Abstract 868P
Background
Unresectable advanced sinonasal epithelial tumors are rare diseases having an overall dismal prognosis (5-year reported PFS less than 15%). No standard treatment is recognized. This prospective study explored the safety and activity of a multimodality treatment modulated by histology, molecular profile and response to IC.
Methods
Pts with untreated inoperable squamous cell carcinoma (SCC), p53 wild-type intestinal type adenocarcinoma (ITAC), sinonasal undifferentiated and neuroendocrine carcinoma (SNUC; SNEC) and Hyams grade III olfactory neuroblastoma (ONB) were enrolled in a single-arm, open-label, phase II, multicenter clinical trial between 2013 and 2018. For each pt, a multidisciplinary team evaluated the best curative treatment. Pts were treated with up to 5 IC cycles, whose regimen was selected according to histotype. Photon and/or proton/carbon ion-based RT was employed according to disease site, stage and IC response. Primary endpoint was 5-year PFS, secondary endpoints were overall survival (OS), radiological response as per RECIST 1.1, safety.
Results
Out of 27 enrolled pts, 25 resulted evaluable for primary endpoint. One pts withdrew from the trial and another one was discontinued by the investigator. Five-year PFS was 26.8% (95% CI 12.6 – 57.1), with a median PFS of 18 months. Five-year OS was 23.8% (95% CI, 9.5 – 59.3), with a median OS of 27 months. The overall response rate to IC was 40%, representing a prognostic factor for 5-yr OS (33.3% in pts with response to IC vs 17.9% in pts without response to IC). Overall treatment safety was in line with multimodality intensive head and neck cancer treatments (3% of pts with G3-4 adverse event during IC). At a median follow up of 27 months, 5 G3-4 RT induced late adverse events have been recorded (1 case of G3 neurotoxicity, 2 cases of G3 hearing impairment, 2 cases of G3 xerostomia). No toxic deaths were recorded.
Conclusions
Multimodal combination of IC and innovative RT provide survival rates only slightly greater than previous experiences, underscoring the need for further treatment improvement. Response to IC confirmed its predictive value on survival. The overall treatment safety is acceptable.
Clinical trial identification
NCT02099188.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Supported by Fondazione Regionale per la Ricerca Biomedica.
Disclosure
P. Bossi: Financial Interests, Institutional, Research Grant: GlaxoSmithKline, MSD, Sanofi, Bristol Myers Squibb. C. Resteghini: Financial Interests, Personal, Advisory Board: Sun Pharma. B. Vischioni: Financial Interests, Personal, Invited Speaker: Merck. N. Facchinetti: Financial Interests, Institutional, Sponsor/Funding: Helsinn Healthcare SA. L.F. Licitra: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene International, Debiopharm International SA, Eisai, Exelixis inc, Hoffmann-La Roche ltd, IRX Therapeutics inc, Medpace inc, Merck–Serono, MSD, Novartis, Pfizer, Roche.; Financial Interests, Personal, Advisory Role: AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, MSD, Merck–Serono, Boehringer Ingelheim, Novartis, Roche, Debiopharm International SA, Sobi, Ipsen, Incyte Biosciences Italy srl, Doxa Pharma, Amgen, Nanobiotics Sa and GlaxoSmithKline. All other authors have declared no conflicts of interest.