Real-world Data of Paclitaxel and Cetuximab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Abstract

Background/Aim: Prior immune-checkpoint inhibitors, weekly paclitaxel-cetuximab was one of the few options for platinum-ineligible patients with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). This real-world study analyzed the long-term outcomes of this regimen. Patients and Methods: A multicenter, retrospective, observational, cross-sectional, chart review study was realized in nine hospitals of the Galician Group of Head and Neck Cancer. Eligible population was adult platinum-ineligible patients with R/M SCCHN (unfit to, or after progressing following EXTREME or other platinum-based regimens) that received weekly paclitaxel plus cetuximab regimen as first- or second-line (1L or 2L) between January 2009 and December 2014. The efficacy was evaluated (1L-2L) in regards to overall survival (OS) and progression-free survival (PFS), and safety was assessed as the incidence of adverse events (AEs). Results: Seventy-five R/M-SCCHN patients received the scheme (1L, n=50; 2L: n=25). The mean age of the patients was 59 years (1L, 59.5 years; 2L, 59.2 years), 90% were male (1L, 96%; 2L, 79%), 55% were smokers (1L, 60.4%; 2L, 45.8%), and 61% presented ECOG performance status (PS) 1 (1L, 54%; 2L, 62.5%). Median OS [interquartile range (IQR)] was 8.85 (4.22-40.96) months. Median PFS (IQR) was 8.5 (3.93-12.55) (1L) and 8.8 (5.62-16.91) (2L) months. Disease control rate was 60% (1L) and 85% (2L). Weekly paclitaxel-cetuximab was well tolerated in 1L/2L (cutaneous-toxicity, mucositis, neuropathy; mainly Grade 1-2). No grade 4 AEs were notified in 2L. Conclusion: Weekly paclitaxel-cetuximab is an active and well tolerated therapeutical option in platinum-ineligible or after platinum regimens in R/M-SCCHN patients.