Salvage Chemotherapy for Pretreated Gastric Cancer: A Randomized Phase III Trial Comparing Chemotherapy Plus Best Supportive Care With Best Supportive Care Alone
Salvage Chemotherapy for Pretreated Gastric Cancer: A Randomized Phase III Trial Comparing Chemotherapy Plus Best Supportive Care With Best Supportive Care Alone
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DOI：
10.1200/jco.2011.39.4585
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发表时间：
2012-05-01
影响因子：
45.3
通讯作者：
Park, Se Hoon
中科院分区：
文献类型：
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作者：
Kang, Jung Hun;Lee, Soon Il;Park, Se Hoon
在设计本试验时，没有证据表明晚期胃癌（AGC）的挽救化疗（SLC）与最佳支持治疗（BSC）相比，可显著延长生存期。然而，SLC通常提供给预处理的患者与AGC的轶事reasontals.Patients和MethodsPatients AGC与一个或两个先前的化疗方案，涉及氟嘧啶和铂和东部肿瘤协作组性能状态（PS）0或1被随机分配的比例为2：1 SLC加BSC或BSC单独。SLC的选择-多西他赛60 mg/m2每3周一次或伊立替康150 mg/m2每2周一次-由研究者自行决定。SLC组133例患者的中位OS为5.3个月，BSC组69例患者的中位OS为3.8个月（风险比为0.657; 95%CI为0.485 ~ 0.891;单侧P = 0.007）。SLC的OS获益在大多数前瞻性定义的亚组中一致，包括年龄、PS、既往治疗次数、转移部位、血红蛋白水平和既往化疗应答。SLC通常耐受良好，SLC和BSC组的不良事件相似。我们发现多西他赛和伊立替康之间没有中位OS差异（5.2 v 6.5个月; P = 0.116）。ConclusionTo our knowledge，this is the largest phase III trial comparing SLC + BSC with BSC alone in AGC.在接受过预治疗的患者中，SLC是耐受的，并且当添加到BSC中时显著改善OS。
PurposeWhen designing this trial, there was no evidence that salvage chemotherapy (SLC) in advanced gastric cancer (AGC) resulted in substantial prolongation of survival when compared with best supportive care (BSC). However, SLC is often offered to pretreated patients with AGC for anecdotal reasons.Patients and MethodsPatients with AGC with one or two prior chemotherapy regimens involving both fluoropyrimidines and platinum and with an Eastern Cooperative Oncology Group performance status (PS) 0 or 1 were randomly assigned in a ratio of 2: 1 to SLC plus BSC or BSC alone. Choice of SLC-either docetaxel 60 mg/m(2) every 3 weeks or irinotecan 150 mg/m(2) every 2 weeks-was left to the discretion of investigators. Primary end point was overall survival (OS).ResultsMedian OS was 5.3 months among 133 patients in the SLC arm and 3.8 months among 69 patients in the BSC arm (hazard ratio, 0.657; 95% CI, 0.485 to 0.891; one-sided P = .007). OS benefit for SLC was consistent in most of the prospectively defined subgroups, including age, PS, number of prior treatments, metastatic sites, hemoglobin levels, and response to prior chemotherapy. SLC was generally well tolerated, and adverse events were similar in the SLC and BSC arms. We found no median OS difference between docetaxel and irinotecan (5.2 v 6.5 months; P = .116).ConclusionTo our knowledge, this is the largest phase III trial comparing SLC plus BSC with BSC alone in AGC. In pretreated patients, SLC is tolerated and significantly improves OS when added to BSC.