Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;
Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;
Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27.
This phase II single-arm trial evaluated afatinib, an irreversible inhibitor of the ErbB receptor family as third-line treatment of Korean patients with advanced non-small cell lung cancer (NSCLC) and tumors with wild-type EGFR. Currently, no standard therapy exists for these patients.
Eligible patients had stage IIIB/IV wild-type EGFR lung adenocarcinoma and had failed to benefit from two previous lines of chemotherapy but had not received anti-EGFR treatment. Patients received oral afatinib at 40 mg per day until disease progression or occurrence of intolerable adverse events (AEs). The primary endpoint was confirmed objective tumor response (OR) rate (confirmed complete response [CR] or partial response [PR]). Secondary endpoints included disease control rate (DCR; OR or stable disease for ≥6 weeks), progression-free survival (PFS), and safety.
Forty-two patients received afatinib treatment, and 38 of those were included in efficacy analyses. No confirmed CRs or PRs were reported. DCR was 24% (9 of 38 patients), with a median disease control duration of 19.3 weeks. Median PFS was 4.1 weeks (95% confidence interval: 3.9-8.0). Frequently reported AEs (mainly grades 1 and 2) were rash/acne (88%), diarrhea (62%), and stomatitis (57%).
Heavily pretreated patients with wild-type EGFR NSCLC treated with afatinib monotherapy did not experience an objective response and only 24% had disease stabilization lasting more than 6 weeks. AEs were manageable and consistent with the expected safety profile.
这项 II 期单臂试验评估了 afatinib，一种不可逆的 ErbB 受体家族抑制剂，作为晚期非小细胞肺癌（NSCLC）和野生型 EGFR 肿瘤的三线治疗方法，目前这些患者尚无标准治疗方法。
符合条件的患者为 IIIB/IV 期野生型 EGFR 肺腺癌，在接受两种先前的化疗方案后无获益，但未接受过抗 EGFR 治疗。患者每天口服 afatinib 40mg，直至疾病进展或发生无法耐受的不良事件（AE）。主要终点是确认的客观肿瘤缓解（OR）率（确认完全缓解[CR]或部分缓解[PR]）。次要终点包括疾病控制率（DCR；OR 或稳定疾病持续≥6 周）、无进展生存期（PFS）和安全性。
42 名患者接受了 afatinib 治疗，其中 38 名患者纳入疗效分析。未报告确认的 CR 或 PR。DCR 为 24%（38 例患者中的 9 例），中位疾病控制持续时间为 19.3 周。中位 PFS 为 4.1 周（95%置信区间：3.9-8.0）。常见的 AE（主要为 1 级和 2 级）为皮疹/痤疮（88%）、腹泻（62%）和口腔炎（57%）。
用 afatinib 单药治疗的野生型 EGFR NSCLC 且预处理较多的患者未出现客观缓解，仅有 24%的患者疾病稳定持续超过 6 周。AE 可管理，且与预期的安全性一致。
