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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, 2019-11, Vol.37 (31), p.2825-2834 [Peer Reviewed Journal]

2019 by American Society of Clinical Oncology 2019 American Society of Clinical Oncology ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/jco.19.00739 ;PMID: 31487218

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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
Author: Naumann, R Wendel ; Hollebecque, Antoine ; Meyer, Tim ; Devlin, Michael-John ; Oaknin, Ana ; Kerger, Joseph ; López-Picazo, Jose M ; Machiels, Jean-Pascal ; Delord, Jean-Pierre ; Evans, Thomas R J ; Boni, Valentina ; Calvo, Emiliano ; Topalian, Suzanne L ; Chen, Tian ; Soumaoro, Ibrahima ; Li, Bin ; Gu, Junchen ; Zwirtes, Ricardo ; Moore, Kathleen N
Subjects: Adult ; Aged ; Antineoplastic Agents, Immunological - adverse effects ; Antineoplastic Agents, Immunological - therapeutic use ; Disease Progression ; Europe ; Female ; Humans ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Nivolumab - adverse effects ; Nivolumab - therapeutic use ; ORIGINAL REPORTS ; Papillomaviridae - isolation & purification ; Progression-Free Survival ; Time Factors ; United States ; Uterine Cervical Neoplasms - drug therapy ; Uterine Cervical Neoplasms - mortality ; Uterine Cervical Neoplasms - pathology ; Uterine Cervical Neoplasms - virology ; Vaginal Neoplasms - drug therapy ; Vaginal Neoplasms - mortality ; Vaginal Neoplasms - pathology ; Vaginal Neoplasms - virology ; Vulvar Neoplasms - drug therapy ; Vulvar Neoplasms - mortality ; Vulvar Neoplasms - pathology ; Vulvar Neoplasms - virology
Is Part Of: Journal of clinical oncology, 2019-11, Vol.37 (31), p.2825-2834
Description: 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 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. 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. 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.
Publisher: United States: American Society of Clinical Oncology
Language: English
Identifier: ISSN: 0732-183X
EISSN: 1527-7755
DOI: 10.1200/jco.19.00739
PMID: 31487218
Source: GFMER Free Medical Journals
MEDLINE
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Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial

2019 by American Society of Clinical Oncology 2019 American Society of Clinical Oncology ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/jco.19.00739 ;PMID: 31487218

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