Full metadata record
DC Field | Value | Language |
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dc.creator | Naumann, R.W. (R. Wendel) | - |
dc.creator | Hollebecque, A. (Antoine) | - |
dc.creator | Meyer, T. (Tim) | - |
dc.creator | Devlin, M.J. (Michael-John) | - |
dc.creator | Oaknin, A. (Ana) | - |
dc.creator | Kerger, J. (Joseph) | - |
dc.creator | Lopez-Picazo, J.M. (José M.) | - |
dc.creator | Machiels, J.P. (Jean-Pascal) | - |
dc.creator | Delord, J.P. (Jean-Pierre) | - |
dc.creator | Evans, T.R.J. (Thomas R.J.) | - |
dc.creator | Boni, V. (Valentina) | - |
dc.creator | Calvo, E. (Emiliano) | - |
dc.creator | Topalian, S.L. (Suzanne L.) | - |
dc.creator | Chen, T. (Tian) | - |
dc.creator | Soumaoro, I. (Ibrahima) | - |
dc.creator | Li, B. (Bin) | - |
dc.creator | Gu, J. (Junchen) | - |
dc.creator | Zwirtes, R. (Ricardo) | - |
dc.creator | Moore, K.N. (Kathleen N.) | - |
dc.date.accessioned | 2021-09-23T08:15:40Z | - |
dc.date.available | 2021-09-23T08:15:40Z | - |
dc.date.issued | 2019 | - |
dc.identifier.citation | Naumann, R.W. (R. Wendel); Hollebecque, A. (Antoine); Meyer, T. (Tim); et al. "Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial". Journal of Clinical Oncology. 37 (31), 2019, 2825 - 2834 | es |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | PMID: 31487218 | - |
dc.identifier.uri | https://hdl.handle.net/10171/62045 | - |
dc.description.abstract | Purpose: Nivolumab was assessed in patients with virus-associated tumors in the phase I/II CheckMate 358 trial (ClinicalTrials.gov identifier: NCT02488759). We report on patients with recurrent/metastatic cervical, vaginal, or vulvar cancers. Patients and methods: Patients received nivolumab 240 mg every 2 weeks. Although patients with unknown human papillomavirus status were enrolled, patients known to have human papillomavirus-negative tumors were ineligible. The primary end point was objective response rate. Duration of response (DOR), progression-free survival, and overall survival were secondary end points. Safety and patient-reported outcomes were exploratory end points. Results: Twenty-four patients (cervical, n = 19; vaginal/vulvar, n = 5) were enrolled. Most patients had received prior systemic therapy for metastatic disease (cervical, 78.9%; vaginal/vulvar, 80.0%). Objective response rates were 26.3% (95% CI, 9.1 to 51.2) for cervical cancer and 20.0% (95% CI, 0.5 to 71.6) for vaginal/vulvar cancers. At a median follow-up of 19.2 months, median DOR was not reached (range, 23.3 to 29.5+ months; + indicates a censored observation) in the five responding patients in the cervical cohort; the DOR was 5.0 months in the single responding patient in the vaginal/vulvar cohort. Median overall survival was 21.9 months (95% CI, 15.1 months to not reached) among patients with cervical cancer. Any-grade treatment-related adverse events were reported in 12 of 19 patients (63.2%) in the cervical cohort and all five patients in the vaginal/vulvar cohort; there were no treatment-related deaths. In the cervical cohort, nivolumab treatment generally resulted in stabilization of patient-reported outcomes associated with health status and health-related quality of life. Conclusion: The efficacy of nivolumab in patients with recurrent/metastatic cervical and vaginal or vulvar cancers is promising and warrants additional investigation. No new safety signals were identified with nivolumab treatment in this population. | es_ES |
dc.description.sponsorship | Supported by Bristol-Myers Squibb | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | American Society of Clinical Oncology (ASCO) | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.subject | Materias Investigacion::Ciencias de la Salud::Oncología | es_ES |
dc.title | Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.description.note | Creative Commons Attribution Non-Commercial No Derivatives 4.0 License | es_ES |
dc.identifier.doi | 10.1200/jco.19.00739 | - |
dadun.citation.endingPage | 2834 | es_ES |
dadun.citation.number | 31 | es_ES |
dadun.citation.publicationName | Journal of Clinical Oncology | es_ES |
dadun.citation.startingPage | 2825 | es_ES |
dadun.citation.volume | 37 | es_ES |
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