There is no standard therapy after progression to immune checkpoint inhibitor (ICI) therapy in patients with recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). Chemotherapy has been shown to increase objective response rates after ICIs. The aim of this study was to evaluate the efficacy and safety of a weekly cetuximab-paclitaxel (PC regimen) after checkpoint inhibitors in R/M SCCHN.
Retrospective study of patients with R/M SCCHN that received post-ICI therapy with weekly cetuximab [400 mg/m2 (load); 250 mg/m2 (follow)] plus paclitaxel (80 mg/m2) at Hospital Clinico Universitario San Carlos. Overall response rate (ORR), disease control rate (DCR), depth of response (DoR) and survival since the start of cetuximab-paclitaxel and since first-line therapy were evaluated. Safety according to CTCAE were recorded.
Female = 24:8; median age: 67 (Min-Max: 54-95); primary tumor: oral cavity (n=17), oropharynx (n=6), hypopharynx (n=3), larynx (n=4), unknown primary (n=2). ORR (n=28 evaluable): was 71% (20/28) (PR: n=17, CR: n=3). DCR: 79% (22/28). Median PCBTL (n=27 available): -45% (-100% to +31%) SD and PD were. Median follow-up since first-line, since the start of ICI and since the start of PC were 23.5 months (0-71), 18 m (0-71) and 11 m (0-63), respectively. Median overall survival (OS) since first-line was 23 months (95%CI: 18.8-27.2) since the start of ICI was 19 months (95%CI 14-24) and since the start of PC was 12 months (95%CI 8.8-15.1). Median OS with PC in first line (n=21, OS= 12 months (95%CI 7.6-16.4) was no different (P=0.798) than OS with PC in second or further lines (n=11, OS= 12 months (95%CI 6.2 - 17.8). Grade 1-2 AEs occurred in 100% of patients. Grade 3 or 4 AEs developed in 65%, being grade 3 in all of them except in 2 patients (grade 4 neutropenia, grade 4 pneumonia). There were no treatment-related deaths.
Weekly, low-dose, cetuximab-based chemotherapy achieves high and deep response rates with a favorable toxicity profile. These findings as well as its potential impact in survival should be evaluated in larger, prospective studies.
The authors.
Has not received any funding.
S. Cabezas-Camarero: Financial Interests, Personal, Invited Speaker: BMS, Merck KgGa, MSD; Financial Interests, Personal, Other, Travel arrangements: Merck KgGa, Janssen; Financial Interests, Institutional, Funding: Merck KgGa; Financial Interests, Personal, Advisory Board: BMS. All other authors have declared no conflicts of interest.