Sublingual Fentanyl Tablets for Relief of Breakthrough Pain in Cancer Patients and Association with Quality-of-Life Outcomes.
OBJECTIVE
Breakthrough pain (BTP) is highly prevalent in patients with cancer and is strongly associated with adverse outcomes related to health status, mood, anxiety and depression. However, studies on the effect of BTP medication on quality of life (QOL) are lacking. The purpose of this study was to provide a qualitative evaluation of the effect of sublingual fentanyl tablets (SFT), a therapy specifically developed for BTP, on the QOL of cancer pain patients.


METHODS
We conducted a multicentre, prospective observation post-authorisation, open-label study between March and December 2013. The study consisted of a screening visit and four assessment points at 3, 7, 15 and 30 days. Pain intensity (PI), frequency of BTP, onset of pain relief and adverse events (AEs) were assessed at each visit. Anxiety and depression were evaluated using the validated Hospital Anxiety and Depression Scale (HADS) and health status using the Short Form 12, version 2 (SF-12v2) Health Survey.


RESULTS
Of the 102 patients considered eligible, 81 (79.4 %) were enrolled; of these, 69 (85.1 %) completed the study. Significant pain reduction was achieved for average PI (p < 0.001) compared with baseline. At the end of the observational period, HADS scores showed significant improvement in the depression subscale (p = 0.005) and the anxiety subscale (p < 0.001). Similarly, SF-12 scores showed significant improvement, both in the mental component score (p < 0.001) and the physical component score (p = 0.002). SFT was well-tolerated and only one patient withdrew from the study due to drug-related AEs.


CONCLUSIONS
SFT represents an effective, well-tolerated treatment for cancer BTP. Results provide consistent evidence for the positive impact of SFT on health-related QOL and physical functioning as well as other co-morbidities of cancer BTP such as anxiety and depression.
Department of Anesthesiology, Hospital Plató, c/ Plató 21., 08006, Barcelona, Spain. jordi.guitart@hospitalplato.com.
Jordi
J
Guitart
Department of Anesthesiology, Parc Sanitari Sant Joan de Deu, Barcelona, Spain.
María Isabel
MI
Vargas
Pain Unit, Department of Anesthesiology, Hospital Universitari Sagrat Cor, Barcelona, Spain.
Vicente
V
De Sanctis
Department of Anesthesiology, Hospital Plató, c/ Plató 21., 08006, Barcelona, Spain.
Jordi
J
Folch
Department of Anesthesiology, Hospital Comarcal d'Inca, Palma de Mallorca, Spain.
Rafael
R
Salazar
Department of Anesthesiology, Pius Hospital de Valls, Tarragona, Spain.
José
J
Fuentes
Department of Anesthesiology, Hospital General de l'Hospitalet, Barcelona, Spain.
Jordi
J
Coma
Pain Unit, Department of Anesthesiology, Hospital Residència Sant Camil, Barcelona, Spain.
Julia
J
Ferreras
Pain Unit, Department of Anesthesiology, Hospital Mateu Orfila, Minorca, Spain.
Jordi
J
Moya
Pain Unit, Department of Anesthesiology, Fundació Hospital Sant Bernabé, Barcelona, Spain.
Albert
A
Tomás
Department of Anesthesiology, Parc Sanitari Sant Joan de Deu, Barcelona, Spain.
Pere
P
Estivill
Department of Anesthesiology, Hospital Comarcal d'Inca, Palma de Mallorca, Spain.
Francisco
F
Rodelas
Laboratorios ProStrakan SLU, Madrid, Spain.
Antonio Javier
AJ
Jiménez
D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059390:Breakthrough Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D013607:Tablets; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D013607:Tablets; D005283:Fentanyl