Phase II trial evaluating the efficacy of sorafenib (BAY 43‐9006) and correlating early fluorodeoxyglucose positron emission tomography–CT response to outcome in patients with recurrent and/or metastatic head and neck cancer. Issue 3 (26th May 2015)

• Record Type: Journal Article
• Authors: Lalami, Yassine; Garcia, Camillo; Flamen, Patrick; Ameye, Lieveke; Paesmans, Marianne; Awada, Ahmad
• Is Part Of: Head & neck. Volume 38:Issue 3(2016)
• Page Start: 347
• Page End: 354
• Publication Date: 2015-05-26
• Subjects: sorafenib -- fluorodeoxyglucose (FDG) positron emission tomography (PET) -- head and neck cancer -- antiangiogenic drugs; Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.23898
• Languages: English
• ISSNs: 1043-3074

Abstract

Abstract: 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. © 2015 Wiley Periodicals, Inc. Head Neck 38: 347–354, 2016