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

被引：13
作者：
Atagi, Shinji [1 ]
Goto, Koichi [2 ]
Seto, Takashi [3 ]
Yamamoto, Nobuyuki [4 ]
Tamura, Tomohide [5 ]
Tajima, Kosei [6 ]
Inagaki, Naohito [6 ]
机构：
[1] Kinki Chuo Chest Med Ctr, Osaka, Japan
[2] Natl Canc Ctr Hosp East, Chiba, Japan
[3] Kyushu Natl Canc Ctr, Fukuoka, Japan
[4] Wakayama Med Univ, Wakayama, Japan
[5] St Lukes Int Hosp, Tokyo, Japan
[6] Chugai Pharmaceut Co Ltd, Tokyo, Japan
来源：
FUTURE ONCOLOGY | 2016年 / 12卷 / 18期
关键词：
combined analyses; EGFR mutations; erlotinib; first line; Japanese patients; non-small-cell lung cancer; MALIGNANT PLEURAL EFFUSION; GROWTH-FACTOR RECEPTOR; OPEN-LABEL; 1ST-LINE TREATMENT; PROGNOSTIC IMPACT; PHASE-III; ADENOCARCINOMA; CHEMOTHERAPY; MULTICENTER; RNA;
D O I：
10.2217/fon-2016-0163
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
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 (singlearm 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.
引用
收藏
页码：2117 / 2126
页数：10
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