Phase 4 Multinational Multicenter Retrospective and Prospective Real-World Study of Nivolumab in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

• Published in: Cancers 2023-07, Vol.15 (14), p.3552
• Main Authors: Gogate, Anagha, Bennett, Bryan, Poonja, Zia, Stewart, Grant, Medina Colmenero, Ana, Szturz, Petr, Carrington, Courtney, Castro, Clara, Gemmen, Eric, Lau, Ashley, Carral Maseda, Alberto, Winquist, Eric, Arrazubi, Virginia, Hao, Desiree, Cook, Audrey, Martinez Galan, Joaquina, Ugidos, Lisardo, Fernández Garay, David, Gutierrez Abad, David, Metcalf, Robert
• Format: Article
• Language: English
• Subjects: Cancer; Clinical medicine; Clinical trials; Drug dosages; Dyspnea; Enrollments; Head & neck cancer; Head and neck carcinoma; Medical prognosis; Medical records; Metastases; Metastasis; Participation; Patient satisfaction; Patients; Quality of life; Questionnaires; Respiration; Response rates; Safety; Saliva; Squamous cell carcinoma
• ISSN: 2072-6694; 2072-6694
• DOI: 10.3390/cancers15143552

This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as 'partial response', with 3.9% reporting 'complete response'. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.