PMID- 37137963
OWN - NLM
STAT- MEDLINE
DCOM- 20230505
LR  - 20230511
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 13
IP  - 1
DP  - 2023 May 3
TI  - Real world evidence of adjuvant trastuzumab in HER2 positive early breast cancer.
PG  - 7168
LID - 10.1038/s41598-023-34429-9 [doi]
LID - 7168
AB  - Adjuvant trastuzumab in HER2+ breast cancer reduces recurrence and mortality, and 
      has been the standard treatment since 2006. The objective was to analyze health 
      outcomes in the real world. Observational, retrospective study of patients with 
      HER2+ breast cancer, stages I-III, treated with adjuvant trastuzumab in the past 
      15 years in only one center and for the first time in Spain. Survival was 
      analyzed according to the number of cycles and cardiotoxicity. Two hundred and 
      seventy-five HER2positive patients (18.60%) out of 1479 received adjuvant (73%) 
      or neoadjuvant/adjuvant (26%) trastuzumab, concomitantly (90%) or sequentially 
      (10%) with chemotherapy. The probability of overall and disease-free survival (OS 
      and DFS) at 5 years was 0.93 (95% CI 0.89-0.96), and 0.88 (95% CI 0.83-0.92). The 
      number of cases with a significant and asymptomatic decrease in ventricular 
      ejection fraction and heart failure were 54 (19.64%) and 12 (4.36%), 
      respectively. Sixty-eight patients (24.70%) received 16 or fewer cycles, 
      especially those older than 65 (OR 0.371, 95% CI 0.152-0.903; p = 0.029) and with 
      cardiotoxicity (OR 15.02, 95% CI 7.437-30.335; p < 0.001). The risk of 
      cardiotoxicity was associated with having received radiotherapy (OR 0.0362, 95% 
      CI 0.139-0.938; p = 0.037). Arterial hypertension (HR 0.361, 95% CI 0.151-0.863, 
      p = 0.022), neoadjuvant treatment (HR 0.314, 95% CI 0.132-0.750, p = 0.009) and 
      cardiotoxicity (HR 2.755, 95% CI 1.235-6.143, p = 0.013) maintained significant 
      association with OS. Only neoadjuvant treatment maintained a significant 
      association with DFS (HR 0.437, 95% CI 0.213-0.899, p = 0.024). The effectiveness 
      of neoadjuvant and adjuvant trastuzumab can be considered comparable to those of 
      clinical trials. In the real world, factors such as age, hypertension, 
      radiotherapy, neoadjuvant treatment, and cardiotoxicity should be taken into 
      consideration to optimize outcomes.
CI  - (c) 2023. The Author(s).
FAU - Lluch-Gomez, J
AU  - Lluch-Gomez J
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Nunez-Alvarez, V
AU  - Nunez-Alvarez V
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - de la Torre-Hita, C
AU  - de la Torre-Hita C
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Bernal-Gomez, M
AU  - Bernal-Gomez M
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Campini-Bermejo, A
AU  - Campini-Bermejo A
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Perdomo-Zaldivar, E
AU  - Perdomo-Zaldivar E
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Rodriguez-Perez, L
AU  - Rodriguez-Perez L
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Calvete-Candenas, J
AU  - Calvete-Candenas J
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Martinez-Bautista, M J
AU  - Martinez-Bautista MJ
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
AD  - Pharmacy Unit, Hospital Universitario Puerta del Mar (HUPM), Avenida de Ana de 
      Viya 21, 11009, Cadiz, Spain.
FAU - Benitez-Rodriguez, E
AU  - Benitez-Rodriguez E
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain.
AD  - Preventive Medicine Department, Hospital Universitario Puerta del Mar, Avenida de 
      Ana de Viya 21, 11009, Cadiz, Spain.
FAU - Baena-Canada, J M
AU  - Baena-Canada JM
AUID- ORCID: 0000-0002-8403-9804
AD  - Medical Oncology Department, Hospital Universitario Puerta del Mar (HUPM), Ana de 
      Viya 21, 11009, Cadiz, Spain. josem.baena.sspa@juntadeandalucia.es.
AD  - Instituto de Investigacion e Innovacion Biomedica de Cadiz (INIBiCA) [Institute 
      for Biomedica Research and Innovation], Ana de Viya 21, 11009, Cadiz, Spain. 
      josem.baena.sspa@juntadeandalucia.es.
LA  - eng
PT  - Journal Article
DEP - 20230503
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - P188ANX8CK (Trastuzumab)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Adjuvants, Immunologic)
SB  - IM
MH  - Humans
MH  - Female
MH  - Trastuzumab/adverse effects
MH  - *Breast Neoplasms/drug therapy
MH  - Cardiotoxicity/etiology/drug therapy
MH  - Retrospective Studies
MH  - Receptor, ErbB-2/genetics
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Disease-Free Survival
MH  - Adjuvants, Immunologic/therapeutic use
MH  - *Hypertension/drug therapy
MH  - Chemotherapy, Adjuvant
MH  - Neoadjuvant Therapy
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
PMC - PMC10156809
COIS- The authors declare no competing interests.
EDAT- 2023/05/04 00:42
MHDA- 2023/05/05 06:42
PMCR- 2023/05/03
CRDT- 2023/05/03 23:20
PHST- 2022/08/11 00:00 [received]
PHST- 2023/04/29 00:00 [accepted]
PHST- 2023/05/05 06:42 [medline]
PHST- 2023/05/04 00:42 [pubmed]
PHST- 2023/05/03 23:20 [entrez]
PHST- 2023/05/03 00:00 [pmc-release]
AID - 10.1038/s41598-023-34429-9 [pii]
AID - 34429 [pii]
AID - 10.1038/s41598-023-34429-9 [doi]
PST - epublish
SO  - Sci Rep. 2023 May 3;13(1):7168. doi: 10.1038/s41598-023-34429-9.