Tapentadol in cancer pain management: a prospective open-label study.
OBJECTIVE
The aim of this prospective, open-label study was to evaluate the efficacy and tolerability of tapentadol (TP) in the management of cancer pain.


METHODS
A 4 weeks' prospective study was carried out in 50 opioid-naive cancer patients with moderate-severe pain. Each patient initially received twice-daily doses of slow-release TP 50 mg. Doses were then managed to maintain adequate relief or dose-limiting toxicity, on the basis of the clinical response. The following parameters were recorded at weekly intervals for 4 weeks: pain and opioid-related adverse effects, quality of life measured with the Spitzer score, TP escalation index percent (TPEI%) and TP escalation index in mg (TPEImg), calculated at the end of the study, pain mechanisms, and PainDETECT at baseline.


RESULTS
Of 50 patients, 39 completed the entire study and 11 discontinued the treatment for different reasons. Pain intensity significantly decreased from baseline to all the week intervals (p < 0.0005), and adverse effects did not changed significantly, while quality of life improved. TP escalation indexes were low and no relationship was found with age, gender, and pain mechanisms.


CONCLUSIONS
Tapentalol started in doses of 100 mg/day was well-tolerated and effective in opioid-naive patients with cancer pain, regardless of the pain mechanism. It can be considered as a flexible drug to be used in patients with moderate-severe pain.


CONCLUSIONS
This was an open-label study for exploratory purposes. Data should be confirmed in controlled studies with a larger number of patients.
Anesthesia & Intensive Care Unit, and Pain Relief & Palliative Care Unit, La Maddalena Cancer Center, 90146 Palermo, Italy. terapiadeldolore@lamaddalenanet.it
Sebastiano
S
Mercadante
Giampiero
G
Porzio
Patrizia
P
Ferrera
Federica
F
Aielli
Claudio
C
Adile
Corrado
C
Ficorella
Antonello
A
Giarratano
Alessandra
A
Casuccio
D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010636:Phenols / Q000627:therapeutic use*; D011446:Prospective Studies; D000077432:Tapentadol
D000700:Analgesics; D010636:Phenols; D000077432:Tapentadol