Randomized phase II trial of uracil/tegafur and cisplatin versus pemetrexed and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-squamous non-small cell lung cancer: NJLCG1001

Kana Watanabe, Yukihiro Toi, Atsushi Nakamura, Ryosuke Chiba, Masachika Akiyama, Jun Sakakibara-Konishi, Hisashi Tanaka, Naruo Yoshimura, Eisaku Miyauchi, Taku Nakagawa, Ryotaro Igusa, Hiroyuki Minemura, Yoshiaki Mori, Keisuke Fujimoto, Haruo Matsushita, Fumiaki Takahashi, Tatsuro Fukuhara, Akira Inoue, Shunichi Sugawara, Makoto Maemondo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The optimal regimen for concurrent chemoradiotherapy (CCRT) of locally advanced non-squamous non-small cell lung cancer (NSCLC) was not definitive. We conducted randomized phase II study, NJLCG0601, and chemoradiotherapy with uracil/tegafur (UFT) and cisplatin achieved promising efficacy without severe toxicities. Here, we evaluated between this regimen and pemetrexed plus cisplatin in chemoradiotherapy for stage III non-squamous NSCLC. Methods: Patients with inoperable stage III non-squamous NSCLC were randomly assigned in a 1:1 ratio to UFT 400 mg/m2 on days 1-14 and 29-42, and cisplatin 80 mg/m2 on days 8 and 36 (UP), or cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on days 1, 22, and 43 (PP). Involved-field radiotherapy (IFRT) underwent from day 1 to a total dose of 66 Gy in 33 fractions. Consolidation chemotherapy after CCRT was prohibited for this study. The primary endpoint was defined as 2-year overall survival (OS). This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000003948). Results: From November 2010 to June 2017, 86 patients were entered from 11 institutions. Median follow-up was 54 months. Of the 85 eligible patients, the 2-year OS rate was 78.6% (95% CI, 62.8-88.3%) in UP and 85.5% (95% CI, 70.5-93.2%) in PP. Median PFS and OS was 12.3 and 64.2 months in UP, 26.2 months and not reached in PP, respectively. Grade 3/4 febrile neutropenia was more frequent in the UP group (14.0% vs. 2.0%). Conclusions: Both UP and PP with IFRT achieved the expected 2-year OS. PP engendered more favorable OS and PFS compared to UP in terms.

Original languageEnglish
Pages (from-to)712-722
Number of pages11
JournalTranslational Lung Cancer Research
Volume10
Issue number2
DOIs
Publication statusPublished - 2021 Feb

Keywords

  • Concurrent chemoradiotherapy (CCRT)
  • Involved-field radiotherapy (IFRT)
  • Non-squamous non-small cell lung cancer (NSCLC)
  • Pemetrexed
  • Uracil/ tegafur (UFT)

ASJC Scopus subject areas

  • Oncology

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