PPA_A_246757 859..868

Yoann Pointreau Rene-Jean Bensadoun 2 Guillaume Bera 3 Christian Sire Amandine Ruffier Guillaume Janoray Gilles Calais Marc Bollet Baptiste Pinel Viorica Braniste 8 Xavier Amores 1Radiotherapy Department, Interregional Cancer Institute (ILC) Jean Bernard Center, Le Mans, France; 2Radiotherapy Department, High Energy Center, Nice, France; 3Oncology and Radiotherapy Department, Southern Brittany Hospital Group, Lorient, France; 4Oncology and Radiotherapy Department, University Hospital of Tours, Tours, France; 5Oncology and Radiotherapy Department, François Rabelais University, EA 7505, Education Ethique Santé (EES), Tours, France; 6Radiotherapy Department, Hartmann Clinic, Neuillysur-Seine, France; 7Oncology and Radiotherapy Department, University Hospital of Poitiers, Poitiers, France; 8Kyowa Kirin Pharma, Neuilly-sur-Seine, France Objective: The severity of breakthrough cancer pain (BTcP) impacts patients’ quality of life, increases the risk of anxiety and depression, lowers functional capacities, and may lead to poor compliance with cancer treatments. The aim of the current study was to assess, in a real-life setting, patient satisfaction with a fentanyl-pectin-nasal-spray (FPNS) for BTcP management in head and neck (H&N) cancer patients treated by radiotherapy. Materials and Methods: This non-interventional, prospective study was conducted in 92 adult H&N-cancer patients undergoing radiotherapy and who started FPNS treatment for BTcP. Throughout the radiotherapy period, the patients completed self-diaries to assess their BTcP episodes, FPNS use, satisfaction on FPNS efficiency (primary outcome), tolerability and ease of use. Results: Prior to FPNS treatment, 86% of the patients were experiencing ≤4 BTcP episodes/day. During the radiotherapy period, the BTcP episodes were treated with a median dose of 100μg of FPNS. Patients were “satisfied/very-satisfied”with the efficiency (73% of assessments), ease of use (87% of assessments) and tolerability (87% of assessments) of FPNS. In total, 27% of patients reported at least one adverse event related to FPNS and 4%of patients discontinued treatment due to adverse events. None of the adverse events were serious. Patient quality of life was maintained throughout the radiotherapy period. Conclusion: This study showed, in a real-life setting, that a clear majority of H&N cancer patients treated with FPNS for BTcP throughout radiotherapy expressed satisfaction with this analgesic treatment.

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