First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation–Positive Non–Small-Cell Lung Cancer

作者：Keunchil Park, Chong‐Jen Yu, Sang-We Kim, Meng‐Chih Lin, Virote Sriuranpong, Chun-Ming Tsai, Jong-Seok Lee, Jin Hyoung Kang, K. C. Allen Chan, Pablo Ernesto Pérez, Peter Button, Myung‐Ju Ahn, Tony S.K. Mok · 发表于：JAMA Oncology · 年份：2015 · DOI：10.1001/jamaoncol.2015.4921 · 被引用次数：231 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Research Studies、Lung Cancer Diagnosis and Treatment

IMPORTANCE: Continuing molecularly targeted treatment beyond disease progression in non-small-cell lung cancer (NSCLC) has appeared promising in retrospective analyses, highlighting the challenge to identify whether progression is the optimal time to switch treatment. OBJECTIVE: To study the efficacy of first-line erlotinib therapy in patients with NSCLC with activating EGFR mutations and postprogression erlotinib therapy. DESIGN, SETTING, AND PARTICIPANTS: ASPIRATION (Asian Pacific trial of Tarceva as first-line in EGFR mutation) was a phase 2, open-label, single-arm study conducted from 2011 to 2012 in 23 centers in Hong Kong, Korea, Taiwan, and Thailand of adults with stage IV, EGFR mutation-positive NSCLC, with ECOG performance status 0 to 2. INTERVENTIONS: Patients received erlotinib 150 mg/d orally until disease progression, after which erlotinib therapy could be continued at patient and/or investigator discretion. MAIN OUTCOMES AND MEASURES: The primary end point was progression-free survival (PFS1; time to Response Evaluation Criteria in Solid Tumours 1.1 progression or death). Secondary end points included PFS2 (time to off-erlotinib progression if erlotinib therapy was extended beyond progression at patient and/or investigator discretion), objective response rate, disease control rate, overall survival, and safety. The use of plasma-based assessment of EGFR mutations was also investigated. RESULTS: Of 359 patients screened, 208 were enrolled. Median follow-up was 11...