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01-12-2014 | Original Article

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

Authors: 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

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2014

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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Title: Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer
Authors: 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
Publication date: 01-12-2014
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 6/2014
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-014-2595-5

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