A single-arm, open-label, multicenter, phase IIIb clinical trial with nivolumab in subjects with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck

Bossi, Paolo; Merlano, Marco; Ghi, M.G.; Rinaldi, Gaetana; Caponigro, Francesco; Morelli, Franco; Airoldi, Mario; Farnesi, A.; Cassano, Alessandra; Ferrari, Daris; Mirabile, Aurora; Tosoni, Alicia; Galizia, Danilo; Moretti, Giacomo; Sponghini, Andrea Pietro; Calareso, Giuseppina; Vingiani, Andrea; Perrone, Federica; Falletta, Antonella; Licitra, Lisa

doi:10.1093/annonc/mdz252.032

Cited by 2 publications

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“…28 In a single-arm, open-label, multicenter clinical trial conducted in Italy of nivolumab in patients with R/M SCCHN (N = 127), median OS was 7 months (95% CI: 5, not reached). 29 Effectiveness of nivolumab in the R/M SCCHN population has also been demonstrated in Japan in an observational study of 248 patients with platinum-resistant R/M head and neck cancer treated with nivolumab for 1 year: median OS was 9.4 months (95% CI: 8.2, 12.0). 30 Median OS (95% CI) was not evaluable (NE; 8.2, NE), 9.4 (5.7, 12.0) and 8.4 (6.9, NE) in patients receiving nivolumab as first-, second-, and third-line therapy, respectively.…”

Section: Discussionmentioning

confidence: 88%

“…An interim analysis of 199 patients treated with nivolumab with R/M SCCHN from the French study, TOPNIVO, reported a median OS of 7.7 months (95% CI: 6.0, 9.5) 28 . In a single‐arm, open‐label, multicenter clinical trial conducted in Italy of nivolumab in patients with R/M SCCHN ( N = 127), median OS was 7 months (95% CI: 5, not reached) 29 . Effectiveness of nivolumab in the R/M SCCHN population has also been demonstrated in Japan in an observational study of 248 patients with platinum‐resistant R/M head and neck cancer treated with nivolumab for 1 year: median OS was 9.4 months (95% CI: 8.2, 12.0) 30 .…”

Section: Discussionmentioning

confidence: 99%

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Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

et al. 2021

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Background: In the Phase-III clinical trial, CheckMate 141, nivolumab significantly improved survival versus standard of care in patients with platinumrefractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Methods: This pooled analysis investigated the real-world effectiveness of nivolumab, following prior platinum-based therapy, in patients with R/M SCCHN from the United States (US) Flatiron Health database and German HANNA prospective observational study. Results: Overall, 782 patients (56% US; 44% Germany) were included. Median overall survival (OS) was 8.71 months, and progression-free survival was 4.11 months. Eastern Cooperative Oncology Group Performance Status 0 or 1, platinum sensitivity, and older age were associated with longer OS, in which number of prior lines of therapy had no significant effect. Conclusion: These findings demonstrate survival benefits of nivolumab in patients with R/M SCCHN in the real-world setting. The observed real-world effectiveness of nivolumab aligns with the efficacy of nivolumab in CheckMate 141.

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Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

et al. 2021

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Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Results of Polish multicenter observational study

Rutkowski,

Kurczyk,

Drosik‐Rutowicz

et al. 2024

Intl Journal of Cancer

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Patients with head and neck squamous cell carcinoma (HNSCC) who have progressed following primary treatment (PT) have a poor prognosis. In this group, nivolumab has been demonstrated to significantly improve outcomes. This study presents the efficacy of nivolumab in Polish patients with recurrent and/or metastatic (R/M) HNSCC using real‐world data. The analyzed group consisted of 324 adult patients with R/M HNSCC following platinum‐based therapy. Patients were divided into 3 groups based on the time from completion of PT to nivolumab initiation (tPT‐N): within 6 months (refractory), between 6 and 24 months (sensitive, tPT‐N ≤24), and beyond 24 months (sensitive, tPT‐N >24). Survival analysis and the Cox proportional hazards model were performed to evaluate how various risk factors affect patient outcomes. The 1‐year and 2‐year overall survival (OS) was 19.1%, 6.1%, 30.7%, 9.4%, and 45.7%, 29.1% in refractory, sensitive tPT‐N ≤24, sensitive tPT‐N >24 patients, respectively and was higher for both sensitivity groups vs. refractory (p = .004) and for sensitive tPT‐N >24 versus refractory and sensitive tPT‐N ≤24 (p <.001). Patients with nasopharyngeal cancer had OS significantly higher than patients with other primary tumor localization. The multivariate Cox analysis showed a significant favorable effect of tPT‐N >24 (HR = 0.53, p = .001) and nasopharyngeal cancer on OS (HR = 0.20, p = .008). Conversely, female sex was identified as an unfavorable factor for OS (HR = 1.48, p = .020). In our study, we established that the benefit of nivolumab increases with the increasing tPT‐N. The probability of death is significantly lower in male patients and patients with nasopharyngeal cancer regardless of tPT‐N.

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A single-arm, open-label, multicenter, phase IIIb clinical trial with nivolumab in subjects with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck

Cited by 2 publications

References 0 publications

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Results of Polish multicenter observational study

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