Oral Prolonged-Release Oxycodone-Naloxone: Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer

Good Response with Appropriate Treatment (GREAT) Collaborators, Oscar Corli, Vittorio Iorno, Lorenzo Legramandi, Eliana Rulli, Anna Roberto, Giuseppe Azzarello, Stefania Schiavon, Luigi Cavanna, Stefano De Santis, Claudio Cartoni, Pierangelo Di Marco, Mario Dauri, Rosario Mistretta, Roberto Bortolussi, Mario Clerico, Manuela Pacchioni, Carlo Crispino, Mirko Marabese, Nicole CorsiSilvia Natoli, Gaspare Lipari, Marta Luzi, Giovanna Palumbo, Leonardo Trentin

Research output: Contribution to journalArticle

Abstract

Background: Oxycodone-naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. Pain intensity, changes of therapy, and adverse drug reactions were recorded at each visit. The primary efficacy endpoint was the proportion of responders (≥30% reduction of pain intensity from baseline to final) and final average pain score ≤ 4 on a scale of 0 to 10. Results: Average and worst pain intensity and breakthrough pain (BTP) prevalence decreased over time, and 81.3% of patients were responders. The starting daily dose of OXN was raised from 25.1 ± 13.0 mg to 44.1 ± 29.9 mg, and dose escalation > 5%/day was observed in 19.4% of patients; 40.8% to 46.2% and 11.0% to 17.0% experienced any constipation and a severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785.

Original languageEnglish
Pages (from-to)633-643
JournalPain Practice
Volume19
Issue number6
DOIs
Publication statusPublished - Jan 1 2019

Keywords

  • analgesia
  • constipation
  • factors influencing the response
  • oxycodone-naloxone
  • patients with cancer

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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    Good Response with Appropriate Treatment (GREAT) Collaborators, Corli, O., Iorno, V., Legramandi, L., Rulli, E., Roberto, A., Azzarello, G., Schiavon, S., Cavanna, L., De Santis, S., Cartoni, C., Di Marco, P., Dauri, M., Mistretta, R., Bortolussi, R., Clerico, M., Pacchioni, M., Crispino, C., Marabese, M., ... Trentin, L. (2019). Oral Prolonged-Release Oxycodone-Naloxone: Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer. Pain Practice, 19(6), 633-643. https://doi.org/10.1111/papr.12784