Table 2.

Fludarabine-based regimens in relapsed or refractory CLL


Study

Treatment and regimen

No. patients*

Refractory, %

OR, %

CR, %

OR, % refractory
O'Brien et al (2001)61   Fludarabine 30 mg/m2 intravenously d 1-3, for 4-6 w, up to 6 courses; cyclophosphamide 300-500 mg/m2 intravenously d 1-3   94   69   80   12   39  
Hallek et al (2001)62   Fludarabine 30 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; cyclophosphamide 250 mg/m2 intravenously d 1-3   18   —   94   11   —  
Bosch et al (2002)63   Fludarabine 25 mg/m2 intravenously d 1-3 for 28 d, up to 6 courses; cyclophosphamide 200-600 mg/m2 intravenously d 1-3; mitoxantrone 6-8 mg/m2 d 1   60   58   78   50   34  
Mauro et al (2002)64   Fludarabine 25 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; Ara-C 1 g/m2 d 1-2; novantrone 10 mg/m2 d 1; dexamethasone 20 mg intravenously d 1-3   23   60   70   48   50  
Schulz et al (2002)65   Fludarabine 25 mg/m2 intravenously d 1-5 for 28 d, courses 1 to 4; rituximab 375 mg/m2 intravenously d 1 for 28 d, courses 3 to 7   11   —   90   27   —  
Wierda et al (2005)66 
 
Fludarabine 25 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; cyclophosphamide 250 mg/m2 intravenously d 1-3; rituximab 375-500 mg/m2 d 1 intravenously
 
177
 
18
 
73
 
25
 
58
 

Study

Treatment and regimen

No. patients*

Refractory, %

OR, %

CR, %

OR, % refractory
O'Brien et al (2001)61   Fludarabine 30 mg/m2 intravenously d 1-3, for 4-6 w, up to 6 courses; cyclophosphamide 300-500 mg/m2 intravenously d 1-3   94   69   80   12   39  
Hallek et al (2001)62   Fludarabine 30 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; cyclophosphamide 250 mg/m2 intravenously d 1-3   18   —   94   11   —  
Bosch et al (2002)63   Fludarabine 25 mg/m2 intravenously d 1-3 for 28 d, up to 6 courses; cyclophosphamide 200-600 mg/m2 intravenously d 1-3; mitoxantrone 6-8 mg/m2 d 1   60   58   78   50   34  
Mauro et al (2002)64   Fludarabine 25 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; Ara-C 1 g/m2 d 1-2; novantrone 10 mg/m2 d 1; dexamethasone 20 mg intravenously d 1-3   23   60   70   48   50  
Schulz et al (2002)65   Fludarabine 25 mg/m2 intravenously d 1-5 for 28 d, courses 1 to 4; rituximab 375 mg/m2 intravenously d 1 for 28 d, courses 3 to 7   11   —   90   27   —  
Wierda et al (2005)66 
 
Fludarabine 25 mg/m2 intravenously d 1-3, for 28 d, up to 6 courses; cyclophosphamide 250 mg/m2 intravenously d 1-3; rituximab 375-500 mg/m2 d 1 intravenously
 
177
 
18
 
73
 
25
 
58
 

— indicates not reported.

*

Only refers to relapsed or refractory patients included in these series

Definition of refractoriness: resistance to the previous treatment including alkylating agents or fludarabine

Fludarabine refractory patients defined as failure to achieve at least a PR with the last fludarabine-based treatment or progression within 6 months of treatment

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