Open AccessA 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)
Author(s) -
Asami Kazuhiro,
Ando Masahiko,
Nishimura Takashi,
Yokoi Takashi,
Tamura Atsuhisa,
Minato Koichi,
Mori Masahide,
Ogushi Fumitaka,
Yamamoto Akiyoshi,
Yoshioka Hiroshige,
Kawahara Masaaki,
Atagi Shinji
Publication year - 2022
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.14465
Subject(s) - medicine , pemetrexed , docetaxel , gefitinib , lung cancer , oncology , chemotherapy , clinical endpoint , hazard ratio , performance status , progressive disease , phases of clinical research , adverse effect , cancer , epidermal growth factor receptor , randomized controlled trial , cisplatin , confidence interval
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.