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Phase I study of vandetanib with radiation therapy with or without cisplatin in locally advanced head and neck squamous cell carcinoma
Author(s) -
Papadimitrakopoulou Vasiliki A.,
Frank Steven J.,
Cohen Ezra W.,
Hirsch Fred R.,
Myers Jeffrey N.,
Heymach John V.,
Lin Heather,
Tran Hai T.,
Chen Changhu R.,
Jimeno Antonio,
Nedzi Lucien,
Vasselli Joseph R.,
Lowe Elizabeth S.,
Raben David
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.23922
Subject(s) - vandetanib , medicine , regimen , oncology , cisplatin , radiation therapy , mucositis , head and neck squamous cell carcinoma , epidermal growth factor receptor , urology , chemotherapy , head and neck cancer , cancer , receptor , tyrosine kinase
Background Vandetanib, added to cisplatin and radiation therapy (RT) overcomes chemoradiation therapy (CRT) and epidermal growth factor receptor (EGFR) inhibitor resistance in head and neck squamous cell carcinoma (HNSCC) lines and models. Methods Patients with previously untreated HNSCC received vandetanib daily for 14 days (starting dose 100 mg) and then vandetanib + RT (2.2 Gy/day, 5 days/week) for 6 weeks (regimen 1) or vandetanib + RT (2 Gy/day, 5 days/week) + cisplatin (30 mg/m 2 weekly) for 7 weeks (regimen 2). The primary objective was the maximum tolerated dose (MTD) of vandetanib with RT +/‐ cisplatin. Results Of 33 treated patients, 30 completed therapy (regimen 1, n = 12; regimen 2, n = 18). MTD in regimen 2 was 100 mg (3 dose limiting toxicities [DLTs] at 200 mg), whereas regimen 1 was stopped because of poor recruitment (1 DLT at 200 mg). Most common grade ≥3 adverse events (AEs) were dysphagia (30%), stomatitis (33%), and mucosal inflammation (27%). Five patients discontinued vandetanib because of AEs. Conclusion Vandetanib with CRT was feasible. © 2015 Wiley Periodicals, Inc. Head Neck 38: 439–447, 2016