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

页码：2117 / 2126

页数：10

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