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A pilot study of bortezomib in Korean patients with relapsed or refractory myeloma
Authors:Lee Keun-Wook  Yun Tak  Song Eun Kee  Na Im Il  Shin Hyunchoon  Bang Soo-Mee  Lee Jae Hoon  Lee Seung Tae  Kim Jee Hyun  Yoon Sung-Soo  Lee Jong Seok  Park Seonyang  Kim Byoung Kook  Kim Noe Kyeong
Affiliation:Department of Internal Medicine, Seoul National University College of Medicine, Korea.
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.
Keywords:Multiple Myeloma   Drug Therapy   bortezomib   Velcade   Proteasome Endopeptidase Complex   Protease Inhibitors
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