• Yoshihiro Hattori, Masahiro Iwasaku, Miyako Satouchi, Akihiro Nishiyama, Yohei Korogi, Kojiro Otsuka, Shiro Fujita, Nobuyuki Katakami, Masahide Mori, Kazumi Nishino, Satoshi Morita, and Shunichi Negoro.
• *Department of Thoracic Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo 673-8558, Japan. satouchi@hp.pref.hyogo.jp.
• Jpn. J. Clin. Oncol. 2013 Dec 1;43(12):1184-9.

ObjectivePemetrexed 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.MethodsIn 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/m(2)) intravenously on Day 1 every 3 weeks until disease progression. The primary endpoint was objective response rate.ResultsForty-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.ConclusionsThis 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.

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