Phase II study of figitumumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck : clinical activity and molecular response (GORTEC 2008-02)

Schmitz, Sandra;Kaminsky-Forrett, Marie-Christine;Henry, Stéphanie;Zanetta, Sylvie;Machiels, Jean-Pascal;et.al.
(2012) Annals of Oncology — Vol. 23, n° 8, p. 2153-2161 (2012)

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BACKGROUND: Preclinical studies suggest that insulin-like growth factor-1 receptor (IGF-1R) blockage could be a promising therapeutic target in squamous cell carcinoma of the head and neck (SCCHN). Therefore, we investigated the efficacy and toxicity of figitumumab, an anti-IGF-1R monoclonal antibody, in palliative SCCHN. PATIENTS AND METHODS: Patients with palliative SCCHN progressing after platinum-based therapy were treated with figitumumab i.v. 20 mg/kg, every 3 weeks. The primary end point was the disease control rate at 6-8 weeks after treatment initiation. Tumor biopsies and plasma samples were collected before and after figitumumab administration to monitor the molecular response. RESULTS: Seventeen patients were included. Only two patients achieved stable disease at 6-8 weeks. Median overall survival and progression-free survival were 63 and 52 days, respectively. The main grade 3-4 adverse event was hyperglycemia (41%). Translational research showed that figitumumab downregulated IGF-1R at the surface of tumor cells with activation of the epidermal growth factor receptor (EGFR) pathway, as shown by the upregulation of p-EGFR in tumor cells (P = 0.016), and an increase in the plasma level of tumor growth factor-alpha (P = 0.006). CONCLUSION: Figitumumab monotherapy has no clinically significant activity in unselected palliative SCCHN.
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Schmitz, S., Kaminsky-Forrett, M.-C., Henry, S., Zanetta, S., Geoffrois, L., Bompas, E., Moxhon, A., Mignion, L., Guigay, J., Knoops, L., Hamoir, M., & Machiels, J.-P. (2012). Phase II study of figitumumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck : clinical activity and molecular response (GORTEC 2008-02). Annals of Oncology, 23(8), 2153-2161. https://doi.org/10.1093/annonc/mdr574 (Original work published 2012)