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 | Zendy

Lalami Yassine | Zendy; Garcia Camillo | Zendy; Flamen Patrick | Zendy; Ameye Lieveke | Zendy; Paesmans Marianne | Zendy; Awada Ahmad | Zendy

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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

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