52%) of patients have died, but there is currently no evidence of a benefit in overall survival to the C group: HR 1.02 (95% CI 0.77-1.35), P = 0.90).

CONCLUSIONS

This trial has failed to observe a survival benefit with adjuvant chemotherapy following complete resection of stage I-III NSCLC. However, the hazard ratio and 95% confidence intervals are consistent with the previously reported meta-analysis and two large recently reported trials, which suggest a small survival benefit with cisplatin-based chemotherapy.

摘要

目的

非小细胞肺癌(NSCLC)的荟萃分析表明,在手术、根治性放疗或“最佳支持治疗”基础上加用顺铂为基础的化疗可带来生存获益。然而,该分析纳入了许多小型试验以及入选标准和化疗方案各异的试验。因此,大肺癌试验的目的是开展一项大型实用试验,以证实荟萃分析中观察到的生存获益。

方法

在手术治疗组中,共有381例患者被随机分为化疗组(C组,192例患者)或非化疗组(NoC组,189例患者)。化疗方案为顺铂/长春地辛、丝裂霉素/异环磷酰胺/顺铂、丝裂霉素/长春花碱/顺铂或长春瑞滨/顺铂,每3周进行3个周期。

结果

3%的患者在手术前接受了化疗,而97%的患者接受了辅助化疗。基线特征为:中位年龄61岁,男性占69%,鳞状细胞癌占48%,93%的患者世界卫生组织(WHO)体力状况评分为0 - 1,27%为Ⅰ期,38%为Ⅱ期,34%为Ⅲ期。约95%的患者实现了完全切除。在C组中,13%的患者未接受化疗,21%的患者接受了1或2个周期的化疗,64%的患者接受了规定的全部3个周期化疗(后者中60%未延迟或修改化疗方案)。30%的患者出现3/4级毒性反应,主要为血液学毒性、恶心/呕吐和中性粒细胞减少性发热,有6例患者报告为与治疗相关的死亡。198例(52%)患者死亡,但目前尚无证据表明C组在总生存方面有获益:风险比(HR)为1.02(95%置信区间[CI]为0.77 - 1.35),P = 0.90)。

结论

本试验未能观察到Ⅰ - Ⅲ期NSCLC完全切除术后辅助化疗的生存获益。然而,风险比和95%置信区间与先前报道的荟萃分析以及最近报道的两项大型试验一致,这些研究提示顺铂为基础的化疗有较小的生存获益。

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