PMID- 28489510
OWN - NLM
STAT- MEDLINE
DCOM- 20170908
LR  - 20220310
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 35
IP  - 22
DP  - 2017 Aug 1
TI  - Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death 
      Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study.
PG  - 2535-2541
LID - 10.1200/JCO.2017.72.5952 [doi]
AB  - Purpose The multicohort phase Ib KEYNOTE-028 (NCT02054806) study was designed to 
      evaluate the safety and efficacy of pembrolizumab, an anti-programmed death 1 
      monoclonal antibody, in patients with programmed death ligand 1 (PD-L1) -positive 
      advanced solid tumors. The results from the advanced endometrial cancer cohort 
      are reported. Patients and Methods Female patients with locally advanced or 
      metastatic PD-L1-positive endometrial cancer who had experienced progression 
      after standard therapy were eligible. Patients received pembrolizumab 10 mg/kg 
      every 2 weeks for up to 24 months or until progression or unacceptable toxicity. 
      Primary efficacy end point was objective response rate by RECIST (version 1.1). 
      Secondary end points included safety, duration of response (DOR), 
      progression-free survival, and overall survival. The data cutoff was February 17, 
      2016. Results Of 75 patients screened, 36 (48.0%) had PD-L1-positive tumors, and 
      24 (32.0%) were enrolled. Fifteen (62.5%) of these 24 patients had received at 
      least two previous lines of therapy for advanced disease. Three patients (13.0%) 
      achieved confirmed partial response (95% CI, 2.8% to 33.6%); the median DOR was 
      not reached. Two patients were still receiving treatment and exhibiting continued 
      response at time of data cutoff. Three additional patients (13.0%) achieved 
      stable disease, with a median duration of 24.6 weeks. One patient who achieved 
      partial response had a polymerase E mutation. Thirteen patients (54.2%) 
      experienced treatment-related adverse events (AEs), with fatigue (20.8%), 
      pruritus (16.7%), pyrexia (12.5%), and decreased appetite (12.5%) occurring in >/= 
      10% of patients. Grade 3 treatment-related AEs were reported in four patients. No 
      patient experienced a grade 4 AE, and no patient discontinued treatment because 
      of an AE. Conclusion Pembrolizumab demonstrated a favorable safety profile and 
      durable antitumor activity in a subgroup of patients with heavily pretreated 
      advanced PD-L1-positive endometrial cancer.
FAU - Ott, Patrick A
AU  - Ott PA
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Bang, Yung-Jue
AU  - Bang YJ
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Berton-Rigaud, Dominique
AU  - Berton-Rigaud D
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Elez, Elena
AU  - Elez E
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Pishvaian, Michael J
AU  - Pishvaian MJ
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Rugo, Hope S
AU  - Rugo HS
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Puzanov, Igor
AU  - Puzanov I
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Mehnert, Janice M
AU  - Mehnert JM
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Aung, Kyaw L
AU  - Aung KL
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Lopez, Juanita
AU  - Lopez J
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Carrigan, Marion
AU  - Carrigan M
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Saraf, Sanatan
AU  - Saraf S
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Chen, Mei
AU  - Chen M
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
FAU - Soria, Jean-Charles
AU  - Soria JC
AD  - Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, 
      Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope 
      S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, 
      Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer 
      Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei 
      Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of 
      Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de 
      Cancerologie de l'Ouest Centre Rene Gauducheau, Saint-Herblain; Jean-Charles 
      Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, 
      Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess 
      Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The 
      Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, 
      United Kingdom.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20170510
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (CD274 protein, human)
RN  - DPT0O3T46P (pembrolizumab)
SB  - IM
CIN - J Clin Oncol. 2017 Nov 1;35(31):3633-3634. PMID: 28880745
CIN - J Clin Oncol. 2017 Nov 1;35(31):3633. PMID: 28880747
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anorexia/chemically induced
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - B7-H1 Antigen/*analysis
MH  - Carcinoma/*chemistry/*drug therapy/genetics/secondary
MH  - Disease-Free Survival
MH  - Endometrial Neoplasms/*chemistry/*drug therapy/genetics/pathology
MH  - Fatigue/chemically induced
MH  - Female
MH  - Fever/chemically induced
MH  - Humans
MH  - Microsatellite Instability
MH  - Middle Aged
MH  - Pruritus/chemically induced
MH  - Response Evaluation Criteria in Solid Tumors
MH  - Retreatment
MH  - Survival Rate
EDAT- 2017/05/11 06:00
MHDA- 2017/09/09 06:00
CRDT- 2017/05/11 06:00
PHST- 2017/05/11 06:00 [pubmed]
PHST- 2017/09/09 06:00 [medline]
PHST- 2017/05/11 06:00 [entrez]
AID - 10.1200/JCO.2017.72.5952 [doi]
PST - ppublish
SO  - J Clin Oncol. 2017 Aug 1;35(22):2535-2541. doi: 10.1200/JCO.2017.72.5952. Epub 
      2017 May 10.