Real-world experience of afatinib as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma

Abstract

We evaluated the real-world efficacy and side effects of afatinib as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma. The medical records of patients receiving afatinib as a first-line therapy after National Health Insurance reimbursement between May 2014 and January 2016 were reviewed, and information on patient characteristics and treatment courses were collected consecutively. Rebiopsy tissue was collected for EGFR mutation and MET amplification analyses. MET amplification was detected by fluorescence in situ hybridization and immunohistochemistry. In total, 140 patients were enrolled (median follow-up, 18.0 months). No significant differences in side effects, treatment responses, progression-free survival, or brain metastasis control were observed between patients receiving 40 mg versus < 40 mg of afatinib during the first 6 months. Patients with significant pretreatment weight loss (> 10.0% in 6 months) had a shorter median progression-free survival. Patients with brain metastases had a poorer Eastern Cooperative Oncology Group performance status and were associated with a shorter median progression-free survival. Nine patients (32.1%) had a p.T790M mutation and only 1 patient gained MET amplifications after disease progression. Afatinib is effective as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma. Afatinib dosage does not affect clinical efficacy and drug-related side effects.

Efficacy and safety of afatinib in a Chinese population with advanced lung adenocarcinoma with sensitive EGFR mutations

“…A previous real world study indicated that a starting afatinib dose of 30 mg daily achieved similar PFS to 40 mg daily, but led to fewer serious adverse events . Our results support this conclusion.…”

“…22 One real world study indicated that a starting afatinib dose of 30mg daily had similar PFS to 40mg daily, but led to fewer serious adverse events. 21 Our research also supported this conclusion. In this study, there were no significant differences in various characteristics and median PFS between these two dose groups.…”

“…These outcomes may lead to a tendency in clinical practice to prescribe afatinib to patients with 19del mutations. Several real‐world studies have also demonstrated this tendency and reported longer median PFS in common EGFR mutation groups . Kim et al revealed that in a subgroup of patients with 19del mutations, the median PFS of afatinib was significantly superior to gefitinib or erlotinib (19.1 vs. 15.0 and 16.3 months, respectively; P = 0.01).…”

“…Several real-world studies have also demonstrated this tendency and reported longer median PFS in common EGFR mutation groups. [19][20][21] Kim et al revealed that in a subgroup of patients with 19del mutations, the median PFS of afatinib was significantly superior to gefitinib or erlotinib (19.1 vs. 15.0 and 16.3 months, respectively; P = 0.01). However, there was no such significant difference in the L858R subgroup (P = 0.46).…”

Clinical analysis of EGFR‐positive non‐small cell lung cancer patients treated with first‐line afatinib: A Nagano Lung Cancer Research Group

“…The median time to progression (TTP) in all patients was 20.8 months and the median TTP in those who commenced at a dose of ≤ 30 mg of afatinib was 25.9 months. In a real‐world cohort study in Taiwan, there was no significant difference in median PFS in the first six months between the 40 mg and < 40 mg groups (12.0 vs. 11.0 months, respectively) . In a retrospective analysis of the efficacy of 40 mg versus dose reduction to < 40 mg of afatinib, there were no significant differences between the groups in the median time to treatment failure (405 vs. 472 days, respectively; P = 0.2271) .…”