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Phase II trial with axitinib in recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract
Author(s) -
Locati Laura D.,
Cavalieri Stefano,
Bergamini Cristiana,
Resteghini Carlo,
Alfieri Salvatore,
Calareso Giuseppina,
Bossi Paolo,
Perrone Federica,
Tamborini Elena,
Quattrone Pasquale,
Granata Roberta,
Galbiati Donata,
Platini Francesca,
Orlandi Ester,
Mariani Luigi,
Licitra Lisa
Publication year - 2019
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.25891
Subject(s) - axitinib , medicine , adenoid cystic carcinoma , adverse effect , clinical endpoint , salivary gland cancer , stomatitis , oncology , gastroenterology , carcinoma , salivary gland , surgery , cancer , clinical trial , sunitinib
Background Patients with prognosis recurrent/metastatic (R/M) salivary gland carcinomas (SGCs) are poor. Activity of axitinib was demonstrated in adenoid cystic carcinoma (ACC). We tested axitinib in a larger cohort of R/M SGCs including non‐ACC. Methods Axitinib was administered at 10 mg daily (dose escalation allowed) until progression or unacceptable toxicity. Null hypothesis would be rejected if more than 3 of 26 responses were observed. Results Twenty‐six patients (50% were male; 6 ACC, 20 non‐ACC) were treated. Response rate was 8% (2 partial responses), 13 stable disease (>6 months in 7 patients) and 11 disease progression. Median progression‐free survival and overall survival were 5.5 and 26.2 months, respectively. All patients had at least one adverse event: stomatitis (69%), fatigue (58%) and hypertension (54%) were the most frequent. Conclusions This trial did not meet its primary endpoint hence axitinib should not be considered for further investigations in SGCs. Safety profile was in line with the scientific literature.