Schiller Joan H, Harrington David, Belani Chandra P, Langer Corey, Sandler Alan, Krook James, Zhu Junming, Johnson David H
University of Wisconsin Hospital and Clinics, Madison, USA.
N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
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.
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.
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.
None of four chemotherapy regimens offered a significant advantage over the others in the treatment of advanced non-small-cell lung cancer.
我们进行了一项随机研究，以确定三种化疗方案中的任何一种在晚期非小细胞肺癌患者中是否优于顺铂和紫杉醇。
总共1207例晚期非小细胞肺癌患者被随机分配至顺铂和紫杉醇的参照方案，或三种试验方案之一：顺铂和吉西他滨、顺铂和多西他赛、或卡铂和紫杉醇。
所有1155例符合条件的患者的缓解率为19%，中位生存期为7.9个月（95%置信区间为7.3至8.5），1年生存率为33%（95%置信区间为30至36%），2年生存率为11%（95%置信区间为8至12%）。接受顺铂和紫杉醇治疗的患者与接受三种试验方案中任何一种治疗的患者之间的缓解率和生存率无显著差异。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显著更长，但更有可能导致3级、4级或5级肾毒性（9%的患者出现，而接受顺铂加紫杉醇治疗的患者为3%）。体能状态为2的患者的生存率显著低于体能状态为0或1的患者。
在晚期非小细胞肺癌的治疗中，四种化疗方案中的任何一种均未显示出相对于其他方案的显著优势。
