Table 2.
Results of clinical trials on B-CLL with fludarabine in combination with alkylating agents
| References | Comp study | No of evaluable patients | Prior therapy | Treatment regimen | Clinical response
|
Survival/duration of response | |
|---|---|---|---|---|---|---|---|
| CR (%) | OR (%) | ||||||
| FAMP + CHL | |||||||
| Elias et al54 | no | 17 | yes | FAMP 10–20 mg/m2 iv × d1–5 + CHL 15–20 mg/m2 iv × d1 q 4 wk |
6 | 53 | na |
| Weiss et al55 | no | 15 | yes | FAMP 10–20 mg/m2 iv × d1–5 +CHL 20 mg/m2 iv × d1 and d15 q 4 wk |
7 | 27 | na |
| FAMP + CTX | |||||||
| O’Brien et al57 | no | 128 | Yes (some) | FAMP 30 mg/m2 iv × d1–3 + CTX 300–500 mg/m2 iv × d1–3 q 4–6 wk |
17 | 74 | 12–38 mo median OS |
| Hallek et al120 | no | 32 | Yes (some) | FAMP 30 mg/m2 iv × d1–3 +CTX 250 mg/m2 iv × d1–3 q 4 wk |
16 | 90 | na |
| Eichhorst et al59 | yes | 328 | no | FAMP 25 mg/m2 iv × d1–5 q 4 wk (n = 164) | 7 | 83 | 20 mo median DFS |
| FAMP 30 mg/m2 iv × d1–3 +CTX 250 mg/m2 iv × d1–3 q 4 wk (n = 164) |
24 | 94 | 48 mo median DFS | ||||
| Flinn et al61 | yes | 278 | no | FAMP 20 mg/m2 iv × d1–5 +CTX
600 mg/m2 iv × d1 |
23 | 74 | 32 mo median PFS, OS 79% at 2 yrs |
| FAMP 25 mg/m2 iv × d1–5 q 4 wk | 7 | 59 | 19 mo median PFS, OS 80% at 2 yrs | ||||
| Catovsky et al62 | yes | 777 | no | FAMP 25 mg/m2 iv or
40 mg/m2 os × d1–5 q 4 wk |
15 | 80 | PFS 36%, OS 2% at 5 yrs |
| FAMP 25 mg/m2 iv x d1–3 or 24 mg/m2 os × d1–5 +CTX 250 mg/m2 iv × d1–3 or 150 mg/m2 os d1–5 q 4 wk |
38 | 95 | PFS 10%, OS 54% at 5 yrs | ||||
| CHL 10 mg/m2 os × d1–7 q 4 wk | 7 | 72 | PFS 10%, OS 59% 5 yrs | ||||
| Cazin et al63 | no | 76 | no | FAMP 30 mg/m2 os × d1–5 +CTX
200 mg/m2 os + d1–5 q 4 wk |
53 | 80 | median OS not reached at 7 yrs
5 yrs median PFS |
| Laurenti et al64 | no | 37 | no | FAMP 30 mg/m2 os × d1–3+
CTX 250 mg/m2 os × d1–3 q 4 wk |
40 | 77 | 23 mo median PFS
38 mo median TTR OS 89% at 30 mo |
| Flinn et al58 | no | 36 | no | FAMP 20 mg/m2 iv × d1–5+ CTX 600 mg/m2 iv × dl + G-CSF 5 mg/kg × d8–18/22 q 4 wk | 42 | 64 | DFS 92.9% 1 yr, 27 mo median DoR |
Abbreviations: Comp, comparative; CR, complete remission; OR, overall response; DFS, disease free survival; OS, overall survival; PFS, progression free survival; TTR, time to retreatment; DoR, duration of response; FAMP, fludarabine; CTX, cyclophosphamide; CHL, chlorambucil; d, days; mo, months; wk, weeks; q, every; iv, intravenous; os, oral; na, not available.