J Korean Med Sci.  2005 Aug;20(4):598-602. 10.3346/jkms.2005.20.4.598.

A Pilot Study of Bortezomib in Korean Patients with Relapsed or Refractory Myeloma

• Lee KW
• Yun T
• Song EK
• Na II
• Shin H
• Bang SM
• Lee JH
• Lee ST
• Kim JH
• Yoon SS
• Lee JS
• Park S
• Kim BK
• Kim NK

• KMID: 1712739
• DOI: http://doi.org/10.3346/jkms.2005.20.4.598

Abstract

Recent clinical trials showed that bortezomib, a novel proteasome inhibitor, had therapeutic activity in multiple myeloma. However, there was no data about the feasibility of bortezomib in Korean patients. We performed a pilot study of bortezomib in patients with relapsed or refractory myeloma (1.3 mg/m2 twice weekly for 2 week in a 3-week cycle). Seven patients were enrolled. The median age of patients was 59 yr. All patients previously received VAD (vincristine, doxorubicin and dexamethasone) and thalidomide chemotherapy. Three patients previously received alkylator-containing chemotherapy and 4 patients, autologous stem cell transplantation. Bortezomib monotherapy resulted in 3 partial remissions (43%), 3 no changes (43%) and 1 progressive disease (14%). One patient who had no response to bortezomib monotherapy experienced partial remission after addition of dexamethasone to bortezomib. The most common serious toxicity was thrombocytopenia (grade 3/4, 10 of 20 cycles (50%)) and grade 3 peripheral neuropathy was developed in 2 of 20 cycles (10%). Drug-related adverse event led to discontinuation of bortezomib in 1 patient. There was no treatment related mortality. Overall, bortezomib seems to be effective and feasible. Conduction of larger clinical studies on Korean patients is necessary to characterize clinical efficacy and safety of bortezomib more precisely.

Keyword

Multiple Myeloma; Drug Therapy; bortezomib; Velcade; Proteasome Endopeptidase Complex; Protease Inhibitors

MeSH Terms

Aged
Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
Boronic Acids/administration & dosage/adverse effects/*therapeutic use
Dexamethasone/administration & dosage/adverse effects
Disease Progression
Drug Resistance, Neoplasm
Female
Humans
Korea
Male
Middle Aged
Multiple Myeloma/*drug therapy
Neoplasm Recurrence, Local
Pilot Projects
Pyrazines/administration & dosage/adverse effects/*therapeutic use
Research Support, Non-U.S. Gov't
Survival Analysis
Thrombocytopenia/chemically induced
Time Factors