title: A pilot study of bortezomib in Korean patients with relapsed or refractory myeloma.
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.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Korea.
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Tak
authors.initials: T
authors.lastname: Yun
authors.forename: Eun Kee
authors.initials: EK
authors.lastname: Song
authors.forename: Im Il
authors.initials: II
authors.lastname: Na
authors.forename: Hyunchoon
authors.initials: H
authors.lastname: Shin
authors.forename: Soo-Mee
authors.initials: SM
authors.lastname: Bang
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
authors.forename: Seung Tae
authors.initials: ST
authors.lastname: Lee
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Sung-Soo
authors.initials: SS
authors.lastname: Yoon
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Seonyang
authors.initials: S
authors.lastname: Park
authors.forename: Byoung Kook
authors.initials: BK
authors.lastname: Kim
authors.forename: Noe Kyeong
authors.initials: NK
authors.lastname: Kim
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007723:Korea; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D009364:Neoplasm Recurrence, Local; D010865:Pilot Projects; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone