Abstract 1644
Background
Cetuximab in combination with platinum-based chemotherapy followed by cetuximab maintenance until progression significantly prolonged overall survival (OS) in patients with first line recurrent and/or metastatic squamous-cell carcinoma of the head and neck (SCCHN) (EXTREME trial).
Methods
SOCCER is an ongoing German prospective, non-interventional study to evaluate symptom control in patients with recurrent and/or metastatic SCCHN treated with cetuximab in combination with platinum-based chemotherapy or radiotherapy in clinical routine. Desciptive statistics were used for the current interim analysis (data cut-off 6 DEC 2017) focusing on efficacy outcomes.
Results
This interim analysis involves 399 patients (median age: 62.0 years (range 29-89 years), 82.2% male, ECOG 0-1: 74.2%, 61.9% metastatic disease) who received at least one dose of cetuximab. In 289 of 399 patients cetuximab was applied in combination with platinum-based chemotherapy (CT) only (165 cis- (41.3%), 124 carboplatin (31.1%)), in 80 patients (20.1%) in combination with radiotherapy (RT) only; and other regimens in 30 patients (7.5%). Current median duration of cetuximab therapy was 6.1 weeks in combination with RT and 12.9 weeks in combination with CT. Median observation time was 11.7 months (reverse Kaplan-Meier estimate). In the 251 patients with available response data (CR, PR, SD, PD) the objective response and disease control rate were 45.0% and 80.5%, respectively. Median progression-free survival and OS after start of cetuximab therapy was 5.5 and 9.3 months (5.2/9.3 months for the cetuximab + CT and 8.7/9.3 months for the cetuximab + RT).
Conclusions
Interim results of the non-interventional SOCCER study indicate that efficacy outcomes of cetuximab in combination with platinum-based CT under routine conditions are in line with the results of the EXTREME trial.
Clinical trial identification
Legal entity responsible for the study
Merck Serono GmbH, Darmstadt, Germany.
Funding
Merck Serono GmbH, Darmstadt, Germany.
Editorial Acknowledgement
Medical writing by Sonja Hartmann, Alcedis GmbH.
Disclosure
M. Hecht: Research funding: Novartis, MSD, AstraZeneca; Honoraria: BMS, Merck Serono; Travel support: Merck Serono, MSD, TEVA. D. Hahn: Travel grants, honoraria for advisory boards and speaker: Merck Serono. M. Hautmann: Honoraria as speaker and consultant: Merck Serono, C. Belka: Honoraria and advisory boards: Merck Serono. D. Hofmann: Employee and stock ownership: Merck. R. Fiektkau: Honoraria as speaker and advisory boards: Merck Serono; Research funding: MSD, AstraZeneca; Honoraria: Roche, Merck Serono, Fresenius, MSD; Travel support: Roche, Merck Serono, Fresenius, MSD. All other authors have declared no conflicts of interest.
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