Cetuximab in combination with platinum-based chemotherapy followed by cetuximab monotherapy until progression significantly prolonged overall survival (OS) in patients with recurrent and/or metastatic squamous-cell carcinoma of the head and neck (SCCHN) (EXTREME trial)1. SOCCER is a 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.
219 patients with recurrent and/or metastatic SCCHN were enrolled. Full information on the concomitant therapy were available for 196 patients. Response rates for the different Cetuximab containing therapy regimes as well as reasons for treatment discontinuations were evaluated.
82 and 76 patients received Cisplatin or Carboplatin + Cetuximab, respectively, and 38 patients were treated with RT + Cetuximab for recurrent disease. Compared to the EXTREME trial, this study included more patients with metastatic disease (62% vs 47%) and more patients with an ECOG score of ≥2 (23% vs 12%). Median treatment duration of Cetuximab was 4.8 weeks in combination with radiotherapy and 11 weeks in combination with chemotherapy. Main reasons for Cetuximab treatment discontinuation was tumor progression (44%), death (14%) and patients wish (12%). Treatment was discontinued due to toxicities in 7% of the patients. Response data were available in 103 patients. The overall response rate (ORR) and the disease conrol rate (DCR) were 50 / 70% in the radiotherapy group, 43 / 76% in the Cisplatin group and 31 / 71% in the Carboplatin group, respectively.The median OS of 8.8 months and the median progression free survival of 5.0 months (both preliminary results) are comparabe to the results in the phase III EXTREME Trial.
The interim analysis of the SOCCER trial (non-selected patient cohort) is in agreement with the published efficacy and safety data of Cetuximab in combination with platinum-based chemotherapy in 1st line treatment of recurrent and/or metastatic SCCHN1. 1 Vermorken JB et al., N Engl J Med 2008; 359: 1116-11127.
Clinical trial identification
Legal entity responsible for the study
Merck Serono, Universitätsklinikum Erlangen
M. Hecht: Research Funding: Novartis Honoraria for lecture: Merck Serono Travel expenses: TEVA, Merck Serono. K. Orlowski, M. Finzsch: employee Merck Serono GmbH. R. Fietkau: Advisor: Merck Serono, Novartis, Pierre Fabre Honoraria: Merck Serono, BrainLab, Fresenius, Novartis, Roche, Pierre Fabre. All other authors have declared no conflicts of interest.