Real-world study of patients with germline BRCA1/2-mutated human epidermal growth factor receptor 2‒Negative advanced breast cancer: Patient demographics, treatment patterns, adverse events, and physician-reported satisfaction in the United States, Europe, and Israel.
Humans
United States
Adolescent
Adult
Middle Aged
Female
Breast Neoplasms
/ drug therapy
Triple Negative Breast Neoplasms
/ drug therapy
Retrospective Studies
Israel
Patient Satisfaction
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Receptor, ErbB-2
/ genetics
Physicians
Demography
BRCA1 Protein
/ genetics
Breast cancer susceptibility gene 1 or 2
Hereditary breast cancer
Real-world
Safety
Treatment patterns
poly(adenosine diphosphate-ribose) polymerase inhibitors
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
07
07
2022
revised:
14
10
2022
accepted:
17
10
2022
pubmed:
12
11
2022
medline:
27
12
2022
entrez:
11
11
2022
Statut:
ppublish
Résumé
Current guidelines for the treatment of human epidermal growth factor receptor 2‒negative (HER2-) advanced breast cancer (ABC) are informed by tumor characteristics and include platinum- and non-platinum-based chemotherapy, chemotherapy plus immunotherapy, endocrine monotherapy, or endocrine therapy plus a targeted therapy. In addition, poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) have recently demonstrated improved clinical and patient-reported outcomes and manageable toxicity profiles compared with chemotherapy in patients with germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2)‒mutated HER2- ABC in clinical trials and are now approved to treat this patient population. This study provides complementary real-world data regarding treatment patterns, adverse events, and physician-reported treatment satisfaction in this population. This retrospective analysis using the Adelphi Real World ABC Disease Specific Programme in the United States, European Union, and Israel included patients aged ≥18 years receiving therapy for stage IIIb or IV gBRCA1/2-mutated HER2- ABC. Oncologists completed a patient record form detailing patient demographics, clinical assessments, and treatment history and a survey regarding their use of and satisfaction with treatments. Among the 543 patients, mean age was 55 years, 25% were premenopausal, 70% had hormone receptor‒positive (HR+) ABC, and 30% had triple-negative breast cancer (TNBC). PARPi were used in 5%, 11%, and 12% of first-line, second-line, and third-line therapies, respectively, for patients with HR+ ABC; for TNBC, percentages were 18%, 44%, and 36%. Across treatment lines, neutropenia, anemia, and nausea occurred in 16%, 24%, and 32% of patients receiving PARPi, respectively; 22%, 38%, and 33% of patients receiving platinum chemotherapy; and 20%, 20%, and 33% of patients receiving non-platinum-based chemotherapy. Physician satisfaction was highest with PARPi and with chemotherapy plus immunotherapy. Findings in this real-world population complement clinical trial observations and provide further support for treatment of patients with PARPi in gBRCA1/2-mutated HER2- ABC.
Sections du résumé
BACKGROUND
BACKGROUND
Current guidelines for the treatment of human epidermal growth factor receptor 2‒negative (HER2-) advanced breast cancer (ABC) are informed by tumor characteristics and include platinum- and non-platinum-based chemotherapy, chemotherapy plus immunotherapy, endocrine monotherapy, or endocrine therapy plus a targeted therapy. In addition, poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) have recently demonstrated improved clinical and patient-reported outcomes and manageable toxicity profiles compared with chemotherapy in patients with germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2)‒mutated HER2- ABC in clinical trials and are now approved to treat this patient population. This study provides complementary real-world data regarding treatment patterns, adverse events, and physician-reported treatment satisfaction in this population.
METHODS
METHODS
This retrospective analysis using the Adelphi Real World ABC Disease Specific Programme in the United States, European Union, and Israel included patients aged ≥18 years receiving therapy for stage IIIb or IV gBRCA1/2-mutated HER2- ABC. Oncologists completed a patient record form detailing patient demographics, clinical assessments, and treatment history and a survey regarding their use of and satisfaction with treatments.
RESULTS
RESULTS
Among the 543 patients, mean age was 55 years, 25% were premenopausal, 70% had hormone receptor‒positive (HR+) ABC, and 30% had triple-negative breast cancer (TNBC). PARPi were used in 5%, 11%, and 12% of first-line, second-line, and third-line therapies, respectively, for patients with HR+ ABC; for TNBC, percentages were 18%, 44%, and 36%. Across treatment lines, neutropenia, anemia, and nausea occurred in 16%, 24%, and 32% of patients receiving PARPi, respectively; 22%, 38%, and 33% of patients receiving platinum chemotherapy; and 20%, 20%, and 33% of patients receiving non-platinum-based chemotherapy. Physician satisfaction was highest with PARPi and with chemotherapy plus immunotherapy.
CONCLUSIONS
CONCLUSIONS
Findings in this real-world population complement clinical trial observations and provide further support for treatment of patients with PARPi in gBRCA1/2-mutated HER2- ABC.
Identifiants
pubmed: 36368161
pii: S0960-9776(22)00174-6
doi: 10.1016/j.breast.2022.10.009
pmc: PMC9650077
pii:
doi:
Substances chimiques
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
BRCA1 protein, human
0
BRCA1 Protein
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
236-244Informations de copyright
Copyright © 2022 The Pfizer, The Author(s). Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest RM contracted research funding from Genentech and acted as consultant for Agendia, Amgen, AstraZeneca, Biotheranostics, Daiichi Sankyo, Eisai, Eli Lilly, Genentech, Immunomedics, Merck, Novartis, Pfizer, Puma, Sanofi, and SeaGen. AN and BA are employees of and own stock in Pfizer Inc. KL, AR, and LM are employees of Adelphi Real World. MPL received honoraria for lectures, consulting, or advisory role for AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Exact Sciences, Gilead, Grünenthal, Medac, MSD, Novartis, Pfizer, PharmaMar, Pierre Fabre, and Roche and travel and accommodations expenses from Pfizer and Roche.