Published in:
Open Access
01-12-2021 | Oral Cancer | Study protocol
Immunotherapy for the prevention of high-risk oral disorders malignant transformation: the IMPEDE trial
Authors:
Cristina Gurizzan, Luigi Lorini, Alberto Paderno, Michele Tomasoni, Gabriele Zigliani, Anna Bozzola, Laura Ardighieri, Simonetta Battocchio, Eliana Bignotti, Antonella Ravaggi, Chiara Romani, Loris De Cecco, Mara Serena Serafini, Rosalba Miceli, Elena Bardellini, Alessandra Majorana, Cesare Piazza, Paolo Bossi
Published in:
BMC Cancer
|
Issue 1/2021
Login to get access
Abstract
Background
Oral Potentially Malignant Disorders (OPMD) have a non-negligible malignant transformation rate of up to 8%. Loss of heterozygosity (LOH) in critical chromosomal loci has proven to be the most effective marker in defining the risk of transformation and it is found in about 28% of OPMD and may therefore identify patients carrying higher risk. To date, clinical management of OPMD is limited to surgical excision and clinical surveillance, which however do not fully prevent oral cancer development. Immune system has been shown to play a key role in transformation surveillance mechanism and an immunosuppressive imbalance may be responsible for progression to cancer. Given all these considerations, we designed a clinical trial with the aim to prevent OPMD neoplastic transformation and revert the LOH status.
Methods
This is a phase II, open label, single arm, multicentric trial involving Italian referral centres and expected to enrol 80 patients out of a total of 175 screened. Patients who meet all inclusion criteria and test positive for LOH after an incisional biopsy of the OPMD will undergo a short course of immunotherapy with 4 administration of avelumab. After 6 months since treatment start, resection of the entire OPMD will be performed and LOH assessment will be repeated. The follow-up for malignant transformation and safety assessment will last 30 months from the end of treatment, for a total planned study duration of approximately 5.5 years.
Discussion
Restoring the activity of immune system through checkpoint inhibitor may play a crucial role against malignant transformation of OPMD by reverting the balance in favour of immune control and preventing cancer occurrence.