Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations.

作者: Akira Inoue , Takuji Suzuki , Tatsuro Fukuhara , Makoto Maemondo , Yuichiro Kimura

DOI: 10.1200/JCO.2005.05.4692

关键词:

摘要: Purpose This study was undertaken to investigate the efficacy and feasibility of gefitinib for chemotherapy-naive patients with advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. Patients Methods The EGFR gene status in various tumor samples obtained from NSCLC examined by DNA sequencing exons 18 23. mutations received (250 mg/d) alone. response rate, progression-free survival (PFS), toxicity profile were assessed prospectively. Results Between June 2004 October 2005, 75 status, 25 (33%) harbored significantly frequent females (P < .01) never or light smokers .001). Sixteen enrolled onto study. overall rate these 75% (95% CI, 54% 96%), disease control 88% 71%...

参考文章(38)
Adi F. Gazdar, Shinichi Toyooka, Kazunori Tsukuda, Mitsune Tanimoto, Masahiro Tabata, Kouichi Ichimura, Masaaki Yano, Toshihide Tsuda, Hisayuki Shigematsu, Hiroshi Date, Kunitoshi Tomii, Nobuyoshi Shimizu, Hiroshi Ueoka, Motoi Aoe, Masaki Tokumo, Katsuyuki Kiura, The Relationship between Epidermal Growth Factor Receptor Mutations and Clinicopathologic Features in Non–Small Cell Lung Cancers Clinical Cancer Research. ,vol. 11, pp. 1167- 1173 ,(2005)
Ming-Sound Tsao, Akira Sakurada, Jean-Claude Cutz, Chang-Qi Zhu, Suzanne Kamel-Reid, Jeremy Squire, Ian Lorimer, Tong Zhang, Ni Liu, Manijeh Daneshmand, Paula Marrano, Gilda da Cunha Santos, Alain Lagarde, Frank Richardson, Lesley Seymour, Marlo Whitehead, Keyue Ding, Joseph Pater, Frances A. Shepherd, Erlotinib in lung cancer - molecular and clinical predictors of outcome. The New England Journal of Medicine. ,vol. 353, pp. 133- 144 ,(2005) , 10.1056/NEJMOA050736
Federico Cappuzzo, Fred R. Hirsch, Elisa Rossi, Stefania Bartolini, Giovanni L. Ceresoli, Lynne Bemis, Jerry Haney, Samir Witta, Kathleen Danenberg, Irene Domenichini, Vienna Ludovini, Elisabetta Magrini, Vanesa Gregorc, Claudio Doglioni, Angelo Sidoni, Maurizio Tonato, Wilbur A. Franklin, Lucio Crino, Paul A. Bunn, Marileila Varella-Garcia, Epidermal Growth Factor Receptor Gene and Protein and Gefitinib Sensitivity in Non–Small-Cell Lung Cancer Journal of the National Cancer Institute. ,vol. 97, pp. 643- 655 ,(2005) , 10.1093/JNCI/DJI112
William Pao, Vincent A Miller, Katerina A Politi, Gregory J Riely, Romel Somwar, Maureen F Zakowski, Mark G Kris, Harold Varmus, Acquired Resistance of Lung Adenocarcinomas to Gefitinib or Erlotinib Is Associated with a Second Mutation in the EGFR Kinase Domain PLoS Medicine. ,vol. 2, pp. e73- ,(2005) , 10.1371/JOURNAL.PMED.0020073
Toshimi Takano, Yuichiro Ohe, Masahiko Kusumoto, Ukihide Tateishi, Seiichiro Yamamoto, Hiroshi Nokihara, Noboru Yamamoto, Ikuo Sekine, Hideo Kunitoh, Tomohide Tamura, Tetsuro Kodama, Nagahiro Saijo, Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib Lung Cancer. ,vol. 45, pp. 93- 104 ,(2004) , 10.1016/J.LUNGCAN.2004.01.010
Richard Simon, Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials. ,vol. 10, pp. 1- 10 ,(1989) , 10.1016/0197-2456(89)90015-9
Joan H. Schiller, David Harrington, Chandra P. Belani, Corey Langer, Alan Sandler, James Krook, Junming Zhu, David H. Johnson, Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. The New England Journal of Medicine. ,vol. 346, pp. 92- 98 ,(2002) , 10.1056/NEJMOA011954
M. Tukumo, S. Toyooka, K. Kiura, H. Shigematsu, H. Asano, M. Aoe, M. Tanimoto, H. Date, A. Gazdar, N. Shimizu, PD-160 The relationship between epidermal growth factor receptor (EGFR) mutations and clinicopathologic features in non-small cell lung cancers Lung Cancer. ,vol. 49, ,(2005) , 10.1016/S0169-5002(05)80493-3
Thomas J. Lynch, Daphne W. Bell, Raffaella Sordella, Sarada Gurubhagavatula, Ross A. Okimoto, Brian W. Brannigan, Patricia L. Harris, Sara M. Haserlat, Jeffrey G. Supko, Frank G. Haluska, David N. Louis, David C. Christiani, Jeff Settleman, Daniel A. Haber, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib The New England Journal of Medicine. ,vol. 350, pp. 2129- 2139 ,(2004) , 10.1056/NEJMOA040938