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Investigational New Drugs

, Volume 31, Issue 5, pp 1275–1282 | Cite as

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

  • Isamu OkamotoEmail author
  • Keisuke Aoe
  • Terufumi Kato
  • Yukio Hosomi
  • Akira Yokoyama
  • Fumio Imamura
  • Katsuyuki Kiura
  • Tomonori Hirashima
  • Makoto Nishio
  • Naoyuki Nogami
  • Hiroaki Okamoto
  • Hideo Saka
  • Nobuyuki Yamamoto
  • Naoto Yoshizuka
  • Risa Sekiguchi
  • Kazuhiro Kiyosawa
  • Kazuhiko Nakagawa
  • Tomohide Tamura
PHASE II STUDIES

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.

Keywords

Pemetrexed Carboplatin Continuation maintenance Nonsquamous NSCLC EGFR mutation status 

Notes

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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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Isamu Okamoto
    • 1
    Email author
  • Keisuke Aoe
    • 2
  • Terufumi Kato
    • 3
  • Yukio Hosomi
    • 4
  • Akira Yokoyama
    • 5
  • Fumio Imamura
    • 6
  • Katsuyuki Kiura
    • 7
  • Tomonori Hirashima
    • 8
  • Makoto Nishio
    • 9
  • Naoyuki Nogami
    • 10
  • Hiroaki Okamoto
    • 11
  • Hideo Saka
    • 12
  • Nobuyuki Yamamoto
    • 13
  • Naoto Yoshizuka
    • 14
  • Risa Sekiguchi
    • 14
  • Kazuhiro Kiyosawa
    • 14
  • Kazuhiko Nakagawa
    • 1
  • Tomohide Tamura
    • 15
  1. 1.Department of Medical OncologyKinki University Faculty of MedicineOsaka-SayamaJapan
  2. 2.National Hospital Organization Yamaguchi-Ube Medical CenterYamaguchiJapan
  3. 3.Kanagawa Cardiovascular and Respiratory CenterKanagawaJapan
  4. 4.Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalTokyoJapan
  5. 5.Niigata Cancer Center HospitalNiigataJapan
  6. 6.Osaka Medical Center for Cancer and Cardiovascular DiseasesOsakaJapan
  7. 7.Okayama University HospitalOkayamaJapan
  8. 8.Osaka Prefectural Medical Center for Respiratory and Allergic DiseasesOsakaJapan
  9. 9.Cancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
  10. 10.National Hospital Organization Shikoku Cancer CenterEhimeJapan
  11. 11.Yokohama Municipal Citizen’s HospitalKanagawaJapan
  12. 12.National Hospital Organization Nagoya Medical CenterAichiJapan
  13. 13.Shizuoka Cancer CenterShizuokaJapan
  14. 14.Eli Lilly Japan K.K.HyogoJapan
  15. 15.National Cancer Center HospitalTokyoJapan

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