Background: The purpose of this study was to assess the efficacy and safety of sorafenib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) and to explore the predictive value of early metabolic responses.
Methods: Sorafenib was administered orally at 400 mg bid on a continuous basis. The primary endpoint was the response rate. Correlation of early (18)fluorodeoxyglucose (FDG) positron emission tomography (PET)-CT response to time-to-event outcomes was a secondary objective.
Results: Twenty-three patients were included in this study. Grade 3 to 4 toxicities included fatigue (22%), hand-foot syndrome (9%), lymphopenia (17%), hyponatremia (39%), and hypophosphatemia (48%). One patient (5%) had a partial response (PR) and 12 patients (55%) had stable disease. Early metabolic response rate was 38%. Median progression-free survival (PFS) was 2.2 months in early metabolic nonresponders (13 of 21 patients) in comparison to 7.4 months in the 8 patients with class I early metabolic response (p = .006).
Conclusion: 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.
Keywords: antiangiogenic drugs; fluorodeoxyglucose (FDG) positron emission tomography (PET); head and neck cancer; sorafenib.
© 2015 Wiley Periodicals, Inc.