• Login
    View Item 
    •   Home
    • UA Faculty Research
    • UA Faculty Publications
    • View Item
    •   Home
    • UA Faculty Research
    • UA Faculty Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UA Campus RepositoryCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsPublisherJournalThis CollectionTitleAuthorsIssue DateSubmit DateSubjectsPublisherJournal

    My Account

    LoginRegister

    About

    AboutUA Faculty PublicationsUA DissertationsUA Master's ThesesUA Honors ThesesUA PressUA YearbooksUA CatalogsUA Libraries

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Survival with Cemiplimab in Recurrent Cervical Cancer

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    nejmoa2112187.pdf
    Size:
    638.1Kb
    Format:
    PDF
    Description:
    Final Published Version
    Download
    Author
    Tewari, Krishnansu S.
    Monk, Bradley J.
    Vergote, Ignace
    Miller, Austin
    de Melo, Andreia C.
    Kim, Hee-Seung
    Kim, Yong Man
    Lisyanskaya, Alla
    Samouëlian, Vanessa
    Lorusso, Domenica
    Damian, Fernanda
    Chang, Chih-Long
    Gotovkin, Evgeniy A.
    Takahashi, Shunji
    Ramone, Daniella
    Pikiel, Joanna
    Maćkowiak-Matejczyk, Beata
    Guerra Alía, Eva M.
    Colombo, Nicoletta
    Makarova, Yulia
    Rischin, Danny
    Lheureux, Stephanie
    Hasegawa, Kosei
    Fujiwara, Keiichi
    Li, Jingjin
    Jamil, Shaheda
    Jankovic, Vladimir
    Chen, Chieh-I
    Seebach, Frank
    Weinreich, David M.
    Yancopoulos, George D.
    Lowy, Israel
    Mathias, Melissa
    Fury, Matthew G.
    Oaknin, Ana
    Show allShow less
    Affiliation
    Division of Gynecologic Oncology, Arizona Oncology, University of Arizona
    Issue Date
    2022-02-10
    
    Metadata
    Show full item record
    Publisher
    Massachusetts Medical Society
    Citation
    Tewari, K. S., Monk, B. J., Vergote, I., Miller, A., de Melo, A. C., Kim, H.-S., Kim, Y. M., Lisyanskaya, A., Samouëlian, V., Lorusso, D., Damian, F., Chang, C.-L., Gotovkin, E. A., Takahashi, S., Ramone, D., Pikiel, J., Maćkowiak-Matejczyk, B., Guerra Alía, E. M., Colombo, N., … Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. (2022). Survival with Cemiplimab in Recurrent Cervical Cancer. The New England Journal of Medicine.
    Journal
    The New England journal of medicine
    Rights
    Copyright © 2022 Massachusetts Medical Society.
    Collection Information
    This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.
    Abstract
    BACKGROUND: Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population. METHODS: In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed. RESULTS: A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001). The overall survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma and adenocarcinoma [including adenosquamous carcinoma]). Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group in the overall population (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P<0.001). In the overall population, an objective response occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group. An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%. Overall, grade 3 or higher adverse events occurred in 45.0% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy. CONCLUSIONS: Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy.
    Note
    6 month embargo; published online: 17 February 2022
    ISSN
    0028-4793
    EISSN
    1533-4406
    PubMed ID
    35139273
    DOI
    10.1056/nejmoa2112187
    Version
    Final published version
    Sponsors
    Regeneron Pharmaceuticals
    ae974a485f413a2113503eed53cd6c53
    10.1056/nejmoa2112187
    Scopus Count
    Collections
    UA Faculty Publications

    entitlement

    Related articles

    • Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial.
    • Authors: Sezer A, Kilickap S, Gümüş M, Bondarenko I, Özgüroğlu M, Gogishvili M, Turk HM, Cicin I, Bentsion D, Gladkov O, Clingan P, Sriuranpong V, Rizvi N, Gao B, Li S, Lee S, McGuire K, Chen CI, Makharadze T, Paydas S, Nechaeva M, Seebach F, Weinreich DM, Yancopoulos GD, Gullo G, Lowy I, Rietschel P
    • Issue date: 2021 Feb 13
    • Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer.
    • Authors: Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yañez E, Gümüş M, Olivera Hurtado de Mendoza M, Samouëlian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ, KEYNOTE-826 Investigators
    • Issue date: 2021 Nov 11
    • First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial.
    • Authors: Özgüroğlu M, Kilickap S, Sezer A, Gümüş M, Bondarenko I, Gogishvili M, Nechaeva M, Schenker M, Cicin I, Ho GF, Kulyaba Y, Zyuhal K, Scheusan RI, Garassino MC, He X, Kaul M, Okoye E, Li Y, Li S, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P
    • Issue date: 2023 Sep
    • EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer.
    • Authors: Oaknin A, Monk BJ, Vergote I, Cristina de Melo A, Kim YM, Lisyanskaya AS, Samouëlian V, Kim HS, Gotovkin EA, Damian F, Chang CL, Takahashi S, Li J, Mathias M, Fury MG, Ivanescu C, Reaney M, LaFontaine PR, Lowy I, Harnett J, Chen CI, Tewari KS
    • Issue date: 2022 Oct
    • Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.
    • Authors: Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF, KEYNOTE-045 Investigators
    • Issue date: 2017 Mar 16
    The University of Arizona Libraries | 1510 E. University Blvd. | Tucson, AZ 85721-0055
    Tel 520-621-6442 | repository@u.library.arizona.edu
    DSpace software copyright © 2002-2017  DuraSpace
    Quick Guide | Contact Us | Send Feedback
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.