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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >A randomised comparison of radical radiotherapy with or without chemotherapy for patients with non-small lung cancer: results from the Big Lung Trial.
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A randomised comparison of radical radiotherapy with or without chemotherapy for patients with non-small lung cancer: results from the Big Lung Trial.

机译：非小细胞肺癌患者接受或不接受化疗的放射线治疗的随机比较：大肺试验的结果。

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BACKGROUND: A meta-analysis of trials comparing primary treatment with or without chemotherapy for patients with non-small cell lung cancer published in 1995 suggested a survival benefit for cisplatin-based chemotherapy in each of the primary treatment settings studied, but it included many small trials, and trials with differing eligibility criteria and chemotherapy regimens. Methods: The Big Lung Trial was a large pragmatic trial designed to confirm the survival benefits seen in the meta-analysis, and this paper reports the findings in the radical radiotherapy setting. The trial closed before the required sample size was achieved due to slow accrual, with a total of 288 patients randomised to receive radical radiotherapy alone (146 patients) or sequential radical radiotherapy and cisplatin-based chemotherapy (142 patients). RESULTS: There was no evidence that patients allocated sequential chemotherapy and radical radiotherapy had a better survival than those allocated radical radiotherapy alone, HR 1.07 (95% CI 0.84-1.38, P=0.57), median survival 13.0 months for the sequential group and 13.2 for the radical radiotherapy alone group. In addition, exploratory analyses could not identify any subgroup that might benefit more or less from chemotherapy. CONCLUSIONS: Despite not suggesting a survival benefit for the sequential addition of chemotherapy to radical radiotherapy, possibly because of the relatively small sample size and consequently wide confidence intervals, the results can still be regarded as consistent with the meta-analysis, and other similarly designed recently published large trials. Combining all these results suggests there may be a small median survival benefit with chemotherapy of between 2 and 8 weeks.
机译：背景：1995年发表的一项比较有无小细胞肺癌患者接受或不接受化疗的主要治疗试验的荟萃分析表明，在每种所研究的主要治疗环境中，基于顺铂的化疗均具有生存优势，但其中包括许多试验以及具有不同资格标准和化疗方案的试验。方法：“大肺试验”是一项大型实用试验，旨在证实荟萃分析中发现的生存获益，并且本文报道了根治性放射治疗中的发现。由于缓慢的累积，该试验在获得所需的样本量之前已结束，共有288例患者随机接受单纯放疗（146例）或序贯放疗和顺铂为基础的化疗（142例）。结果：没有证据表明序贯化学疗法和根治性放射疗法的患者比单独采用根治性放射疗法的患者具有更好的生存率，HR 1.07（95％CI 0.84-1.38，P = 0.57），序贯组的中位生存期为13.0个月，而中位生存期为13.2个月仅用于根治性放疗组。此外，探索性分析无法确定任何可能从化疗中获得或多或少受益的亚组。结论：尽管未暗示将化学疗法序贯加入根治性放疗会带来生存益处，可能是由于样本量相对较小，因此置信区间较宽，但结果仍可被认为与荟萃分析和其他类似设计一致最近发表的大型试验。综合所有这些结果表明，化疗2至8周可能会带来较小的中位生存期收益。

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