First-Line Gefitinib for Patients With Advanced Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy Export

@article{citeulike:5206086, abstract = {PurposeThis multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS). Patients and MethodsChemotherapy-naive patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and [\&ge;] 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone. ResultsBetween February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66\% (90\% CI, 51\% to 80\%), and the disease control rate was 90\%. PS improvement rate was 79\% (P < .00005); in particular, 68\% of the 22 patients improved from [\&ge;] PS 3 at baseline to [\&le;] PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63\%, respectively. No treatment-related deaths were observed. ConclusionThis is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population. 10.1200/JCO.2008.18.7658}, author = {Inoue, Akira and Kobayashi, Kunihiko and Usui, Kazuhiro and Maemondo, Makoto and Okinaga, Shoji and Mikami, Iwao and Ando, Masahiro and Yamazaki, Koichi and Saijo, Yasuo and Gemma, Akihiko and Miyazawa, Hitoshi and Tanaka, Tomoaki and Ikebuchi, Kenji and Nukiwa, Toshihiro and Morita, Satoshi and Hagiwara, Koichi}, citeulike-article-id = {5206086}, citeulike-linkout-0 = {http://dx.doi.org/10.1200/JCO.2008.18.7658}, citeulike-linkout-1 = {http://jco.ascopubs.org/cgi/content/abstract/27/9/1394}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/19224850}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=19224850}, day = {20}, doi = {10.1200/JCO.2008.18.7658}, journal = {J Clin Oncol}, keywords = {nsclc}, month = {March}, number = {9}, pages = {1394--1400}, posted-at = {2009-07-20 03:46:40}, priority = {2}, title = {First-Line Gefitinib for Patients With Advanced Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy}, url = {http://dx.doi.org/10.1200/JCO.2008.18.7658}, volume = {27}, year = {2009} }

TY - JOUR ID - citeulike:5206086 L3 - citeulike-article-id:5206086 N2 - PurposeThis multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS). Patients and MethodsChemotherapy-naive patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and [&ge;] 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone. ResultsBetween February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from [&ge;] PS 3 at baseline to [&le;] PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed. ConclusionThis is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population. 10.1200/JCO.2008.18.7658 IS - 9 JF - J Clin Oncol EP - 1400 TI - First-Line Gefitinib for Patients With Advanced Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy VL - 27 SP - 1394 KW - nsclc AU - Inoue, Akira AU - Kobayashi, Kunihiko AU - Usui, Kazuhiro AU - Maemondo, Makoto AU - Okinaga, Shoji AU - Mikami, Iwao AU - Ando, Masahiro AU - Yamazaki, Koichi AU - Saijo, Yasuo AU - Gemma, Akihiko AU - Miyazawa, Hitoshi AU - Tanaka, Tomoaki AU - Ikebuchi, Kenji AU - Nukiwa, Toshihiro AU - Morita, Satoshi AU - Hagiwara, Koichi PY - 2009/03/20/ UR - http://dx.doi.org/10.1200/JCO.2008.18.7658 ER -