Annals of Oncology 25 (Supplement 5): v75–v109, 2014 doi:10.1093/annonc/mdu436.90
Poster Session (Poster presentations categorized by each organ) P2
13
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Makoto Nagamata, Yusuke Okuma, Kuniko Sunami, Yukio Hosomi, Tatsuru Okamura Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome
abstracts
Background: The phase II NEJ001 trial suggested that gefitinib was active against advanced non-small cell lung cancer (NSCLC), even in patients with poor performance
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CLINICAL OUTCOMES AFTER FIRST-LINE EGFR-TKI FOR PATIENTS WITH NSCLC, EGFR MUTATION, AND POOR PERFORMANCE STATUS
status (PS). Because the NEJ001 trial established definitive clinical evidence, and a further phase III trial may not be required, there is little additional information on the clinical outcomes of gefitinib in poor PS patients. Patients and Methods: This was a retrospective review of patients with EGFR mutation-positive NSCLC and poor PS (PS ≥2 for patients >75 years or PS 3 or 4 for patients of any age) who were treated with first-line gefitinib between 2004 and 2013 at Tokyo Metropolitan Cancer and Infectious Diseases Center at Komagome Hospital. Results: A total of 52 patients (median age, 75 years; range, 54–87 years) met the inclusion criteria. The overall response rate was 65.4%. The median progression-free survival, median survival time, and one-year survival rate were 6.6 months, 19.6 months, and 62.9%, respectively. Gefitinib was terminated in 17 patients (32.7%) due to toxicity (6 patients due to interstitial lung disease, 3 patients due to inability to continue oral intake, and 3 patients due to elevated transaminase levels). Conclusions: Gefitinib is effective in patients with poor PS, even in the clinical setting. The overall response rate, progression-free survival, and median survival time were similar to those in NEJ001. As in NEJ001, progression-free survival was shorter than reported in clinical trials for patients with EGFR mutation and good PS.
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