U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA.
Oncologist. 2012;17(7):992-7. doi: 10.1634/theoncologist.2012-0109. Epub 2012 May 29.
On January 31, 2012, the U.S. Food and Drug Administration granted regular approval of imatinib mesylate tablets (Gleevec®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) for the adjuvant treatment of adult patients following complete gross resection of Kit(+) (CD117(+)) gastrointestinal stromal tumors (GISTs). The recommended dose of imatinib is 400 mg/day administered daily for 3 years. Three hundred ninety-seven patients were enrolled in a randomized adjuvant, multicenter, open label, phase III trial comparing 12 months with 36 months of imatinib treatment. Eligible patients had one of the following: tumor diameter >5 cm and mitotic count >5 per 50 high power fields (HPFs); tumor diameter >10 cm and any mitotic count; tumor of any size with mitotic count >10/50 HPFs; or tumor ruptured into the peritoneal cavity. The primary endpoint was the recurrence-free survival (RFS) interval. The median follow-up for patients without an RFS event was 42 months. There were 84 (42%) RFS events in the 12-month treatment arm and 50 (25%) RFS events in the 36-month treatment arm. Thirty-six months of imatinib treatment led to a significantly longer RFS interval than with 12 months of treatment. The median follow-up for overall survival (OS) evaluation in patients still living was 48 months. Thirty-six months of imatinib treatment led to a significantly longer OS time than with 12 months of imatinib treatment. The most common adverse reactions, as noted in previous imatinib studies, were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain.
2012 年 1 月 31 日，美国食品和药物管理局批准甲磺酸伊马替尼片（Gleevec®；诺华制药公司，新泽西州东不伦瑞克）用于完全大体切除 Kit(+)（CD117(+)）胃肠道间质瘤（GIST）的成年患者的辅助治疗。伊马替尼的推荐剂量为 400mg/天，每日服用，持续 3 年。397 名患者入组了一项随机辅助、多中心、开放性标签、III 期临床试验，比较了 12 个月和 36 个月伊马替尼治疗。符合条件的患者有以下情况之一：肿瘤直径>5cm，每 50 个高倍视野（HPF）有>5 个有丝分裂计数；肿瘤直径>10cm，任何有丝分裂计数；任何大小的肿瘤，有丝分裂计数>10/50 HPF；或肿瘤破裂进入腹腔。主要终点是无复发生存（RFS）间隔。无 RFS 事件的患者中位随访时间为 42 个月。在 12 个月治疗组中，有 84 例（42%）出现 RFS 事件，在 36 个月治疗组中，有 50 例（25%）出现 RFS 事件。与 12 个月的治疗相比，36 个月的伊马替尼治疗可显著延长 RFS 间隔。在仍存活的患者中，中位总生存（OS）随访时间为 48 个月。与 12 个月的伊马替尼治疗相比，36 个月的伊马替尼治疗可显著延长 OS 时间。与之前的伊马替尼研究一样，最常见的不良反应是腹泻、疲劳、恶心、水肿、血红蛋白减少、皮疹、呕吐和腹痛。
