Korean J Intern Med.
2011 Dec;26(4):403-409. 10.3904/kjim.2011.26.4.403.
A Combination of Melphalan, Prednisone, and 50 mg Thalidomide Treatment in Non-Transplant-Candidate Patients with Newly Diagnosed Multiple Myeloma
- Affiliations
-
- 1Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. smbang7@snu.ac.kr
- 2Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Korea.
- 3Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
- 4Department of Internal Medicine, Catholic University of Daegu, Daegu, Korea.
- 5Department of Internal Medicine, Daegu Fatima Hospital, Daegu, Korea.
- 6Department of Internal Medicine, Seoul Veterans Hospital, Seoul, Korea.
- 7Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
- KMID: 1729242
- DOI: http://doi.org/10.3904/kjim.2011.26.4.403
Abstract
- BACKGROUND/AIMS
The clinical efficacy and safety of a three-drug combination of melphalan, prednisone, and thalidomide were assessed in patients with multiple myeloma who were not candidates for high-dose therapy as a first-line treatment. Because the side effects of thalidomide at a dose of > or = 100 mg daily can be a barrier to effective treatment for these patients, we evaluated the efficacy and safety of a reduced dose of thalidomide, 50 mg, for non-transplant candidates.
METHODS
Twenty-one patients were treated in 4-week cycles, receiving 4 mg/m2 melphalan and 40 mg/m2 prednisone on days 1-7 and 50 mg thalidomide daily. The primary efficacy outcome was the overall response rate. Aspirin (100 mg daily) was also provided as prophylactic treatment for thromboembolism.
RESULTS
The overall response rate was 57.1%; a complete response was seen in 23.8% of patients, a partial response in 33.3%, and stable disease in 9.5%. After a median follow-up time of 16.1 months, the median time to progression was 11.4 months (95% confidence interval, 2.1 to 20.6); the median overall survival was not reached. Grades 3 and 4 adverse events included infection (10%), peripheral neuropathy (5%), diarrhea (5%), thrombosis (10%), and loss of consciousness (10%). Two patients discontinued treatment due to loss of consciousness and neuropathy.
CONCLUSIONS
Low-dose thalidomide (50 mg) plus melphalan and prednisone is an effective combination drug therapy option for newly diagnosed myeloma patients who are ineligible for high-dose chemotherapy.
Keyword
MeSH Terms
-
Aged
Angiogenesis Inhibitors/*therapeutic use
Antineoplastic Agents, Alkylating/*therapeutic use
Antineoplastic Agents, Hormonal/*therapeutic use
Confidence Intervals
Disease Progression
Drug Therapy, Combination
Female
Humans
Kaplan-Meier Estimate
Korea
Male
Melphalan/*therapeutic use
Middle Aged
Multiple Myeloma/*drug therapy/mortality
Prednisone/*therapeutic use
Risk
Thalidomide/*therapeutic use
Time Factors
Treatment Outcome
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