Supportive Care in Cancer

, Volume 22, Issue 3, pp 741–750

A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics

  • Hye-Suk Han
  • Ki Hyeong Lee
  • Kyung Hee Lee
  • Jeong Seon Ryu
  • Young Chul Kim
  • Seung Woo Park
  • Ho-Suk Oh
  • Kyung Tae Park
  • Jung Hye Kwon
  • Pyung Bok Lee
  • Won Sik Lee
  • Yang Soo Kim
  • Joong Bae Ahn
  • Seong Woo Jeon
  • Sung Yong Lee
  • Young Mi Seol
  • Jung Hun Kang
  • Young Jin Yuh
  • So Yeon Oh
  • Suk Ran Kim
  • Jin Seok Ahn
Original Article

DOI: 10.1007/s00520-013-2030-1

Cite this article as:
Han, HS., Lee, K.H., Lee, K.H. et al. Support Care Cancer (2014) 22: 741. doi:10.1007/s00520-013-2030-1

Abstract

Purpose

The objective of this study was to evaluate whether extended-release hydromorphone (osmotic-controlled release oral delivery system [OROS] hydromorphone) treatment provided pain relief in cancer patients whose pain was inadequately controlled by other analgesics.

Methods

In this prospective, open-label, multicenter trial, patients who have sustained cancer pain with other analgesics were enrolled. After the baseline evaluation (visit 1), OROS hydromorphone was administered. Two evaluations (visits 2 and 3) were made: 29 ± 7 and 57 ± 7 days later, respectively. The primary end point was the pain intensity difference (PID) at visit 3 relative to visit 1 (expressed as percent PID).

Results

In total, 879 patients were screened and 432 completed all three visits. Of the 874 full analysis set patients, 343 (39.2 %) improved by more than 30 % PID. Of the 432 per-protocol patients, 282 (65.3 %) improved by more than 30 % PID. At visits 2 and 3, the degree of sleep disturbance, the number of awakenings, and the degree of sleep satisfaction were significantly better than at visit 1 (all P < 0.0001 for both visit 1–visit 2 and visit 1–visit 3). However, this pain relief was not associated with improved quality of life (P = 0.326 and P = 0.055 for visit 1–visit 2 and visit 1–visit 3, respectively).

Conclusions

This study suggested that active pain management using the strong opioid OROS hydromorphone was beneficial in the management of cancer pain that was not controlled by other analgesics.

Keywords

Analgesics Cancer Hydromorphone Opioid Pain 

Supplementary material

520_2013_2030_MOESM1_ESM.doc (132 kb)
ESM 1(DOC 131 kb)
520_2013_2030_MOESM2_ESM.doc (122 kb)
ESM 2(DOC 121 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Hye-Suk Han
    • 1
  • Ki Hyeong Lee
    • 1
  • Kyung Hee Lee
    • 2
  • Jeong Seon Ryu
    • 3
  • Young Chul Kim
    • 4
  • Seung Woo Park
    • 5
  • Ho-Suk Oh
    • 6
  • Kyung Tae Park
    • 7
  • Jung Hye Kwon
    • 8
  • Pyung Bok Lee
    • 9
  • Won Sik Lee
    • 10
  • Yang Soo Kim
    • 11
  • Joong Bae Ahn
    • 5
  • Seong Woo Jeon
    • 12
  • Sung Yong Lee
    • 13
  • Young Mi Seol
    • 14
  • Jung Hun Kang
    • 15
  • Young Jin Yuh
    • 16
  • So Yeon Oh
    • 17
  • Suk Ran Kim
    • 18
  • Jin Seok Ahn
    • 19
    • 20
  1. 1.Department of Internal Medicine, College of MedicineChungbuk National UniversityCheongjuSouth Korea
  2. 2.Department of Internal MedicineYeungnam University College of MedicineDaeguSouth Korea
  3. 3.Department of Internal MedicineInha University College of MedicineIncheonSouth Korea
  4. 4.Department of Internal MedicineChonnam National University Hwasun HospitalGwangjuSouth Korea
  5. 5.Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea
  6. 6.Department of Internal Medicine, Gangneung Asan HospitalUniversity of Ulsan College of MedicineGangneungSouth Korea
  7. 7.Department of Internal Medicine, Samsung Changwon HospitalSungkyunkwan University School of MedicineChangwonSouth Korea
  8. 8.Department of Internal Medicine, Hallym University Medical CenterHallym University College of MedicineSeoulSouth Korea
  9. 9.Department of Anesthesiology and Pain MedicineSeoul National University Bundang HospitalSeongnamSouth Korea
  10. 10.Department of Oncology/HematologyHwawon Jeil Internal Medicine ClinicDaeguSouth Korea
  11. 11.Department of Internal MedicineGospel Hospital Kosin University College of MedicineBusanSouth Korea
  12. 12.Department of Internal MedicineKyungpook National University Medical CenterDaeguSouth Korea
  13. 13.Department of Internal Medicine, College of MedicineKorea UniversitySeoulSouth Korea
  14. 14.Department of Internal Medicine, School of MedicinePusan National UniversityBusanSouth Korea
  15. 15.Department of Internal MedicineGyeongsang National University School of MedicineJinjuSouth Korea
  16. 16.Department of Internal MedicineInje University Sanggye Paik HospitalSeoulSouth Korea
  17. 17.Department of Internal MedicineSeoul Medical CenterSeoulSouth Korea
  18. 18.Medical AffairsJanssen KoreaSeoulSouth Korea
  19. 19.Department of MedicineSamsung Medical CenterSeoulSouth Korea
  20. 20.Division of Hematology-Oncology, Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea

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