Phase III Trial Comparing Docetaxel and Cisplatin Combination Chemotherapy With Mitomycin, Vindesine, and Cisplatin Combination Chemotherapy With Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: OLCSG 0007
Phase III Trial Comparing Docetaxel and Cisplatin Combination Chemotherapy With Mitomycin, Vindesine, and Cisplatin Combination Chemotherapy With Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: OLCSG 0007
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DOI：
10.1200/jco.2009.24.7577
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发表时间：
2010-07-10
影响因子：
45.3
通讯作者：
Tanimoto, Mitsune
中科院分区：
文献类型：
--
作者：
Segawa, Yoshihiko;Kiura, Katsuyuki;Tanimoto, Mitsune
目的探讨多西紫杉醇联合顺铂化疗（DP）联合胸部放疗（TRT）治疗局部晚期非小细胞肺癌（LA-NSCLC）的疗效。患者和方法年龄在75岁或以下的LA-NSCLC患者，根据表现状态、分期和机构进行分层，随机分配到DP(多西他赛40 mg/m（2)和顺铂40 mg/m(2)，在第1、8、29和36天）或丝裂霉素、长春地辛和顺铂（MVP）化疗合并TRT的两组。结果2000年7月至2005年7月，200名患者被分配到DP组或MVP组。2年的生存时间，一个主要终点，对DP组有利（计划分析的分层对数秩检验P = 0.059，早期加权对数秩分析P = 0.044）。与MVP组（分别为70.3%、48.1%、10.5个月和23.7个月）相比，DP组的缓解率、2年生存率、中位无进展时间和中位生存期（分别为78.8%、60.3%、13.4个月和26.8个月）有改善的趋势，但差异无统计学意义（P < 0.05）。3级发热性中性粒细胞减少症在MVP组比DP组更常见（分别为39% vs 22%， P = 0.012）， 3 - 4级放射性食管炎在DP组比MVP组更常见（14% vs 6%, P = 0.056）。结论DP化疗联合TRT治疗LA-NSCLC可替代MVP化疗。
Purpose To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC).Patients and Methods Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m(2) and cisplatin 40 mg/m(2) on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT.Results Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%, 13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056).Conclusion DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.