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 __________________________________________________________________________________________ 7 AO Alessandria, Oncologia, Alessandria, Italy 8 INT Milano, Oncology, Milano, Italy 9 AO città della Salute Torino, Oncology, Torino, Italy 10 ASL3 genova, Oncology, Genova, Italy 11 ASO Santa Croce e Carle, Oncologia Ufficio Trials, CUNEO, Italy 12 ASO Santa Croce e Carle, Oncology, Cuneo, Italy toxicity (CLDT) and overall survival (OS) in cancer patients. In contrast to other cancers, sarcopenia has not yet been researched as a prognostic factor in head and neck cancer. We recently published a novel method for accurate and easy measurement of skeletal muscle mass in head and neck cancer patients. Using this method, we aimed to determine the prognostic impact of sarcopenia on CDLT and OS in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated with primary radiochemotherapy (RCT). Material and Methods page 13

Purpose/Objective On January 2010 We started a randomized multicenter phase III study comparing chemoradiation (Aldestein RTOG regimen) (CRT) versus induction chemotherapy followed by bioradiation (RT +Cetuximab). The main objective of the trial is Overall Survival and secondary end points are Response Rate (RR), Progression Free survival (PFS) role of Biomolecular prognostic factors (EGFR,HPV) and Toxicities Material/Methods Naïve patients with locally advanced head and neck squamous cell carcinoma (HNSCC), histological proven, of the oral cavity larynx hypopharynx oropharynx stage III or IV are eligible. Additional requirement for enrolment included adequate bone marrow function, renal function, hepatic function and age higher than 18 yr old. Treatment consisted of: Arm A Taxotere 75 mg/mq and Cisplatin 75 mg/mq day 1, 5FU c.i. 750mg/mq 96h, every 3 weeks for 3 times and Cetuximab loading dose 400 mg/mq followed by weekly 250mg/mq with a standard Radiotherapy program equivalent daily dose 2Gy up to 70 Gy; Arm B Cisplatin 100 mg/mq day 1,22,43 concurrent with the same RT scheduling. Statistic: 278 pts twill be accrued. Primary end-point is OS; secondary end-points include PFS, LRC, Complete response rate, toxicity and metastasis free survival. Results 276/278 pts were enrolled up to now. Accrual will be stopped on December 2016 and the final analyses will be provided by April 2018. Preliminary toxicity data on 170 pts previously presented (ESMO 2015) were as follows: (85 and 85 on Arm A and B). M/F were 70/15 and 66/19 in Arm A and B respectively. Toxicities are reported as the worst grade observed during the treatment. Haematological toxicities G3 + G4 in Arm A and B were: leukopenia 8 and 6; neutropenia: 18 and 7; anaemia: 2 and 3 ; thrombocytopenia were 0 and 1 respectively in arm A and arm B. Stomatitis G3/4 were 28/4 and 23/1. Weight loss G1/2/3 weight loss was 25/10/2 and 25/ 12/2 in arm A and in Arm B respectively. Radio-dermatitis G 3/4 was 14/1 and 3/0 in Arm A and B. Dysphagia G2/3 was reported in 16/11 and 10/15 patients at first post treatment clinical evaluation. 2 patients (1 in Arm A and 1 in Arm B) developed Renal toxicity. Final results on patients’ population and toxicity will be presented at the ICHNO meeting. Conclusion The study will finish accrual in few weeks. Data from comparison of these two arms will be presented. OC-020 Sarcopenia predicts chemotherapy dose- limiting toxicity in patients with head and neck cancer S.I. Bril 1 , A.W. Wendrich 2 , J.E. Swartz 2 , I. Wegner 2 , A. De Graeff 3 , E.J. Smid 4 , R. De Bree 1 , A.J. Pothen 1 1 UMC Utrecht, Head and Neck Surgical Oncology, Utrecht, The Netherlands 2 UMC Utrecht, Otorhinolaryngology - Head and Neck Surgery, Utrecht, The Netherlands 3 UMC Utrecht, Medical Oncology, Utrecht, The Netherlands 4 UMC Utrecht, Radiotherapy, Utrecht, The Netherlands Purpose or Objective Low skeletal muscle mass or sarcopenia is emerging as an adverse prognostic factor for chemotherapy dose limiting

All patients diagnosed with LA-HNSCC and treated with primary RCT between January 2007 and December 2011 in the University Medical Center Utrecht, the Netherlands, were included in this study. Clinical variables were retrospectively retrieved. Skeletal muscle mass was measured at the level of the third cervical vertebra (C3) using pre-therapy CT scans and controlled for height (cm 2 /m 2 ). A cut-off point for sarcopenia was determined using optimum stratification. We performed multivariate analysis to determine prognostic factors for CDLT and OS.

Results 112 patients were included in this study. 34 (30.4%) experienced CDLT. The optimal cut-off value for defining sarcopenia as a predictor of CDLT was ≤43.2 cm2/m2. Using this cut-off, 61 patients were sarcopenic (54.5%). Sarcopenic patients experienced significantly more CDLT than non-sarcopenic patients (44.3% versus 13.7%, p < 0.000). In multivariate analysis, an increase in skeletal muscle mass was associated with lower odds of CDLT (OR 0.93, 95% CI: 0.88–0.98). OS did not differ significantly between sarcopenic and non-sarcopenic (45.1 versus 49.0 months, p = 0.189). Patients who experienced CDLT had a significantly lower OS than patients who did not (36.6 versus 54.2 months, p = 0.038). Conclusion Sarcopenia is an independent predictor of CDLT in LA- HNSCC patients treated with primary RCT. OS did not differ significantly between sarcopenic and non- sarcopenic patients, but patients with CDLT had a significantly lower OS. Pre-therapeutic assessment of skeletal muscle mass can help identifying patients at risk of CDLT. In the future, routine skeletal muscle mass assessment may allow for personalized cancer care regarding optimal chemotherapy dose and early supportive care interventions.