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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
Author(s) -
Lalami Yassine,
Garcia Camillo,
Flamen Patrick,
Ameye Lieveke,
Paesmans Marianne,
Awada Ahmad
Publication year - 2016
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.23898
Subject(s) - medicine , sorafenib , positron emission tomography , fluorodeoxyglucose , standardized uptake value , head and neck squamous cell carcinoma , response evaluation criteria in solid tumors , oncology , nuclear medicine , phases of clinical research , head and neck cancer , radiation therapy , clinical trial , hepatocellular carcinoma
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