Tapentadol in cancer pain management: a prospective open-label study

Abstract

c i a l D i s t r i b u t i o n U n a u t h o r i z e d u s e p r o h i b i t e d . A u t h o r i s e d u s e r s c a n d o w n l o a d , d i s p l a y , v i e w a n d p r i n t a s i n g l e c o p y f o r p e r s o n a l u s eCurrent Medical Research & Opinion Vol. 28, No. 11, 2012, 1775-1779 AbstractObjectives: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 (p50.0005), 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. Conclusion: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. Limitations:This was an open-label study for exploratory purposes. Data should be confirmed in controlled studies with a larger number of patients. IntroductionCancer pain management is based on a sequential approach of drugs, as suggested by the WHO, through steps corresponding to drugs with different potencies. Application of the WHO three-step analgesic ladder has been reported to provide satisfactory pain relief in up to 90% of patients with cancer pain 1 . This approach has had an impact of paramount importance in terms of clinical outcome and educational perspective, although evidence is lacking, particularly with regard to possible alternatives, because of the paucity of controlled studies in this field. More recently, studies have examined the role of opioid analgesics and confirmed that more data are necessary 2 . It is anticipated that new drugs will be evaluated in the near future. For personal use only.

Spinal neuronal correlates of tapentadol analgesia in cancer pain: A back‐translational approach

“…In cancer patients, controlled studies of tapentadol are still lacking. However, the existing data are encouraging; a slow development of tolerance and fewer adverse effects (Mercadante et al, 2012b;Imanaka et al, 2013) and an unexpected beneficial effect in incident bone pain previously treated with methadone (Mercadante et al, 2012a), possibly explained by bone pain having a masked state of hyperalgesia (Portenoy, 2011). This prompted us to perform an experimental analysis of tapentadol on spinal neuronal signalling in a rat model of metastatic bone pain to reveal the potential mechanisms underlying the analgesic effect observed in cancer patients with bone metastases.…”

Validation of Pain Severity Assessment using the PainDETECT Questionnaire

“…Some studies have reported the PD-Q score and used it to identify patients with NeP components at baseline [8][9][10][11]. Other studies have used the PD-Q to assess the response of NeP components to therapy [12,13]. These studies showed that the PD-Q score significantly improved at the end of the treatment period.…”

“…Previous longitudinal studies on drug treatment used the PD-Q score as one of the inclusion criteria (i.e., score ≥ 13) to identify patients with NeP components [8][9][10][11], and these studies successfully revealed that the experimental drug showed significant improvements in the NRS as well as the PD-Q scores. Different from these studies, a small prospective open-label study [13] used the PD-Q in addition to the NRS to evaluate cancer pain severity. That study included 46% patients without NeP components on the basis of their PD-Q scores (i.e., <13).…”

“…These correlations were also observed in the subset of 35 patients with a high PD-Q score (≥ 13) (current pain, r=0.38, p=0.03; average pain in the past 4 weeks, r=0.53, p=0.001; worst pain in the past 4 weeks, r=0.28, p=0.098). However, the and secondary endpoints [8][9][10][11][12][13]15]. The patients were asked to complete them twice.…”

Cancer pain physiology

“…The drug has been demonstrated to treat effectively both acute and chronic pain, both in animal models and in patients and is also effective on mixed pains, namely, low-back pain and, importantly, in cancer pain patients. 72,73 The drug acts by stimulating inhibitory MOR and mediating noradrenaline reuptake inhibition (NRI) leading to activation of the inhibitory alpha-2 adrenoceptor at spinal levels. These dual actions produce effective analgesia but with a reduced opioid load tolerability.…”