Cancer Chemotherapy and Pharmacology

, Volume 74, Issue 6, pp 1199–1206 | Cite as

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

  • Makoto Sonobe
  • Ken-ichi Okubo
  • Satoshi Teramukai
  • Kazuhiro Yanagihara
  • Masaaki Sato
  • Toshihiko Sato
  • Fengshi Chen
  • Kiyoshi Sato
  • Takuji Fujinaga
  • Tsuyoshi Shoji
  • Mitsugu Omasa
  • Hiroaki Sakai
  • Ryo Miyahara
  • Toru Bando
  • Hiroshi Date
Original Article

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.

Keywords

Non-small cell lung cancer Adjuvant chemotherapy Cisplatin Vinorelbine 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Makoto Sonobe
    • 1
  • Ken-ichi Okubo
    • 1
  • Satoshi Teramukai
    • 2
  • Kazuhiro Yanagihara
    • 3
  • Masaaki Sato
    • 1
  • Toshihiko Sato
    • 1
  • Fengshi Chen
    • 1
  • Kiyoshi Sato
    • 1
  • Takuji Fujinaga
    • 1
  • Tsuyoshi Shoji
    • 1
  • Mitsugu Omasa
    • 1
  • Hiroaki Sakai
    • 1
  • Ryo Miyahara
    • 1
  • Toru Bando
    • 1
  • Hiroshi Date
    • 1
  1. 1.Department of Thoracic SurgeryKyoto University HospitalKyotoJapan
  2. 2.Department of Clinical Trial Design and Management, Translational Research CenterKyoto University HospitalKyotoJapan
  3. 3.Outpatient Oncology UnitKyoto University HospitalKyotoJapan

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