Clin Drug Invest 2008; 28 (7): 399-407 ORIGINAL RESEARCH ARTICLE 1173-2563/08/0007-0399/$48.00/0 © 2008 Adis Data Information BV. All rights reserved. Oxycodone Controlled-Release as First-Choice Therapy for Moderate-to-Severe Cancer Pain in Italian Patients Results of an Open-Label, Multicentre, Observational Study Barbara Silvestri, 1 Elena Bandieri, 2 Salvatore Del Prete, 3 Giovanni Pietro Ianniello, 4 Giuseppe Micheletto, 5 Mario Dambrosio, 6 Giovanni Sabbatini, 7 Luigi Endrizzi, 8 Alessandro Marra, 9 Enrico Aitini, 10 Angioletta Calorio, 11 Ferdinando Garetto, 12 Giuseppe Nastasi, 13 Francovito Piantedosi, 14 Vincenzo Sidoti 15 and Piergiorgio Spanu 16 1 General Hospital, Noale, Venice, Italy 2 Operative Unit Medical Oncology, Carpi-Mirandola Hospital, Modena, Italy 3 San Giovanni di Dio Hospital, Frattamaggiore, Naples, Italy 4 A.O.S. Anna e S. Sebastiano, Caserta, Italy 5 General Hospital, Nolo, Italy 6 Multimedica, Sesto San Giovanni, Milan, Italy 7 Villa Pini d’Abruzzo Nursing Home, Chieti, Italy 8 General Hospital, Bassano del Grappa, Vicenza, Italy 9 UO Palliative Therapy and Pain Control Centre ASL Salerno 2, Eboli, Salerno, Italy 10 General Hospital ‘C.Poma’, Mantova, Italy 11 Martini Hospital, Turin, Italy 12 Gradenigo Hospital, Turin, Italy 13 General Hospital, Alzano Lombardo, Bergamo, Italy 14 Monaldi Hospital, Naples, Italy 15 Pinerolo Hospital ASL 10, Pinerolo, Turin, Italy 16 Mauriziano Hospital, Turin, Italy Background and objectives: Cancer pain affects patients at all stages of the Abstract disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; how- ever, numerous studies have shown that oxycodone controlled-release (CR) has a similar efficacy and safety profile. The purpose of this study was to evaluate the efficacy and tolerability of oxycodone CR as a first-line strong opioid for the treatment of moderate-to-severe pain in Italian cancer patients. Methods: This was a prospective, open-label, multicentre, observational trial carried out at 15 locations across Italy. Patients with a referral for cancer-related pain of ≥5 on a 10-point numerical rating scale were enrolled. Patients were treated with oral oxycodone CR and monitored for 21 days. Dosage was individu-