Tomohito Kuwako1, Hisao Imai2, Tomomi Masuda1, Yosuke Miura3, Kaori Seki1, Reiko Yoshino4, Kyoichi Kaira5, Mitsuyoshi Utsugi6, Kimihiro Shimizu7, Noriaki Sunaga1, Yoshio Tomizawa4, Shinichi Ishihara8, Takao Ishizuka9, Akira Mogi10, Takeshi Hisada1, Koichi Minato3, Atsushi Takise11, Ryusei Saito4, Masanobu Yamada1. 1. Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. 2. Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. m06701014@gunma-u.ac.jp. 3. Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, Gunma, Japan. 4. Division of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma, Japan. 5. Department of Oncology Clinical Development, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. 6. Division of Internal Medicine, Kiryu Kosei General Hospital, Kiryu, Gunma, Japan. 7. Department of Thoracic Visceral Organ Surgery, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. 8. Division of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Gunma, Japan. 9. Division of Internal Medicine, Public Tomioka General Hospital, Tomioka, Gunma, Japan. 10. Department of General Surgical Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. 11. Division of Respiratory Medicine, Maebashi Red Cross Hospital, Maebashi, Gunma, Japan.
Abstract
PURPOSE: The efficacy of gefitinib [an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor] in elderly patients with non-small cell lung cancer (NSCLC) and EGFR mutation has not been elucidated. Therefore, the objective of this study was to investigate the efficacy and feasibility of gefitinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations. METHODS: We retrospectively evaluated the clinical effects of gefitinib as a first-line treatment for elderly (≥75 years) NSCLC patients with EGFR mutations (exon 19 deletion or exon 21 L858R mutation). All patients were initially treated with gefitinib (250 mg/day) at seven institutions. RESULTS: Between January 2006 and December 2012, 62 patients (17 men, 45 women) with a median age of 80 years (range, 75-89 years) were included in our analysis. The overall response and disease control rates were 61.2 and 83.8 %, respectively, and the median progression-free survival and overall survival were 13.2 and 19.0 months, respectively. Common adverse events included rash, diarrhea, and liver dysfunction. Major grade 3 or 4 toxicities included skin rash (3.2 %) and increased levels of aspartate aminotransferase or alanine aminotransferase (21.0 %). Gefitinib treatment was discontinued owing to adverse events of liver dysfunction in 3 patients, drug-induced pneumonitis in 2, and diarrhea in 1. CONCLUSION: First-line gefitinib could be a preferable standard treatment in elderly patients with advanced NSCLC harboring sensitive EGFR mutations.
PURPOSE: The efficacy of gefitinib [an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor] in elderly patients with non-small cell lung cancer (NSCLC) and EGFR mutation has not been elucidated. Therefore, the objective of this study was to investigate the efficacy and feasibility of gefitinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations. METHODS: We retrospectively evaluated the clinical effects of gefitinib as a first-line treatment for elderly (≥75 years) NSCLCpatients with EGFR mutations (exon 19 deletion or exon 21 L858R mutation). All patients were initially treated with gefitinib (250 mg/day) at seven institutions. RESULTS: Between January 2006 and December 2012, 62 patients (17 men, 45 women) with a median age of 80 years (range, 75-89 years) were included in our analysis. The overall response and disease control rates were 61.2 and 83.8 %, respectively, and the median progression-free survival and overall survival were 13.2 and 19.0 months, respectively. Common adverse events included rash, diarrhea, and liver dysfunction. Major grade 3 or 4 toxicities included skin rash (3.2 %) and increased levels of aspartate aminotransferase or alanine aminotransferase (21.0 %). Gefitinib treatment was discontinued owing to adverse events of liver dysfunction in 3 patients, drug-induced pneumonitis in 2, and diarrhea in 1. CONCLUSION: First-line gefitinib could be a preferable standard treatment in elderly patients with advanced NSCLC harboring sensitive EGFR mutations.