Pain treatment with high-dose, controlled-release oxycodone: an Italian perspective

Fabio Ferrarese¹, Gioia Becchimanzi², Massimo Bernardo³, Maria Anna Conte⁴, Angela Gioia⁵, Davide Ottaviani⁶, Rosa Palomba⁷, Gianfranco Pedelini⁸, Laura Rigotti⁹, Elvira Scelzi¹⁰

¹Ospedale Ca’Foncello, Treviso; ²Cure Palliative, Terapia Antalgica, Ospedale Civile Pinerolo, Torino; ³Serv. Cure Palliative, Osp. Bolzano, Bolzano; ⁴Casa di cura “Pineta del Carso”, Aurisina, Trieste; ⁵Terapia Antalgica, Ospedale S. Chiara, Pisa; ⁶Ospedale Molinette, Torino; ⁷AOU Federico II, Napoli; ⁸Hospice S. Cristoforo Cologna Veneta, Verona; ⁹Servizio Cure Palliative Rovereto, Trento; ¹⁰U.O. di Oncologia Castelfranco Veneto, Treviso, Italy

Objective: To investigate the possible role and tolerability of high-dose (>160 mg/day) oxycodone controlled release (CR) for the treatment of cancer and non-cancer pain.

Design: 227 patients with cancer or non-cancer pain were enrolled in an open-label, multi-center, Italian study in order to assess the adequacy of their existing pain management (using a numerical rating scale [NRS]) and the possible benefit high-dose oxycodone CR may offer patients experiencing uncontrolled pain.

Results: Pain was poorly controlled at baseline, with only 18.1% of patients reporting adequate pain relief (NRS <3.5). All other patients reported uncontrolled pain, with an average NRS of 7.81. At baseline assessment, 47.89% of patients had been in pain for up to 3 months, 32.82% for 3–6 months, and 19.19% for more than 6 months. After baseline assessment, patients were switched to oxycodone CR monotherapy. The starting dose was individualized to each patient and titrated up over a 3- to 4-day period until effective pain management was achieved. Treatment was continued for an average of 37.24 days during the study. Pain control (final mean NRS of 2.85) was attained with an average dose of oxycodone CR 221.84 mg/day. Standard adverse events (including constipations, nausea, and vomiting) were recorded in 39.64% of patients receiving high-dose oxycodone CR monotherapy. Side-effects tended to subside after the initial week of treatment and did not result in any participants leaving the study.

Conclusion: High-dose oxycodone CR can achieve rapid and effective management of moderate to severe cancer and non-cancer pain with minimum side-effects.

Keywords: oxycodone CR, pain, high-dose, opioid, moderate-severe-pain, cancer, noncancer