Cetuximab as last-line treatment for rmHNSCC outside clinical trials. A retrospective DAHANCA study
PO-0178
Abstract
Cetuximab as last-line treatment for rmHNSCC outside clinical trials. A retrospective DAHANCA study
Authors: Jesper Grau Eriksen1, Sofie Lunden Jensen2, Kristine Bjerg Andersen1, Abdirisag Qasim Ali Mohamed3, Kinga Nowicka-Matus2
1Aarhus University Hospital, Dept. of Eksperimental Clinical Oncology, Aarhus, Denmark; 2Aalborg University Hospital, Dept. of Oncology, Aalborg, Denmark; 3Aarhus University Hospital, Dept. of Experimental Clinical Oncology, Aarhus, Denmark
Show Affiliations
Hide Affiliations
Purpose or Objective
The routine use of cetuximab monotherapy as palliative treatment of
recurrent or metastatic Head and Neck Squamous Cell Carcinoma (rmHNSCC) is
restricted to only two head and neck cancer centres in Denmark and predominantly
as last-line treatment, when options for chemotherapy or immunotherapy are
exhausted. The aim of the present study was to evaluate the efficacy of
cetuximab monotherapy administered outside clinical trials.
Material and Methods
Patients who initiated weekly cetuximab monotherapy outside clinical
trials at the two centres in the period June 1 2010 to December 31 2020 were
included in the analysis. Loading-dose was 400mg/m² and subsequent doses were
given with 250mg/m². All patients who received at least one cetuximab infusion
were included and analysed in an intention-to-treat approach. Patients were
treated until unacceptable toxicity, progression of disease or death, whichever
occurred first. Patients were identified using the DAHANCA database and the
local treatment registries at the hospitals. Missing data was identified using
the patient charts. Descriptive statistics and the Kaplan-Meier method was used
for analysing the data in SPSS version 28.
Results
In total 79 patients received weekly cetuximab monotherapy as intended
last-line treatment in the study-period. 77% were males and median age at start
of cetuximab was 63 years (range 46-81years). The majority of patients (67%)
were WHO PS 0-1; 33% were WHO PS 2. Half of the patients had previously
received two lines of systemic palliative therapy. Patients received median eight
infusions of cetuximab (range 1-90 infusions). Response rate (RR) was 28% but
only one patient obtained complete response. Progression-free survival (PFS) was
median 3.2 months [95% CI: 1.7-4.6] and median overall survival (OS) 7.6 months
[95% CI: 5.2-9.9]. One-year survival was 15%. No significant associations
between WHO PS, degree of folliculitis and PFS/OS were found. In total 25% of the
patients stopped treatment due to deteriorated health or side-effects.
Conclusion
Cetuximab monotherapy as intended last-line treatment outside clinical
trials show efficacy that are in line with data obtained from clinical studies
using cetuximab as first-line systemic treatment.