PMID- 31670262
OWN - NLM
STAT- MEDLINE
DCOM- 20201119
LR  - 20201119
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Print)
IS  - 0960-9776 (Linking)
VI  - 49
DP  - 2020 Feb
TI  - Safety profile of subcutaneous trastuzumab in patients with HER2-positive early 
      breast cancer: The French HERmione non-interventional prospective study.
PG  - 1-7
LID - S0960-9776(19)30565-X [pii]
LID - 10.1016/j.breast.2019.10.002 [doi]
AB  - OBJECTIVES: HERmione study was conducted to assess, in human epidermal growth 
      factor receptor 2 (HER2)-positive early breast cancer (eBC), the safety profile 
      of subcutaneous (SC) formulation of trastuzumab in real-life in France. MATERIALS 
      AND METHODS: This prospective, non-interventional study included 511 patients 
      planned to be treated in both neoadjuvant and adjuvant settings with a follow-up 
      of 12 months maximum in 101 sites. The safety analyses concerned 505 patients. 
      Primary endpoint was the description of systemic safety and local tolerability of 
      the SC trastuzumab. RESULTS: The median age of patients was 58 years. Over the 
      study, 2449 adverse events (AEs) occurred in 422 (83.6%) patients (asthenia, 
      arthralgia, radiation skin injury, myalgia, hot flush and diarrhea in >/=10% of 
      patients): 92 AEs (3.8%) were grade >/=3 (radiation skin injury in 1.8% of patients 
      and febrile neutropenia in 1.4% of patients), 76 (3.1%) were serious (mainly 
      febrile neutropenia in 1.4% of patients) and 336 (13.7%) were treatment-related 
      (mainly injection site pain in 9.1% of patients). Congestive Heart Failure 
      occurred in 58 (11.5%) patients and was related to treatment in 4.6% of patients. 
      Only 34 AEs (1.4%) in 27 (5.4%) patients led to permanent treatment 
      discontinuation. One death was assessed as not treatment-related. Quality of life 
      (QoL) analyses showed no deterioration of global health status. CONCLUSION: The 
      HERmione study showed that, in a real-life setting, the safety of SC trastuzumab 
      administered in HER2-positive eBC patients is consistent with data reported from 
      previous clinical trials, without new safety concerns or QoL deterioration.
CI  - Copyright (c) 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Jacquin, Jean-Philippe
AU  - Jacquin JP
AD  - Institut de Cancerologie de La Loire, Lucien Neuwirth, Saint-Priest-en-Jarez, 
      France. Electronic address: Jean-Philippe.JACQUIN@icloire.fr.
FAU - Uwer, Lionel
AU  - Uwer L
AD  - Institut de Cancerologie de Lorraine, Alexis Vautrin, Vandoeuvre-les-Nancy, 
      France. Electronic address: l.uwer@nancy.unicancer.fr.
FAU - Savignoni, Alexia
AU  - Savignoni A
AD  - Institut Curie, Paris, France. Electronic address: alexia.savignoni@curie.fr.
FAU - Ferrero, Jean-Marc
AU  - Ferrero JM
AD  - Centre Antoine Lacassagne, Nice, France. Electronic address: 
      jean-marc.ferrero@nice.unicancer.fr.
FAU - Lortholary, Alain
AU  - Lortholary A
AD  - Hopital Prive Du Confluent, Institut de Cancerologie Catherine de Sienne, Nantes, 
      France. Electronic address: ALAIN.LORTHOLARY@groupeconfluent.fr.
FAU - Solub, David
AU  - Solub D
AD  - Centre Hospitalier de Chartres, Centre Hospitalier Louis Pasteur, Le Coudray, 
      France. Electronic address: dsolub@ch-chartres.fr.
FAU - Delaporte, Flore
AU  - Delaporte F
AD  - ITM pour Roche, Boulogne-Billancourt, France. Electronic address: 
      flore.delaporte@contractors.roche.com.
FAU - Chalabi, Nassera
AU  - Chalabi N
AD  - Roche, Boulogne-Billancourt, France. Electronic address: 
      nassera.chalabi@roche.com.
FAU - Pibre, Sophie
AU  - Pibre S
AD  - Roche, Boulogne-Billancourt, France. Electronic address: sophie.pibre@roche.com.
FAU - Belkacemi, Yazid
AU  - Belkacemi Y
AD  - AP-HP, Henri Mondor University Hospital, Henri Mondor Breast Cancer Center and 
      Department of Radiation Oncology, University of Paris-Est Creteil (UPEC), 
      Creteil, France. Electronic address: yazid.belkacemi@hmn.aphp.fr.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20191018
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Antineoplastic Agents, Immunological/*adverse effects
MH  - Breast Neoplasms/*drug therapy/metabolism
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Female
MH  - France/epidemiology
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Middle Aged
MH  - Prospective Studies
MH  - Quality of Life
MH  - Receptor, ErbB-2/metabolism
MH  - Trastuzumab/*adverse effects
MH  - Treatment Outcome
PMC - PMC7375678
OTO - NOTNLM
OT  - Early breast cancer
OT  - HER2-Positive
OT  - Prospective non-interventional study
OT  - SC
OT  - Safety profile
OT  - Sub-cutaneous injection
OT  - Trastuzumab
COIS- Declaration of competing interest Y. Belkacemi: ROCHE National board of experts 
      (HERmione study, Breast cancer) and FERRING board of experts (Prostate Cancer). 
      F. Delaporte, N. Chalabi and S. Pibre: Full-time employees of ROCHE. All 
      remaining authors have declared no conflicts of interest.
EDAT- 2019/11/02 06:00
MHDA- 2020/11/20 06:00
PMCR- 2019/10/18
CRDT- 2019/11/01 06:00
PHST- 2019/08/26 00:00 [received]
PHST- 2019/10/13 00:00 [revised]
PHST- 2019/10/14 00:00 [accepted]
PHST- 2019/11/02 06:00 [pubmed]
PHST- 2020/11/20 06:00 [medline]
PHST- 2019/11/01 06:00 [entrez]
PHST- 2019/10/18 00:00 [pmc-release]
AID - S0960-9776(19)30565-X [pii]
AID - 10.1016/j.breast.2019.10.002 [doi]
PST - ppublish
SO  - Breast. 2020 Feb;49:1-7. doi: 10.1016/j.breast.2019.10.002. Epub 2019 Oct 18.