Fentanyl sublingual tablets (FST) are a potentially
useful alternative to parenteral opioids such as
subcutaneous morphine (SCM) to treat severe cancer
No direct comparison between FST and SCM is
available. The aim of this new study was to test
noninferiority of FST versus SCM during the first 30
Patients receiving stable opioid therapy and
experiencing a severe pain episode were randomly
assigned to either 100 µg FST or 5 mg SCM in a
double-blind, double-dummy trial.
Average pain intensity (PI) assessed on a 0 to 10
numerical rating scale at 10, 20, and 30 min
postadministration was the main end point.
Analysis of covariance, adjusted by baseline PI, was
the main analysis.
The noninferiority margin (NIm) for the
between-group difference was set at −0.6, that is,
equal to one third of the minimum clinically
important PI difference of two points.
A total of 114 patients were randomly assigned to
either FST (n = 58) or SCM (n = 56).
One patient (in the FST group) withdrew consent
before drug administration and was excluded from
Baseline mean PIs were 7.5 in both groups; mean
average PIs assessed at 10, 20, and 30 min
postadministration were 5.0 and 4.5 for FST and SCM,
respectively, with the 95% CI of the between-group
difference including the NIm (−0.49; 95% CI, −1.10
Patients taking FST received a second drug dose
after 30 min more frequently than did patients
taking SCM (51% v 37%, respectively; risk
difference, −13%; 95% CI, −30% to 3%).
Both treatments were well tolerated, with average
follow-up adverse event scores below the response of
“A Little.” Ninety-three percent of patients
preferred the sublingual administration.
This trial did not show noninferiority of FST versus
SCM within the chosen NIm.
Both treatments were safe, and patients preferred
the sublingual route of administration.
FST provides analgesia with modest to moderate
increased risk of lower efficacy compared with SCM.
For more information
Journal of Clinical Oncology
Fentanyl Sublingual Tablets Versus Subcutaneous
Morphine for the Management of Severe Cancer Pain
Episodes in Patients Receiving Opioid Treatment: A
Double-Blind, Randomized, Noninferiority Trial
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