6th ICHNO Abstract Book

6th ICHNO 6 th ICHNO Conference International Conference on innovative approaches in Head and Neck Oncology 16 – 18 March 2017 Barcelona, Spain __________________________________________________________________________________________ page 61

PO-127 Melatonin oral gel for prevention oral mucositis head and neck cancer undergoing chemo/bio radiation (MUCOMEL) A. Lozano 1 , J. Marruecos 2 , N. Farre 3 , J. Giralt 4 , R. Morera 5 , I. Planas 6 , M. Lanzuela 7 , A. Escribano 5 , L.A. Glaria 5 , R. Mesia 8 , J. Rubio 9 , A. Lopez-Pousa 10 , N. Baste 11 , B. Castelo 12 , B. Cirauqui 13 , J. Martinez-Trufero 14 , J. Ortiz 15 , P.M. Grima 15 , V. Valenti 16 , C. Tarrago 15 , R. Bosser 15 1 Institut Català d'Oncologia, Radiation Oncology, L'Hospitalet de Llobregat, Spain 2 Institut Català d'Oncologia, Radiation Oncology, Girona, Spain 3 Hospital Universitari de la Santa Creu i Sant Pau, Radiation Oncology, Barcelona, Spain 4 Hospital Universitari de la Vall d´Hebron, Radiation Oncology, Barcelona, Spain 5 Hospital Universitario La Paz, Radiation Oncology, Madrid, Spain 6 Institut Catala d´Oncologia, Radiation Oncology, Badalona, Spain 7 Hospital Universitario Miguel Servet, Radiation Oncology, Zaragoza, Spain 8 Institut Català d'Oncologia, Medical Oncology, L'Hospitalet de Llobregat, Spain 9 Institut Català d'Oncologia, Medical Oncology, Girona, Spain 10 Hospital Universitari de la Santa Creu i Sant Pau, Medical Oncology, Barcelona, Spain 11 Hospital Universitari de la Vall d´Hebron, Medical Oncology, Barcelona, Spain 12 Hospital Universitario La Paz, Medical Oncology, Madrid, Spain 13 Institut Català d'Oncologia, Medical Oncology, Badalona, Spain 14 Hospital Universitario Miguel Servet, Medical Oncology, Zaragoza, Spain 15 Spherium Biomed S.L., Project Management, Esplugues de Llobregat, Spain 16 Hospital de Santa Tecla, Medical Oncology, Tarragona, Spain Purpose or Objective Oral mucositis (OM) is the most significant adverse event (AE) in patients undergoing concurrent chemo/biotherapy plus radiotherapy for treating head and neck (H&N) cancer. The objective of the ongoing Phase Ib-II trial is to evaluate the safety of melatonin (MLT) oral gel, its efficacy in the prevention of severe OM in H&N cancer patients (84) and to assess the pharmacokinetic profile of MLT in the subgroup of the first 24 patients. Material and Methods Prospective, randomized, double blind and placebo- controlled study. Eligible patients are assigned at 1:1 ratio to receive 3% melatonin or matching placebo oral gels (mouthwashes followed by swallowing). All patients receive concomitant standard symptomatic treatment for OM along the study, according to the clinical practice of the hospitals. All patients take MLT oral-gel or placebo oral gel from two to three days before start of systemic treatment until one to four weeks after completion of radiotherapy. Eight additional weeks of observation are needed to rule out late-onset adverse events related to MLT. The selected radiotherapy is VMAT-SIB once daily (5 days a week), 50.4 Gy (low risk area), 69.96 Gy (high risk area) and 66 Gy (post-operative oral cavity tumour). Radiotherapy plan was previously agreed between all the radiotherapists participating in the study in order to ensure homogeneity between centres. Concurrent systemic treatment is either cisplatin or cetuximab.

Primary endpoint: Num. of patients with severe OM (G3- G4 / RTOG). Secondary endpoints: Efficacy: Num. of patients with SOM (G3-G4 / NCI-CTCAE), Num. of days with OM (RTOG), Num. of days with G3-G4 OM (RTOG), Time to onset of G3-G4 OM (RTOG) Quality of Life: Change from baseline in EORTC QLQ-C30 & EORTC QLQ-H&N35 scores ,Change from baseline in ECOG-PS Safety: Num. of patients with G1-G4 NCI-CTCAE rel. to IMP , Num. of patients who develop cisplatin or cetuximab- associated G1-G4 AEs (NCI-CTCAE)., Num. of patients who develop RT-associated AEs different from OM (RTOG) PK: C max , C min, T max , AUC, T 1/2 , V d , Clearance (Cl) Results The first patient was enrolled in November 2015 and, up to 10 October 2016, 40 patients were randomized to treatment with either MLT or placebo oral gel. Results are expected by mid of 2017. Conclusion This prospective, randomized, double-blind and placebo- controlled study will demonstrate if melatonin oral gel 3% is safe and has been able to prevent severe OM in H&N cancer patients undergoing QRT, and if has shown efficacy in the other evaluated endpoints. PO-128 Follow up dysphagia in head and neck cancers is related to RT dose received by swallowing structures K. George 1 , R. Bhalavat 1 , M. Chandra 1 , L. Nellore 1 , D. Borade 1 , K. Kalariya 1 , V. Pareek 1 , Z. Moosa 1 , N. Reddy 1 , A. Srivastava 1 1 Jupiter Hospital- Thane, Radiation Oncology, Thane, India Purpose or Objective To study relationship of radiation dose received by Dysphagia and Aspiration Related Structures (DARS) and degree of dysphagia in head and neck cancers post radical radiation therapy (IMRT) with or without Chemotherapy (CT). If positive correlation exists, then assess the dose to DARS in patients previously treated with Brachytherapy boost and suggest Brachytherapy as a good boost modality to further reduce dysphagia and aspiration. Material and Methods 42 patients of head and neck cancers, satisfying the inclusion criteria were included from April 2014 to May 2015 and were treated with radical IMRT. DARS structures which included superior (SC), middle (MC) and inferior constrictors (IC), supraglottic (SGL) and glottic larynx (GL) and cervical esophagus (CE) were contoured on the planning CT scan along with other Organs at risk (OAR’s). Dysphagia was evaluated at baseline and at 6 months post treatment using Subjective questionnaires M.D Anderson Dysphagia Inventory (MDADI) and Performance Status Scale for Head and Neck Cancers (PSSN) and using Modified Barium Swallow for Objective Scoring of dysphagia: Swallowing Performance Scale (SPS) and Penetration Aspiration Scale (PAS). 42 patients of cancer of the pharynx and larynx who were treated with EBRT followed by Brachytherapy boost from 2009 to 2016 were also evaluated (dosimetrically) retrospectively. Results On applying non-parametric correlation, there’s correlation between V30 of SC and the PSSN Score at 6 months and Dmax of SC and PSSN score at 6 months. For MDADI scores, there’s a positive relationship of Dmax of SC and 6 month MDADI score. There’s correlation between V30, V50, V60, V66, V70, Mean doses of MC and the PSSN Score at 6 months; For MDADI scores, there’s a positive relationship of V30, V50, V60, V66 and V70 of MC and 6 month MDADI score. There’s correlation between V30, V50