دورية أكاديمية
Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial.
| العنوان: | Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. |
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| المؤلفون: | Harrington KJ; Royal Marsden Hospital/The Institute of Cancer Research National Institute for Health and Care Research Biomedical Research Centre, London, United Kingdom., Ferris RL; UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania., Gillison M; The University of Texas MD Anderson Cancer Center, Houston., Tahara M; National Cancer Center Hospital East, Chiba, Japan., Argiris A; Hygeia Hospital, Marousi, Greece.; Thomas Jefferson University, Philadelphia, Pennsylvania., Fayette J; Centre Léon Bérard, Lyon, France.; Hôpital Saint-André, Bordeaux, France., Schenker M; Centrul de Oncologie Sf Nectarie, Craiova, Romania., Bratland Å; Oslo University Hospital, Oslo, Norway., Walker JWT; University of Alberta, Edmonton, Alberta, Canada., Grell P; Masaryk Memorial Cancer Institute, Brno, Czech Republic., Even C; Gustave Roussy, Villejuif, France., Chung CH; Moffitt Cancer Center, Tampa, Florida., Redman R; University of Louisville, Brown Cancer Center, Louisville, Kentucky., Coutte A; Centre Hospitalier Universitaire d'Amiens, Amiens, France., Salas S; Assistance Publique-Hôpitaux de Marseille, Marseille, France., Grant C; St James's Hospital, Dublin, Ireland., de Azevedo S; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Soulières D; Université de Montréal, Montréal, Quebec, Canada., Hansen AR; Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada., Wei L; Bristol Myers Squibb, Princeton, New Jersey., Khan TA; Bristol Myers Squibb, Princeton, New Jersey., Miller-Moslin K; Bristol Myers Squibb, Princeton, New Jersey., Roberts M; Bristol Myers Squibb, Princeton, New Jersey., Haddad R; Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts. |
| المصدر: | JAMA oncology [JAMA Oncol] 2023 Jun 01; Vol. 9 (6), pp. 779-789. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print Cited Medium: Internet ISSN: 2374-2445 (Electronic) Linking ISSN: 23742437 NLM ISO Abbreviation: JAMA Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, Il : American Medical Association, [2015]- |
| مواضيع طبية MeSH: | Carcinoma, Squamous Cell*/drug therapy , Head and Neck Neoplasms*/drug therapy, Male ; Humans ; Middle Aged ; Nivolumab/adverse effects ; Nivolumab/administration & dosage ; Squamous Cell Carcinoma of Head and Neck/drug therapy ; Double-Blind Method ; Platinum ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/pathology ; Ipilimumab/adverse effects ; Ipilimumab/administration & dosage ; Immunotherapy |
| مستخلص: | Importance: There remains an unmet need to improve clinical outcomes in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Objective: To evaluate clinical benefit of first-line nivolumab plus ipilimumab vs nivolumab alone in patients with R/M SCCHN. Design, Setting, and Participants: The CheckMate 714, double-blind, phase 2 randomized clinical trial was conducted at 83 sites in 21 countries between October 20, 2016, and January 23, 2019. Eligible participants were aged 18 years or older and had platinum-refractory or platinum-eligible R/M SCCHN and no prior systemic therapy for R/M disease. Data were analyzed from October 20, 2016 (first patient, first visit), to March 8, 2019 (primary database lock), and April 6, 2020 (overall survival database lock). Interventions: Patients were randomized 2:1 to receive nivolumab (3 mg/kg intravenously [IV] every 2 weeks) plus ipilimumab (1 mg/kg IV every 6 weeks) or nivolumab (3 mg/kg IV every 2 weeks) plus placebo for up to 2 years or until disease progression, unacceptable toxic effects, or consent withdrawal. Main Outcomes and Measures: The primary end points were objective response rate (ORR) and duration of response between treatment arms by blinded independent central review in the population with platinum-refractory R/M SCCHN. Exploratory end points included safety. Results: Of 425 included patients, 241 (56.7%; median age, 59 [range, 24-82] years; 194 males [80.5%]) had platinum-refractory disease (nivolumab plus ipilimumab, n = 159; nivolumab, n = 82) and 184 (43.3%; median age, 62 [range, 33-88] years; 152 males [82.6%]) had platinum-eligible disease (nivolumab plus ipilimumab, n = 123; nivolumab, n = 61). At primary database lock, the ORR in the population with platinum-refractory disease was 13.2% (95% CI, 8.4%-19.5%) with nivolumab plus ipilimumab vs 18.3% (95% CI, 10.6%-28.4%) with nivolumab (odds ratio [OR], 0.68; 95.5% CI, 0.33-1.43; P = .29). Median duration of response for nivolumab plus ipilimumab was not reached (NR) (95% CI, 11.0 months to NR) vs 11.1 months (95% CI, 4.1 months to NR) for nivolumab. In the population with platinum-eligible disease, the ORR was 20.3% (95% CI, 13.6%-28.5%) with nivolumab plus ipilimumab vs 29.5% (95% CI, 18.5%-42.6%) with nivolumab. The rates of grade 3 or 4 treatment-related adverse events with nivolumab plus ipilimumab vs nivolumab were 15.8% (25 of 158) vs 14.6% (12 of 82) in the population with platinum-refractory disease and 24.6% (30 of 122) vs 13.1% (8 of 61) in the population with platinum-eligible disease. Conclusions and Relevance: The CheckMate 714 randomized clinical trial did not meet its primary end point of ORR benefit with first-line nivolumab plus ipilimumab vs nivolumab alone in platinum-refractory R/M SCCHN. Nivolumab plus ipilimumab was associated with an acceptable safety profile. Research to identify patient subpopulations in R/M SCCHN that would benefit from nivolumab plus ipilimumab over nivolumab monotherapy is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT02823574. |
| التعليقات: | Comment in: JAMA Oncol. 2023 Jun 1;9(6):789-790. (PMID: 37022697) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT02823574 |
| المشرفين على المادة: | 31YO63LBSN (Nivolumab) 49DFR088MY (Platinum) 0 (Ipilimumab) |
| تواريخ الأحداث: | Date Created: 20230406 Date Completed: 20230619 Latest Revision: 20240301 |
| رمز التحديث: | 20240301 |
| مُعرف محوري في PubMed: | PMC10080406 |
| DOI: | 10.1001/jamaoncol.2023.0147 |
| PMID: | 37022706 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2374-2445 |
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| DOI: | 10.1001/jamaoncol.2023.0147 |