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Open Access 01-02-2021 | Breast Cancer | Clinical trial

Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur–uracil with CMF (N·SAS-BC 01 trial and CUBC trial)

Authors: Shinji Ohno, Shigehira Saji, Norikazu Masuda, Hitoshi Tsuda, Futoshi Akiyama, Masafumi Kurosumi, Akihiko Shimomura, Nobuaki Sato, Shintaro Takao, Shozo Ohsumi, Yutaka Tokuda, Hideo Inaji, Toru Watanabe, Yasuo Ohashi

Published in: Breast Cancer Research and Treatment | Issue 1/2021

Abstract

Purpose

To evaluate the efficacies of cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur–uracil (UFT) as adjuvant therapy in patients with resected stage I–IIIA breast cancer by immunohistochemistry (IHC)-based subtype and to determine the relationships between clinicopathological factors and long-term outcomes.

Methods

A pooled analysis of the randomized controlled N·SAS-BC 01 and CUBC studies was conducted. Expression of hormone receptors (HRs; estrogen and progesterone receptors), human epidermal growth factor receptor 2 (HER2), and Ki67were assessed by IHC. Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades were determined by hematoxylin and eosin staining. Relapse-free survival (RFS) and overall survival (OS) were estimated by Kaplan–Meier analysis and hazard ratios were determined by Cox model adjusted for baseline tumor size and nodal status.

Results

A total of 689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1 years. There was no significant difference in RFS or OS between the two cohorts (RFS: 0.96 [95% confidence interval: 0.71–1.30], log-rank test p = 0.80; OS: 0.93 [0.64–1.35], p = 0.70). There was no difference in RFS or OS between the two cohorts for HR+/HER2− and HR+/HER2+ subtypes. RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR−/HER2+ subtype (0.30 [0.10–0.88], p = 0.03). A high TILs level was associated with a better OS compared with low TILs level (p = 0.02).

Conclusions

This long-term follow-up study showed that RFS and OS were similar in patients with luminal-type breast cancer treated with CMF and UFT.

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Title: Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur–uracil with CMF (N·SAS-BC 01 trial and CUBC trial)
Authors: Shinji Ohno
Shigehira Saji
Norikazu Masuda
Hitoshi Tsuda
Futoshi Akiyama
Masafumi Kurosumi
Akihiko Shimomura
Nobuaki Sato
Shintaro Takao
Shozo Ohsumi
Yutaka Tokuda
Hideo Inaji
Toru Watanabe
Yasuo Ohashi
Publication date: 01-02-2021
Publisher: Springer US
Keywords: Breast Cancer
Methotrexate
Methotrexate
Breast Cancer
Tamoxifen
Cytostatic Therapy
Published in: Breast Cancer Research and Treatment / Issue 1/2021
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-020-06018-1

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