Phase II trial with axitinib in recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract. Issue 10 (29th July 2019)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Head & neck. Volume 41:Issue 10(2019)
• Page Start: 3670
• Page End: 3676
• Publication Date: 2019-07-29
• Subjects: adenoid cystic carcinoma -- antiangiogenetic -- axitinib -- salivary gland cancer -- tyrosine kinase inhibitor; Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.25891
• Languages: English
• ISSNs: 1043-3074

Abstract

Abstract: 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.