Literature DB >> 33259001

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).

Shinji Ohno1, Shigehira Saji2, Norikazu Masuda3, Hitoshi Tsuda4, Futoshi Akiyama5, Masafumi Kurosumi6, Akihiko Shimomura7, Nobuaki Sato8, Shintaro Takao9, Shozo Ohsumi10, Yutaka Tokuda11, Hideo Inaji12, Toru Watanabe13, Yasuo Ohashi14.   

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.

Entities:  

Keywords:  Adjuvant chemotherapy; Breast cancer; CMF; Tegafur–uracil; Tumor-infiltrating lymphocyte

Mesh:

Substances:

Year:  2020        PMID: 33259001      PMCID: PMC7940338          DOI: 10.1007/s10549-020-06018-1

Source DB:  PubMed          Journal:  Breast Cancer Res Treat        ISSN: 0167-6806            Impact factor:   4.872


  18 in total

1.  Breast cancer adjuvant therapy: time to consider its time-dependent effects.

Authors:  Ismail Jatoi; William F Anderson; Jong-Hyeon Jeong; Carol K Redmond
Journal:  J Clin Oncol       Date:  2011-05-09       Impact factor: 44.544

Review 2.  Assessing Tumor-infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method From the International Immunooncology Biomarkers Working Group: Part 1: Assessing the Host Immune Response, TILs in Invasive Breast Carcinoma and Ductal Carcinoma In Situ, Metastatic Tumor Deposits and Areas for Further Research.

Authors:  Shona Hendry; Roberto Salgado; Thomas Gevaert; Prudence A Russell; Tom John; Bibhusal Thapa; Michael Christie; Koen van de Vijver; M V Estrada; Paula I Gonzalez-Ericsson; Melinda Sanders; Benjamin Solomon; Cinzia Solinas; Gert G G M Van den Eynden; Yves Allory; Matthias Preusser; Johannes Hainfellner; Giancarlo Pruneri; Andrea Vingiani; Sandra Demaria; Fraser Symmans; Paolo Nuciforo; Laura Comerma; E A Thompson; Sunil Lakhani; Seong-Rim Kim; Stuart Schnitt; Cecile Colpaert; Christos Sotiriou; Stefan J Scherer; Michail Ignatiadis; Sunil Badve; Robert H Pierce; Giuseppe Viale; Nicolas Sirtaine; Frederique Penault-Llorca; Tomohagu Sugie; Susan Fineberg; Soonmyung Paik; Ashok Srinivasan; Andrea Richardson; Yihong Wang; Ewa Chmielik; Jane Brock; Douglas B Johnson; Justin Balko; Stephan Wienert; Veerle Bossuyt; Stefan Michiels; Nils Ternes; Nicole Burchardi; Stephen J Luen; Peter Savas; Frederick Klauschen; Peter H Watson; Brad H Nelson; Carmen Criscitiello; Sandra O'Toole; Denis Larsimont; Roland de Wind; Giuseppe Curigliano; Fabrice André; Magali Lacroix-Triki; Mark van de Vijver; Federico Rojo; Giuseppe Floris; Shahinaz Bedri; Joseph Sparano; David Rimm; Torsten Nielsen; Zuzana Kos; Stephen Hewitt; Baljit Singh; Gelareh Farshid; Sibylle Loibl; Kimberly H Allison; Nadine Tung; Sylvia Adams; Karen Willard-Gallo; Hugo M Horlings; Leena Gandhi; Andre Moreira; Fred Hirsch; Maria V Dieci; Maria Urbanowicz; Iva Brcic; Konstanty Korski; Fabien Gaire; Hartmut Koeppen; Amy Lo; Jennifer Giltnane; Marlon C Rebelatto; Keith E Steele; Jiping Zha; Kenneth Emancipator; Jonathan W Juco; Carsten Denkert; Jorge Reis-Filho; Sherene Loi; Stephen B Fox
Journal:  Adv Anat Pathol       Date:  2017-09       Impact factor: 3.875

3.  The evaluation of tumor-infiltrating lymphocytes (TILs) in breast cancer: recommendations by an International TILs Working Group 2014.

Authors:  R Salgado; C Denkert; S Demaria; N Sirtaine; F Klauschen; G Pruneri; S Wienert; G Van den Eynden; F L Baehner; F Penault-Llorca; E A Perez; E A Thompson; W F Symmans; A L Richardson; J Brock; C Criscitiello; H Bailey; M Ignatiadis; G Floris; J Sparano; Z Kos; T Nielsen; D L Rimm; K H Allison; J S Reis-Filho; S Loibl; C Sotiriou; G Viale; S Badve; S Adams; K Willard-Gallo; S Loi
Journal:  Ann Oncol       Date:  2014-09-11       Impact factor: 32.976

4.  Postoperative adjuvant therapy with tamoxifen, tegafur plus uracil, or both in women with node-negative breast cancer: a pooled analysis of six randomized controlled trials.

