A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01). Issue 12 (13th May 2022)

• Record Type: Journal Article
• Authors: Asami, Kazuhiro; Ando, Masahiko; Nishimura, Takashi; Yokoi, Takashi; Tamura, Atsuhisa; Minato, Koichi; Mori, Masahide; Ogushi, Fumitaka; Yamamoto, Akiyoshi; Yoshioka, Hiroshige; Kawahara, Masaaki; Atagi, Shinji
• Is Part Of: Thoracic cancer. Volume 13:Issue 12(2022)
• Page Start: 1827
• Page End: 1836
• Publication Date: 2022-05-13
• Subjects: chemotherapy -- elderly -- epidermal growth factor receptor mutation -- gefitinib -- non‐small cell lung cancer; Chest -- Cancer -- Periodicals; Chest -- Cancer -- Treatment -- Periodicals; Chest -- Surgery -- Periodicals; 616.99494005
• DOI: 10.1111/1759-7714.14465
• Languages: English
• ISSNs: 1759-7706

Abstract

Abstract: Background: Gefitinib (G) is a recommended molecular‐targeted agent for elderly patients with epidermal growth factor receptor (EGFR)‐mutant non‐small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during treatment. The efficacy of continuing G after progressive disease (PD) develops has been reported. It remains unclear whether the continuation of G in combination with a single cytotoxic agent beyond PD is beneficial for elderly patients. Here, we conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with G for elderly patients with progressive EGFR ‐mutant NSCLC. Methods: Elderly patients with EGFR ‐mutant NSCLC with PD previously treated with G were enrolled. Patients received Pem 500 mg/m or Doc 60 mg/m every 21 days and were randomly assigned to receive chemotherapy with 250 mg G (G+ Doc/Pem arm) or without G (Doc/Pem arm) until further disease progression or unacceptable toxicity. Results: This trial was terminated early owing to slow accrual. A group of 22 patients underwent analysis. The primary endpoint, progression‐free survival (PFS), was significantly longer in the G + Doc/Pem arm (median: 1.6 months vs. 5.6 months, hazard ratio = 0.40, 95% CI: 0.16–0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the G + Doc/Pem arm (45.5% vs. 90.9%, p = 0.032). Conclusions: Patients on G and Pem or Doc beyond PD showed a longer PFS than those on single‐agent chemotherapy; however, it was associated with increased toxicity. Abstract : We conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with gefitinib for elderly patients with progressive EGFR ‐mutant NSCLC. PFS was significantly longer in the gefitinib with chemotherapy arm (median: 1.6 months vs. 5.6 months, HR = 0.40, 95% CI: 0.16–0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the gefitinib with chemotherapy arm (45.5% vs. 90.9%, p = 0.032). Based on our results, combination chemotherapy with continuing gefitinib beyond PD may have potential benefit in limited elderly NSCLC without information on acquired resistance to gefitinib.