Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer.
Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer.
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DOI：
10.1007/s10147-016-1039-0
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发表时间：
2017-02
影响因子：
3.3
通讯作者：
Tamura T
中科院分区：
文献类型：
--
作者：
Yamamoto N;Goto K;Nishio M;Chikamori K;Hida T;Maemondo M;Katakami N;Kozuki T;Yoshioka H;Seto T;Tajima K;Tamura T
在日本，厄洛替尼单药治疗表皮生长因子受体（EGFR）突变阳性非小细胞肺癌的临床疗效在II期JO22903试验中得到证实，该试验报告的中位无进展生存期为11.8个月。在此，我们报告JO22903的最终总生存期数据。JO22903 （japicci -101085）是一项单组、多中心、II期、开放标签、非随机的研究，研究一线厄洛替尼单药治疗EGFR突变阳性的非小细胞肺癌。符合条件的IIIB/IV期或复发性非小细胞肺癌患者（≥20岁），并确认EGFR激活突变（19外显子缺失或21外显子L858R点突变）接受口服厄洛替尼150mg /天，直到疾病进展或不可接受的毒性。主要终点为无进展生存期和安全性；总生存期是次要终点。在最后的分析中，102名患者被纳入修改意向治疗人群，103名患者被纳入安全人群。中位随访时间为32.3个月。中位总生存期为36.3个月（95%置信区间29.4 -未达到）。总生存期的亚组分析表明，脑转移的存在是一个负面预后因素（中位总生存期22.7个月，95%可信区间19.6-29.4）。在疾病进展后的任何治疗中，使用或不使用EGFR酪氨酸激酶抑制剂对总生存期的影响尚不清楚（中位分别为32.8个月和36.3个月）。没有观察到新的安全问题。在这项生存更新中，单药厄洛替尼在EGFR突变阳性的非小细胞肺癌患者中实现了超过3年的中位总生存期。
In Japan, the clinical efficacy of erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer was demonstrated in the phase II JO22903 trial, which reported a median progression-free survival of 11.8 months. Here we report final overall survival data from JO22903. JO22903 (JapicCTI-101085) was a single-arm, multicenter, phase II, open-label, non-randomized study of first-line erlotinib monotherapy in EGFR mutation-positive non-small-cell lung cancer. Eligible patients (≥20 years) with stage IIIB/IV or recurrent non-small-cell lung cancer and confirmed activating mutations of EGFR (exon 19 deletion or L858R point mutation in exon 21) received oral erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival and safety; overall survival was a secondary endpoint. At the final analysis, 102 patients were included in the modified intent-to-treat population and 103 in the safety population. Median follow-up was 32.3 months. Median overall survival was 36.3 months (95 % confidence interval 29.4–not reached). Subgroup analyses of overall survival suggested that the presence of brain metastases was a negative prognostic factor (median overall survival 22.7 months, 95 % confidence interval 19.6–29.4). The impact on overall survival of using versus not using EGFR tyrosine kinase inhibitors in any line of treatment following disease progression was unclear (median 32.8 versus 36.3 months, respectively). No new safety issues were observed. In this survival update, single-agent erlotinib achieved a median overall survival of more than 3 years in patients with EGFR mutation-positive non-small-cell lung cancer.