Erlotinib for Japanese patients with activating EGFR mutation-positive non-small-cell lung cancer: combined analyses from two Phase II studies

Author:

Atagi Shinji1,Goto Koichi2,Seto Takashi3,Yamamoto Nobuyuki4,Tamura Tomohide5,Tajima Kosei6,Inagaki Naohito6

Affiliation:

1. Kinki-chuo Chest Medical Center, Osaka, Japan

2. National Cancer Center Hospital East, Chiba, Japan

3. National Kyushu Cancer Center, Fukuoka, Japan

4. Wakayama Medical University, Wakayama, Japan

5. St Luke's International Hospital, Tokyo, Japan

6. Chugai Pharmaceutical Co. Ltd, Tokyo, Japan

Abstract

Aims: We evaluated the efficacy and safety of erlotinib, and patient characteristics affecting progression-free survival (PFS), by analyzing data from two Phase II studies of first-line erlotinib in activating EGFR mutation-positive non-small-cell lung cancer. Methods: Data were combined from patients who received first-line erlotinib monotherapy in JO22903 (single-arm study; JapicCTI-101085) and JO25567 (randomized study; JapicCTI-111390). Results: Median PFS was 10.9 months in efficacy-evaluable patients (n = 177). Major adverse events were dermatologic; no new safety signals were observed. Baseline pleural/cardiac effusion notably affected PFS (yes median 8.0 months vs no median 15.3 months) as confirmed in multivariate analysis (hazard ratio: 0.38; 95% CI: 0.25–0.58). Conclusion: Efficacy and safety of erlotinib monotherapy were consistent with previous studies. Baseline pleural/pericardial effusion was associated with shorter PFS.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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