Adjuvant Imatinib for High-Risk GI Stromal Tumor: Analysis of a Randomized Trial
Adjuvant Imatinib for High-Risk GI Stromal Tumor: Analysis of a Randomized Trial
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DOI：
10.1200/jco.2015.62.9170
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发表时间：
2016-01-20
影响因子：
45.3
通讯作者：
Reichardt, Peter
中科院分区：
文献类型：
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作者：
Joensuu, Heikki;Eriksson, Mikael;Reichardt, Peter
目的根据斯堪的纳维亚肉瘤第 XVIII 组/AIO (Arbeitsgemeinschaft Internistische Onkologie) 试验的生存结果，建议具有高危特征的胃肠道间质瘤 (GIST) 患者接受三年伊马替尼辅助治疗。为了调查生存获益是否持续存在，我们对试验进行了第二次计划分析。 患者和方法符合条件的患者已宏观完全切除 KIT 阳性 GIST，根据修改后的美国国立卫生研究院标准确定，具有高复发风险。手术后，患者被随机分配接受伊马替尼治疗 1 年或 3 年。主要目标是无复发生存率（RFS），次要目标包括生存率。 结果 2004年2月4日至2008年9月29日期间，共有400名患者参加了这项开放标签研究。在中位随访90个月期间，检测到171例复发和69例死亡。分配到 3 年组的患者比分配到 1 年组的患者具有更长的 RFS； 5 年 RFS 分别为 71.1% 和 52.3%（风险比 [HR]，0.60；95% CI 0.44 至 0.81；P < .001），生存率为 91.9% 和 85.3%（HR，0.60；95% CI，0.37 至 0.97；P = .036）。 3 年组中，在研究开始时患有集中确诊的 GIST 且没有肉眼可见转移的亚组中，患者的生存期更长（93.4% vs 86.8%；HR，0.53；95% CI，0.30 至 0.93；P - 0.024）。各组中记录的心脏事件和继发癌症的数量相似。 结论 伊马替尼辅助治疗三年比伊马替尼一年的生存期更长。高危 GIST 患者群体可以实现较高的 5 年生存率。 (C) 2015 年美国临床肿瘤学会
PurposeThree years of adjuvant imatinib therapy are recommended for patients with GI stromal tumor (GIST) with high-risk features, according to survival findings in the Scandinavian Sarcoma Group XVIII/AIO (Arbeitsgemeinschaft Internistische Onkologie) trial. To investigate whether the survival benefits have persisted, we performed the second planned analysis of the trial.Patients and MethodsEligible patients had macroscopically completely excised, KIT-positive GIST with a high risk of recurrence, as determined by using the modified National Institutes of Health criteria. After surgery, the patients were randomly assigned to receive imatinib for either 1 or 3 years. The primary objective was recurrence-free survival (RFS), and the secondary objectives included survival.ResultsA total of 400 patients were entered onto this open-label study between February 4, 2004, and September 29, 2008. During a median follow-up of 90 months, 171 recurrences and 69 deaths were detected. Patients assigned to the 3-year group had longer RFS than those assigned to the 1-year group; 5-year RFS was 71.1% versus 52.3%, respectively (hazard ratio [HR], 0.60; 95% CI 0.44 to 0.81; P < .001), and survival was 91.9% versus 85.3% (HR, 0.60; 95% CI, 0.37 to 0.97; P = .036). Patients in the 3-year group survived longer in the subset with centrally confirmed GIST and without macroscopic metastases at study entry (93.4% v 86.8%; HR, 0.53; 95% CI, 0.30 to 0.93; P - .024). Similar numbers of cardiac events and second cancers were recorded in the groups.ConclusionThree years of adjuvant imatinib therapy results in longer survival than 1 year of imatinib. High 5-year survival rates are achievable in patient populations with high-risk GIST. (C) 2015 by American Society of Clinical Oncology