PMID- 37028000
OWN - NLM
STAT- MEDLINE
DCOM- 20230425
LR  - 20230508
IS  - 2059-7029 (Electronic)
IS  - 2059-7029 (Linking)
VI  - 8
IP  - 2
DP  - 2023 Apr
TI  - A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic 
      breast cancer (PEMBRACA).
PG  - 101207
LID - S2059-7029(23)00432-5 [pii]
LID - 10.1016/j.esmoop.2023.101207 [doi]
LID - 101207
AB  - BACKGROUND: BRCA1/2-related metastatic breast cancers (mBC) are sensitive to 
      DNA-damage agents and show high tumor-infiltrated lymphocytes. We hypothesized 
      that the association between pembrolizumab and carboplatin could be active in 
      BRCA-related mBC. PATIENTS AND METHODS: In this phase II Simon's design 
      multicenter single-arm study, BRCA1/2-related mBC patients received carboplatin 
      at area under the curve 6 every 3 weeks for six courses associated with 200 mg 
      pembrolizumab every 3 weeks until disease progression or unacceptable toxicity. 
      The primary aim at first stage was overall response rate (ORR) >/=70%. Disease 
      control rate (DCR), time to progression (TTP), duration of response (DOR), and 
      overall survival (OS) were the secondary aims. RESULTS: Among 22 patients 
      enrolled at the first stage, 5 BRCA1 and 17 BRCA2, 16 (76%) were luminal tumors 
      and 6 (24%) triple-negative BC (TNBC). In 21 patients, ORR and DCR were 43% and 
      76% (47% and 87% in luminal, 33% and 50% in TNBC), respectively. TTP was 7.1 
      months, DOR was 6.3 months, and median OS was not reached. Grade >/=3 adverse 
      events (AEs) or serious AEs occurred in 5/22 patients (22.7%). Since the primary 
      aim was not met, the study was terminated at the first stage. CONCLUSIONS: 
      Although the primary aim was not reached, data on efficacy and safety of 
      pembrolizumab plus carboplatin in first-line visceral disease BRCA-related 
      luminal mBC were provided and they need to be further investigated.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Cortesi, L
AU  - Cortesi L
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena. 
      Electronic address: hbc@unimore.it.
FAU - Venturelli, M
AU  - Venturelli M
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
FAU - Cortesi, G
AU  - Cortesi G
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
FAU - Caggia, F
AU  - Caggia F
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
FAU - Toss, A
AU  - Toss A
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
FAU - Barbieri, E
AU  - Barbieri E
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
FAU - De Giorgi, U
AU  - De Giorgi U
AD  - Department of Medical Oncology, "Dino Amadori Scientific Institute of Romagna for 
      the Study of Cancer", Meldola.
FAU - Guarneri, V
AU  - Guarneri V
AD  - Department of Surgery, Oncology and Gastroenterology, University of Padua, 
      Padova; Division of Oncology, Istituto Oncologico Veneto IRCCS, Padova.
FAU - Musolino, A
AU  - Musolino A
AD  - Department of Medicine and Surgery, University of Parma, Parma; Medical Oncology, 
      Breast Unit and Cancer Genetics Service, University Hospital of Parma, Parma.
FAU - De Matteis, E
AU  - De Matteis E
AD  - Oncology Unit, Hospital "Vito Fazzi", Lecce.
FAU - Zambelli, A
AU  - Zambelli A
AD  - Papa Giovanni XXIII Cancer Center Hospital, Bergamo.
FAU - Bisagni, G
AU  - Bisagni G
AD  - Oncology Department, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
FAU - Dominici, M
AU  - Dominici M
AD  - Department of Oncology and Haematology, University Hospital Modena, Modena.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230405
PL  - England
TA  - ESMO Open
JT  - ESMO open
JID - 101690685
RN  - BG3F62OND5 (Carboplatin)
RN  - 0 (BRCA1 protein, human)
RN  - 0 (BRCA1 Protein)
RN  - DPT0O3T46P (pembrolizumab)
RN  - 0 (BRCA2 protein, human)
RN  - 0 (BRCA2 Protein)
SB  - IM
MH  - Humans
MH  - Carboplatin/adverse effects
MH  - *BRCA1 Protein/genetics
MH  - *Triple Negative Breast Neoplasms/drug therapy/pathology
MH  - BRCA2 Protein/genetics
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
PMC - PMC10163155
OTO - NOTNLM
OT  - BRCA1
OT  - BRCA2
OT  - carboplatin
OT  - pembrolizumab
OT  - phase II
EDAT- 2023/04/08 06:00
MHDA- 2023/04/25 06:42
PMCR- 2023/04/05
CRDT- 2023/04/07 18:03
PHST- 2023/01/29 00:00 [received]
PHST- 2023/02/25 00:00 [revised]
PHST- 2023/02/28 00:00 [accepted]
PHST- 2023/04/25 06:42 [medline]
PHST- 2023/04/08 06:00 [pubmed]
PHST- 2023/04/07 18:03 [entrez]
PHST- 2023/04/05 00:00 [pmc-release]
AID - S2059-7029(23)00432-5 [pii]
AID - 101207 [pii]
AID - 10.1016/j.esmoop.2023.101207 [doi]
PST - ppublish
SO  - ESMO Open. 2023 Apr;8(2):101207. doi: 10.1016/j.esmoop.2023.101207. Epub 2023 Apr 
      5.