title: A prospective multicentre study to evaluate the efficacy and tolerability of osmotic release oral system (OROS) hydromorphone in opioid-naive cancer patients: Results of the Korean South West Oncology Group study.
abstract: BACKGROUND
  Osmotic release oral system (OROS) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients.
  
  
  OBJECTIVE
  A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain.
  
  
  METHODS
  OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg⁄day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients' and investigators' global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID).
  
  
  RESULTS
  A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment.
  
  
  CONCLUSIONS
  OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered rapid pain control.
authors.forename: Eun-Kee
authors.initials: EK
authors.lastname: Song
authors.forename: Hyunjeong
authors.initials: H
authors.lastname: Shim
authors.forename: Hye-Suk
authors.initials: HS
authors.lastname: Han
authors.forename: DerSheng
authors.initials: D
authors.lastname: Sun
authors.forename: Soon-Il
authors.initials: SI
authors.lastname: Lee
authors.forename: Myung Hee
authors.initials: MH
authors.lastname: Kang
authors.forename: KyuTaek
authors.initials: K
authors.lastname: Lee
authors.forename: DoYeun
authors.initials: D
authors.lastname: Cho
authors.forename: In Sung
authors.initials: IS
authors.lastname: Cho
authors.forename: Suk Young
authors.initials: SY
authors.lastname: Park
authors.forename: Samyong
authors.initials: S
authors.lastname: Kim
authors.forename: Chang-Yeol
authors.initials: CY
authors.lastname: Yim
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management; D010147:Pain Measurement; D010349:Patient Compliance; D011446:Prospective Studies; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004091:Hydromorphone