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非小细胞肺癌的化疗:一项使用来自52项随机临床试验的个体患者最新数据的荟萃分析。非小细胞肺癌协作组

Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group.

出版信息

BMJ. 1995 Oct 7;311(7010):899-909.

Abstract

OBJECTIVE

To evaluate the effect of cytotoxic chemotherapy on survival in patients with non-small cell lung cancer.

DESIGN

Meta-analysis using updated data on individual patients from all available randomised trials, both published and unpublished.

SUBJECTS

9387 patients (7151 deaths) from 52 randomised clinical trials.

MAIN OUTCOME MEASURE

Survival.

RESULTS

The results for modern regimens containing cisplatin favoured chemotherapy in all comparisons and reached conventional levels of significance when used with radical radiotherapy and with supportive care. Trials comparing surgery with surgery plus chemotherapy gave a hazard ratio of 0.87 (13% reduction in the risk of death, equivalent to an absolute benefit of 5% at five years). Trials comparing radical radiotherapy with radical radiotherapy plus chemotherapy gave a hazard ratio of 0.87 (13% reduction in the risk of death; absolute benefit of 4% at two years), and trials comparing supportive care with supportive care plus chemotherapy 0.73 (27% reduction in the risk of death; 10% improvement in survival at one year). The essential drugs needed to achieve these effects were not identified. No difference in the size of effect was seen in any subgroup of patients. In all but the radical radiotherapy setting, older trials using long term alkylating agents tended to show a detrimental effect of chemotherapy. This effect reached conventional significance in the adjuvant surgical comparison.

CONCLUSION

At the outset of this meta-analysis there was considerable pessimism about the role of chemotherapy in non-small cell lung cancer. These results offer hope of progress and suggest that chemotherapy may have a role in treating this disease.

摘要

目的

评估细胞毒性化疗对非小细胞肺癌患者生存率的影响。

设计

采用已发表和未发表的所有可用随机试验中个体患者的最新数据进行荟萃分析。

研究对象

来自52项随机临床试验的9387例患者(7151例死亡)。

主要观察指标

生存率。

结果

含顺铂的现代化疗方案在所有比较中均显示化疗有益,与根治性放疗及支持治疗联合使用时达到了传统的显著水平。比较手术与手术加化疗的试验得出风险比为0.87(死亡风险降低13%,相当于5年时绝对获益5%)。比较根治性放疗与根治性放疗加化疗的试验得出风险比为0.87(死亡风险降低13%;2年时绝对获益4%),比较支持治疗与支持治疗加化疗的试验得出风险比为0.73(死亡风险降低27%;1年时生存率提高10%)。未确定产生这些效果所需的关键药物。在任何患者亚组中均未观察到效应大小的差异。除根治性放疗外,使用长期烷化剂的早期试验往往显示化疗有有害作用。在辅助手术比较中,这种作用达到了传统的显著水平。

结论

在这项荟萃分析开始时,人们对化疗在非小细胞肺癌中的作用相当悲观。这些结果带来了进展的希望,并表明化疗可能在治疗这种疾病中发挥作用。

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