An exploratory analysis on the effectiveness of four strong opioids in patients with cancer pain.
OBJECTIVE
This analysis, carried out in the context of a wider observational prospective study, tried to explore whether four World Health Organization/step-III opioids (morphine, oxycodone, fentanyl, and buprenorphine) had different effectiveness when using several different outcomes and endpoints.


METHODS
Cross-sectional and longitudinal design.


METHODS
Oncologic, palliative, and pain centers in Italy.


METHODS
Two hundred fifty-eight cancer patients monitored over a 3-week follow-up program. Intervention.  Not applicable.


METHODS
The analgesic efficacy was assessed using effectiveness endpoints, such as pain intensity, pain intensity difference (PID), proportion of nonresponders (NR) and full-responders (FR) subjects, percentage of switches and dose escalation.


RESULTS
Mean values of PID led to differences among opioids ranging from 10% to 30%. FR (PID ≥ 30%) were more frequent in buprenorphine-fentanyl-oxycodone groups than in morphine; NR (PID ≤ 0%) were variable. The percentage of switches resulted three times more frequent when using morphine than buprenorphine (24.4% vs 8.6%). An increase of dose ≥ 5% a day was observed in 33.3% of fentanyl patients vs 15% of buprenorphine. As a whole, opioids show some different behaviors on the basis of the considered endpoints.


CONCLUSIONS
The observed results, even if the small sample size and the nature itself of the study do not allow a definitive evaluation of the effectiveness of the drugs, underline a degree of variability among opioids and address toward a correct planning of a comparative randomized clinical trial that is now underway in Italy. For this reason, a confirmative effectiveness randomized controlled trial is required.
Center for the Evaluation and Research on Pain, Mario Negri Institute of Pharmacological Research, Milan, Italy. oscar.corli@marionegri.it
Oscar
O
Corli
Mauro
M
Montanari
Silvia
S
Deandrea
Maria Teresa
MT
Greco
Walter
W
Villani
Giovanni
G
Apolone
D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology*; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology*; D010147:Pain Measurement / Q000187:drug effects* / Q000706:statistics & numerical data; D010865:Pilot Projects; D015995:Prevalence; D016896:Treatment Outcome
D000701:Analgesics, Opioid