Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer

Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer
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DOI:
10.1056/nejmoa011954
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发表时间:
2002-01-10
影响因子:
158.5
通讯作者:
Johnson, DH
Johnson, DH
中科院分区:
医学1区
文献类型:
--
作者:
Schiller, JH;Harrington, D;Johnson, DH

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背景 我们进行了一项随机研究,以确定对于晚期非小细胞肺癌患者,三种化疗方案中的任何一种是否优于顺铂和紫杉醇。方法共有 1207 例晚期非小细胞肺癌患者被随机分配至顺铂和紫杉醇参考方案或三种实验方案之一:顺铂和吉西他滨、顺铂和多西他赛或卡铂和卡铂。结果 所有 1155 名符合条件的患者的缓解率为 19%,中位生存率为 7.9 个月(95% 置信区间,7.3% 至 8.5),1 年生存率为 33%(95% 置信区间,30% 至 36%),2 年生存率为 11%(95% 置信区间,8% 至 12%)。分配接受顺铂和紫杉醇的患者与分配接受三种实验方案中任何一种的患者之间的缓解率和生存率没有显着差异。与顺铂和紫杉醇治疗相比,顺铂和吉西他滨治疗的疾病进展时间明显更长,但更有可能引起 3、4 或 5 级肾毒性(9% 的患者,而顺铂加紫杉醇治疗的患者为 3%)。体能状态为 2 的患者的生存率显着低于体能状态为 0 或 1 的患者。 结论 在治疗晚期非小细胞肺癌方面,四种化疗方案均未比其他化疗方案具有显着优势。 (N Engl J Med 2002;346:92-8。)版权所有 (C) 2002 马萨诸塞州医学会。
Background We conducted a randomized study to determine whether any of three chemotherapy regimens was superior to cisplatin and paclitaxel in patients with advanced non-small-cell lung cancer.Methods A total of 1207 patients with advanced non-small-cell lung cancer were randomly assigned to a reference regimen of cisplatin and paclitaxel or to one of three experimental regimens: cisplatin and gemcitabine, cisplatin and docetaxel, or carboplatin and paclitaxel.Results The response rate for all 1155 eligible patients was 19 percent, with a median survival of 7.9 months (95 percent confidence interval, 7.3 to 8.5), a 1-year survival rate of 33 percent (95 percent confidence interval, 30 to 36 percent), and a 2-year survival rate of 11 percent (95 percent confidence interval, 8 to 12 percent). The response rate and survival did not differ significantly between patients assigned to receive cisplatin and paclitaxel and those assigned to receive any of the three experimental regimens. Treatment with cisplatin and gemcitabine was associated with a significantly longer time to the progression of disease than was treatment with cisplatin and paclitaxel but was more likely to cause grade 3, 4, or 5 renal toxicity (in 9 percent of patients, vs. 3 percent of those treated with cisplatin plus paclitaxel). Patients with a performance status of 2 had a significantly lower rate of survival than did those with a performance status of 0 or 1.Conclusions None of four chemotherapy regimens offered a significant advantage over the others in the treatment of advanced non-small-cell lung cancer. (N Engl J Med 2002;346:92-8.) Copyright (C) 2002 Massachusetts Medical Society.