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Friday, June 23rd, 2017
Table of Contents

1 Introduction
5 PMID
 [F] Diseases Research  / PubMed Research Articles  /
Superimposable outcomes for sequential and concomitant administration of adjuvant trastuzumab in HER2-positive breast cancer: Results from the SIGNAL/PHARE prospective cohort.

PubMed

 

Resource

European journal of cancer (Oxford, England : 1990) 2017 Jun 18; 81()

Authors

Pivot X1; Fumoleau P2; Pierga JY3; Delaloge S4; Bonnefoi H5; Bachelot T6; Jouannaud C7; Bourgeois H8; Rios M9; Soulié P10; Jacquin JP11; Lavau-Denes S12; Kerbrat P13; Cox D14; Faure-Mercier C15; Pauporte I16; Gligorov J17; Curtit E18; Henriques J19; Paget-Bailly S20; Romieu G21;

Author Information
  • 1Hôpital Jean-Minjoz, Centre Hospitalier Universitaire INSERM 1098, Boulevard Fleming, 25030 Besançon, France. Electronic address: xavier.pivot@univ-fcomte.fr.
  • 2Georges-François Leclerc, 1 Rue du Professeur Marion, 21000 Dijon, France.
  • 3Institut Curie, Department of Medical Oncology, 26 rue d'Ulm, 75248 Paris Cedex 05, France.
  • 4Institut Gustave Roussy, Comité de Pathologie mammaire, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France.
  • 5Institut Bergonié, Département d'Oncologie Médicale, 229 Cours de l'Argonne, 33000 Bordeaux, France.
  • 6Centre Léon Bérard, Département de Cancérologie Médicale, 28 rue Laënnec, Lyon Cedex 08, France.
  • 7Institut Jean Godinot, Service Oncologie Médicale, 1 rue du Général Koenig, 51056 Reims Cedex, France.
  • 8Clinique Victor Hugo-Centre Jean Bernard, 18 rue Victor Hugo, 72015 Le Mans Cedex 2, France.
  • 9Institut de Cancérologie de Lorraine - Alexis Vautrin, département d'Oncologie Médicale, 6, avenue de Bourgogne, 54511 Vandoeuvre Les Nancy Cedex, France.
  • 10Institut de Cancérologie de l'Ouest, Service Oncologie Médicale, 2 rue Moll, 49993 Angers Cedex 09, France.
  • 11Institut de Cancérologie Lucien Neuwirth, Service Oncologie Médicale, 108 bis avenue Albert Raimond, 42270 Saint Priest en Jarez, France.
  • 12Centre Hospitalier de Limoges, Service d'Oncologie Médicale, 2 avenue Martin Luther King, 87042 Limoges Cedex, France.
  • 13Centre Eugène Marquis, Service Oncologie médicale, Rue de la Bataille Flandres-Dunkerque, CS 44229, 35042 Rennes Cedex, France.
  • 14Centre de Recherche en Cancérologie de Lyon, INSERM U1052 - Centre Léon Bérard, 28 rue Laennec, 69373 Lyon, France.
  • 15Institut National du Cancer, Direction de la Recherche, 52 avenue Morizet, 92513 Boulogne-Billancourt, France.
  • 16Institut National du Cancer, Direction de la Recherche, 52 avenue Morizet, 92513 Boulogne-Billancourt, France.
  • 17Hôpital Tenon, Service Oncologie médicale, 4 rue de la Chine, 75970 Paris Cedex 20, France.
  • 18Hôpital Jean-Minjoz, Centre Hospitalier Universitaire INSERM 1098, Boulevard Fleming, 25030 Besançon, France.
  • 19Centre Hospitalier Universitaire, Unité de Méthodologie et de Qualité de Vie en Cancérologie, 2 place St Jacques, 25000 Besançon, France.
  • 20Centre Hospitalier Universitaire, Unité de Méthodologie et de Qualité de Vie en Cancérologie, 2 place St Jacques, 25000 Besançon, France.
  • 21Oncologie Sénologie, ICM Institut Régional du Cancer, 34298 Montpellier Cedex, France.

Abstract

AIM: Adjuvant clinical trials in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer have assessed either sequential or concomitant incorporation of trastuzumab with chemotherapy; only the North Central Cancer Treatment Group (NCCTG)-N9831 trial prospectively compared both modalities. In routine trastuzumab has been incorporated into a concurrent regimen with taxane chemotherapy instead of sequential modality on the basis of a positive risk-benefit ratio. This present study assessed sequential versus concomitant administration of adjuvant trastuzumab.

METHODS: A population combining patients from Protocol for Herceptin(®) as Adjuvant therapy with Reduced Exposure (PHARE) a randomised phase III clinical trial (NCT00381901) and SIGNAL (RECF1098) a prospective study specifically designed for Genome-wide Association Studies (GWAS) analyses was studied. In this cohort with 58 months of median follow-up, the comparison in the HER2-positive group of adjuvant trastuzumab and chemotherapy modalities was based on a propensity score methodology. Treatment modalities were based on physician's choice and comparisons adjustment were made by a propensity score methodology. Overall Survival (OS) and Disease-Free Survival (DFS) were estimated using the Kaplan-Meier method, and comparisons between groups were based on the log rank test.

RESULTS: The SIGNAL/PHARE cohort included 11,728 breast cancer cases treated in adjuvant setting; some 5502 of them with HER2-positive tumour: 34.5% (1897/5502) were treated by sequential and 65.5% (3605/5502) by concomitant modality of administration for taxane-chemotherapy and trastuzumab. The adjusted comparison found similar OS (HR = 1.01; 95% CI: 0.86-1.19) and similar DFS (HR = 1.08; 95% CI: 0.96-1.21).

CONCLUSION: These results suggest that the sequential administration of trastuzumab given after the completion of adjuvant chemotherapy might be as valid as the concomitant administration of trastuzumab and taxane chemotherapy in the adjuvant setting.

Copyright © 2017 Elsevier Ltd. All rights reserved.

PMID

28624696

Others

Publication Type: Journal Article


This article is licensed under the the National Library of Medicine License. It uses material from the PubMed National Library of Medicine Data.


Last Modified:   2016-03-27


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