論文

査読有り 国際誌
2018年4月

Randomized phase II study of anastrozole plus tegafur-uracil as neoadjuvant therapy for ER-positive breast cancer in postmenopausal Japanese women (Neo-ACET BC).

Cancer chemotherapy and pharmacology
  • Takahiro Nakayama
  • Yasuaki Sagara
  • Tsutomu Takashima
  • Nobuki Matsunami
  • Norikazu Masuda
  • Yasuo Miyoshi
  • Tetsuya Taguchi
  • Toyokazu Aono
  • Toshikazu Ito
  • Tatsuo Kagimura
  • Shinzaburo Noguchi
  • 全て表示

81
4
開始ページ
755
終了ページ
762
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s00280-018-3544-5

PURPOSE: This phase II study evaluated the efficacy and safety of anastrozole concurrent with tegafur/uracil (UFT) as neoadjuvant therapy for ER-positive postmenopausal breast cancer. METHODS: Postmenopausal Japanese women with ER-positive, HER2-negative, T2,N0-1,M0 breast cancer seen at tertiary hospitals were eligible for this open-label, randomized, multicenter study. Patients were randomized 1:1 by minimization to orally receive either anastrozole (1 mg once daily) plus UFT (tegafur/uracil combination in 1:4 molar ratio; 270 mg/m2/day in two divided doses) or anastrozole (as above) alone for 24 weeks. Tumor response was assessed by investigator and central review as per RECIST v1.1. The primary endpoint was the proportion of patients with best overall response of CR or PR [clinical response rate (RR)] determined by central radiologic review. RESULTS: The study was prematurely terminated due to Grade ≥ 3 liver dysfunction reported in 3 patients receiving anastrozole/UFT. Of 57 patients randomized before termination (29 anastrozole/UFT, 28 anastrozole), all were analyzed for safety and 56 (28 each group) for tumor response. Compared with anastrozole alone, anastrozole/UFT did not achieve significantly higher RR [39.3% (90% CI 23.8-56.5%) vs 14.3% (90% CI 5.0-29.8%); p = 0.0683, Fisher's exact test], but produced significantly greater tumor shrinkage (mean tumor reduction rate 31.0 vs. 14.2%; p = 0.0181, unpaired t-test). Grade ≥ 3 adverse events were more common with anastrozole/UFT than with anastrozole (17.2 vs. 0%). CONCLUSION: Although the study was terminated owing to the altered liver function, it showed that there was a trend to greater shrinkage of tumor in the combination group for ER-positive, HER2-negative postmenopausal breast cancer.

リンク情報
DOI
https://doi.org/10.1007/s00280-018-3544-5
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29468454
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5854715
ID情報
  • DOI : 10.1007/s00280-018-3544-5
  • ISSN : 0344-5704
  • PubMed ID : 29468454
  • PubMed Central 記事ID : PMC5854715

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