Efficacy and safety of oral tapentadol for cancer-related pain: an updated systematic review and meta-analysis

Minerva Med. 2026 Jun;117(3):126-138. doi: 10.23736/S0026-4806.26.09857-5.

ABSTRACT

BACKGROUND: This systematic review aims to evaluate the efficacy, safety, and tolerability of oral tapentadol in the management of cancer-related pain in adults. It updates the 2015 Cochrane review on the same topic by including newer trials up to March 2024.

METHODS: A systematic search of Medline (via PubMed), the Cochrane Central Register of Controlled Trials, and references from the previous review was conducted. Randomized controlled trials comparing oral tapentadol with placebo or other opioids (e.g., morphine, oxycodone, tramadol/paracetamol) in adults with chronic cancer pain were included. The main outcomes assessed were pain reduction, need and dose of rescue medication, adverse events, treatment discontinuation, and patient-reported global impression of change. Risk of bias was evaluated using the Cochrane tool. Meta-analyses were performed using a random-effects model.

RESULTS: Five randomized controlled trials comprising 1152 patients were included. Across all outcomes evaluated, there was no significant difference between tapentadol and comparator opioids. Pain reduction was comparable (MD=-0.06; 95% CI: [-0.44, 0.31]), as were adverse effects (RR=0.98; 95% CI: [0.90, 1.08]), need for rescue medication (RR=1.07; 95% CI: [0.93, 1.22]), and dropout rates (RR=1.10; 95% CI: [0.87, 1.40]). All outcomes were rated as inconclusive due to overlapping confidence intervals with the null effect. The overall risk of bias was high in three studies and unclear in two.

CONCLUSIONS: Tapentadol demonstrated similar efficacy and safety compared to other opioids for cancer-related pain, with no evidence of superiority. Given the limited number and methodological quality of studies, further high-quality trials are needed to establish more robust conclusions.

PMID:42312727 | DOI:10.23736/S0026-4806.26.09857-5