A Phase II Study of Pemetrexed in Chemotherapy-naive Elderly Patients Aged >=75 years with Advanced Non-squamous Non-small-cell Lung Cancer (HANSHIN Oncology Group 003)

Yoshihiro Hattori, Masahiro Iwasaku, Miyako Satouchi, Akihiro Nishiyama, Yohei Korogi, Kojiro Otsuka, Shiro Fujita, Nobuyuki Katakami, Masahide Mori, Kazumi Nishino, Satoshi Morita, Shunichi Negoro
Japanese Journal of Clinical Oncology 2013, 43 (12): 1184-9

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/m(2)) 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.

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