Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer.
Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer.
复制标题
DOI：
10.1186/1471-2407-14-290
复制
发表时间：
2014-04-25
期刊：
影响因子：
3.8
通讯作者：
Scagliotti GV
中科院分区：
文献类型：
--
作者：
Belani CP;Yamamoto N;Bondarenko IM;Poltoratskiy A;Novello S;Tang J;Bycott P;Niethammer AG;Ingrosso A;Kim S;Scagliotti GV
在晚期非鳞状非小细胞肺癌（NSCLC）患者中评价了阿西替尼（一种强效和选择性的第二代血管内皮生长因子受体1、2和3抑制剂）联合培美曲塞和顺铂的疗效和安全性。总体而言，170例患者被随机分配接受阿西替尼，起始剂量为5 mg，每日两次，连续给药，第1天联合培美曲塞500 mg/m2和顺铂75 mg/m2，共6个21天周期（I组）;每个周期第2 - 19天联合阿西替尼联合培美曲塞/顺铂（II组）;或培美曲塞/顺铂单药（III组）。主要终点是无进展生存期（PFS）。组I、组II和组III的中位PFS分别为8.0、7.9和7.1个月（风险比：组I vs. III，0.89 [P = 0.36];组II vs. III，1.02 [P = 0.54]）。中位总生存期为17.0个月（I组）、14.7个月（II组）和15.9个月（III组）。含阿昔替尼组的客观缓解率（ORR）为45.5%（组I）和39.7%（组II），而培美曲塞/顺铂单药组（组III）为26.3%。所有治疗组中经常报告胃肠道疾病和疲乏。最常见的全因≥3级不良事件为含阿昔替尼组的高血压（I组和II组分别为20%和17%）和培美曲塞/顺铂单药组的疲乏（16%）。阿昔替尼联合培美曲塞/顺铂通常耐受良好。与单独化疗相比，阿西替尼联合治疗晚期非小细胞肺癌的无进展生存期（PFS）无显著差异，ORR在数值上更高。ClinicalTrials.gov：NCT 00768755（2008年10月7日）。
The efficacy and safety of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non–small-cell lung cancer (NSCLC). Overall, 170 patients were randomly assigned to receive axitinib at a starting dose of 5-mg twice daily continuously plus pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of up to six 21-day cycles (arm I); axitinib on days 2 through 19 of each cycle plus pemetrexed/cisplatin (arm II); or pemetrexed/cisplatin alone (arm III). The primary endpoint was progression-free survival (PFS). Median PFS was 8.0, 7.9, and 7.1 months in arms I, II, and III, respectively (hazard ratio: arms I vs. III, 0.89 [P = 0.36] and arms II vs. III, 1.02 [P = 0.54]). Median overall survival was 17.0 months (arm I), 14.7 months (arm II), and 15.9 months (arm III). Objective response rates (ORRs) for axitinib-containing arms were 45.5% (arm I) and 39.7% (arm II) compared with 26.3% for pemetrexed/cisplatin alone (arm III). Gastrointestinal disorders and fatigue were frequently reported across all treatment arms. The most common all-causality grade ≥3 adverse events were hypertension in axitinib-containing arms (20% and 17%, arms I and II, respectively) and fatigue with pemetrexed/cisplatin alone (16%). Axitinib in combination with pemetrexed/cisplatin was generally well tolerated. Axitinib combinations resulted in non-significant differences in PFS and numerically higher ORR compared with chemotherapy alone in advanced NSCLC. ClinicalTrials.gov: NCT00768755 (October 7, 2008).
登录
查看更多内容
DOI：
10.1158/1078-0432.ccr-07-1772
发表时间：
2008-08-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Henderson YC;Ahn SH;Kang Y;Clayman GL
通讯作者：
Clayman GL
影响因子：
45.3
作者：
Scagliotti, Giorgio;Novello, Silvia;Hanna, Nasser
通讯作者：
Hanna, Nasser
影响因子：
45.3
作者：
Scagliotti, Giorgio Vittorio;Parikh, Purvish;Gandara, David
通讯作者：
Gandara, David
影响因子：
8.8
作者：
Kozloff, M. F.;Martin, L. P.;Krzakowski, M.;Samuel, T. A.;Rado, T. A.;Arriola, E.;De Castro Carpeno, J.;Herbst, R. S.;Tarazi, J.;Kim, S.;Rosbrook, B.;Tortorici, M.;Olszanski, A. J.;Cohen, R. B.
通讯作者：
Cohen, R. B.
影响因子：
158.5
作者：
Sandler, Alan;Gray, Robert;Johnson, David H.
通讯作者：
Johnson, David H.