50th Annual Meeting of the American Society of Clinical Oncology (ASCO):

Fast and Effective Relief for Breakthrough Cancer Pain

Fast-acting fentanyl nasal spray may provide an effective and convenient alternative to standard therapy for breakthrough cancer pain, according to results of a study presented by Ignacio Delgado, MD, and colleagues at the Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois.

Fentanyl pectin nasal spray (FPNS) was FDA-approved for the management of breakthrough cancer pain in 2011. Since then, there has been limited data regarding the use of FPNS outside the setting of clinical trials. Therefore, the multicenter, open-label, prospective, observational QualiPec study was undertaken to gain a better understanding of the use of FPNS in a real-world setting.

Study Design
The study was open to adult patients with cancer receiving at least  60 mg morphine or equivalent per day for chronic pain whose physician elected to initiate FPNS for breakthrough pain. Patients had agreed to receive phone calls after starting FPNS therapy and complete self-questionnaires during the observation period. The study has enrolled 259 patients in France and 74 patients in Spain. Preliminary data were presented for 34 evaluable patients.

The evaluable group included 59% males; the average age was 64 years in men and 54 years in women. Metastases were reported in 26 patients, including 21 with bone metastases. The bone was the primary site of chronic pain in 53% of patients. Approximately 35% of patients had previously received fentanyl for chronic pain. The average time since onset of breakthrough pain was 9.6 months. Treatment for breakthrough pain, which had been administered in 78% of patients, included FPNS (32%), ibuprofen (32%), paracetamol (32%), morphine (24%), metamizole (12%), and tramadol (8%).

Follow-up Results
In the first day of starting FPNS, 56% of patients reported a positive overall satisfaction; this increased to 79% at Day 7. A satisfactory dose was attained after an average of 2.9 days. The 23 patients who completed the study reported improvements in global health status, emotional functioning, cognitive functioning, and social functioning during the 28-day follow-up period. Improvements were not reported in physical functioning or role functioning. Patients also reported a decrease in the degree of dependence over the treatment period, as assessed using the Instrumental Activities of Daily Living scale.

Fewer Episodes of Breakthrough Pain
Patients reported a decrease in the average number of episodes of breakthrough pain from 3.24 (range, 1-15) at the inclusion visit to 2.00 (range, 0-5) at the Day 28 visit. The average intensity of breakthrough pain on a scale of 1-10 decreased from 7.53 (range, 5-10) to 6.00 (range, 0-10) over the same period.

In regards to safety, one patient reported drug-related dizziness and vomiting that was not considered serious. Five patients died during the study due to disease progression. All but one patient who completed the 4-week study continued taking FPNS after the study completion; the remaining patient did not continue because breakthrough pain was no longer occurring.

Drs. Delgado and Anton-Aparicio have disclosed that they have received honorarium and research grants from Archimedes.


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