N19 - Efficacy and tolerability of oxycodone-naloxone prolonged release tablets (o/n –prt) for moderate to severe bone pain in cancer patients (pts) bone metastases (bm): data from a single-centre experience

Abstract

Background: Bone pain still represents a major issue in cancer pts with bone metastases. Mild to moderate bone pain can be efficiently controlled using NSAIDs +/- weak opioids +/- adjuvant drugs whereas strong opioids are needed to control moderate to severe pain. Due to its unique mechanism of action, O/N-PRT can achieve a satisfactory control of pain with less side effects in terms of constipation. In our center we have evaluated efficacy and safety of O/N-PRT in cancer pts with symptomatic BM. Patients And methods: From March 2013 to November 2014, we evaluated efficacy and tolerability of O/N-PRT in 203 consecutive cancer pts with painful BM. Median age was 62.4 years ( range: 37-86 yrs); all pts had moderate to severe bone pain despite analgesic treatment with NSAIDs +/- weak opioids +/- adjuvant drugs. Median pain intensity (assessed on a 10-point NRS) at baseline was 6.9 (range: 6-9). After discontinuation of weak opioids, O/N-PRT was administered at dose 20/10 mg bid; after baseline, pain intensity was evaluated at day 1, 3, 5 and 7 whereas adverse events and QoL scores were daily assessed for 7 consecutive days. Results: Efficacy and safety of O/N-PRT were assessed in all recruited pts. Median pain intensity progressively decreased as follows: at day 1 a median NRS of 4.8 (range 3-6)was detected; at day 3, 5 and 7 median NRS values were 3.6 (range 3-5), 3.1 (range 2-5) and 2,2 (range 1-4), respectively. During the entire period of evaluation no modifications of QoL scores were reported; adverse events were modest: only 43 pts experienced mild constipation easily treated with common laxatives. Conclusions: In our experience, O/N-PRT confirmed its satisfactory efficacy and tolerability in cancer pts with moderate to severe pain due to BM: it represents an effective therapeutic option in cancer pts with symptomatic BM.