International Journal of Hematology

, Volume 83, Issue 4, pp 309–313 | Cite as

A Multicenter Retrospective Analysis of Adverse Events in Korean Patients Using Bortezomib for Multiple Myeloma

  • Soo-Mee Bang
  • Jae Hoon Lee
  • Sung-Soo Yoon
  • Seonyang Park
  • Chang-Ki Min
  • Chun-Choo Kim
  • Cheolwon Suh
  • Sang Kyun Sohn
  • Yoo-Hong Min
  • Je-Jung Lee
  • Kihyun Kim
  • Chu-Myong Seong
  • Hwi-Joong Yoon
  • Kyung Sam Cho
  • Deog-Yeon Jo
  • Kyung Hee Lee
  • Na-Ri Lee
  • Chul Soo Kim
  • Korean Multiple Myeloma Working Party (KMMWP)
Rapid Communication

Abstract

The proteasome inhibitor bortezomib has demonstrated clinical activity in patients with multiple myeloma (MM). Adverse events, including thrombocytopenia and peripheral neuropathy, have affected 30% to 60% of patients overall, and interrupted therapy in 10% to 20%. No prior toxicity data are available for Asian patients who have used bortezomib for MM. We used National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, to review the clinical records of patients with an MM diagnosis from 25 centers in Korea. The included patients were treated with bortezomib alone or in combination with other agents, including thalidomide. Ninety-five MM patients were treated. The patients had a median age of 60 years (range, 42-77 years). The median number of previous treatments was 3 (range, 0–10), and 39% of the patients had been treated with 4 or more major classes of agents, including thalidomide (67%), and autologous stem cell transplantation (51%). Regimens included bortezomib only in 38 patients (40%), bortezomib plus dexamethasone in 34 patients (36%), and bortezomib plus a thalidomide-containing regimen in 23 patients (24%). The analysis of patient response to therapy revealed a complete response (CR) or a near-CR in 31 patients (33%) and a partial response in 30 patients (32%), for an objective response rate of 65% in 93 patients. The most common adverse events reported were thrombocytopenia (47%), sensory neuropathy (42%), anemia (31%), and leukopenia (31%). Thirteen patients (14%) stopped therapy because of adverse events (neuropathy, 8; infection, 4; diarrhea, 1). Neuropathy greater than grade 2 was more frequent in patients who received 4 or more prior therapy regimens (17/37) than in those who received 3 or fewer (14/58). In addition, therapy including thalidomide was significantly correlated with neuropathy of grades 1 to 3 (P = .001). We identified 6 therapy-related deaths (6%) within 20 days after the last dose of borte-zomib. The causes of death were infection in 3 patients, disease progression in 2 patients, and suicide in 1 patient. The incidences of thrombocytopenia and neurotoxicity were similar; however, gastrointestinal toxicities were relatively low in Korean patients compared with those reported in Western studies. Significant neuropathy was associated with the number of prior regimens and combination with thalidomide. These findings provide useful information for clinicians and patients using bortezomib.

Key words

Bortezomib Adverse events Neurotoxicity Thalidomide Multiple myeloma 

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Copyright information

© The Japanese Society of Hematology 2006

Authors and Affiliations

  • Soo-Mee Bang
    • 1
  • Jae Hoon Lee
    • 1
  • Sung-Soo Yoon
    • 2
  • Seonyang Park
    • 2
  • Chang-Ki Min
    • 3
  • Chun-Choo Kim
    • 3
  • Cheolwon Suh
    • 4
  • Sang Kyun Sohn
    • 5
  • Yoo-Hong Min
    • 6
  • Je-Jung Lee
    • 7
  • Kihyun Kim
    • 8
  • Chu-Myong Seong
    • 9
  • Hwi-Joong Yoon
    • 10
  • Kyung Sam Cho
    • 10
  • Deog-Yeon Jo
    • 11
  • Kyung Hee Lee
    • 12
  • Na-Ri Lee
    • 13
  • Chul Soo Kim
    • 14
  • Korean Multiple Myeloma Working Party (KMMWP)
  1. 1.Department of Internal Medicine, Gil Medical CenterGachon Medical SchoolIncheonKorea
  2. 2.Seoul National University College of MedicineSeoul
  3. 3.Catholic HSCT CenterSeoul
  4. 4.Asan Medical CenterSeoul
  5. 5.Kyungpook National University HospitalDaegu
  6. 6.Yonsei University HospitalSeoul
  7. 7.Chonnam National University Hwasun HospitalJeonnam
  8. 8.Sungkyunkwan University School of MedicineSeoul
  9. 9.Ehwa Womens University HospitalSeoul
  10. 10.Kyunghee University HospitalSeoul
  11. 11.Chungnam National University HospitalDaejeon
  12. 12.Yeungnam University HospitalDaegu
  13. 13.Chonbuk National University HospitalJeonju
  14. 14.Inha University HospitalIncheonKorea

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