• Citer

A Phase II trial evaluating the efficacy of sorafenib (BAY 43-9006) and correlating early FDG PET-CT response to outcome in patients with recurrent and/or metastatic head and neck cancer.

par Lalami, Yassine ;Garcia, Camilo ;Flamen, Patrick ;Ameye, Lieveke;Paesmans, M.;Awada, Ahmad
Référence Head & neck
Publication A Paraître, 2015

Article révisé par les pairs

• Détails
• Contenu

Résumé :

Purpose To assess the efficacy and safety of sorafenib in patients with R/M SCCHN and to explore the predictive value of early metabolic responses. Patients and methods Sorafenib was administered orally at 400 mg BID on a continuous basis. Primary endpoint was response rate. Correlation of early (18) FDG PET-CT response to time-to-event outcomes was a secondary objective. Results Twenty-three pts were included. Grade 3-4 toxicities included fatigue (22%), hand-foot syndrome (9%), lymphopenia (17%), hyponatremia (39%) and hypophosphatemia (48%). One pt (5%) had PR; 12 pts (55%) had SD. Early metabolic response rate was 38%. Median PFS was 2.2 months in early metabolic non responders (13/21 pts) in comparison to 7.4 months in the 8 pts with class I early metabolic response (p 0.006). Conclusions Sorafenib showed a modest antitumor activity. Data suggest a possible role of (18) FDG PET metabolic response as an early predictor of a prolonged PFS. Head Neck, 2014.