Table 5.

Randomized trials of rituximab added to CHOP in newly diagnosed previously untreated aggressive lymphomas


Trial

Design/regimen

Patients/diseases

Diseases

Significant results
Coiffier et al69  (2002)   R-CHOP vs CHOP   399 patients, aged 60-80 y, stage II-IV   REAL/WHO: DLBCL (84%), Burkitt, mantle-cell, marginal-zone, follicular lymphoma, SLL, Hodgkin lymphoma, B-cell lymphoma NOS, T-cell lymphoma   2-y EFS*: R-CHOP 43% vs CHOP 61% (P = .002); 2-y OS: R-CHOP 70% vs CHOP 57% (P = .007)  
Habermann et al72  (2003)   First randomization: R-CHOP vs CHOP; second randomization: MR vs no maintenance   632 patients, aged >60 y   REAL/WHO: DLBCL   2.7-y TTF favors R-CHOP (P = .025) and MR (P = .01); no difference in OS  
Pfreundschuh et al73  (2004)
 
R-CHOP-like vs CHOP-like
 
326 patients, aged 18-60 y, stage I (bulky), II-IV, low risk (IPI of 0-1)
 
REAL/WHO:DLBCL
 
2-y TTF: R-CHOP-like 76% vs CHOP-like 60% (P<.001); 2-y OS: R-CHOP-like 94% vs CHOP-like 87% (P = .001)
 

Trial

Design/regimen

Patients/diseases

Diseases

Significant results
Coiffier et al69  (2002)   R-CHOP vs CHOP   399 patients, aged 60-80 y, stage II-IV   REAL/WHO: DLBCL (84%), Burkitt, mantle-cell, marginal-zone, follicular lymphoma, SLL, Hodgkin lymphoma, B-cell lymphoma NOS, T-cell lymphoma   2-y EFS*: R-CHOP 43% vs CHOP 61% (P = .002); 2-y OS: R-CHOP 70% vs CHOP 57% (P = .007)  
Habermann et al72  (2003)   First randomization: R-CHOP vs CHOP; second randomization: MR vs no maintenance   632 patients, aged >60 y   REAL/WHO: DLBCL   2.7-y TTF favors R-CHOP (P = .025) and MR (P = .01); no difference in OS  
Pfreundschuh et al73  (2004)
 
R-CHOP-like vs CHOP-like
 
326 patients, aged 18-60 y, stage I (bulky), II-IV, low risk (IPI of 0-1)
 
REAL/WHO:DLBCL
 
2-y TTF: R-CHOP-like 76% vs CHOP-like 60% (P<.001); 2-y OS: R-CHOP-like 94% vs CHOP-like 87% (P = .001)
 

R-CHOP indicates rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; SLL, small lymphocytic lymphoma; NOS, not otherwise specified; EFS, event-free survival; OS, overall survival; TTF, time to treatment failure; MR, maintenance rituximab; IPI, International Prognostic Index.

*

Updated results at 5 years70  show 5-y EFS: R-CHOP 47% vs CHOP 29% (P < .001); 5-y OS R-CHOP 58% vs CHOP 45% (P = .007).

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