医脉通编译，转载请务必注明出处
2015年ASCO年会于5月29日—6月2日在美国芝加哥召开。5月31日上午的消化系统（非结直肠）肿瘤口头报告专场上，一项摘要号为4004的SWOG S0518 III期前瞻性随机对照试验中，善龙（奥曲肽）联合干扰素α-2b与善龙（奥曲肽）联合贝伐珠单抗（NSC＃704865）在治疗晚期，预后不良的类癌患者中的疗效进行比较。医脉通整理如下：
晚期类癌（NETs）的治疗选择方案有限。生长抑素类似物（SSA）可以延长初次治疗或疾病稳定患者的无进展生存期（PFS）。干扰素（INF）联合SSA的抗肿瘤活性已被证实。一项II期临床研究表明贝伐珠单抗（BEV）联合SSA，奥曲肽（OCT），能够影响肿瘤缩小，增强抗肿瘤活性。这项研究比较BEV+OCT与INF α-2b+OCT两种方案的效果。
在该项研究中，将转移性或不能手术切除，分化良好，伴有疾病进展或不良预后的G1/2NETs患者按1：1随机分配接受OCT LAR 20mg q21天联合BEV 15mg/kg q21天，或者INF α-2b 500万单位 q21天。主要终点为PFS，评定结果由中心复审。
2007年12月至2012年9月共入组427例，其中402例符合条件。中心复审的中位PFS：BEV组16.6个月（95%CI：12.9-19.6），INF组15.4个月（95%CI：9.6-18.6），（HR 0.93；95%CI 0.73-1.18；P=0.55）。研究人员评估的中位PFS（HR 0.90；95%CI：0.72-1.12，P=0.33）：BEV组15.4个月（95%CI：12.6-17.2），INF组10.6个月（95%CI：8.5-14.4）。BEV组的TTF较INF组有显著优势（HR 0.72；95%CI 0.58-0.89；P=0.003）。BEV组的中位TTF为9.9个月（95%CI：7.3-11.1），而INF组为5.6个月（95%CI：4.3-6.4）。BEV组的确认影像学反应率为12%（95%CI：8%-18%），而INF组为4%（95%CI：2%-8%）。
BEV+OCT治疗组的常见副反应包括高血压（32%）、蛋白尿（9%）和疲劳（7%）；而INF+OCT治疗组的副反应包括疲劳（27%）、中性粒细胞减少（12%）和恶心（6%）。
因此，综上所述，BEV+OCT相比于IFN+OCT，其TTF更长；同样，影像学反应率也是BEV+OCT组更高。然而，两组PFS未观察显著差异，提示BEV和IFN在晚期类癌中具有相似的抗肿瘤活性。支持：NIH/NCI准许的CA180888、CA180819、CA180799、CA180820、CA180821和CA025224，部分来源于Genentech。临床试验信息：NCT00569127。
会议专题》》》2015年ASCO年会专题报道
阅读原文摘要
SWOG S0518: Phase III prospective randomized comparison of depot octreotide plus interferon alpha-2b versus depot octreotide plus bevacizumab (NSC #704865) in advanced, poor prognosis carcinoid patients (NCT00569127).（Abstract 4004）
Authors：James C. Yao, Katherine Guthrie,et al.
Session Type：Oral Abstract Session
Background：Treatment options for advanced carcinoid tumors (NETs) are limited. Somatostatin analogues (SSA) prolong progression-free survival (PFS) among patients (pts) who are treatment naïve or have stable disease. Interferon (INF) added to SSA has also demonstrated antitumor activity. Bevacizumab (BEV), added to SSA, octreotide (OCT), was associated with tumor regression and encouraging antitumor activity in a phase II study. The current study compares BEV + OCT to INF α-2b + OCT.
Method：Pts with metastatic or unresectable, well-differentiated, G1/2 NETs with progressive disease or other poor prognostic features were randomly assigned (1:1) to receive OCT LAR 20 mg q 21 days with either BEV 15 mg/kg every 21 days or INF α-2b 5 million units three times per week. PFS by central review was the primary endpoint.
Results：427 pts were enrolled, of whom 402 were eligible, between December 2007 and September 2012. Median PFS by central review was 16.6 (95% CI: 12.9 – 19.6) months in BEV arm and 15.4 (95% CI: 9.6 – 18.6) months in the INF arm (HR 0.93; 95% CI 0.73-1.18; P = 0.55). By investigator review, median PFS was 15.4 (95% CI: 12.6 – 17.2) months in BEV arm and 10.6 (95% CI: 8.5 – 14.4) months in the INF arm (HR 0.90; 95% CI: 0.72 - 1.12; P = 0.33). TTF was significantly longer with BEV compared to INF (HR 0.72; 95% CI 0.58 - 0.89; P = 0.003). Median TTF was 9.9 (95% CI: 7.3 – 11.1) months in the BEV arm and 5.6 (95% CI 4.3 – 6.4) months in the INF arm. Confirmed radiologic response rates were 12% (95% CI: 8% - 18%) in the BEV arm and 4% (95% CI: 2% - 8%) in the INF arm. Common AEs with BEV + OCT included HTN (32%), proteinuria (9%), and fatigue (7%); and with INF + OCT included fatigue (27%), neutropenia (12%), and nausea (6%).
Conclusion：BEV + OCT was associated with longer TTF compared to IFN + OCT; radiologic responses also appeared to be more frequent among pts treated with BEV + OCT. However, no significant differences in PFS were observed, suggesting that BEV and IFN have similar antitumor activity in pts with advanced carcinoid. Support: NIH/NCI grants CA180888, CA180819, CA180799, CA180820, CA180821 and CA025224, and in part by Genentech. Clinical trial information: NCT00569127。
