Kazuhiko Yamada1, Koichi Azuma2, Masafumi Takeshita3, Junji Uchino4, Chinatsu Nishida5, Takayuki Suetsugu6, Akira Kondo7, Taishi Harada8, Hirofumi Eida9, Junji Kishimoto10, Goki Eriguchi11, Koichi Takayama8, Yoichi Nakanishi8, Kenji Sugio12. 1. Division of Respirology, Neurology and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan kayamada@med.kurume-u.ac.jp. 2. Division of Respirology, Neurology and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan. 3. Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Fukuoka, Japan. 4. Department of Respiratory Medicine, Fukuoka University School of Medicine, Fukuoka, Japan. 5. Department of Respiratory Medicine, University of Occupational and Environmental Health, Fukuoka, Japan. 6. Department of Respiratory Medicine, Sendai Medical Association Hospital, Kagoshima, Japan. 7. Department of Respiratory Medicine, Japan Community Health care Organization Isahaya General Hospital, Nagasaki, Japan. 8. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 9. Department of Respiratory Medicine, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan. 10. Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan. 11. Department of Clinical Research Promotion, Kyushu University Hospital, Fukuoka, Japan. 12. Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.
Abstract
BACKGROUND: As the incidence of lung cancer in the elderly is increasing worldwide, there exists a need to develop a clinically effective, less toxic therapy for this patient population. Although erlotinib has shown proven effectiveness against non-small cell lung cancer (NSCLC), few studies have prospectively investigated its application to elderly patients. PATIENTS AND METHODS: Patients aged ≥75 years with advanced or recurrent NSCLC including wild-type EGFR who had previously received one or two chemotherapy regimens were enrolled in this trial. Erlotinib was initially administered at a dose of 150 mg/day orally until disease progression or unacceptable toxicities occurred. The primary endpoint was the objective response rate. RESULTS: Forty patients were enrolled between May 2009 and January 2014. An objective response was observed in 8 patients (20%, 95%CI=9.1-35.7%), and the disease control rate reached 62.5% (95%CI=45.8-77.3%). After a median follow-up period of 12.2 months (range=1.4-47.2 months), the median progression-free survival period was 5.0 months (95%CI=2.3-7.6 months), and the median survival period was 12.2 months (95%CI=6.1-24.7 months). Major toxicities were skin disorders, fatigue, and anorexia. Most adverse events were grade 2 or less, but 13 patients (32.5%) required a dose reduction. Two patients developed interstitial lung disease, that was nevertheless reversible, and there were no treatment-related deaths. CONCLUSION: Although the percentage of patients requiring dose reduction seemed relatively higher than that in previous studies, erlotinib is a potentially useful therapeutic option for unselected elderly patients with previously treated advanced or recurrent NSCLC, as has been also shown for younger patients. Copyright
BACKGROUND: As the incidence of lung cancer in the elderly is increasing worldwide, there exists a need to develop a clinically effective, less toxic therapy for this patient population. Although erlotinib has shown proven effectiveness against non-small cell lung cancer (NSCLC), few studies have prospectively investigated its application to elderly patients. PATIENTS AND METHODS: Patients aged ≥75 years with advanced or recurrent NSCLC including wild-type EGFR who had previously received one or two chemotherapy regimens were enrolled in this trial. Erlotinib was initially administered at a dose of 150 mg/day orally until disease progression or unacceptable toxicities occurred. The primary endpoint was the objective response rate. RESULTS: Forty patients were enrolled between May 2009 and January 2014. An objective response was observed in 8 patients (20%, 95%CI=9.1-35.7%), and the disease control rate reached 62.5% (95%CI=45.8-77.3%). After a median follow-up period of 12.2 months (range=1.4-47.2 months), the median progression-free survival period was 5.0 months (95%CI=2.3-7.6 months), and the median survival period was 12.2 months (95%CI=6.1-24.7 months). Major toxicities were skin disorders, fatigue, and anorexia. Most adverse events were grade 2 or less, but 13 patients (32.5%) required a dose reduction. Two patients developed interstitial lung disease, that was nevertheless reversible, and there were no treatment-related deaths. CONCLUSION: Although the percentage of patients requiring dose reduction seemed relatively higher than that in previous studies, erlotinib is a potentially useful therapeutic option for unselected elderly patients with previously treated advanced or recurrent NSCLC, as has been also shown for younger patients. Copyright