Efficacy and tolerability of transdermal fentanyl versus oral prolonged-release oxycodone/naloxone in patients with moderate to severe cancer pain: A propensity analysis comparison

Background

In cancer patients treated with opioids, both transdermal Fentanyl (TF) and oral PR Oxycodone-Naloxone (OXN) have been found effective in reducing pain, with less constipation in comparison with other opioids. No direct comparison is available between TF and OXN.

Methods

Consecutive cancer patients with moderate to severe cancer pain and naïve to WHO-III strong opioids enrolled in a two prospective 28-day studies (NCT01809106, NCT02293785) and receiving TF or OXN were selected; to adjust for bias inherent to heterogeneity and decision about their opioid therapy, we performed a propensity score analysis by multivariable logistic regression. Outcome measures included analgesic efficacy over time [worst and average pain NRS intensity decrease (APID); analgesic response (APID >30%); daily opioid dosage (morphine-equivalent MEQ, mg); daily opioid dose increase and rate of abnormal (>5%) escalation index] and safety profile as premature switch to other analgesics, constipation and other adverse events (AEs).

Results

124 TF and 173 OXN patients were included in the comparative analysis (age 68.3 ± 10.3; female 41.8%; average pain intensity at baseline 6.2 ± 1.3). The 28-day APID were similar after TF and OXN (worst -45.3 vs -43.3%; average -53.9 vs -52.0%; both NS); response rates were also comparable (75.9% TF vs 82.5% OXN, NS), indicating similar analgesic efficacy. However, different daily MEQ dosages were used both at baseline (53.4 TF vs 25.5 mg OXN, p 

Conclusions

In this propensity analysis of patients with moderate-severe cancer pain, OXN showed similar analgesic efficacy compared to TF, despite strikingly lower daily dosages and need of drug escalation, suggesting less mid-term tolerance with OXN in cancer pain.

Clinical trial identification

NCT01809106, NCT0229378

Legal entity responsible for the study

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri

Funding

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri

Disclosure

All authors have declared no conflicts of interest.