First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto City, Japan.
Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, Matsumoto City, Japan.
Thorac Cancer. 2019 May;10(5):1078-1085. doi: 10.1111/1759-7714.13047. Epub 2019 Apr 20.
In the LUX-Lung 3 and LUX-Lung 6 trials, afatinib improved overall survival in previously untreated patients with EGFR 19del mutated non-small cell lung cancer (NSCLC) compared to chemotherapy. The appropriate management of adverse events and dose reduction of afatinib are important for EGFR-positive NSCLC patients. We conducted a retrospective and observational study of patients treated with first-line afatinib for EGFR-positive NSCLC in Nagano prefecture, Japan, focusing on efficacy and toxicities.
We retrospectively collected the medical records of NSCLC patients initially treated with afatinib between May 2014 and March 2018.
A total of 62 patients with a median age of 67 years and a median body surface area (BSA) of 1.57 m were included. The overall response rate was 87.7% and median progression-free survival (PFS) was 15.7 months. The median PFS was similar between standard initial dose (40 mg) and reduced initial doses (30 and 20 mg) (15.7 vs. 14.2 months; P = 0.978). The frequency of dose reduction and the discontinuation rate in the 40 mg daily dose group was higher in patients with BSA < 1.58 m (100%) compared to BSA ≥ 1.58 m (68.2%) (P = 0.014). The frequency of diarrhea was higher in patients with BSA < 1.58 m (93.5%) compared to BSA ≥ 1.58 m (71.0%) (P = 0.02).
In real-world clinical practice, first-line afatinib was well managed and was equally as effective as in previous clinical trials of EGFR-positive NSCLC. BSA is considered a predictive marker for appropriate afatinib dose reduction.
在 LUX-Lung 3 和 LUX-Lung 6 试验中，与化疗相比，阿法替尼改善了未经治疗的 EGFR 19del 突变非小细胞肺癌（NSCLC）患者的总生存期。对于 EGFR 阳性 NSCLC 患者，不良事件的适当管理和阿法替尼的剂量减少是很重要的。我们对日本长野县接受一线阿法替尼治疗的 EGFR 阳性 NSCLC 患者进行了一项回顾性和观察性研究，重点关注疗效和毒性。
我们回顾性收集了 2014 年 5 月至 2018 年 3 月期间首次接受阿法替尼治疗的 NSCLC 患者的病历。
共纳入 62 例患者，中位年龄为 67 岁，中位体表面积（BSA）为 1.57m。总缓解率为 87.7%，中位无进展生存期（PFS）为 15.7 个月。标准初始剂量（40mg）和初始剂量降低（30mg 和 20mg）之间的中位 PFS 相似（15.7 与 14.2 个月；P=0.978）。BSA<1.58m 的患者中，每日 40mg 剂量组的剂量降低频率和停药率高于 BSA≥1.58m 的患者（100%比 68.2%；P=0.014）。BSA<1.58m 的患者腹泻发生率高于 BSA≥1.58m 的患者（93.5%比 71.0%；P=0.02）。
在真实世界的临床实践中，一线阿法替尼得到了很好的管理，与之前 EGFR 阳性 NSCLC 的临床试验一样有效。BSA 被认为是适当阿法替尼剂量降低的预测标志物。
