1612P - Breakthrough pain (BTP) in opioid-tolerant cancer patients: a pan-European open-label multicentre study with fentanyl buccal tablet (FBT)

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive measures
Presenter Sebastiano Mercadante
Authors S. Mercadante1, A. Davies2, J. Jarosz3, U.R. Kleeberg4, T. O'Brien5, P. Poulain6, H. Schneid7
  • 1La Maddacena Cancer Center, Palermo/IT
  • 2Palliative Medicine, Royal Surrey County Hospital NHS Foundation Trust, Guildford/UK
  • 3Palliative Medicine Unit, SCMCC and Institute of Oncology, Warsaw/PL
  • 4Hematology And Medical Oncology, H, DE-22767 - Hamburg/DE
  • 5Palliative Medicine, Marymount Hospice, Cork/IE
  • 6Palliative Unit, Polyclinique de l'Ormeau, Tarbes/FR
  • 7Medical Affairs Eu, Teva Pharmaceutical, Maisons-Alfort/FR


BTP, a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain, is a common problem in cancer patients. FBT is indicated for the treatment of BTP in adults with cancer already receiving maintenance opioid therapy for chronic cancer pain and should be titrated to an effective dose that provides adequate analgesia and minimises undesirable events. In this study, patients entered a screening period and were randomized during an open-label titration period to a starting FBT dose of 100 µg (group A) or 200 µg (group B) to identify the FBT effective dose and then treated in an open-label period (for 8 BTP episodes). Patients' inclusion followed the FBT label. 442 patients were screened from 135 European sites (7 countries) and 330 were enrolled into the titration period [group A (156); group B (174)]. Cancer history of the patients: breast (20.3%), lung (14.2%), colon/rectum (12.1%), other (24.5%). The most frequent extent of the disease was bone metastasis and local disease, for 45.8% and 40.6% of patients, respectively. 312 (94.5%) received at least one dose of study drug during the titration period [group A (145; 92.9%); group B (167; 96.0%). The effective dose rate (primary outcome) was 75.2% in the group A compared to 81.4% in the group B with non-inferiority established. Medication performance was assessed during the treatment period using a 5-point scale (0 = poor to 4 = excellent). Responses at 30 min. and at 60 min. post dose were “good” to “excellent” for 70.3% (1248/1176 BTP) and 82.4% (1374/1668 BTP) respectively. Patients' quality of life and functional status [modified Brief Pain Inventory-short version 7 item subscale (BPI-7S)] improved after treatment with FBT [BPI-7S global score [mean (SD)] decreased from 39.7 (15.85) before to 31.6 (16.8) after treatment. The ease of use of FBT was rated “very easy/convenient” and “easy/convenient” for 82.5% (174/211) of patients. Safety data do not indicate concerns with use of FBT and were as expected for cancer patients with opioid treatments. These results demonstrate that FBT was safe and efficacious in a real-world clinical practice setting with a large number of cancer patients experiencing BTP.


S. Mercadante: Investigator,

A. Davies: Investigator,

J. Jarosz: Investigator,

U.R. Kleeberg: Investigator,

T. O'Brien: Investigator,

P. Poulain: Investigator

H. Schneid: Teva Pharmaceutical employee.