CHARACTERISTICS OF PATIENTS TREATED WITH CETUXIMAB-BASED EXTREME REGIMEN IN 1ST LINE R/M SCCHN CANCER IN REAL LIFE SETTING, IN FRANCE IN 2012-2015.
Author(s)
Guigay J1, Chamorey E1, van Hille B2, Seronde A2, Le Tourneau C3
1Comprehensive Cancer Center Antoine Lacassagne, NICE Cedex 2, France, 2Merck s.a.s., LYON, France, 3Institut Curie, Paris, France
OBJECTIVES: The objective of the study was to assess the EXTREME chemotherapy regimen in real life setting. In this abstract, we present patient characteristics and primary endpoint which was the rate of patients with relative dose intensity (RDI) of cetuximab ≥ 80% in patients with 1st line R/M SCCHN. METHODS: DIRECT is a national, observational, longitudinal, multicenter, cohort-type study performed in adult patients with R/M SCCHN treated in first-line with cetuximab according to the administration schedule of the EXTREME study in usual medical practice. Sociodemographics, clinical and management data were collected through e-CRF, and the analysis of the full sample was defined as all subjects who received at least one dose of cetuximab after the loading dose. RESULTS: Of the prospective population (n=169), 157 patients received at least the loading dose of cetuximab for R/M SCCHN, and 140 received at least one dose of cetuximab in addition to the loading dose. Among them, 96 had received chemotherapy in the LA SCCHN setting, and 30 patients had previously received cetuximab. 139 patients had recurrent disease, whereas 17 metastasis upon initial diagnosis. 29.9% of patients in DIRECT were ≥ 65 years old, 85.4% were males, 18.4% of patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥ 2. Regarding the primary endpoint, mean RDI for these patients (n=130) for the whole treatment was 86.1% ± 16.1%, and 63.1% had an RDI ≥ 80%. 72 patients (45.9%) continued cetuximab in maintenance phase. CONCLUSIONS: Baseline characteristics of the DIRECT prospective patient population who received at least the loading dose of cetuximab were quite similar to those in the EXTREME trial. Results demonstrated that the EXTREME regimen is a feasible treatment regimen in a real world setting.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN278
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Prescribing Behavior
Disease
Oncology