Phase II trial with axitinib in recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract.

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.

• Authors: Laura D Locati, Stefano Cavalieri, Cristiana Bergamini, Carlo Resteghini, Salvatore Alfieri, Giuseppina Calareso, Paolo Bossi, Federica Perrone, Elena Tamborini, Pasquale Quattrone, Roberta Granata, Donata Galbiati, Francesca Platini, Ester Orlandi, Luigi Mariani, Lisa Licitra
• Journal: Head & neck (Head Neck) Vol. 41 Issue 10 Pg. 3670-3676 (10 2019) ISSN: 1097-0347 [Electronic] United States
• PMID: 31355973 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article)
• Copyright: © 2019 Wiley Periodicals, Inc.

Chemical References

• Antineoplastic Agents
• Axitinib

Topics

• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Axitinib (adverse effects, therapeutic use)
• Carcinoma, Adenoid Cystic (drug therapy, mortality, pathology)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, mortality, pathology)
• Risk Assessment
• Salivary Gland Neoplasms (drug therapy, mortality, pathology)
• Survival Analysis
• Treatment Failure