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First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies |
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| Authors: | Naoto Morikawa Yuji Minegishi Akira Inoue Makoto Maemondo Kunihiko Kobayashi Shunichi Sugawara |
| Affiliation: | 1. Iwate Medical University School of Medicine, Division of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine, 19-1 Uchimaru, Morioka, Iwate 020-8505, Japan +81 19 651 5111 (ext. 2334);2. +81 19 626 8040;3. carcinoma@nifty.com;4. Nippon Medical School, Tokyo, Japan;5. Tohoku University, Miyagi, Japan;6. Miyagi Cancer Center, Miyagi, Japan;7. Saitama Medical University, Saitama, Japan;8. Sendai Kousei Hospital, Miyagi, Japan |
| Abstract: | Objective: To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL). Methods: We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0 – 2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL. Results: Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups. Conclusion: First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation. |
| Keywords: | EGFR tyrosine kinase inhibitors elderly patients gefitinib NSCLC |