Journal List > Korean J Hematol > v.41(2) > 1032705

Jeong, Lee, Sohn, Shin, Yang, Kim, Kim, Baek, Kim, Kim, Chung, Cho, and Kim: Clinical Efficacy of Thalidomide Containing Regimens as a Primary Therapy in Patients with Multiple Myeloma

Abstract

Background:

The aim of this study was to assess the efficacy and toxicity of thalidomide-containing regimens as the first-line therapy for patients with multiple myeloma.

Methods:

A total of 60 patients were initially treated with thalidomide-containing regimens at three institutions. Thalidomide was given with two different regimens: the TD regimen (thalidomide and dexamethasone) and the TCD regimen (thalidomide, cyclophosphamide, and dexamethasone). Autologous peripheral blood stem cells (PBSC) were collected after mobilizing with G-CSF with or without cyclophosphamide.

Results:

Of all the patients, 56 patients (TD regimen: 12 patients, TCD regimen: 44 patients) who received at least 4 cycles or more were evaluated for response and toxicity. The median age of the patients was 65.5 years (age range: 39~80 years). The overall response rate for the thalidomide-containing regimens was 85.5%. There were 3 (25%) complete responses and 6 (50%) partial responses for the TD regimen and there were 17 (38.6%) complete responses and 21 (47.7%) partial responses for the TCD regimen, respectively. The toxicity, according to the NCI-CTC (grade 3/4) included neutropenia in 7 patients (12.5%), thrombocytopenia in 4 patients (7.1%), infection in 6 patients (10.7%) and neuropathy in 10 patients (17.8%). In addition, there were 2 patients (3.6%) with thrombosis. Thirteen patients, who achieved more than a partial response to the thalidomide-containing regimen, proceeded to PBSC collection and the median number of CD34+ cells collected was 3.8×106/kg.

Conclusion:

Thalidomide-based combination chemotherapy is a safe, well tolerated and effective regimen for patients with newly diagnosed multiple myeloma, and it showed a high response rates, relatively low toxicity and sufficient collection of PBSCs.

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Fig. 1
Overall survival (OS) and progression-free survival (PFS) of 56 multiple myeloma patients treated with thalidomide-containing regimens as a primary therapy.
kjh-41-83f1.tif
Fig. 2
OS (A) and PFS (B) of 56 multiple myeloma patients, according to thalidomide-containing regimens as a primary therapy (OS: P=0.82; PFS: P=0.27).
kjh-41-83f2.tif
Fig. 3
OS (A) and PFS (B) of 56 multiple myeloma patients, according to the undergoing autologous transplantation (OS: P=0.27; PFS: P=0.18).
kjh-41-83f3.tif
Table 1.
Characteristics of patients
Patients characteristics Total (n=56) TD regimen (n=12) TCD regimen (n=44) P
Age, median (range) (year) 65.5 (38~80) 68.5 (39~73) 63 (38~80) .280
Sex        
  Male 32 (57.1%) 4 (33.3%) 28 (63.6%) .099
  Female 24 (42.9%) 8 (66.7%) 16 (36.4%)  
ISS stage        
  I 17 (30.4%) 1 (8.3%) 16 (36.4%)  
  II 22 (39.3%) 7 (58.3%) 15 (34.1%) .143
  III 17 (30.4%) 4 (33.3%) 13 (29.5%)  
Immunoglobulin chain type        
  IgG 34 (60.7%) 9 (75.0%) 25 (56.8%)  
  IgA 15 (26.8%) 2 (16.7%) 13 (29.5%) .648
  IgM 5 (8.9%) 0 (0%) 4 (9.1%)  
  Light chain only 2 (3.6%) 1 (8.3%) 2 (4.5%)  
Serum albumin <3.5g/dL 34 (60.7%) 2 (16.7%) 24 (54.5%) .084
β2-microglobulin ≥5.5mg/L 17 (30.4%) 4 (33.3%) 13 (29.5%) .363
Serum creatinine >2.0mg/dL 10 (17.9%) 3 (25.0%) 6 (13.6%) .429

Abbreviations: TD, thalidomide+dexamethasone; TCD, thalidomide+cyclophosphamide+dexamethasone; ISS, international staging system. 15)

Table 2.
Response after thalidomide-containing combination chemotherapy
  Total (n=56) TD regimen (n=12) TCD regimen (n=44)
CR 22 (39.3%) 3 (25.0%) 17 (38.6%)
PR 25 (44.6%) 6 (50.0%) 21 (47.7%)
MR 4 (7.1%) 1 (8.3%) 3 (6.8%)
NC 2 (3.6%) 2 (16.7%) 0 (0%)
PD 2 (3.6%) 0 (0%) 2 (4.5%)
NM 1 (1.8%) 0 (0%) 1 (2.3%)

Abbreviations: CR, complete response; PR, partial response; MR, minimal response; NC, no change; PD, progressive disease.

Table 3.
Adverse events regimens by more than g following thalido grade III omide-containing
  TD regimen (n=12) TCD regimen (n=44)
Neutropenia 1 (8.3%) 6 (13.6%)
Thrombocytopenia 1 (8.3%) 3 (6.8%)
Infection 2 (16.6%) 4 (9.1%)
Neuropathy 4 (33.3%) 6 (13.6%)
Constipation 1 (8.3%) 3 (6.8%)
Deep vein thrombosis 1 (8.3%) 1 (2.3%)
Skin rash 0 (0%) 1 (2.3%)
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