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Original Article

Pain outcomes in patients with advanced breast cancer and bone metastases

Results from a randomized, double-blind study of denosumab and zoledronic acid

  1. Charles S. Cleeland PhD1,†,*,
  2. Jean-Jacques Body MD, PhD2,
  3. Alison Stopeck MD3,
  4. Roger von Moos MD4,
  5. Lesley Fallowfield BSc, DPhil, FMedSci5,
  6. Susan D. Mathias MPH6,
  7. Donald L. Patrick PhD, MSPH7,
  8. Mark Clemons MD8,
  9. Katia Tonkin MD9,
  10. Norikazu Masuda MD, PhD10,
  11. Allan Lipton MD11,
  12. Richard de Boer MD12,
  13. Stefania Salvagni MD13,
  14. Celia Tosello Oliveira MD14,
  15. Yi Qian PhD15,
  16. Qi Jiang PhD15,
  17. Roger Dansey MD16,
  18. Ada Braun MD, PhD16,
  19. Karen Chung PharmD, MS17

Article first published online: 5 SEP 2012

DOI: 10.1002/cncr.27789

Issue

Cancer

Cancer

Volume 119, Issue 4, pages 832–838, 15 February 2013

Additional Information

How to Cite

Cleeland, C. S., Body, J.-J., Stopeck, A., von Moos, R., Fallowfield, L., Mathias, S. D., Patrick, D. L., Clemons, M., Tonkin, K., Masuda, N., Lipton, A., de Boer, R., Salvagni, S., Oliveira, C. T., Qian, Y., Jiang, Q., Dansey, R., Braun, A. and Chung, K. (2013), Pain outcomes in patients with advanced breast cancer and bone metastases. Cancer, 119: 832–838. doi: 10.1002/cncr.27789

Author Information

  1. 1

    University of Texas, MD Anderson Cancer Center, Department of Symptom Research, Houston, Texas

  2. 2

    Brugmann University Hospital, Department of Medicine, Brussels, Belgium

  3. 3

    Arizona Cancer Center, University of Arizona, Department of Hematology and Oncology, Tucson, Arizona

  4. 4

    Cantonal Hospital Graubünden, Department of Oncology and Hematology, Chur, Switzerland

  5. 5

    Sussex Health Outcomes Research and Education in Cancer (SHORE-C), University of Sussex, Brighton, United Kingdom

  6. 6

    Health Outcomes Solutions, Winter Park, Florida

  7. 7

    University of Washington, Department of Health Services, Seattle, Washington

  8. 8

    The Ottawa Hospital Cancer Centre, Division of Medical Oncology, Ottawa, Ontario, Canada

  9. 9

    Cross Cancer Institute, Division of Medical Oncology, Edmonton, Alberta, Canada

  10. 10

    Osaka National Hospital, Department of Surgery, Breast Oncology Unit, Osaka, Japan

  11. 11

    Penn State Milton S. Hershey Medical Center, Department of Oncology and Hematology, Hershey, Pennsylvania

  12. 12

    Western and Royal Melbourne Hospitals, Department of Medical Oncology, Melbourne, Australia

  13. 13

    University Hospital of Parma, Division of Medical Oncology, Parma, Italy

  14. 14

    The Brazilian Institute For Cancer Control, Department of Clinical Oncology, Sao Paulo, Brazil

  15. 15

    Amgen Inc., Department of Biostatistics and Epidemiology, Thousand Oaks, California

  16. 16

    Amgen Inc., Department of Hematology/Oncology, Thousand Oaks, California

  17. 17

    Amgen Inc., Department of Global Health Economics, Thousand Oaks, California

  1. †

    Fax: (713) 745-3593

*University of Texas, MD Anderson Cancer Center, 1100 Holcombe Boulevard, Unit 221, Houston, TX 77030

  1. †

    Fax: (713) 745-3593

Publication History

  1. Issue published online: 4 FEB 2013
  2. Article first published online: 5 SEP 2012
  3. Manuscript Accepted: 11 JUL 2012
  4. Manuscript Received: 20 JUN 2012

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Keywords:

  • RANK ligand;
  • denosumab;
  • clinical trial;
  • zoledronic acid;
  • breast neoplasms;
  • pain;
  • analgesics

Abstract

BACKGROUND:

In this study, the authors evaluated the effect of denosumab versus zoledronic acid (ZA) on pain in patients with advanced breast cancer and bone metastases.

METHODS:

The prevention of pain, reduction in pain interference with daily life activities, and the proportion of patients requiring strong opioid analgesics were assessed in a randomized, double-blind, double-dummy phase 3 study comparing denosumab with ZA for preventing skeletal-related events in 2046 patients who had breast cancer and bone metastases. Patients completed the Brief Pain Inventory-Short Form at baseline and monthly thereafter.

RESULTS:

Fewer patients who received denosumab reported a clinically meaningful worsening of pain severity (≥2-point increase) from baseline compared with patients who received ZA, and a trend was observed toward delayed time to pain worsening with denosumab versus ZA (denosumab, 8.5 months; ZA, 7.4 months; P = .08). In patients who had no/mild pain at baseline, a 4-month delay in progression to moderate/severe pain was observed with denosumab compared with ZA (9.7 months vs 5.8 months; P = .002). Denosumab delayed the time to increased pain interference by approximately 1 month compared with ZA (denosumab, 16.0 months; ZA, 14.9 months; P = .09). The time to pain improvement (P = .72) and the time to decreased pain interference (P = .92) were similar between the groups. Fewer denosumab-treated patients reported increased analgesic use from no/low use at baseline to strong opioid use.

CONCLUSIONS:

Denosumab demonstrated improved pain prevention and comparable pain palliation compared with ZA. In addition, fewer denosumab-treated patients shifted to strong opioid analgesic use. Cancer 2013. © 2012 American Cancer Society.

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