Full metadata record
DC FieldValueLanguage
dc.creatorRischin, D. (Danny)-
dc.creatorGil-Martin, M. (Marta)-
dc.creatorGonzález-Martín, A. (Antonio)-
dc.creatorBraña, I. (Irene)-
dc.creatorHou, J.Y. (June Y.)-
dc.creatorCho, D. (Daniel)-
dc.creatorFalchook, G.S. (Gerald S.)-
dc.creatorFormenti, S.C. (Silvia C.)-
dc.creatorJabbour, S. (Salma)-
dc.creatorMoore, K. (Kathleen)-
dc.creatorNaing, A. (Aung)-
dc.creatorPapadopoulos, K.P. (Kyriakos P.)-
dc.creatorBaranda, J. (Joaquina)-
dc.creatorFury, W. (Wen)-
dc.creatorFeng, M. (Minjie)-
dc.creatorStankevich, E. (Elizabeth)-
dc.creatorLi, J. (Jingjin)-
dc.creatorYama-Dang, N.A. (N. Alice)-
dc.creatorYoo, S.Y. (Suk-Young)-
dc.creatorLowy, I. (Israel)-
dc.creatorMathias, M. (Melissa)-
dc.creatorFury, M.G. (Matthew G.)-
dc.identifier.citationRischin, D. (Danny); Gil-Martin, M. (Marta); González-Martín, A. (Antonio); et al. "PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer". Gynecologic Oncology. 159 (2), 2020, 322 - 328es_ES
dc.description.abstractObjectives: To characterize the safety, tolerability, and anti-tumor activity of cemiplimab as monotherapy or in combination with hypofractionated radiation therapy (hfRT) in patients with recurrent or metastatic cervical cancer. To determine the association between histology and programmed death-ligand 1 (PD-L1) expression. Methods: In non-randomized phase I expansion cohorts, patients (squamous or non-squamous histology) received cemiplimab 3 mg/kg intravenously every 2 weeks for 48 weeks, either alone (monotherapy cohort) or with hfRT during week 2 (combination cohort). Due to insufficient tissue material, PD-L1 protein expression was evaluated in commercially purchased samples and mRNA expression levels were analyzed from The Cancer Genome Atlas (TCGA). Results: Twenty patients enrolled in both cohorts in total; 10 had squamous histology. The most common adverse events of any grade were diarrhea, fatigue, and hypokalemia, occurring in 35%, 25%, and 25%, respectively. Objective response rate was 10% in each cohort; responders had squamous histology. Duration of response was 11.2 months and 6.4 months for the responder in the monotherapy and combination cohort, respectively. Irradiated lesions were not included in the response assessments. In separate archived specimens (N = 155), PD-L1 protein expression in tumor and immune cells was negative (<1%) more commonly in adenocarcinoma than in squamous tumors. PD-L1 mRNA levels were lower in adenocarcinoma than squamous cell tumors (1.2 vs 5.0 mean transcripts per million, respectively) in TCGA. Conclusions: Cemiplimab has activity in cervical squamous cell carcinoma. The phase I results, combined with results from other anti-PD-1 trials in cervical cancer and our biomarker analyses have informed the design of the ongoing phase III trial, with the primary overall survival hierarchical analyses being done first in patients with squamous histology.es_ES
dc.description.sponsorshipMedical writing support under the direction of the authors was provided by Cindi Hoover, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publica- tion Practice guidelines (http://annals.org/aim/article/2424869/ good-publication-practice-communicating-company-sponsored- medical-research-gpp3). The sponsor was involved in the study de- sign; collection, analysis, and interpretation of data; and data checking of information provided in the manuscript. The authors had unrestricted access to study data, were responsible for all con- tent and editorial decisions, and received no honoraria related to the development of this publicationes_ES
dc.subjectRecurrent cervical canceres_ES
dc.subjectMetastatic cervical canceres_ES
dc.titlePD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical canceres_ES
dc.description.noteThis is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).es_ES
dadun.citation.publicationNameGynecologic Oncologyes_ES

Files in This Item:
459.54 kB
Adobe PDF

Statistics and impact
0 citas en
0 citas en

Items in Dadun are protected by copyright, with all rights reserved, unless otherwise indicated.