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 NakayamaShinzaburo Noguchi

Abstract

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. 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. 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% ...Continue Reading

References

Jun 2, 2004·Nature Reviews. Cancer·Robert S Kerbel, Barton A Kamen
Apr 1, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Shinzaburo NoguchiOsahiko Abe
May 1, 2007·Breast Cancer Research and Treatment·Fabrice AndreLajos Pusztai
Sep 20, 2007·Breast Cancer Research and Treatment·Masakazu ToiUNKNOWN Japan Breast Cancer Research Group (JBCRG)
Jun 19, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A GoldhirschUNKNOWN Panel members
Feb 4, 2012·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·Antonio Llombart-CussacVicente Guillem Porta
Dec 14, 2016·The New England Journal of Medicine·Richard S FinnDennis J Slamon

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