Table 2

Trials comparing MPT plus thalidomide maintenance versus MP

Study groupMedian age, y (no. of patients)Induction therapyMaintenance dose, duration of treatmentImprovement in quality of responseEFS or PFS*OS*Survival after relapseThalidomide tolerance
GIMEMA: Palumbo et al26  (2006) 72 (N = 255) (A) MPT thalidomide 100 mg/d 6 cycles Thalidomide 100 mg/d until relapse CR + PR: (A) 76.0% 2-y EFS: (A) 54% 3-y OS: (A) 80% NA Grades 3 or 4 AEs: (A) 48% 
   (B) 47.6%    (B) 25% P = .0002 
   nCR/CR:     
 (B) MP  (A) 27.9% (B) 27% (B) 64%   
  6 cycles None (B) 7.2% P = .0006 P = .19   
GIMEMA: Palumbo et al27  (2008) 72 (N = 331) A) MPT 6 cycles Thalidomide 100 mg/d until relapse CR + VGPR: (A) 44.9% PFS: (A) 21.8 mo (A) 45 mo (A) 11.5 mo Grades 3 or 4: (A) 55% 
(B) MP 6 cycles None (B) 14.7% (B) 14.5 mo (B) 47.6 mo (B) 24.3 mo (B) 22% 
  P < .001 P = .001 P = .79 P = .01  
HOVON: Wijermans et al30  (2010) 72 (N = 333) (A) MPT: thalidomide 50 mg/d 8 cycles Thalidomide 50 mg/d until relapse > PR: (A) 66% (B) 45% P < .001 EFS: (A) 13 mo (B) 9 mo P < .001 (A) 40 mo (B) 31 mo P = .05 NA Grade ≥ 2 toxicities: (A) 87% (B) 60% 
 (B) MP 8 cycles  ≥VGPR PFS: 2-y OS:   
  None (A) 27% (B) 10% P < .001 (A) 33% (B) 21% P = .05 67 vs. 61%   
   4-y OS: 43% vs 30%   
    2 y-PFS:    
 (A) 34% 
 (B) 14% 
NMSG: Waage et al31  (2010) 74.5 (N = 357) (A) MPT: thalidomide up to 400 mg/d; cycles were given until plateau phase Thalidomide 200 mg/d until relapse ≥ PR: (A) 57% (B) 40% PFS: (A) 15 mo (B) 14 mo P = .84† (A) 29 mo (B) 32 mo P = .16 NA Grades 3 or 4 nonhematologic: (A) 40% (B) 19% 
    PNP: (A) 6% 
(B) MP: cycles were given until plateau phase None ≥ VGPR: (A) 23%    (B) 1% 
    (B) 7% P < .0001    TVT: (A) 8% 
        (B) 8% 
TMSG: Beksac et al32  (2011) (N = 122) (A) MPT: thalidomide 100 mg, 12 mo Thalidomide 100 mg/d continuously ≥ PR: (A) 57.9% (B) 37.5% P = .03 DFS: (A) 21.0 mo (B) 14.0 mo P = .342 (A) 26 mo (B) 28 mo P = .655  Infections (grades 3 or 4): (A) 22.4% (B) 7% 
(B) MP, 12 mo None     
Study groupMedian age, y (no. of patients)Induction therapyMaintenance dose, duration of treatmentImprovement in quality of responseEFS or PFS*OS*Survival after relapseThalidomide tolerance
GIMEMA: Palumbo et al26  (2006) 72 (N = 255) (A) MPT thalidomide 100 mg/d 6 cycles Thalidomide 100 mg/d until relapse CR + PR: (A) 76.0% 2-y EFS: (A) 54% 3-y OS: (A) 80% NA Grades 3 or 4 AEs: (A) 48% 
   (B) 47.6%    (B) 25% P = .0002 
   nCR/CR:     
 (B) MP  (A) 27.9% (B) 27% (B) 64%   
  6 cycles None (B) 7.2% P = .0006 P = .19   
GIMEMA: Palumbo et al27  (2008) 72 (N = 331) A) MPT 6 cycles Thalidomide 100 mg/d until relapse CR + VGPR: (A) 44.9% PFS: (A) 21.8 mo (A) 45 mo (A) 11.5 mo Grades 3 or 4: (A) 55% 
(B) MP 6 cycles None (B) 14.7% (B) 14.5 mo (B) 47.6 mo (B) 24.3 mo (B) 22% 
  P < .001 P = .001 P = .79 P = .01  
HOVON: Wijermans et al30  (2010) 72 (N = 333) (A) MPT: thalidomide 50 mg/d 8 cycles Thalidomide 50 mg/d until relapse > PR: (A) 66% (B) 45% P < .001 EFS: (A) 13 mo (B) 9 mo P < .001 (A) 40 mo (B) 31 mo P = .05 NA Grade ≥ 2 toxicities: (A) 87% (B) 60% 
 (B) MP 8 cycles  ≥VGPR PFS: 2-y OS:   
  None (A) 27% (B) 10% P < .001 (A) 33% (B) 21% P = .05 67 vs. 61%   
   4-y OS: 43% vs 30%   
    2 y-PFS:    
 (A) 34% 
 (B) 14% 
NMSG: Waage et al31  (2010) 74.5 (N = 357) (A) MPT: thalidomide up to 400 mg/d; cycles were given until plateau phase Thalidomide 200 mg/d until relapse ≥ PR: (A) 57% (B) 40% PFS: (A) 15 mo (B) 14 mo P = .84† (A) 29 mo (B) 32 mo P = .16 NA Grades 3 or 4 nonhematologic: (A) 40% (B) 19% 
    PNP: (A) 6% 
(B) MP: cycles were given until plateau phase None ≥ VGPR: (A) 23%    (B) 1% 
    (B) 7% P < .0001    TVT: (A) 8% 
        (B) 8% 
TMSG: Beksac et al32  (2011) (N = 122) (A) MPT: thalidomide 100 mg, 12 mo Thalidomide 100 mg/d continuously ≥ PR: (A) 57.9% (B) 37.5% P = .03 DFS: (A) 21.0 mo (B) 14.0 mo P = .342 (A) 26 mo (B) 28 mo P = .655  Infections (grades 3 or 4): (A) 22.4% (B) 7% 
(B) MP, 12 mo None     

NA indicates not available.

*

Data are median values unless otherwise stated.

†

P value from oral presentation; definite value not stated in final publication.

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