Division of Pulmonary Medicine, Department of Internal Medicine, Far-Eastern Memorial Hospital, New Taipei, Taiwan; Oriental Institute of Technology, New Taipei, Taiwan.
Division of Pulmonary Medicine, Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan; Institute of Biotechnology and Chemical Engineering, I-Shou University, Kaohsiung, Taiwan.
Eur J Cancer. 2018 Nov;103:32-40. doi: 10.1016/j.ejca.2018.07.128. Epub 2018 Sep 8.
Afatinib is commonly used as the first-line treatment for EGFR-mutated lung adenocarcinoma. However, dose adjustments are frequently required. This study aimed to investigate the treatment effectiveness of afatinib administered at different doses to patients with EGFR-mutated lung adenocarcinoma.
Treatment-naïve patients with advanced EGFR-mutated lung adenocarcinoma who received afatinib therapy between May 2014 and September 2016 were enrolled retrospectively. Collected clinical data included age, sex, smoking history, performance status, disease stages, EGFR mutation status, initial doses of afatinib, dose adjustments, treatment responses, progression-free survival and treatment-associated adverse events. The average daily dose was calculated by dividing the summation of all doses of prescribed tablets during the treatment period by the total days of afatinib use. The patients were classified into five treatment groups based on average daily doses: 40 mg, <40 and >30 mg, 30 mg, <30 and ≥ 20 mg and <20 mg.
A total of 254 patients were included. No significant differences were found among these five treatment groups with respect to response rates (69.3%, 68.3%, 70.5%, 77.8% and 66.7%, respectively, p = 0.920) and disease control rates (97.4%, 95.2%, 97.7%, 100% and 100%, respectively, p = 0.749). However, the treatment group with an average daily dose of <20 mg had a significant shorter progression-free survival as compared with the other groups (16.8, 12.4, 13.9, 17.0 and 5.3 months, respectively, p = 0.049).
Dose reduction may not affect the treatment effectiveness until the average daily dose is below 20 mg. Further prospective studies of afatinib therapy at different daily doses are warranted.
阿法替尼通常被用作 EGFR 突变型肺腺癌的一线治疗药物。然而，经常需要调整剂量。本研究旨在探讨不同剂量阿法替尼治疗 EGFR 突变型肺腺癌患者的治疗效果。
回顾性纳入 2014 年 5 月至 2016 年 9 月期间接受阿法替尼治疗的初治晚期 EGFR 突变型肺腺癌患者。收集的临床数据包括年龄、性别、吸烟史、体能状态、疾病分期、EGFR 突变状态、阿法替尼初始剂量、剂量调整、治疗反应、无进展生存期和治疗相关不良事件。平均日剂量通过将治疗期间所有规定片剂剂量的总和除以阿法替尼使用的总天数来计算。根据平均日剂量将患者分为五组治疗组：40mg、<40 且>30mg、30mg、<30 且≥20mg 和<20mg。
共纳入 254 例患者。这五组治疗组之间的缓解率（分别为 69.3%、68.3%、70.5%、77.8%和 66.7%，p=0.920）和疾病控制率（分别为 97.4%、95.2%、97.7%、100%和 100%，p=0.749）无显著差异。然而，与其他组相比，平均日剂量<20mg 的治疗组的无进展生存期显著缩短（分别为 16.8、12.4、13.9、17.0 和 5.3 个月，p=0.049）。
直到平均日剂量低于 20mg，剂量减少可能不会影响治疗效果。需要进一步开展不同日剂量阿法替尼治疗的前瞻性研究。
