Pignon J P, Arriagada R, Ihde D C, Johnson D H, Perry M C, Souhami R L, Brodin O, Joss R A, Kies M S, Lebeau B
Institut Gustave-Roussy, Villejuif, France.
N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.
In spite of 16 randomized trials conducted during the past 15 years, the effect of thoracic radiotherapy on the survival of patients with limited small-cell lung cancer remains controversial. The majority of these trials did not have enough statistical power to detect a difference in survival of 5 to 10 percent at five years. This meta-analysis was designed to evaluate the hypothesis that thoracic radiotherapy contributes to a moderate increase in overall survival in limited small-cell lung cancer.
We collected individual data on all patients enrolled before December 1988 in randomized trials comparing chemotherapy alone with chemotherapy combined with thoracic radiotherapy. Trials that included only patients with extensive disease were excluded.
The meta-analysis included 13 trials and 2140 patients with limited disease. A total of 433 patients with extensive disease were excluded. Overall, 1862 of 2103 patients who could be evaluated died; the median follow-up period for the surviving patients was 43 months. The relative risk of death in the combined-therapy group as compared with the chemotherapy group was 0.86 (95 percent confidence interval, 0.78 to 0.94; P = 0.001), corresponding to a 14 percent reduction in the mortality rate. The benefit in terms of overall survival at three years (+/- SD) was 5.4 +/- 1.4 percent. Indirect comparison of early with late radiotherapy and of sequential with non-sequential radiotherapy did not reveal any optimal time for treatment. There was a trend toward a larger reduction in mortality among younger patients: the relative risk of death in the combined-therapy as compared with the chemotherapy group ranged from 0.72 for patients less than 55 years old (95 percent confidence interval, 0.56 to 0.93) to 1.07 (0.70 to 1.64) for patients over 70.
Thoracic radiotherapy moderately improves survival in patients with limited small-cell lung cancer who are treated with combination chemotherapy. Identification of the optimal combination of chemotherapy and radiotherapy will require further trials.
尽管在过去15年中进行了16项随机试验，但胸段放疗对局限期小细胞肺癌患者生存的影响仍存在争议。这些试验中的大多数没有足够的统计效力来检测出5年生存率5%至10%的差异。本荟萃分析旨在评估胸段放疗有助于适度提高局限期小细胞肺癌总体生存率这一假设。
我们收集了1988年12月之前纳入的所有患者的个体数据，这些患者来自比较单纯化疗与化疗联合胸段放疗的随机试验。仅纳入广泛期疾病患者的试验被排除。
该荟萃分析纳入了13项试验和2140例局限期疾病患者。共排除433例广泛期疾病患者。总体而言，2103例可评估患者中有1862例死亡；存活患者的中位随访期为43个月。联合治疗组与化疗组相比的死亡相对风险为0.86（95%置信区间为0.78至0.94；P = 0.001），相当于死亡率降低14%。三年时总体生存率的获益（±标准差）为5.4±1.4%。早期与晚期放疗以及序贯与非序贯放疗的间接比较未发现任何最佳治疗时间。年轻患者死亡率降低幅度有更大的趋势：联合治疗组与化疗组相比的死亡相对风险在小于55岁的患者中为0.72（95%置信区间为0.56至0.93），在70岁以上患者中为1.07（0.70至1.64）。
胸段放疗可适度提高接受联合化疗的局限期小细胞肺癌患者的生存率。确定化疗与放疗的最佳组合需要进一步试验。
