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- Title
A phase II study of pemetrexed monotherapy in chemo-naïve Eastern Cooperative Oncology Group performance status 2 patients with EGFR wild-type or unknown advanced non-squamous non-small cell lung cancer (HANSHIN Oncology Group 002).
- Authors
Hata, Akito; Katakami, Nobuyuki; Fujita, Shiro; Nanjo, Shigeki; Takeshita, Jumpei; Tanaka, Kosuke; Kaneda, Toshihiko; Nishiyama, Akihiro; Nishimura, Takashi; Nakagawa, Atsushi; Otsuka, Kojiro; Morita, Satoshi; Urata, Yoshiko; Negoro, Shunichi
- Abstract
Purpose: The aim of our study was to investigate the efficacy and safety of pemetrexed monotherapy in chemo-naïve Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients with epidermal growth factor receptor ( EGFR) wild-type or unknown advanced non-squamous non-small cell lung cancer (NSCLC). Methods: Pemetrexed was administered at 500 mg/m triweekly until progression with supplementations in chemo-naïve ECOG PS 2 patients with EGFR wild-type or unknown advanced non-squamous NSCLC. Results: Between September 2009 and April 2013, twenty-eight patients were enrolled. Median age was 75 (range 59-89). Nineteen (68 %) of 28 were ever smoker, and 18 (64 %) had pulmonary emphysema. Sixteen (57 %) had comorbidities such as hypertension, heart disease, and/or diabetes. In 26 eligible patients, the overall response rate, disease control rate, median PFS, and median overall survival were 11.5, 53.8 %, 3.0 [95 % confidence interval (CI) 1.9-5.7] months and 9.5 (95 % CI 3.3-12.5) months, respectively. Median administered course number was 3 (range 1-14). Median duration of PS maintenance ≤2 was 4.9 (95 % CI 1.3-9.7) months. Common (≥10 %) grade 3/4 toxicities included 7 (27 %) neutropenia, 7 (27 %) leukopenia, 4 (15 %) fatigue, and 3 (12 %) thrombocytopenia. Febrile neutropenia and interstitial lung disease were not observed. There were no treatment-related deaths. Conclusion: Pemetrexed monotherapy demonstrated moderate efficacy and good safety in chemo-naïve PS 2 patients with EGFR wild-type or unknown non-squamous NSCLC. It can be a therapeutic option in 'frail' PS 2 non-squamous NSCLC patients without the indication of combination regimens, if the patient is EGFR wild-type.
- Subjects
CANCER treatment; NON-small-cell lung carcinoma; PEMETREXED; EPIDERMAL growth factor receptors; TUMOR classification; DRUG efficacy; ONCOLOGY
- Publication
Cancer Chemotherapy & Pharmacology, 2015, Vol 75, Issue 6, p1267
- ISSN
0344-5704
- Publication type
Article
- DOI
10.1007/s00280-015-2755-2