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- Title
A Phase II Study of Pemetrexed in Chemotherapy-naïve Elderly Patients Aged ≥75 years with Advanced Non-squamous Non-small-cell Lung Cancer (HANSHIN Oncology Group 003).
- Authors
Hattori, Yoshihiro; Iwasaku, Masahiro; Satouchi, Miyako; Nishiyama, Akihiro; Korogi, Yohei; Otsuka, Kojiro; Fujita, Shiro; Katakami, Nobuyuki; Mori, Masahide; Nishino, Kazumi; Morita, Satoshi; Negoro, Shunichi
- Abstract
Objective Pemetrexed has relatively mild toxicity and possibly can be administered long term to patients with non-small-cell lung cancer. We conducted a Phase II trial to evaluate the efficacy and safety of pemetrexed in chemotherapy-naïve elderly patients with advanced non-squamous non-small-cell lung cancer. Methods In this multicenter Phase II trial, we recruited elderly patients with non-squamous non-small-cell lung cancer. Patients with previously untreated Stage IIIB or IV non-squamous non-small-cell lung cancer, ≥75 years, Eastern Cooperative Oncology Group performance status 0–1 and adequate organ functions were eligible. Patients received pemetrexed (500 mg/m2) intravenously on Day 1 every 3 weeks until disease progression. The primary endpoint was objective response rate. Results Forty-seven patients were enrolled from August 2009 to July 2011, and 46 patients were eligible. The median age was 79 years (range 75–91 years), 57% were males, 37% had never smoked, 87% had adenocarcinoma, 74% had Stage IV and 33% had epidermal growth factor receptor tyrosine kinase-activating mutation. The median number of cycles was 4 (1–20). The objective response rate was 13.3% (95% confidence interval; 5.1–26.8%), the disease control rate was 66.7% (95% confidence interval 51.0–80.0%), the median progression-free survival was 4.9 months (95% confidence interval 3.0–6.1 months) and the median overall survival was 18.2 months (95% confidence interval 13.2–23.5 months). One Grade 5 infection (pneumonia) was observed. Conclusions This study did not meet the primary endpoint. Pemetrexed monotherapy is not recommended in chemotherapy-naïve elderly patients aged ≥75 years with advanced non-squamous non-small-cell lung cancer.
- Publication
Japanese Journal of Clinical Oncology, 2013, Vol 43, Issue 12, p1184
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyt159