The observational ENCORE study: Cetuximab + platinum-based therapy (PBT) for first-line (1L) treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)

Abstract

Background: The randomized, phase 3 EXTREME study established cetuximab + platinum+ 5‐flurouracil (5‐FU) followed by cetuximab maintenance until progressive disease (PD) as the first regimen to yield survival benefits in the 1L management of patients with R/M SCCHN. In EXTREME, the addition of cetuximab increased the overall response rate from 20% to 36%, and extended progression‐free survival from 3.3 to 5.6 months and overall survival from 7.4 to 10.1 months. ENCORE is a multinational, non‐interventional, prospective, open‐label study, seeking to determine how treatment decisions are made, planned and executed by oncologists treating patients with 1L therapy for R/M SCCHN in the real world. Methods: ENCORE prospectively enrolled 219 patients with R/M SCCHN from Algeria, France, Italy, Portugal and Russia. The recommended treatment for these patients is cetuximab + PBT for up to 6 cycles followed by cetuximab maintenance until PD. Patient characteristics, drugs and schedule were recorded; as the study is still ongoing, safety and efficacy will not be reported here. Results: ENCORE patients and the EXTREME patients who received cetuximab + platinum + 5‐FU had similar performance status (PS: 13.7 and 12% with PS≥2, respectively), but dissimilar median age (64 and 56 years, respectively). In ENCORE, 94.1% of patients had a planned treatment of cetuximab + PBT with cetuximab maintenance until PD. The remaining 13 (5.9%) had a fixed treatment duration of 4 to 24 weeks. 37.9% of treatment plans used cisplatin, 61.6% included carboplatin and 3.2% used a taxane. Also, only 53.4% of plans included 5‐FU. When developing the treatment plan, 72.1% of all patients were discussed within the context of a multidisciplinary team (MDT). Most plans had the goal of palliative care, and 80% were formulated without a p16 or human papillomavirus status test. Updated data will be presented at congress. Conclusions: The ENCORE study shows that a real‐world R/M SCCHN patient population treated with the EXTREME regimen has diverse characteristics and is treated per current recommendations (e.g. in an MDT setting, with cetuximab until PD).