Randomized phase II trial of uracil/tegafur and cisplatin versus vinorelbine and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-small-cell lung cancer: NJLCG 0601

Shunichi Sugawara, Makoto Maemondo, Motoko Tachihara, Akira Inoue, Osamu Ishimoto, Tomohiro Sakakibara, Kazuhiro Usui, Hiroshi Watanabe, Nobumichi Matsubara, Kana Watanabe, Kenya Kanazawa, Takashi Ishida, Yasuo Saijo, Toshihiro Nukiwa

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

Abstract

Introduction: The optimal chemotherapy with thoracic radiotherapy (TRT) for locally advanced non-small-cell lung cancer (NSCLC) remains to be established. This randomized phase II study of concurrent chemoradiotherapy was conducted to compare uracil/tegafur (UFT) and cisplatin with vinorelbine and cisplatin for stage III NSCLC. Patients and methods: Patients with unresectable stage III NSCLC were randomized to receive UP (400mg/m2 UFT on days 1-14 and 29-42 and 80mg/m2 cisplatin on days 8 and 36) or NP (20mg/m2 vinorelbine on days 1, 8, 29, and 36 and 80mg/m2 cisplatin on days 1 and 29). TRT began on day 1 (total 60Gy in 30 fractions). Results: Of 70 enrolled patients, 66 were evaluable for efficacy and safety. The overall response rates were 80% (95% CI: 67-93%) and 71% (95% CI: 55-87%) for the UP arm and the NP arm. With a median follow-up of 20.2 months, the progression-free survival and median survival time were 8.8 and 26.9 months in the UP arm, and 6.8 and 21.7 months in the NP arm. The 2-/3-year survival rates were 51.0/34.3% and 46.9/33.4% for the UP arm and the NP arm, respectively. Grade 3/4 neutropenia occurred in 20% and 58% of patients in the UP and NP arms, respectively. Conclusion: Combined with concurrent TRT, the UP arm achieved better efficacy and safety compared with the NP arm, suggesting it to be a promising candidate as a standard regimen for locally advanced NSCLC. Further evaluation of the UP arm is warranted.

Original languageEnglish
Pages (from-to)91-96
Number of pages6
JournalLung Cancer
Volume81
Issue number1
DOIs
Publication statusPublished - 2013 Jul

Keywords

  • Chemoradiotherapy
  • Cisplatin
  • Locally advanced
  • Non-small-cell lung cancer
  • Randomized phase II trial
  • UFT
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Fingerprint Dive into the research topics of 'Randomized phase II trial of uracil/tegafur and cisplatin versus vinorelbine and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-small-cell lung cancer: NJLCG 0601'. Together they form a unique fingerprint.

Cite this