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Phase II study of pemetrexed as first-line treatment in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group Trial 0901

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Abstract

Background

Single-agent chemotherapy with third-generation non-platinum agents, such as docetaxel, vinorelbine, is a standard therapeutic option for elderly patients with non-small-cell lung cancer (NSCLC). Subset analysis of a previous phase III study comparing pemetrexed with docetaxel in the second-line setting showed the superiority of pemetrexed in an elderly (≥70) population in both efficacy and toxicity.

Patients and methods

This was a single-arm phase II study of pemetrexed in elderly (≥75) Japanese patients with advanced non-squamous NSCLC. Patients received four cycles of pemetrexed (500 mg/m2) every 3 weeks. The primary endpoint was the response rate, and secondary endpoints were safety and survival.

Results

Twenty-eight patients were enrolled between January 2010 and April 2012. The median age of the patients was 77 years (range 75–88). All but one patient had adenocarcinoma histology. The median number of chemotherapy cycles administered was 4 (range, 1–12). Seventeen (60 %) patients completed four cycles of chemotherapy. Partial response was achieved in 7 patients (response rate: 25 %) and stable disease in 11 patients (disease control rate: 64 %). Median progression-free survival and overall survival were 3.3 and 17.5 months, respectively. Grade 3/4 neutropenia and thrombocytopenia were observed in 8 patients (29 %) and 2 (7 %), respectively. Non-hematologic toxicities were generally mild, and there were no treatment-related deaths.

Conclusions

Although this study did not meet our primary endpoint, pemetrexed showed favorable antitumor activity with mild toxicity in elderly patients with non-squamous NSCLC. Further investigations of pemetrexed in this population are warranted (UMIN-CTR number, 000002452).

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Authors and Affiliations

  1. Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan

    Young Hak Kim, Hiroki Nagai, Yuichi Sakamori & Michiaki Mishima

  2. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki Hospital, 1-1-1, Higashidaimotsucho, Amagasaki, 660-0828, Japan

    Masataka Hirabayashi, Junichi Nikaidoh & Masatoshi Shimada

  3. Department of Thoracic Surgery, Shimane Prefectural Central Hospital, 4-1-1, Himehara, Izumo, 693-8555, Japan

    Shinji Kosaka, Yasumichi Yamamoto & Toshiya Toyazaki

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  1. Young Hak Kim
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  2. Masataka Hirabayashi
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Correspondence to Young Hak Kim.

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Kim, Y.H., Hirabayashi, M., Kosaka, S. et al. Phase II study of pemetrexed as first-line treatment in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group Trial 0901. Cancer Chemother Pharmacol 71, 1445–1451 (2013). https://doi.org/10.1007/s00280-013-2142-9

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  • DOI: https://doi.org/10.1007/s00280-013-2142-9

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