PURPOSE: This study was undertaken to investigate the efficacy and the feasibility of gefitinib for chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. PATIENTS AND METHODS: The EGFR gene status in various tumor samples obtained from chemotherapy-naïve advanced NSCLC patients was examined by DNA sequencing of EGFR exons 18 to 23. Patients harboring EGFR mutations received gefitinib (250 mg/d) alone. The response rate, progression-free survival (PFS), and toxicity profile were assessed prospectively. RESULTS:Between June 2004 and October 2005, 75 patients were examined for the EGFR status, and 25 patients (33%) harbored EGFR mutations. EGFR mutations were significantly frequent in females (P < .01) and never or light smokers (P < .001). Sixteen patients with EGFR mutations were enrolled onto the study. The overall response rate in these patients was 75% (95% CI, 54% to 96%), and the disease control rate was 88% (95% CI, 71% to 100%). The median PFS time of these patients was 9.7 months (95% CI, 7.4 to 9.9 months). No life-threatening toxicity was observed. CONCLUSION: Treatment with gefitinib alonefor chemotherapy-naïve NSCLC patients with EGFR mutations could achieve a high efficacy with acceptable toxicity. To assess the proper timing of gefitinib in such patients, a subsequent randomized trial comparing gefitinib with standard chemotherapy is warranted.
RCT Entities:
PURPOSE: This study was undertaken to investigate the efficacy and the feasibility of gefitinib for chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. PATIENTS AND METHODS: The EGFR gene status in various tumor samples obtained from chemotherapy-naïve advanced NSCLCpatients was examined by DNA sequencing of EGFR exons 18 to 23. Patients harboring EGFR mutations received gefitinib (250 mg/d) alone. The response rate, progression-free survival (PFS), and toxicity profile were assessed prospectively. RESULTS: Between June 2004 and October 2005, 75 patients were examined for the EGFR status, and 25 patients (33%) harbored EGFR mutations. EGFR mutations were significantly frequent in females (P < .01) and never or light smokers (P < .001). Sixteen patients with EGFR mutations were enrolled onto the study. The overall response rate in these patients was 75% (95% CI, 54% to 96%), and the disease control rate was 88% (95% CI, 71% to 100%). The median PFS time of these patients was 9.7 months (95% CI, 7.4 to 9.9 months). No life-threatening toxicity was observed. CONCLUSION: Treatment with gefitinib alone for chemotherapy-naïve NSCLCpatients with EGFR mutations could achieve a high efficacy with acceptable toxicity. To assess the proper timing of gefitinib in such patients, a subsequent randomized trial comparing gefitinib with standard chemotherapy is warranted.
Authors: Adam S Crystal; Alice T Shaw; Lecia V Sequist; Luc Friboulet; Matthew J Niederst; Elizabeth L Lockerman; Rosa L Frias; Justin F Gainor; Arnaud Amzallag; Patricia Greninger; Dana Lee; Anuj Kalsy; Maria Gomez-Caraballo; Leila Elamine; Emily Howe; Wooyoung Hur; Eugene Lifshits; Hayley E Robinson; Ryohei Katayama; Anthony C Faber; Mark M Awad; Sridhar Ramaswamy; Mari Mino-Kenudson; A John Iafrate; Cyril H Benes; Jeffrey A Engelman Journal: Science Date: 2014-11-13 Impact factor: 47.728
Authors: Mizuki Nishino; David M Jackman; Hiroto Hatabu; Pasi A Jänne; Bruce E Johnson; Annick D Van den Abbeele Journal: Acad Radiol Date: 2011-01-28 Impact factor: 3.173
Authors: Mathewos Tessema; Christin M Yingling; Amanda M Snider; Kieu Do; Daniel E Juri; Maria A Picchi; Xiequn Zhang; Yushi Liu; Shuguang Leng; Carmen S Tellez; Steven A Belinsky Journal: J Thorac Oncol Date: 2014-06 Impact factor: 15.609