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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)3670-3676
Number of pages7
JournalHead and Neck
Volume41
Issue number10
DOIs
Publication statusPublished - Oct 1 2019

Fingerprint

Salivary Gland Neoplasms
Carcinoma
Salivary Glands
Adenoid Cystic Carcinoma
Literature
Stomatitis
Disease-Free Survival
Fatigue
Disease Progression
axitinib
Hypertension
Safety
Survival

Keywords

  • adenoid cystic carcinoma
  • antiangiogenetic
  • axitinib
  • salivary gland cancer
  • tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

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

In: Head and Neck, Vol. 41, No. 10, 01.10.2019, p. 3670-3676.

Research output: Contribution to journalArticle

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AU - Cavalieri, Stefano

AU - Bergamini, Cristiana

AU - Resteghini, Carlo

AU - Alfieri, Salvatore

AU - Calareso, Giuseppina

AU - Bossi, Paolo

AU - Perrone, Federica

AU - Tamborini, Elena

AU - Quattrone, Pasquale

AU - Granata, Roberta

AU - Galbiati, Donata

AU - Platini, Francesca

AU - Orlandi, Ester

AU - Mariani, Luigi

AU - Licitra, Lisa

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