Clinical trials for patients with salivary gland cancers: A systematic review of worldwide registers and an evaluation of current challenges
Jiménez-Labaig, P. Lorini, L. Gurizzan, C. Kinloch, E. Burton, S. Forster, M. D. Metcalf, R. Ferrarotto, R. Bossi, P. B, O. L.
Jiménez-Labaig, P.
Lorini, L.
Gurizzan, C.
Kinloch, E.
Burton, S.
Forster, M. D.
Metcalf, R.
Ferrarotto, R.
Bossi, P.
B, O. L.
Abstract
BACKGROUND: Clinical trials (CT) are crucial for generating scientific evidence and improving clinical outcomes, but they can be challenging in the context of rare cancers. Salivary gland cancers (SGC) are rare and heterogeneous tumors, without standard-of-care approved systemic therapies. We analyzed completed and ongoing CTs to assess the current state of clinical research activity in the field. METHODS: ClinicalTrials.gov, WHO-ICTRP, HealthCanadaCT were searched for antineoplastic pharmacological and interventional CT involving patients with SGC from the trials database creation until August 6th, 2024. CT characteristics and status were collected. RESULTS: 134 clinical trials met inclusion criteria. Of these, 78 % were sponsored by non-industry entities. 49 % were conducted at only one site, and 61 % at up to five centers. Only 25 trials (19 %) were multinational, being 15 industry-sponsored, a significantly higher proportion compared to non-industry-sponsored trials(p < 0.01). 16 % CTs were umbrella or basket, and 6 % were randomized, again predominantly industry-sponsored(p < 0.01). Regarding SGC-specific trials, 32 % were open to all patients with SGC, regardless of specific histology. Patients with adenoid cystic, salivary duct, and mucoepidermoid carcinoma had access to 92 %, 66 % and 62 % of trials, respectively. 88 % CT targeted palliative setting, and 38 % incorporated predictive biomarkers. Tyrosine kinase inhibitors were the most studied therapy(26 %), followed by immunotherapy(15 %), chemotherapy and antibody-drug conjugate(12 % each) and androgen-blockade(8 %), among others. CONCLUSION: Clinical research for patients with SGC relies mainly in non-industry organisations, most of them limited to run trials in one to five sites, in a single country. Further collaboration between investigators is needed, as well as reconsidering inclusion criteria and trial designs.
Description
Date
2025
Publisher
Collections
Keywords
Type
Article
Citation
Jiménez-Labaig P, Lorini L, Gurizzan C, Kinloch E, Burton S, Forster MD, et al. Clinical trials for patients with salivary gland cancers: A systematic review of worldwide registers and an evaluation of current challenges. Crit Rev Oncol Hematol. 2025 Jul;211:104747. PubMed PMID: 40294876. Epub 2025/04/29. eng.