https://orcid.org/0000-0003-1290-7497
Abstract
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.
Abbreviations
AE, adverse event; BTcP, breakthrough cancer pain; CI, Confidence Interval; ECOG, Eastern Cooperative Oncology Group; ER/LA, extended-release/long-acting; FPNS, fentanyl pectin nasal spray; H&N, head and neck; IR, immediate release; ROO, rapid-onset opioids.
Data Sharing Statement
Data are not publicly available, but may be provided upon request.
Ethics Approval and Informed Consent
In agreement with the French regulation for non-interventional studies, the study protocol #CP090/13, Version 1.0 dated March 25, 2014) was approved by the Consultative Committee on Information Processing for Research in the Field of Health (Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé, CCTIRS) and was authorized by the National Commission on Data Processing and Liberties (Commission Nationale de l’Informatique et des Libertés, CNIL) prior to implementation, on respectively June 18, 2014 and October 14, 2014. Similarly, tacit approval by the French College of Physicians (Conseil National de l’Ordre des Médecins, CNOM) was obtained on April 12, 2015.
In agreement with the French laws on non-interventional studies, the participating clinicians gave an oral information to patients on the study, supported by an information sheet provided to each patient. Patients gave then a verbal consent to participating to the study without any objections for the use of his/her personal data.
Acknowledgments
The authors would like to thank all the patients included and who participated in this study. Assistance funded by Kyowa Kirin Pharma was provided by STATITEC (Carine Vera, logistic services and monitoring, data management, and statistical analysis), and AUXESIA (Marie-Odile Barbaza, MD, medical writing assistance under the direction of the authors).
Author Contributions
All authors were involved in the study design, data interpretation, revising the manuscript critically for intellectual content, and in the final approval of the version to be published. YP, RJB, GB, CS, AR, GJ, MB, and BP were also involved in data acquisition. VB and XA were also involved in the study conception. All authors agree to be accountable for all aspects of the work.
Disclosure
YP has participated in advisory boards for BMS, Kyowa Kirin Pharma, Merck, MSD, and Pierre Fabre Oncology, and in speakers’ bureau for BMS and MSD. He is also a paid consultant to MSD and BMS. RJB and AR have participated in advisory boards for Kyowa Kirin Pharma. GB has participated in advisory boards for BMS, Janssen and Sanofi, and he is also a paid consultant to Janssen. GJ has participated in advisory boards for Kyowa Kirin Pharma and Pierre Fabre Oncology, and in speakers’ bureau for BMS and Merck. VB and XA are employees at Kyowa Kirin Pharma. BP, GC, MB and CS have no relationships to declare. The authors report no other conflicts of interest in this work.