PMID- 30475947
OWN - NLM
STAT- MEDLINE
DCOM- 20200324
LR  - 20200324
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 30
IP  - 3
DP  - 2019 Mar 1
TI  - Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic 
      triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study.
PG  - 405-411
LID - S0923-7534(19)31076-2 [pii]
LID - 10.1093/annonc/mdy518 [doi]
AB  - BACKGROUND: Standard first-line treatment of metastatic triple-negative breast 
      cancer (mTNBC) is chemotherapy. However, outcomes are poor, and new treatment 
      options are needed. In cohort B of the phase II KEYNOTE-086 study, we evaluated 
      pembrolizumab as first-line therapy for patients with PD-L1-positive mTNBC. 
      PATIENTS AND METHODS: Eligible patients had centrally confirmed mTNBC, no prior 
      systemic anticancer therapy for metastatic disease, measurable disease at 
      baseline per RECIST v1.1 by central review, no radiographic evidence of central 
      nervous system metastases, and a tumor PD-L1 combined positive score >/=1. Patients 
      received pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years. The 
      primary end point was safety. Secondary end points included objective response 
      rate, disease control rate (percentage of patients with complete or partial 
      response or stable disease for >/=24 weeks), duration of response, progression-free 
      survival and overall survival. RESULTS: All 84 patients enrolled were women, and 
      73 (86.9%) received prior (neo)adjuvant therapy. Fifty-three (63.1%) patients had 
      treatment-related adverse events (AEs), including 8 patients (9.5%) with grade 3 
      severity; no patients experienced grade 4 AEs or died because of 
      treatment-related AEs. Four patients had a complete response and 14 had a partial 
      response, for an objective response rate of 21.4% (95% CI 13.9-31.4). Of the 13 
      patients with stable disease, 2 had stable disease lasting >/=24 weeks, for a 
      disease control rate of 23.8% (95% CI 15.9-34.0). At data cut-off, 8 of 18 
      (44.4%) responses were ongoing, and median duration of response was 10.4 months 
      (range 4.2 to 19.2+). Median progression-free survival was 2.1 months (95% CI 
      2.0-2.2), and median overall survival was 18.0 months (95% CI 12.9-23.0). 
      CONCLUSIONS: Pembrolizumab monotherapy had a manageable safety profile and showed 
      durable antitumor activity as first-line therapy for patients with PD-L1-positive 
      mTNBC. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02447003.
CI  - (c) The Author(s) 2018. Published by Oxford University Press on behalf of the 
      European Society for Medical Oncology. All rights reserved. For permissions, 
      please email: journals.permissions@oup.com.
FAU - Adams, S
AU  - Adams S
AD  - Department of Medicine, Perlmutter Cancer Center, New York University School of 
      Medicine, New York, USA. Electronic address: sylvia.adams@nyumc.org.
FAU - Loi, S
AU  - Loi S
AD  - Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre, 
      Melbourne, Australia.
FAU - Toppmeyer, D
AU  - Toppmeyer D
AD  - Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.
FAU - Cescon, D W
AU  - Cescon DW
AD  - Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.
FAU - De Laurentiis, M
AU  - De Laurentiis M
AD  - Dipartimento di Senologia, Istituto Nazionale Tumori - "Fondazione Pascale," 
      Naples, Italy.
FAU - Nanda, R
AU  - Nanda R
AD  - Section of Hematology/Oncology, Department of Medicine, The University of 
      Chicago, Chicago.
FAU - Winer, E P
AU  - Winer EP
AD  - Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
FAU - Mukai, H
AU  - Mukai H
AD  - Department of Breast and Medical Oncology, National Cancer Center Hospital East, 
      Kashiwa.
FAU - Tamura, K
AU  - Tamura K
AD  - Department of Breast and Medical Oncology, National Cancer Center Hospital, 
      Tokyo, Japan.
FAU - Armstrong, A
AU  - Armstrong A
AD  - Breast Disease Research Group, The Christie NHS Foundation Trust, Manchester, UK.
FAU - Liu, M C
AU  - Liu MC
AD  - Department of Oncology, Mayo Clinic, Rochester, USA.
FAU - Iwata, H
AU  - Iwata H
AD  - Aichi Cancer Center Hospital, Nagoya, Japan.
FAU - Ryvo, L
AU  - Ryvo L
AD  - Division of Oncology, Sourasky Medical Center (Ichilov), Tel Aviv, Israel.
FAU - Wimberger, P
AU  - Wimberger P
AD  - Department of Gynecology and Obstetric, University Carl Gustav Carus, TU Dresden, 
      Dresden, Germany.
FAU - Rugo, H S
AU  - Rugo HS
AD  - Department of Medicine, University of California San Francisco Helen Diller 
      Family Comprehensive Cancer Center, San Francisco.
FAU - Tan, A R
AU  - Tan AR
AD  - Levine Cancer Institute, Atrium Health, Charlotte.
FAU - Jia, L
AU  - Jia L
AD  - Merck & Co., Inc., Kenilworth, USA.
FAU - Ding, Y
AU  - Ding Y
AD  - Merck & Co., Inc., Kenilworth, USA.
FAU - Karantza, V
AU  - Karantza V
AD  - Merck & Co., Inc., Kenilworth, USA.
FAU - Schmid, P
AU  - Schmid P
AD  - Centre for Experimental Cancer Medicin, Barts Cancer Institute, Queen Mary 
      University London, London, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT02447003
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (CD274 protein, human)
RN  - DPT0O3T46P (pembrolizumab)
SB  - IM
CIN - Ann Oncol. 2019 Jan 1;30(1):13-16. PMID: 30351400
CIN - Ann Oncol. 2019 Mar 1;30(3):347-348. PMID: 30753266
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - B7-H1 Antigen/*genetics
MH  - Cohort Studies
MH  - Female
MH  - Gene Expression Regulation, Neoplastic/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Progression-Free Survival
MH  - Triple Negative Breast Neoplasms/*drug therapy/genetics/pathology
OTO - NOTNLM
OT  - anti-PD-1
OT  - immunotherapy
OT  - pembrolizumab
OT  - triple-negative breast neoplasms
EDAT- 2018/11/27 06:00
MHDA- 2020/03/25 06:00
CRDT- 2018/11/27 06:00
PHST- 2018/11/27 06:00 [pubmed]
PHST- 2020/03/25 06:00 [medline]
PHST- 2018/11/27 06:00 [entrez]
AID - S0923-7534(19)31076-2 [pii]
AID - 10.1093/annonc/mdy518 [doi]
PST - ppublish
SO  - Ann Oncol. 2019 Mar 1;30(3):405-411. doi: 10.1093/annonc/mdy518.