Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer - A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)
Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer - A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)
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DOI：
10.1016/j.ejca.2011.06.002
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发表时间：
2011-10-01
影响因子：
8.4
通讯作者：
Reichardt, Peter
中科院分区：
文献类型：
--
作者：
Thuss-Patience, Peter C.;Kretzschmar, Albrecht;Reichardt, Peter
背景：转移性胃癌二线治疗的价值尚不清楚。到目前为止，还没有比较二线化疗与最佳支持治疗（BSC）的随机III期数据。在这一前瞻性，多中心，开放标签，随机III期研究，我们比较伊立替康BSC二线chemotherapy.Methods的生存评估的影响：符合条件的患者（患者）有转移性或局部晚期胃食管交界处或胃腺癌，客观肿瘤进展期间或6个月内一线化疗和ECOG体能状态0-2。一线治疗后的进展时间分层、ECOG PS和治疗前确保了重要预后因素的均匀分布。治疗：A组：伊立替康250 mg/m2（2）q3 w（第一周期）根据毒性增加至350 mg/m2（，）。B组：BSC。结果：2002年10月至2006年12月，40例患者接受随机化。由于入组不良，研究提前关闭。A组缓解（19例患者可评价）：无客观缓解，SD 53%，PD 47%。肿瘤相关症状改善：A组50%的患者，B组7%。总生存期：（40例患者的所有事件均发生）：伊立替康组的死亡风险比降至0.48（95%CI 0.25-0.92）（p = 0.012）。A组中位生存期：4.0个月（95% CI 3.6-7.5），B组：2.4个月（95% CI 1.7-4.9）。解释：在研究患者中，与BSC相比，伊立替康作为二线化疗显著延长了总生存期。二线化疗现在可以被认为是转移性或局部晚期胃癌的一种经过验证的治疗选择。资金来源：这项研究得到了安万特和辉瑞的研究资助。(C)2011爱思唯尔有限公司保留所有权利。
Background: The value of second-line therapy for metastatic gastric cancer is unclear. So far there are no randomised phase III data comparing second-line chemotherapy to best supportive care (BSC). In this prospective, multicenter, open label, randomised phase III study we compared irinotecan to BSC to evaluate the impact on survival of second-line chemotherapy.Methods: Eligible patients (pts) had metastatic or locally advanced gastro-oesophageal junction or gastric adenocarcinoma, objective tumour progression during or within 6 months after first-line chemotherapy and ECOG performance status 0-2. Stratification for time of progression after first-line therapy, ECOG PS and pretreatment secured even distribution of important prognostic factors.Treatment: Arm A: Irinotecan 250 mg/m(2) q3w (first cycle) to be increased to 350 mg/m2(,) depending on toxicity. Arm B: BSC.Findings: Between 10/2002 and 12/2006 40 pts were randomised. The study was closed prematurely due to poor accrual. Response for arm A (19 pts evaluable): No objective responses, SD 53%, PD 47%. Improvement of tumour related symptoms: Arm A 50% of pts, arm B 7%. Overall Survival: (all events in 40 pts have occurred): The hazard ratio for death was reduced to 0.48 (95%CI 0.25-0.92) in the irinotecan-arm (p = 0.012). Median survival arm A: 4.0 months (95% CI 3.6-7.5), arm B: 2.4 months (95% CI 1.7-4.9).Interpretation: Irinotecan as second-line chemotherapy significantly prolongs overall survival compared to BSC in the studied pts. Second-line chemotherapy can now be considered as a proven treatment option for metastatic or locally advanced gastric cancer.Funding: The study was supported by a research grant from Aventis and Pfizer. (C) 2011 Elsevier Ltd. All rights reserved.