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A pilot study of bortezomib in Korean patients with relapsed or refractory myeloma
Keun-Wook Lee1, Tak Yun, Eun Kee Song
1Department 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.
Insights
Bortezomib showed therapeutic activity in Korean multiple myeloma patients, with 43% achieving partial remission. This pilot study suggests bortezomib is feasible and effective, warranting further investigation in larger trials.
Area of Science:
- Hematology
- Clinical Oncology
- Pharmacology
Background:
- Bortezomib, a proteasome inhibitor, demonstrates therapeutic activity in multiple myeloma.
- Limited data exists on bortezomib's feasibility in Korean patient populations.
Purpose of the Study:
- To evaluate the feasibility and efficacy of bortezomib in Korean patients with relapsed or refractory multiple myeloma.
- To assess the safety profile of bortezomib in this specific demographic.
Main Methods:
- A pilot study involving seven Korean patients with relapsed or refractory multiple myeloma.
- Patients received bortezomib at 1.3 mg/m2 twice weekly for 2 weeks in a 3-week cycle.
- Prior treatments included VAD chemotherapy, thalidomide, alkylators, and autologous stem cell transplantation.
Main Results:
- Bortezomib monotherapy achieved 43% partial remission, 43% no change, and 14% progressive disease.
- Addition of dexamethasone to bortezomib resulted in partial remission in one non-responder.
- Common serious toxicities included thrombocytopenia (50% of cycles) and peripheral neuropathy (10% of cycles).
Conclusions:
- Bortezomib appears to be an effective and feasible treatment option for Korean patients with relapsed or refractory multiple myeloma.
- Larger clinical studies are needed to precisely define the efficacy and safety of bortezomib in this population.