PMID- 36077811
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230214
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 14
IP  - 17
DP  - 2022 Sep 1
TI  - Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with 
      Metastatic Hormone Receptor Positive Breast Cancer.
LID - 10.3390/cancers14174279 [doi]
LID - 4279
AB  - This study investigated the safety and antitumor activity of aromatase inhibitors 
      (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with 
      hormone receptor positive (HR(+)) human epidermal growth factor receptor 
      2-negative (HER2(-)) metastatic breast cancer (MBC) in a phase II study with a 
      safety lead-in (NCT02648477). Patients received pembrolizumab plus AI up to 2 
      years or until confirmed progression or unacceptable toxicity. Key eligibility 
      criteria were HR(+) HER2(-) MBC; RECIST v1.1 measurable disease; adequate organ 
      function; and ECOG 0-1. Primary endpoints were safety and overall response rate. 
      A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 
      patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% 
      hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 
      5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial 
      responses, three (15%) had stable disease, and 15 (75%) had progression of 
      disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), 
      median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up 
      time was 40.1 months (range 31.3-46.8 months). The combination was well 
      tolerated, but clinical activity was comparable to AI alone.
FAU - Ge, Xuan
AU  - Ge X
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Yost, Susan E
AU  - Yost SE
AUID- ORCID: 0000-0002-9422-0316
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Lee, Jin Sun
AU  - Lee JS
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Frankel, Paul H
AU  - Frankel PH
AD  - Department of Statistics, City of Hope Comprehensive Cancer Center, Duarte, CA 
      91010, USA.
FAU - Ruel, Christopher
AU  - Ruel C
AD  - Department of Statistics, City of Hope Comprehensive Cancer Center, Duarte, CA 
      91010, USA.
FAU - Cui, Yujie
AU  - Cui Y
AD  - Department of Statistics, City of Hope Comprehensive Cancer Center, Duarte, CA 
      91010, USA.
FAU - Murga, Mireya
AU  - Murga M
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Tang, Aileen
AU  - Tang A
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Martinez, Norma
AU  - Martinez N
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Chung, Samuel
AU  - Chung S
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Yeon, Christina
AU  - Yeon C
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Stewart, Daphne
AU  - Stewart D
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Li, Daneng
AU  - Li D
AUID- ORCID: 0000-0001-5330-7522
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Rajurkar, Swapnil
AU  - Rajurkar S
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Somlo, George
AU  - Somlo G
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Mortimer, Joanne
AU  - Mortimer J
AUID- ORCID: 0000-0002-2935-1934
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Waisman, James
AU  - Waisman J
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
FAU - Yuan, Yuan
AU  - Yuan Y
AD  - Department of Medical Oncology & Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte, CA 91010, USA.
AD  - Cedars-Sinai Cancer, Los Angeles, CA 90048, USA.
LA  - eng
GR  - P30CA033572/National Institute of Health/
GR  - NA/Merck/
PT  - Journal Article
DEP - 20220901
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC9454514
OTO - NOTNLM
OT  - aromatase inhibitor
OT  - breast cancer
OT  - hormone receptor positive
OT  - metastatic
OT  - pembrolizumab
COIS- Y.Y. has contracted research with Merck, Eisai, Novartis, Puma, Genentech, 
      Celgene, and Pfizer; consults for Puma, Pfizer, and Immunomedics; and is on the 
      Eisai, Novartis, Genentech, AstraZeneca, Daiichi Sankyo, and Immunomedics 
      Speakers Bureau. The other authors have no competing interests. The funders had 
      no role in the design of the study; in the collection, analyses, or 
      interpretation of data; in the writing of the manuscript; or in the decision to 
      publish the results.
EDAT- 2022/09/10 06:00
MHDA- 2022/09/10 06:01
PMCR- 2022/09/01
CRDT- 2022/09/09 01:11
PHST- 2022/07/26 00:00 [received]
PHST- 2022/08/29 00:00 [revised]
PHST- 2022/08/30 00:00 [accepted]
PHST- 2022/09/09 01:11 [entrez]
PHST- 2022/09/10 06:00 [pubmed]
PHST- 2022/09/10 06:01 [medline]
PHST- 2022/09/01 00:00 [pmc-release]
AID - cancers14174279 [pii]
AID - cancers-14-04279 [pii]
AID - 10.3390/cancers14174279 [doi]
PST - epublish
SO  - Cancers (Basel). 2022 Sep 1;14(17):4279. doi: 10.3390/cancers14174279.