Osimertinib for patients with non-small-cell lung cancer harboring uncommon EGFR mutations: A multicenter, open-label, phase II trial (KCSG-Lu15-09)

Jang Ho Cho, Sung Hee Lim, Ho Jung An, Ki Hwan Kim, Keon Uk Park, Eun Joo Kang, Yoon Hee Choi, Mi Sun Ahn, Myung Hee Lee, Jong Mu Sun, Se Hoon Lee, Jin Seok Ahn, Keunchil Park, Myung Ju Ahn

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    85 Citations (Scopus)

    Abstract

    PURPOSE Approximately 10% of patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) harbor uncommon mutations. Here, we report the efficacy and safety of osimertinib in patients with NSCLC harboring uncommon EGFR mutations. PATIENT AND METHODS This was a multicenter, single-arm, open-label, phase II study in Korea. Patients with histologically confirmed metastatic or recurrent NSCLC harboring EGFR mutations other than the exon 19 deletion, L858R and T790M mutations, and exon 20 insertion were eligible for the study. The primary end point of objective response rate was assessed every 6 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary end points were progression-free survival, overall survival, duration of response, and safety. RESULTS Between March 2016 and October 2017, 37 patients were enrolled. All were evaluable except one patient who withdrew consent after starting treatment. Median age was 60 years, and 22 (61%) were male. Among patients, 61% received osimertinib as first-line therapy. The mutations identified were G719X (n = 19; 53%), followed by L861Q (n = 9; 25%), S768I (n = 8; 22%), and others (n = 4; 11%). Objective response rate was 50% (18 of 36 patients; 95% CI, 33% to 67%). Median progression-free survival was 8.2 months (95% CI, 5.9 to 10.5 months), and median overall survival was not reached. Median duration of response was 11.2 months (95% CI, 7.7 to 14.7 months). Adverse events of any grade were rash (n = 11; 31%), pruritus (n = 9; 25%), decreased appetite (n = 9; 25%), diarrhea (n = 8; 22%), and dyspnea (n = 8; 22%), but all adverse events were manageable. CONCLUSION Osimertinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations.

    Original languageEnglish
    Pages (from-to)488-495
    Number of pages8
    JournalJournal of Clinical Oncology
    Volume38
    Issue number5
    DOIs
    Publication statusPublished - 2020 Feb 10

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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