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Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer

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Abstract

Purpose

Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients.

Methods

This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m2 of body surface area (BSA)] and cisplatin (40 mg/m2 of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety.

Results

Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0 % (95 % confidence interval 42.4–67.6 %). Three- and five-year overall survival rates were 83.3 and 77.8 %, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable.

Conclusions

Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.

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Acknowledgments

This work was supported by a grant-in-aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan to Makoto Sonobe (#25462174). None of the authors have any conflicts of interest to disclose with regard to this study.

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Authors and Affiliations

  1. Department of Thoracic Surgery, Kyoto University Hospital, Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan

    Makoto Sonobe, Ken-ichi Okubo, Masaaki Sato, Toshihiko Sato, Fengshi Chen, Kiyoshi Sato, Takuji Fujinaga, Tsuyoshi Shoji, Mitsugu Omasa, Hiroaki Sakai, Ryo Miyahara, Toru Bando & Hiroshi Date

  2. Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan

    Satoshi Teramukai

  3. Outpatient Oncology Unit, Kyoto University Hospital, Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan

    Kazuhiro Yanagihara

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  1. Makoto Sonobe
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  2. Ken-ichi Okubo
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  3. Satoshi Teramukai
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  4. Kazuhiro Yanagihara
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  7. Fengshi Chen
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  11. Mitsugu Omasa
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  13. Ryo Miyahara
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  14. Toru Bando
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  15. Hiroshi Date
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Correspondence to Makoto Sonobe.

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Sonobe, M., Okubo, Ki., Teramukai, S. et al. Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer. Cancer Chemother Pharmacol 74, 1199–1206 (2014). https://doi.org/10.1007/s00280-014-2595-5

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  • DOI: https://doi.org/10.1007/s00280-014-2595-5

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