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首页> 外文期刊>The lancet oncology >Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: Overall survival analysis and updated results from a randomised phase 3 trial
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Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: Overall survival analysis and updated results from a randomised phase 3 trial

机译：阿昔替尼vs索拉非尼作为晚期肾细胞癌的二线治疗：总体生存分析和一项随机3期试验的更新结果

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Background: In a phase 3 trial comparing the efficacy and safety of axitinib versus sorafenib as second-line treatment for metastatic renal cell carcinoma, patients given axitinib had a longer progression-free survival (PFS). Here, we report overall survival and updated efficacy, quality of life, and safety results. Methods: Eligible patients had clear cell metastatic renal cell carcinoma, progressive disease after one approved systemic treatment, and an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. 723 patients were stratified by ECOG PS and previous treatment and randomly allocated (1:1) to receive axitinib (5 mg twice daily; n=361) or sorafenib (400 mg twice daily; n=362). The primary endpoint was PFS assessed by a masked, independent radiology review committee. We assessed patient-reported outcomes using validated questionnaires. Baseline characteristics and development of hypertension on treatment were studied as prognostic factors. Efficacy was assessed in the intention-to-treat population, and safety was assessed in patients who received at least one dose of the study drug. This ongoing trial is registered on ClinicalTrials.gov, number NCT00678392. Findings: Median overall survival was 20·1 months (95% CI 16·7-23·4) with axitinib and 19·2 months (17·5-22·3) with sorafenib (hazard ratio [HR] 0·969, 95% CI 0·800-1·174; one-sided p=0·3744). Median investigator-assessed PFS was 8·3 months (95% CI 6·7-9·2) with axitinib and 5·7 months (4·7-6·5) with sorafenib (HR 0·656, 95% CI 0·552-0·779; one-sided p<0·0001). Patient-reported outcomes scores were similar in the treatment groups at baseline, were maintained during treatment, but decreased at end-of-treatment. Common grade 3 or higher treatment-related adverse events were hypertension (60 [17%]), diarrhoea (40 [11%]), and fatigue (37 [10%]) in 359 axitinib-treated patients and hand-foot syndrome (61 [17%]), hypertension (43 [12%]), and diarrhoea (27 [8%]) in 355 sorafenib-treated patients. In a post-hoc 12-week landmark analysis, median overall survival was longer in patients with a diastolic blood pressure of 90 mm Hg or greater than in those with a diastolic blood pressure of less than 90 mm Hg: 20·7 months (95% CI 18·4-24·6) versus 12·9 months (10·1-20·4) in the axitinib group (p=0·0116), and 20·2 months (17·1-32·0) versus 14·8 months (12·0-17·7) in the sorafenib group (one-sided p=0·0020). Interpretation: Although overall survival, a secondary endpoint for the study, did not differ between the two groups, investigator-assessed PFS remained longer in the axitinib group compared with the sorafenib group. These results establish axitinib as a second-line treatment option for patients with metastatic renal cell carcinoma. Funding: Pfizer Inc.
机译：背景：在一项比较阿西替尼与索拉非尼作为转移性肾细胞癌二线治疗的疗效和安全性的3期试验中，接受阿西替尼治疗的患者的无进展生存期更长。在这里，我们报告了总体生存率和更新的疗效，生活质量和安全性结果。方法：符合条件的患者患有透明细胞转移性肾细胞癌，经批准的一种全身治疗后可进行性疾病，并且东部合作肿瘤小组的工作状态（ECOG PS）为0-1。 723例患者通过ECOG PS和既往治疗进行分层，随机分配（1：1）接受阿昔替尼（5 mg，每天两次; n = 361）或索拉非尼（400 mg，每天两次; n = 362）。主要研究终点是由独立的放射学评审委员会评估的PFS。我们使用经过验证的问卷评估了患者报告的结局。研究了高血压的基线特征和发展趋势作为预后因素。在意向治疗人群中评估疗效，并在接受至少一剂研究药物的患者中评估安全性。该正在进行的试验已在ClinicalTrials.gov上注册，编号为NCT00678392。结果：阿昔替尼的中位总生存期为20·1个月（95％CI 16·7-23·4），索拉非尼为19·2个月（17·5-22·3）（危险比[HR] 0·969， 95％CI 0·800-1·174;一侧p = 0·3744）。研究者评估的阿昔替尼的PFS为8·3个月（95％CI 6·7-9·2），索拉非尼（HR 0·656，95％CI 0）为5·7个月（4·7-6·5）。 ·552-0·779;单面p <0·0001）。在基线时，治疗组的患者报告结局评分相似，在治疗期间保持不变，但在治疗结束时降低。在359名接受阿昔替尼治疗的患者和手足综合征中，常见的3级或更高级别的治疗相关不良事件为高血压（60 [17％]），腹泻（40 [11％]）和疲劳（37 [10％]）。 355名索拉非尼治疗的患者中有61名[17％]），高血压（43名[12％]）和腹泻（27名[8％]）。在事后12周的里程碑分析中，舒张压≥90 mm Hg的患者的平均中位生存期比舒张压≤90 mm Hg的患者更长：20·7个月（95 ％CI 18·4-24·6）与阿西替尼组的12·9个月（10·1-20·4）（p = 0·0116）和20·2个月（17·1-32·0）相比索拉非尼组为14·8个月（12·0-17·7）（单侧p = 0·0020）。解释：尽管总体生存率（该研究的次要终点）在两组之间没有差异，但与索拉非尼组相比，阿西替尼组的研究者评估的PFS仍更长。这些结果使阿昔替尼成为转移性肾细胞癌患者的二线治疗选择。资金来源：辉瑞公司

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