医脉通编译整理，转载请务必注明出处。
2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society ofClinicalOncology, ASCO）年会将在芝加哥举办。本次大会将吸引30000名全世界的肿瘤领域专家学者和参会人员，会议摘要收录了多个我国学者主导的肿瘤前沿研究。
来自中国医学科学院肿瘤医院的石远凯教授带领中国团队开展了一项开放标签、Ⅲ期临床研究CONVINCE，比较国产靶向药埃克替尼vs培美曲塞基础化疗作为一线治疗EGFR+肺腺癌的疗效。
埃克替尼是我国完全自主知识产权的口服小分子靶向抗癌新药，2013年石远凯教授团队曾在Lancet Oncology发表文章，头对头比较埃克替尼和吉非替尼在中国晚期非小细胞肺癌（NSCLC）患者中的疗效，证实了埃克替尼在PFS和安全性上不劣于吉非替尼，可大大降低患者治疗成本。(详细内容点击这里:[Lancet]埃克替尼或为NSCLC新的治疗选择）
摘要编号：9041
时间：6月4日，上午8:00-11:30
报告形式：壁报展示
CONVINCE研究包含中国18个不同地区的医疗中心，肺癌患者的主要入组要求：
◆年龄18-75岁
◆病理确诊为肺腺癌
◆EGFR 19/21突变阳性
◆未接受其他治疗
2013年1月至2014年8月，研究纳入296名患者进行随机化分配，分别进入埃克替尼治疗组和培美曲塞+顺铂化疗组，对化疗无进展患者给予培美曲塞维持治疗直到疾病进展或不能耐受毒性。
主要临床终点是无进展生存（PFS）。
结果
所有CONVINCE研究纳入的患者中285例接受治疗，其中埃克替尼组148例，化疗组137例。
埃克替尼组肺癌患者PFS相比化疗组有较大提升，分别为296天 vs 219天。
埃克替尼组肺癌患者肿瘤缓解率显著优于化疗组，分别为为64.8% vs 33.8%。
此外，埃克替尼组肺癌患者不良反应发生率低于化疗组，分别为70.3% vs 88.3%。
埃克替尼组最常见的不良反应依次为转氨酶升高（29.1%）、皮疹（17.6%）、腹泻（9.5%）。化疗组最常见的不良反应依次为中性粒细胞减少（77.4%）、红细胞减少（76.6%）、白细胞减少（70.1%）、恶心（54.7%）、转氨酶升高（40.1%）。
结论
中国的CONVINCE研究证实了埃克替尼在EGFR突变敏感性肺腺癌中的治疗作用。与化疗相比，国产靶向埃克替尼显著延长了PFS，且副作用耐受性好。前期研究已证实对于NSCLC患者，埃克替尼和吉非替尼作为二线可选药物疗效旗鼓相当。
会议专题》》》2016年ASCO年会专题报道
摘要阅读
Abstract No:9041
First-line icotinib versus cisplatine/pemetrexed plus pemetrexed maintenance therapy in lung adenocarcinoma patients with sensitizing EGFR mutation (CONVINCE)
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Author(s):Yuankai Shi,Lin Wang,Baohui Han,et al.
Background: Icotinib is an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), which is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced non-small cell lung cancer (NSCLC) patients as second-line therapy. We assess icotinib as first-line therapy in lung adenocarcinoma patients with EGFR mutation.
Methods: This phase 3, open-label, randomized study (CONVINCE, NCT01719536) was conducted at 18 sites in China. Eligible patients (pathologically confirmed lung adenocarcinoma, 19/21 EGFR mutation, treatment naive) were 1:1 randomized to receive icotinib (125 mg, three times daily) or pemetrexed (500 mg/m2, day 1) plus cisplatine (75 mg/m2, day 1), non-progressive patients after 4-cycle chemotherapy continue to receive pemetrexed (500 mg/m2, day 1) as maintenance therapy until disease progression or intolerable toxicity. Randomization was stratified by performance status, smoking status, disease stage, and mutation type. The primary endpoint was progression free survival (PFS).
Results: Six hundred and sixty-nine patients were screened (January, 2013 to August, 2014), in which 296 were enrolled and randomized (148 for each group), and 285 patients were treated (icotinib: 148, chemotherapy: 137). Baseline patients’ characteristics were well balanced between groups. Icotinib significantly improved PFS (296 days [95% CI 255–355] vs 219 days [189–253]; HR 0.67, 95% CI 0.49-0.90, p = 0.008) compared with the chemotherapy group. Icotinib also showed better tumor response rate (64.8% vs 33.8%, p < 0.001). Significantly fewer adverse events (AEs) were seen in the icotinib group (104 [70.3%] vs 121 [88.3%], p < 0.001). The most common AEs were elevated transaminase (29.1%), rash (17.6%) and diarrhea (9.5%) in icotinib group,and were neutropenia (77.4%), erythropenia (76.6%), leukopenia (70.1%), nausea (54.7%), elevated transaminase (40.1%) in chemotherapy group.
Conclusions: First-line icotinib is well tolerated and offers superior PFS compared with cisplatine/pemetrexed plus pemetrexed maintenance therapy in lung adenocarcinoma patients with sensitizing EGFR mutation. Clinical trial information: NCT01719536
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医脉通编译自：Yuankai Shi,et al.First-line icotinib versus cisplatine/pemetrexed plus pemetrexed maintenance therapy in lung adenocarcinoma patients with sensitizing EGFR mutation (CONVINCE).J Clin Oncol 34, 2016 (suppl; abstr 9041).
