Phase II Study of Erlotinib in Japanese Patients with Advanced Non-small Cell Lung Cancer

被引：0

作者：

Takahashi, Toshiaki ^{[1
]}

Yamamoto, Nobuyuki ^{[1
]}

Nukiwa, Toshihiro ^{[2
]}

Mori, Kiyoshi ^{[3
]}

Tsuboi, Masahiro ^{[4
]}

Horai, Takeshi ^{[5
]}

Masuda, Noriyuki ^{[6
]}

Eguchi, Kenji ^{[7
]}

Mitsudomi, Tetsuya ^{[8
]}

Yokota, Soichiro ^{[9
]}

Segawa, Yoshihiko ^{[10
]}

Ichinose, Yukito ^{[11
]}

Fukuoka, Masahiro ^{[12
]}

Saijo, Nagahiro ^{[13
]}

机构：

[1] Shizuoka Canc Ctr, Div Thorac Oncol, Shizuoka, Japan

[2] Tohoku Univ, Inst Dev Aging & Canc, Dept Resp Oncol & Mol Med, Sendai, Miyagi 980, Japan

[3] Tochigi Canc Ctr, Dept Med Oncol, Div Thorac Oncol, Mibu, Tochigi, Japan

[4] Tokyo Med Univ, Dept Surg, Tokyo, Japan

[5] Japanese Fdn Canc Res, Canc Inst Hosp, Thorac Ctr, Tokyo, Japan

[6] Kitasato Univ, Grad Sch Med Sci, Dept Resp Med, Kanagawa, Japan

[7] Tokai Univ, Sch Med, Dept Med Oncol, Kanagawa 2591100, Japan

[8] Aichi Canc Ctr Hosp, Dept Thorac Surg, Aichi, Japan

[9] Toneyama Natl Hosp, Natl Hosp Org, Dept Resp Med, Osaka, Japan

[10] Shikoku Canc Ctr, Natl Hosp Org, Dept Med & Thorac Oncol, Shikoku, Ehime, Japan

[11] Kyushu Natl Canc Ctr, Natl Hosp Org, Dept Thorac Oncol, Fukuoka, Japan

[12] Kinki Univ, Sch Med, Dept Med Oncol, Osaka 589, Japan

[13] Natl Canc Ctr Hosp E, Chiba, Japan

来源：

ANTICANCER RESEARCH | 2010年 / 30卷 / 02期

关键词：

Non-small cell lung cancer; erlotinib; Tarceva; EGFR-TKIs; EGFR mutation; phase II; TYROSINE-KINASE INHIBITOR; SOLID TUMORS; PHARMACOKINETICS; EFFICACY; BENEFIT; GEFITINIB; SURVIVAL;

D O I：

暂无

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The aim of this study was to evaluate the efficacy and safety of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in Japanese patients with relapsed or recurrent advanced non-small cell lung cancer (NSCLC). Patients and Methods: This was a multicentre, open-label phase 11 study of erlotinib (150 mg/day) in patients with stage IIIB or IV NSCLC. The primary endpoint was the objective tumour response rate. Results: Of the 46 patients, 13 were assessed to have a partial response and 9 had stable disease. The median duration of response was 449 days and time to progression vas 75 days. Median overall survival (OS) was 13.5 months and the 1-year survival rate was 56.5%. The most common adverse events were dermal or gastrointestinal, and were mainly grade 2 or less. An exploratory analysis suggested a link between rash severity and OS. Conclusion: Erlotinib has promising antitumour activity and is generally well tolerated in Japanese patients with previously treated NSCLC.

引用

页码：557 / 563

页数：7

共 29 条

[1] Are there any ethnic differences in molecular predictors of erlotinib efficacy in advanced non-small cell lung cancer? [J].

Ahn, Myung-Ju ;

Park, Byeong-Bae ;

Ahn, Jin Seok ;

Kim, Sang We ;

Kim, Heung-Tae ;

Lee, Jong Seog ;

Kang, Jin Hyung ;

Cho, Jae Yong ;

Song, Hong Suk ;

Park, Se Hoon ;

Sohn, Chang Hak ;

Shin, Sang Won ;

Choi, Jin Hyuck ;

Ki, Chang-Seok ;

Park, Chan Keum ;

Holmes, Alison J. ;

Janne, Pasi A. ;

Park, Keunchil .

CLINICAL CANCER RESEARCH, 2008, 14 (12) :3860-3866

[2]

[Anonymous], J CLIN ONCOL

[3] Clinical surrogate markers of survival in advanced non-small cell lung cancer (NSCLC) patients treated with second-third line erlotinib [J].

Cedres, Susana ;

Prat, Aleix ;

Martinez, Pablo ;

Pallisa, Esther ;

Sala, Gemma ;

Andreu, Jordi ;

del Campo, J. M. ;

Quispe, Isela ;

Baselga, Jose ;

Felip, Enriqueta .

LUNG CANCER, 2009, 66 (02) :257-261

[4] RELIABILITY AND VALIDITY OF THE FUNCTIONAL ASSESSMENT OF CANCER-THERAPY - LUNG (FACT-L) QUALITY-OF-LIFE INSTRUMENT [J].

CELLA, DF ;

BONOMI, AE ;

LLOYD, SR ;

TULSKY, DS ;

KAPLAN, E ;

BONOMI, P .

LUNG CANCER, 1995, 12 (03) :199-220

[5] Validation of treatment induced specific adverse effect as a predictor of treatment benefit: A case study of NCIC CTG BR21 [J].

Ding, K. ;

Pater, J. ;

Whitehead, M. ;

Seymour, L. ;

Shepherd, F. A. .

CONTEMPORARY CLINICAL TRIALS, 2008, 29 (04) :527-536

[6] Factors predicting response to EGFR tyrosine kinase inhibitors [J].

Engelman, JA ;

Jänne, PA .

SEMINARS IN RESPIRATORY AND CRITICAL CARE MEDICINE, 2005, 26 (03) :314-322

[7] Estimates of the cancer incidence and mortality in Europe in 2006 [J].

Ferlay, J. ;

Autier, P. ;

Boniol, M. ;

Heanue, M. ;

Colombet, M. ;

Boyle, P. .

ANNALS OF ONCOLOGY, 2007, 18 (03) :581-592

[8]

FUKUOKA M, 2009, J CLIN ONCOL, V27, pS15

[9] Effects of smoking on the pharmacokinetics of erlotinib [J].

Hamilton, M ;

Wolf, JL ;

Rusk, J ;

Beard, SE ;

Clark, GM ;

Witt, K ;

Cagnoni, PJ .

CLINICAL CANCER RESEARCH, 2006, 12 (07) :2166-2171

[10] Gefitinib for the treatment of non-small-cell lung cancer [J].

Hida, Toyoaki ;

Ogawa, Shizu ;

Park, Jang Chul ;

Park, Ji Young ;

Shimizu, Junichi ;

Horio, Yoshitsugu ;

Yoshida, Kimihide .

EXPERT REVIEW OF ANTICANCER THERAPY, 2009, 9 (01) :17-35

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