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Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer

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An Erratum to this article was published on 01 October 2013

Summary

Introduction This study prospectively evaluated the efficacy and safety of pemetrexed and carboplatin followed by maintenance pemetrexed in chemo-naïve patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Methods A total of 109 patients received pemetrexed (500 mg/m2) and carboplatin (area under the curve = 6 mg/mL·min) every 21 days. For patients without disease progression after 4 cycles, pemetrexed was continued until disease progression or unacceptable toxicity. Pre-planned subgroup analysis results based on the presence of epidermal growth factor receptor (EGFR) mutations are also presented. Results The median number of treatment cycles was 5 (range: 1–30) in the entire study period. Most of the grade ≥3 toxicities observed were hematologic in nature, with no increase in the relative incidence associated with continuation maintenance therapy with pemetrexed. Among the 106 total patients assessable for efficacy, the objective response rate was 35.8 %, median progression free survival (PFS) 5.7 months, and median overall survival (OS) 20.2 months. Sixty patients received maintenance pemetrexed (median: 4 cycles, range: 1–26 cycles); median PFS from the beginning of induction treatment was 7.5 months. From the subgroup analysis for EGFR mutation status, the median OS of EGFR wild-type patients (n = 61) was 20.2 months. Conclusions Pemetrexed/carboplatin followed by pemetrexed was well tolerated and active for front-line treatment of advanced nonsquamous NSCLC. Encouraging survival outcomes were observed even in EGFR-wild type patients.

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Acknowledgments

The authors thank all the patients and investigators who participated in this study. This study was sponsored by Eli Lilly Japan K.K.

Disclosure of potential conflicts of interest

Keisuke Aoe, Nobuyuki Yamamoto, Naoyuki Nogami, Terufumi Kato and Kazuhiko Nakagawa received honoraria from Eli Lilly Japan K.K. Immediate family of Terufumi Kato is currently employed by Eli Lilly Japan K.K. Naoto Yoshizuka, Risa Sekiguchi and Kazuhiro Kiyosawa are currently employed by Eli Lilly Japan K.K. Other authors declare no conflicts of interest.

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Authors and Affiliations

  1. Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan

    Isamu Okamoto & Kazuhiko Nakagawa

  2. National Hospital Organization Yamaguchi-Ube Medical Center, Yamaguchi, Japan

    Keisuke Aoe

  3. Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan

    Terufumi Kato

  4. Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan

    Yukio Hosomi

  5. Niigata Cancer Center Hospital, Niigata, Japan

    Akira Yokoyama

  6. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Fumio Imamura

  7. Okayama University Hospital, Okayama, Japan

    Katsuyuki Kiura

  8. Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan

    Tomonori Hirashima

  9. Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

    Makoto Nishio

  10. National Hospital Organization Shikoku Cancer Center, Ehime, Japan

    Naoyuki Nogami

  11. Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan

    Hiroaki Okamoto

  12. National Hospital Organization Nagoya Medical Center, Aichi, Japan

    Hideo Saka

  13. Shizuoka Cancer Center, Shizuoka, Japan

    Nobuyuki Yamamoto

  14. Eli Lilly Japan K.K., Hyogo, Japan

    Naoto Yoshizuka, Risa Sekiguchi & Kazuhiro Kiyosawa

  15. National Cancer Center Hospital, Tokyo, Japan

    Tomohide Tamura

Authors
  1. Isamu Okamoto
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  2. Keisuke Aoe
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  3. Terufumi Kato
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  11. Hiroaki Okamoto
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  15. Risa Sekiguchi
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  16. Kazuhiro Kiyosawa
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  17. Kazuhiko Nakagawa
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  18. Tomohide Tamura
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Corresponding author

Correspondence to Isamu Okamoto.

Additional information

This study is registered with ClinicalTrials.gov. identifier NCT01020786

Funding source: This trial is sponsored by Eli Lilly Japan K.K.

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Okamoto, I., Aoe, K., Kato, T. et al. Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer. Invest New Drugs 31, 1275–1282 (2013). https://doi.org/10.1007/s10637-013-9941-z

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  • DOI: https://doi.org/10.1007/s10637-013-9941-z

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