2014年ASCO大会中的肺癌口头报告中，有一项报告公布了一项开放标签的随机试验结果，该试验对比厄洛替尼+贝伐珠单抗（EB）与单独厄洛替尼（E）一线治疗EGFR突变阳性晚期NSCLC患者的疗效。下面和大家提前分享这项研究。

背景

尽管EGFR-TKI药物有了很大的发展，目前EGFR突变阳性NSCLC患者的中位PFS只有约13个月。来自于BeTa Lung研究EGFR突变的亚组人群的结果表明，EB方案可能会延长此类病人的PFS。

方法

该试验为开放标签的随机对照试验。3b/4期或者复发性非鳞状EGFR突变阳性的NSCLC患者，ECOG评分0/1，既往无化疗，患者随机接受EB（E，150mg/d；B，15mg/kg，每三周）或者E（150mg/d）治疗，直到疾病进展或出现不可接受的毒性。

主要终点是PFS。次要终点包括总生存期，客观缓解率（ORR），安全性和生活质量。计划样本量为150，α误差为0.2，目标HR为0.7。

结果

从2011年2月到2012年3月，154名患者入组（EB组，n=77；E组，n=77）。两组间的病人特征无明显差异，包括年龄、性别、分期、EGFR突变类型。EB组和E组的中位PFS为16.0和9.7个月（HR,0.54；95%CI,0.36–0.79；log-rank p = 0.0015）。

在EGFR外显子19缺失的亚组，EB组和E组的中位PFS为18.0和10.3个月。L858R亚组，EB组和E组的中位PFS为13.9和7.1个月。EB组和E组的ORR分别为69.9%和63.6%。分别有3个和1个病人完全缓解。

EB组中3或4级皮疹更为多见（25.3%vs19.5%），3或4级出血也更为常见（2.7% vs 0.0%）。但是，大多数不良反应是可控制的，也没发现新的安全信号。5例病人出现1-3级的间质性肺病，但两组间无差异。E组中出现一例与治疗相关的死亡。

结论

对于EGFR突变阳性的NSCLC患者，厄洛替尼+贝伐珠单抗明显比单独的厄洛替尼带来更长的PFS。

医脉通整理报道，转载请注明出处。

会议专题》》》2014年ASCO年会专题报道

阅读摘要原文

Erlotinib plus bevacizumab (EB) versus erlotinib alone (E) as first-line treatment for advanced EGFR mutation–positive nonsquamous non-small cell lung cancer (NSCLC): An open-label randomized trial.(Abstract No:8005)

Author(s): Terufumi Kato, Takashi Seto, Makoto Nishio,et al.

Type: Oral Abstract Session

Background: Despite the development of EGFR tyrosine kinase inhibitors, median progression-free survival (PFS) is only about 13 months in patients with EGFR mutation–positive NSCLC. However, results from the BeTa Lung study for a subgroup of patients with EGFR mutation suggest that EB may prolong PFS in these patients. 

Methods: Open-label randomized trial. Patients with stage 3b/4 or recurrent non-squamous EGFR mutation–positive NSCLC, ECOG performance status 0/1, and no previous chemotherapy were randomly allocated to receive EB (E, 150 mg/day; B, 15 mg/kg every 3 weeks) or E (150 mg/day) until disease progression or unacceptable toxicity. The primary endpoint was PFS determined by blinded independent review committee. Secondary endpoints included overall survival, objective response rate (ORR), safety, and quality of life. The planned sample size was 150, with an alpha error of 0.2 and a power of 80% for a target hazard ratio (HR) of 0.7. 

Results: From February 2011 to March 2012, 154 patients were enrolled (EB group, n = 77; E group, n = 77). There were no major differences in patient characteristics, including age, gender, stage, and EGFR mutation type, between the two groups. Median PFS was 16.0 months for EB and 9.7 months for E (HR, 0.54; 95% CI, 0.36–0.79; log-rank p = 0.0015). In the EGFR exon 19 deletion subgroup, median PFS was 18.0 months for EB and 10.3 months for E. In the L858R subgroup, median PFS was 13.9 months for EB and 7.1 months for E. ORR was 69.3% for EB and 63.6% for E. There were 3 and 1 complete responses to EB and E, respectively. Grade 3 or 4 rash was more common in the EB group (25.3% versus 19.5%). Grade 3 or 4 bleeding was more common in the EB group (2.7% versus 0.0%). However, most adverse events were manageable, and no new safety signals arose. Five patients experienced grade 1–3 interstitial lung disease, but there was no difference between the groups. One treatment-related death occurred in the E group. 

Conclusions: EB results in significantly longer PFS than E in patients with EGFR mutation–positive NSCLC. Clinical trial information: JapicCTI-111390.

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