4.6 Article

Immunotherapy for the prevention of high-risk oral disorders malignant transformation: the IMPEDE trial

Journal

BMC CANCER
Volume 21, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s12885-021-08297-3

Keywords

Oral potentially malignant disorder; LOH; Malignant transformation; Immunotherapy; Prevention; Oral cancer

Categories

Funding

  1. AIRC [21740]

Ask authors/readers for more resources

OPMD have a significant risk of malignant transformation, with potential progression to oral cancer. This clinical trial aims to prevent neoplastic transformation of OPMD and revert LOH status by restoring immune system activity through immunotherapy. By using checkpoint inhibitors, the trial seeks to tip the balance in favor of immune control and prevent cancer occurrence.
BackgroundOral 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.MethodsThis 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 6months 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 30months from the end of treatment, for a total planned study duration of approximately 5.5years.DiscussionRestoring 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.Trial registrationThis trial was prospectively registered in ClinicalTrials.gov as NCT04504552 on 7th August 2020.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.6
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

Article Oncology

A homogeneous treatment for non-DIPG diffuse midline glioma

Elisabetta Schiavello, Veronica Biassoni, Giovanna Gattuso, Marta Podda, Stefano Chiaravalli, Francesco Barretta, Manila Antonelli, Loris De Cecco, Emilia Pecori, Lorenza Gandola, Maura Massimino

Summary: This is a small series of homogeneously-treated DMG patients with H3K27M mutation. The treatment approach is similar to DIPG and the results obtained are comparable with those of DIPG patients. Therefore, these DMG patients should be included in registries and protocols of DIPG.

TUMORI JOURNAL (2023)

Article Oncology

Reduction of Staphylococcus epidermidis in the mammary tumor microbiota induces antitumor immunity and decreases breast cancer aggressiveness

Giancarla Bernardo, Valentino Le Noci, Emerenziana Ottaviano, Loris De Cecco, Chiara Camisaschi, Simone Guglielmetti, Martina Di Modica, Giorgio Gargari, Francesca Bianchi, Serena Indino, Patrizia Sartori, Elisa Borghi, Michele Sommariva, Elda Tagliabue, Tiziana Triulzi, Lucia Sfondrini

Summary: This study highlights the significant influence of mammary tumor microbiota on local immune status and the relevance of its treatment with antibiotics, in combination with breast cancer therapies.

CANCER LETTERS (2023)

Review Geriatrics & Gerontology

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in Older Patients: Are New Agents Bringing New Hope?

Maria Cossu Rocca, Luigi Lorini, Petr Szturz, Paolo Bossi, Jan B. Vermorken

Summary: Head and neck cancer, mainly squamous cell carcinoma, is a group of diseases that affect the mucosa lining the upper aerodigestive tract. Despite multimodality treatment, they often recur or progress, leading to poor prognosis. The treatment of older patients with head and neck squamous cell carcinoma is challenging due to their underrepresentation in clinical trials and lack of evidence-based guidelines. This article aims to address the specific needs of older patients, including differences in epidemiology and biology, measurement and use of frailty in treatment personalization, desired outcomes, and considerations for new treatments.

DRUGS & AGING (2023)

Article Otorhinolaryngology

General anaesthetic vs local anaesthetic myringoplasties: a systematic review and meta-analysis

Anna Kaleva, Amit Raithatha, Michele Tomasoni, Daniele Borsetto, Ananth Vijendren

Summary: This study aims to compare the success rates and tolerability of local anaesthetic myringoplasty with those undertaken under general anaesthetic myringoplasty. The results showed no significant difference in the success rate of myringoplasty surgery between local and general anaesthesia. Factors such as minimizing anaesthetic risks, reducing costs, and reducing environmental impact can drive the choice of local anaesthetic surgery.

EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY (2023)

Letter Otorhinolaryngology

Reply to Letter to the Editor regarding Salvage surgery in recurrent sinonasal cancers: Proposal for a prognostic model based on clinicopathologic and treatment-related parameters

Davide Mattavelli, Michele Tomasoni, Marco Ferrari, Alberto Schreiber, Vittorio Rampinelli, Paolo Bossi, Cesare Piazza, Piero Nicolai

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK (2023)

Review Biology

Ovarian Cancer Radiosensitivity: What Have We Understood So Far?

Amelia Barcellini, Alexandra Charalampopoulou, Loris De Cecco, Andrei Fodor, Emanuela Rabaiotti, Giorgio Candotti, Simona Secondino, Angelica Facoetti, Laura Deborah Locati, Sandro Pignata, Ester Orlandi, Giorgia Mangili

Summary: Radiotherapy is increasingly being used in combination with surgery, chemotherapy, and novel drugs to treat ovarian cancer. This review aims to summarize the current understanding of the radiosensitivity and radioresistance of ovarian cancer, which is the deadliest gynecological cancer worldwide. Understanding the mechanisms of radiosensitivity and identifying potential biomarkers of radioresistance could be crucial in guiding clinical decision-making, considering the high rate of recurrence in and out of the radiotherapy fields, especially in the era of personalized oncology.

LIFE-BASEL (2023)

Review Otorhinolaryngology

Lymph node metastasis from olfactory neuroblastoma at presentation and as disease relapse: A systematic review and proportion meta-analysis of prevalence data and variables influencing regional control

Michele Tomasoni, Elisa Marazzi, Vittorio Rampinelli, Davide Mattavelli, Alberto Schreiber, Alberto Deganello, Cesare Piazza

Summary: The aim of this study was to investigate the prevalence of cervical nodal metastasis in primary, treatment-naive olfactory neuroblastoma (ONB) at presentation and as disease relapse, as well as to review treatment modalities and risk factors for regional failure and survival outcomes based on nodal status. A systematic review and meta-analysis were conducted based on PubMed, Web of Science, and Scopus. The results showed that cervical nodal involvement is common in both the presentation and during follow-up of cN0 ONB. The highest risk of developing late nodal metastasis is seen in cN0 patients with Kadish stage C tumors not receiving elective neck treatment. Based on these findings, selective neck treatment should be encouraged in selected patients to improve regional control.

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK (2023)

Article Oncology

Biological and clinical impact of membrane EGFR expression in a subgroup of OC patients from the phase IV ovarian cancer MITO-16A/MANGO-OV2A trial

Luca Forlani, Loris De Cecco, Vittorio Simeon, Biagio Paolini, Marina Bagnoli, Sabrina Chiara Cecere, Anna Spina, Eleonora Citeroni, Eliana Bignotti, Domenica Lorusso, Laura Arenare, Daniela Russo, Carmine De Angelis, Laura Ardighieri, Giosue Scognamiglio, Michele Del Sesto, Germana Tognon, Daniela Califano, Clorinda Schettino, Paolo Chiodini, Francesco Perrone, Delia Mezzanzanica, Sandro Pignata, Antonella Tomassetti

Summary: The membrane expression of EGFR can serve as a prognostic biomarker in ovarian cancer patients and is associated with the efficacy of anti-angiogenic therapy.

JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH (2023)

Article Medicine, Research & Experimental

Analysis of Complications in (Crico-) Tracheal Resection Anastomosis in Adults: A Multicenter Study

Ivana Fiz, Marta Filauro, Claudio Sampieri, Alessandro Ioppi, Alberto Vallin, Francesco Fiz, Jan Costantin Koelmel, Davide Lancini, Cesare Piazza, Christian Sittel, Giorgio Peretti

Summary: This study investigated the impact of different stenosis and patient-related factors on complications in patients undergoing partial crico-tracheal or tracheal resection and anastomosis for advanced laryngotracheal stenosis. The presence of systemic comorbidities was found to be the only independent predictor of postoperative complications. Patients with complications required additional surgeries more frequently and had a longer duration of hospitalization.

