HANNA: Effectiveness and quality-of-life data from a real-world study of patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) treated with nivolumab (NIVO) in Germany

NIS HANNA (NCT03114163) is a prospective, multicenter study in Germany that collects real-world data from patients (pts) with R/M SCCHN treated with nivolumab after platinum-based therapy. Overall, 485 adults with R/M SCCHN will be enrolled and treated according to the label of nivolumab. This interim analysis represents data from 442 pts enrolled between May 2017 and January 2021. The primary study objective is overall survival (OS, estimated using the Kaplan–Meier method). Secondary study objectives include duration of treatment, safety, patient-reported outcomes (PROs), and quality of life (QoL) measured with Functional Assessment of Cancer Therapy – Head & Neck (FACT-H&N), and EQ-5D questionnaires. All data were analyzed in a descriptive manner. Median follow-up was 22.3 mo. Median age was 64 (range, 30–86) y. Most pts were men (82.1%), and most pts (73.1%) had a history of smoking. Eastern Cooperative Oncology Group performance status (ECOG PS) was 0 in 14.0%, 1 in 43.9%, 2 in 25.3%, and 3 in 6.1% of pts. The locations of the primary tumor were oropharynx, 37.6%; oral cavity, 22.9%; hypopharynx, 19.0%; larynx, 14.3%; and others, 6.1%. 42.5% of pts received nivolumab as first-line (1L) therapy for R/M SCCHN after platinum-based therapy, 47.3% in second line (2L), and 9.7% in third and later lines (3+L). Median OS (mOS) was 10.5 mo. Former or current smoking did not impair mOS (10.6 mo for current/former smokers vs 10.4 mo for nonsmokers, P = 0.7994). mOS was 25.7, 10.5, and 5.7 mo for pts with ECOG PS 0, 1, and 2/3, respectively. The overall median duration of treatment (mDOT) was 4.9 mo. mDOT was 5.2 mo for 1L, and 4.6 mo for both 2L and 3+L. For pts with ECOG PS 0, 1, 2, and 3, mDOT was 6.3, 4.9, 3.1, and 1.9 mo, respectively. Grade 3/4 treatment-related or immune-related adverse events were observed in 10% of all pts. QoL measured with FACT-H&N remained stable until mo 18 overall and in all subscale scores. PROs measured with EQ-5D reflected similar outcomes. Real-world data from HANNA show that nivolumab is effective in a broad patient population. The treatment is well tolerated and the PRO/QoL remained stable under therapy.