Stivarga获准治疗晚期胃肠道间质瘤

圣路易斯(MD Consult)——2013年2月25日，美国食品药品管理局(FDA)宣布，已批准Stivarga (regorafenib，瑞格非尼)用于治疗不能手术切除且对格列卫(伊马替尼)和索坦(舒尼替尼)治疗无应答的晚期胃肠道间质瘤(GIST)。后两者是FDA已批准的另外2种治疗GIST的药物。Stivarga是一种多种激酶抑制剂，已于2012年9月获准用于结直肠癌治疗。

一项纳入199例不能手术切除且在格列卫或索坦治疗后出现进展的GITS患者的临床研究中评价了Stivarga新适应症的有效性和安全性。患者被随机分入Stivarga组或安慰机组，所有患者还接受最佳支持性治疗。受试者在出现癌症进展或不能耐受的不良反应之前，一直接受Stivarga治疗或安慰剂。结果显示，与安慰机组相比，Stivarga组患者无进展生存期平均延长3.9个月。安慰机组患者一旦癌症出现进展，可转为Stivarga治疗。

接受Stivarga治疗的患者最常见不良反应包括虚弱、乏力、手足综合征、腹泻、食欲下降、高血压、口腔溃疡、感染、音量或音质改变、疼痛、体重下降、腹痛、皮疹、发热以及恶心。

严重不良反应包括肝损伤、严重出血、皮肤起泡和脱皮、需要急诊治疗的严重高血压、心肌梗死和肠穿孔。

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ST LOUIS (MD Consult) - On February 25, 2013, the US Food and Drug Administration (FDA) announced the approval of Stivarga (regorafenib) for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed, and whose tumors no longer respond to Gleevec (imatinib) and Sutent (sunitinib), 2 other FDA-approved drugs used to treat GIST. Stivarga is a multikinase inhibitor. The drug was previously approved in September 2012 for the treatment of colorectal cancer.

The safety and effectiveness of Stivarga for this new indication were evaluated in a clinical study of 199 patients with GIST whose cancer could not be surgically removed and progressed after treatment with Gleevec or Sutent. Patients were randomly assigned to receive either Stivarga or a placebo. All patients also received optimal supportive care. Patients in the study received Stivarga or placebo until either the cancer progressed or the adverse effects became unacceptable. Results showed that patients who received Stivarga experienced progression-free survival that was, on average, 3.9 months longer than patients who received placebo. Placebo-treated patients were given the opportunity to switch to Stivarga when their cancer progressed.

The most common adverse effects reported in patients treated with Stivarga were weakness, fatigue, palmar-plantar erythrodysesthesia, diarrhea, loss of appetite, hypertension, mouth sores, infection, changes in voice volume or quality, pain, weight loss, abdominal pain, rash, fever, and nausea.

Serious adverse effects, which occurred in < 1% of patients, were liver damage, severe bleeding, blistering and peeling of skin, very high blood pressures requiring emergency treatment, myocardial infarction, and intestinal perforation.