6th ICHNO Abstract Book

page 58 6 th ICHNO Conference International Conference on innovative approaches in Head and Neck Oncology 16 – 18 March 2017 Barcelona, Spain __________________________________________________________________________________________ 6th ICHNO

PO-121 Fentanyl Pectin Nasal Spray in head and neck cancer irradiation. First results of the PecDICO study Y. Pointreau 1 , G. Bera 2 , C. Sire 2 , A. Ruffier 3 , G. Janoray 3 , G. Calais 3 , R. Bensadoun 4 , M. Bollet 5 , B. Pinel 6 , L. Martin 7 , X. Amores 8 1 Centre Jean Bernard - Clinique Victor Hugo - Institut interrégionaL de Cancérologie, Radiothérapie, Le Mans, France 2 Bretagne Sud hospital, radiotherapy, Lorient, France 3 Bretonneau university hospital, radiotherapy, Tours, France 4 Haute Energie Centre, radiotherapy, Nice, France 5 Hartmann clinic, radiotherapy, Neuilly-sur-Seine, France 6 La Miletrie university hospital, radiotherapy, Poitiers, France 7 Radiotherapy center, radiotherapy, Le Havre, France 8 Kyowa Kirin Pharma, Medical Department, Neuilly-sur- Seine, France Purpose or Objective Previous pivotal clinical trials demonstrated efficacy and safety of Fentanyl Pectin Nasal Spray (FPNS) in breakthrough pain in cancer patients (BTPc). Considering the specific profile of patients with head and neck (H&N) cancer, this non-interventional study mainly aims to describe the real-life satisfaction with FPNS in patients treated with radiotherapy. Material and Methods PecDICO is an ongoing French non-interventional, prospective, and multicentre study conducted in patients receiving radiation therapy for H&N cancer and who started FPNS treatment for BTPc at inclusion. Data collection is mainly based on a patient BTPc diary and medical visits. We present here the results from inclusion data collected between November 2014 and June 2016. Results When introducing FPNS, the characteristics of the 93 patients enrolled in 7 centres were as follows: mean age 60±8 years, 80% male, 94% BMI ≥18.5 kg/m², 100% ECOG score ≤2 , 77% at least one concomitant disease/risk factor (past or current smoking 67%, past or current alcoholism 41%). The H&N cancer was located at oropharynx (44%), oral cavity (25%), hypopharynx (19%), larynx (14%), and/or other sites (3%); median time from initial diagnosis was 3.8 months (range: 1.8-30.9). At inclusion, disease stage was III/IV in 19%/56% of the cases. Cancer treatments included surgery (30%), chemotherapy (67%; chemoradiotherapy: 54%), and/or cetuximab (23%). Radiotherapy was started 4 weeks (median; range: 0.4- 7.9) prior to FPNS start. Patients’ nutritional assessment showed dysphagia in 97% of the cases (grade 1/2/3/4: 20%/61%/7%/9%), oral food supplements (65%), feeding tube (15%) or gastrostomy (15%). A weight loss >10% over the last month was observed in 22% of patients. As opioid therapy for chronic pain, 93% of patients received transdermal fentanyl and rescue treatment was added in 40% of cases (morphine sulfate 18%, oxycodone 17%). Other treatments with an analgesic effect were given in 94% of the patients (grade 1/2 analgesics 62%/26%, lidocaine gel 43% and/or corticosteroids 19%). The first BTPc episode occurred 4 days prior FPNS initiation (median; range: 0-78). BTPc were nociceptive (45%) or mixed pain (55%) and they were procedural, predictable or spontaneous in 8%, 90% and/or 30% of the patients. The duration of BTPc episodes was ≤20 minutes in 83% of the cases. At FPNS initiation, BTPc intensity was assessed ≥5 by 60% of patients (30/50) on the basis of a 0-10 numerical scale, with up to 4 daily episodes (86%; 37/43). Conclusion These first results provides detailed information about patient characteristics receiving radiotherapy for H&N

cancer and starting FPNS for BTPc, as well as on cancer management, BTPc episodes, and pain treatments. Real- world data on patient satisfaction with FPNS (and then its perceived efficiency and tolerability) are expected in 2017. PO-122 Psychological profile of patients with head and neck cancer during radiotherapy: preliminary data M. Massaccesi 1 , L. Dinapoli 1 , A. Pesce 1 , F. Miccichè 1 , R. Autorino 1 , A. Tenore 1 , M. Balducci 1 , V. Valentini 1 1 Università Cattolica del Sacro Cuore -Policlinico A. Gemelli, Radiation Oncology Gemelli ART, Rome, Italy Purpose or Objective Radiation treatment (RT) with radical intent for head and neck (H&N) cancer is usually complex and burdensome. The radiation course generally lasts 6 to 7 weeks and more than half patients can experience relevant acute toxicity. Toxic effects may be even more frequent in patients who also receive concurrent chemotherapy (CT). Therefore the experience of receiving RT can be both uncomfortable and anxiety provoking. Aim of this study is to evaluate the psychological profile of patients with H&N cancer during RT. Material and Methods Consecutive patients with H&N cancer who underwent RT with radical intent were included between January and September 2016. Psychological support was available for all patients and Distress Thermometer (DT) and Hospital Anxiety and Depression Scale (HADS) were administered to evaluate emotional distress and mood, respectively. These tests were administered at the beginning (T0), the middle (T1), and the end (T2) of the RT course. Results Fifty patients (36 male and 14 female, mean age 61, range 14-82 years) who underwent radical RT for H&N cancer were included. RT was post-operative in 22 patients (44.0%) and was delivered up to a medial total dose of 68 Gy (range 50-70 Gy). Twenty-five (50.0%) patients received concurrent CT. All 50 patients underwent the T0 evaluation. The T1 and T2 evaluations were done in 40 (80.0%) and 34 (68.0%) patients, respectively. At T0 evaluation, 32/50 patients (64.0%) were emotionally distressed (cut off value DT score≥4) and 12/50 patients (24%) showed anxiety/depression (cut off value HADS score≥14). At T1, 27/40 (67.5%) patients had significant emotional distress and 9/40 (22.5%) patients had significant anxiety and depression. At T2, 25/34 (73.5%) patients had significant emotional distress and 12/34 (35.3%) patients had significant anxiety and depression. During RT, patients who were distressed (32/50) or anxious and depressed (12/50) at the beginning of treatment did not show any significant variation of their DT score, while HADS score significantly improved at T2 evaluation (median HADS score 19 and 15, at T0 and T2 respectively, p=0.03). Patients who were not distressed (18/50) or anxious and depressed (38/50) at baseline, showed a worsening of DT score at both T1 (p=0.02) and T2 (p=0.01) as compared to baseline; HADS score remained substantially stable at T1 while worsened at T2 (p=0.03). Conclusion In this small series of consecutive patients with H&N cancer treated with RT, a psychological support during treatment allowed to prevent any further deterioration in distressed patients. However, it did not completely prevent a worsening in patients who had initially normal scores. The occurrence of acute treatment related toxic effects could explain such deterioration and further analysis is ongoing to test this hypothesis.