A Pilot Study of Bortezomib in Korean Patients with Relapsed or Refractory Myeloma.
10.3346/jkms.2005.20.4.598
- Author:
Keun Wook LEE
1
;
Tak YUN
;
Eun Kee SONG
;
Im Il NA
;
Hyunchoon SHIN
;
Soo Mee BANG
;
Jae Hoon LEE
;
Seung Tae LEE
;
Jee Hyun KIM
;
Sung Soo YOON
;
Jong Seok LEE
;
Seonyang PARK
;
Byoung Kook KIM
;
Noe Kyeong KIM
Author Information
1. Department of Internal Medicine, Seoul National University College of Medicine, Korea. ssysmc@snu.ac.kr
- Publication Type:Original Article ; Clinical Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Multiple Myeloma;
Drug Therapy;
bortezomib;
Velcade;
Proteasome Endopeptidase Complex;
Protease Inhibitors
- MeSH:
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
- From:Journal of Korean Medical Science
2005;20(4):598-602
- CountryRepublic of Korea
- Language:English
-
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.