LARYNGOSCOPE (2023)

Review Otorhinolaryngology

The Risk of Meningitis After Cochlear Implantation: A Systematic Review and Meta-Analysis

Shravan V. Gowrishankar, Alex Fleet, Michele Tomasoni, Rory Durham, Rishi Umeria, Serena A. Merchant, Syed F. H. Shah, Jameel Muzaffar, Hassan Mohammed, Isla Kuhn, James Tysome, Matthew E. Smith, Neil Donnelly, Patrick Axon, Manohar Bance, Daniele Borsetto

Summary: This study aimed to estimate the rate of postoperative meningitis in patients following cochlear implants through a systematic review and meta-analysis. The overall rate of postoperative meningitis was estimated to be 0.07%, which is lower than prior estimates but still higher than the general population.

OTOLARYNGOLOGY-HEAD AND NECK SURGERY (2023)

Article Otorhinolaryngology

Impact of lymph node ratio and number of lymph node metastases on survival and recurrence in laryngeal squamous cell carcinoma

Gabriele Molteni, Riccardo Nocini, Francesco Mattioli, Meijin Nakayama, Rogerio A. Dedivitis, Giuditta Mannelli, Erika Crosetti, Carlos Miguel Chiesa-Estomba, Jon A. Sistiaga-Suarez, Leone Giordano, Andrea Galli, Marco Lionello, Giuseppe Mercante, Massimo Ralli, Matteo Fermi, Alejandro Klein-Rodriguez, Miguel Mayo-Yanez, Edoardo Serafini, Francesca Pirola, Alberto Paderno, Francesca Cambria, Nobuhiko Oridate, Daisuke Sano, Paolo Boscolo-Rizzo, Alberto Vito Marcuzzo, Giampiero Parrinello, Filippo Marchi, Alberto Maria Saibene, Manuel Tucciarone, Guillem Viscasillas, Karol Zelenik, Daniel Marin Ramos, Jose Palacios-Garcia, Giancarlo Tirelli, Raul Pellini, Gaetano Paludetti, Jacopo Galli, Giorgia Rossi, Marco De Vincentiis, Claudio Roberto Cernea, Giuseppe Spriano, Mario Bussi, Giorgio Peretti, Giovanni Succo, Cesare Piazza, Andy Bertolin, Luiz Paulo Kowalski, Livio Presutti, Andrea Sacchetto

Summary: This study aims to evaluate the impact of lymph node ratio (LNR) and number of positive lymph nodes (NPLN) on mortality and recurrence rates in patients with laryngeal squamous cell carcinoma. The results showed significant differences in disease-specific survival (DSS) and disease-free survival (DFS) among patient groups stratified according to LNR and NPLN. The 5-year DSS and DFS based on LNR and NPLN outperformed pN staging in stratifying patients.

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK (2023)

Article Multidisciplinary Sciences

Functional profiles of curatively treated adenoid cystic carcinoma unveil prognostic features and potentially targetable pathways

Chiara Romani, Luigi Lorini, Anna Bozzola, Eliana Bignotti, Michele Tomasoni, Laura Ardighieri, Mattia Bugatti, Simonetta Battocchio, Antonella Ravaggi, Davide Tomasini, Marco Ravanelli, Cristina Gurizzan, Davide Lombardi, Davide Mattavelli, Stefano Calza, Cesare Piazza, Paolo Bossi

Summary: Adenoid cystic carcinoma (ACC) of salivary gland is a slowly growing tumor with a tendency to recur and decreased survival rates. Through gene expression analysis, specific pathway alterations associated with aggressive ACC were identified, providing new avenues for therapeutic intervention.

SCIENTIFIC REPORTS (2023)

Letter Surgery

Peritoneal fluid COVID-19 testing in patients with a negative nasopharyngeal swab: prospective study

Armando G. Licata, Chiara M. Ciniselli, Luca Sorrentino, Arianna Micali, Maria Grazia Daidone, Marcello Guaglio, Manuela Gariboldi, Paolo Verderio, Loris De Cecco, Maurizio Cosimelli

BRITISH JOURNAL OF SURGERY (2023)

No Data Available