• Marina Chiara Garassino, Sheila Piva, Nicla La Verde, Ilaria Spagnoletti, Vittorio Iorno, Claudia Carbone, Antonio Febbraro, Anna Bianchi, Annalisa Bramati, Anna Moretti, Monica Ganzinelli, Mirko Marabese, Marta Gentili, Valter Torri, and Gabriella Farina.
• Medical Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
• Plos One. 2013 Jan 1;8(4):e59981.

PurposeNeuropathic pain is commonly associated with cancer. Current treatments include combination opioid and adjuvant therapies, but no guidelines are available for dose escalation strategies. This phase II study compared the efficacy and tolerability of two dose escalation strategies for oxycodone and pregabalin combination therapy.MethodsPatients (N = 75) with oncological neuropathic pain, previously untreated with pregabalin, were recruited in 5 Italian institutions between 2007 and 2010. Patients were randomised to two different dose escalation strategies (arm A; N = 38) oxycodone at a fixed dose with increasing pregabalin doses; (arm B; N = 37) pregabalin at a fixed dose with increasing oxycodone doses. Patients were evaluated from daily diaries and follow-ups at 3, 7, 10, and 14 days after beginning treatment with a numerical rating scale (NRS), neuropathic pain scale (SDN), and well-being scale (ESAS). The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects. The study had a 90% probability of detecting the best strategy for a true difference of at least 15%.ResultsMore patients in arm A (76%) than arm B (64%) achieved ≥1/3 overall pain reduction even after controlling for baseline factors (gender, baseline pain). Group A reported fewer side effects than group B; constipation 52.8% vs. 66.7%; nausea: 27.8% vs. 44.4%; drowsiness: 44.4% vs. 55.6%; confusion: 16.7% vs. 27.8%; itching: 8.3% vs. 19.4%.ConclusionsBoth strategies effectively controlled neuropathic pain, but according to the adopted selection design arm A is preferable to arm B for pain control.Trial RegistrationClinicalTrials.gov NCT00637975.

27 keywords...

hide…