Show simple item record

dc.contributor.authorOtt, PA
dc.contributor.authorBang, Y-J
dc.contributor.authorBerton-Rigaud, D
dc.contributor.authorElez, E
dc.contributor.authorPishvaian, MJ
dc.contributor.authorRugo, HS
dc.contributor.authorPuzanov, I
dc.contributor.authorMehnert, JM
dc.contributor.authorAung, KL
dc.contributor.authorLopez, J
dc.contributor.authorCarrigan, M
dc.contributor.authorSaraf, S
dc.contributor.authorChen, M
dc.contributor.authorSoria, J-C
dc.date.accessioned2018-03-05T15:02:01Z
dc.date.issued2017-08
dc.identifier.citationJournal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, 35 (22), pp. 2535 - 2541
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1553
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/jco.2017.72.5952
dc.description.abstractPurpose 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.
dc.formatPrint-Electronic
dc.format.extent2535 - 2541
dc.languageeng
dc.language.isoeng
dc.subjectHumans
dc.subjectCarcinoma
dc.subjectEndometrial Neoplasms
dc.subjectPruritus
dc.subjectFever
dc.subjectFatigue
dc.subjectAnorexia
dc.subjectAntineoplastic Agents
dc.subjectDisease-Free Survival
dc.subjectRetreatment
dc.subjectSurvival Rate
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMicrosatellite Instability
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectResponse Evaluation Criteria in Solid Tumors
dc.subjectB7-H1 Antigen
dc.titleSafety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study.
dc.typeJournal Article
rioxxterms.versionofrecord10.1200/jco.2017.72.5952
rioxxterms.licenseref.startdate2017-08
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of clinical oncology : official journal of the American Society of Clinical Oncology
pubs.issue22
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Medicine (de Bono Prostate)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Medicine (de Bono Prostate)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume35en_US
pubs.embargo.termsNot known
icr.researchteamMedicine (de Bono Prostate)en_US
dc.contributor.icrauthorLopez, Juanitaen
dc.contributor.icrauthorMarsden,en


Files in this item

Thumbnail

This item appears in the following collection(s)

Show simple item record