Authors:  Shinzaburo Noguchi; Hiroki Koyama; Junichi Uchino; Rikiya Abe; Shigeto Miura; Keizo Sugimachi; Kohei Akazawa; Osahiko Abe
Journal:  J Clin Oncol       Date:  2005-04-01       Impact factor: 44.544

5.  Efficacy of oral tegafur-uracil (UFT) as adjuvant therapy as compared with classical cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) in early breast cancer: a pooled analysis of two randomized controlled trials (N.SAS-BC 01 trial and CUBC trial).

Authors:  Yasuo Ohashi; Toru Watanabe; Muneaki Sano; Hiroki Koyama; Hideo Inaji; Takaichiro Suzuki
Journal:  Breast Cancer Res Treat       Date:  2010-02       Impact factor: 4.872

6.  Establishment of histological criteria for high-risk node-negative breast carcinoma for a multi-institutional randomized clinical trial of adjuvant therapy. Japan National Surgical Adjuvant Study of Breast Cancer (NSAS-BC) Pathology Section.

Authors:  H Tsuda; F Akiyama; M Kurosumi; G Sakamoto; T Watanabe
Journal:  Jpn J Clin Oncol       Date:  1998-08       Impact factor: 3.019

7.  Meta-analysis of five studies on tegafur plus uracil (UFT) as post-operative adjuvant chemotherapy for breast cancer.

Authors:  Fujio Kasumi; Masataka Yoshimoto; Junichi Uchino; Rikiya Abe; Yasuo Nomura; Keizo Sugimachi; Hiroaki Nakazato; Osahiko Abe
Journal:  Oncology       Date:  2003       Impact factor: 2.935

8.  Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.

Authors:  Joseph A Sparano; Robert J Gray; Della F Makower; Kathleen I Pritchard; Kathy S Albain; Daniel F Hayes; Charles E Geyer; Elizabeth C Dees; Matthew P Goetz; John A Olson; Tracy Lively; Sunil S Badve; Thomas J Saphner; Lynne I Wagner; Timothy J Whelan; Matthew J Ellis; Soonmyung Paik; William C Wood; Peter M Ravdin; Maccon M Keane; Henry L Gomez Moreno; Pavan S Reddy; Timothy F Goggins; Ingrid A Mayer; Adam M Brufsky; Deborah L Toppmeyer; Virginia G Kaklamani; Jeffrey L Berenberg; Jeffrey Abrams; George W Sledge
Journal:  N Engl J Med       Date:  2018-06-03       Impact factor: 91.245

9.  Prognostic utility of tumor-infiltrating lymphocytes in residual tumor after neoadjuvant chemotherapy with trastuzumab for HER2-positive breast cancer.

Authors:  Sasagu Kurozumi; Kenichi Inoue; Hiroshi Matsumoto; Takaaki Fujii; Jun Horiguchi; Tetsunari Oyama; Masafumi Kurosumi; Ken Shirabe
Journal:  Sci Rep       Date:  2019-02-07       Impact factor: 4.379

10.  Prognostic value of tumor-infiltrating lymphocytes in triple-negative breast cancers from two phase III randomized adjuvant breast cancer trials: ECOG 2197 and ECOG 1199.

Authors:  Sylvia Adams; Robert J Gray; Sandra Demaria; Lori Goldstein; Edith A Perez; Lawrence N Shulman; Silvana Martino; Molin Wang; Vicky E Jones; Thomas J Saphner; Antonio C Wolff; William C Wood; Nancy E Davidson; George W Sledge; Joseph A Sparano; Sunil S Badve
Journal:  J Clin Oncol       Date:  2014-09-20       Impact factor: 44.544

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  1 in total

1.  Validation of a nuclear grading system for resected stage I-IIIA, high-risk, node-negative invasive breast carcinoma in the N·SAS-BC 01 trial.

Authors:  Hitoshi Tsuda; Masafumi Kurosumi; Futoshi Akiyama; Shinji Ohno; Shigehira Saji; Norikazu Masuda; Akihiko Shimomura; Nobuaki Sato; Shintaro Takao; Shozo Ohsumi; Yutaka Tokuda; Hideo Inaji; Toru Watanabe
Journal:  Breast Cancer       Date:  2022-04-18       Impact factor: 3.307

  1 in total

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