First-line CIT trials for CLL
| Regimen and trial . | No. of patients . | Median age (y) . | Older patents (%) . | Creatinine clearance <70 mL/min (%) . | CR% . | ORR% . | PFS (mo) . | Comments . |
|---|---|---|---|---|---|---|---|---|
| FCR | ||||||||
| MDACC12,13 | 300 | 57 | 14% (≥70 y) | NR (creatinine ≥2 excluded) | 72 | 95 | 80 | Lower CR rate in older patients |
| CLL8 trial (FCR arm)14 | 408 | 61 | 11% (≥70 y) | Excluded | 44 | 90 | 52 | Patients (≥65 y) had similar CR and PFS as younger patients; however, there was more hematologic toxicity and bacterial infections in older patients |
| 31% (≥65 y) | ||||||||
| CLL10 trial (FCR arm)16 | 282 | 61 | 31% (≥65 y) | Excluded | 40 | 95 | 55 | |
| FCR-lite25,26 | 63 | 58 | 15% (≥70 y) | NR (creatinine ≥1.8 excluded) | 73 | 94 | 70 | |
| BR | ||||||||
| GCLLSG phase 215 | 117 | 64 | 26% (>70 y) | 35% | 23 | 88 | 34 | ORR inferior for older patients but similar PFS; patients with lower GFR had a response and PFS similar to those with GFR ≥70 mL/min |
| CLL10 trial (BR arm)16 | 279 | 62 | 39% (≥65 y) | Excluded | 31 | 96 | 42 | |
| FR | ||||||||
| CALGB 971223,24 | 104 | 63 | NR | NR (creatinine >1.5 × ULN excluded) | 47 | 84 | 42 | |
| PCR | ||||||||
| Kay27,28 | 64 | 63 | 28% (≥70 y) | 40% | 41 | 91 | 33 | No difference in PFS between older and younger or between those with poor renal function and normal renal function |
| FCO | ||||||||
| Wierda29 | 61 | 56 | 18% (≥65 y) | NR (creatinine > 1.5 × ULN excluded) | 41 | 75 | ∼70% at 1 y | |
| PCO | ||||||||
| Shanafelt30 | 48 | 65 | 38% (≥70 y) | NR (creatinine > 1.5 × ULN excluded) | 46 | 96 | NR | |
| G-FC | ||||||||
| Brown22 | 21 | 58 | NR | NR (creatinine clearance ≤ 60 mL/min excluded) | 24 | 62 | 100% at a median follow-up of 20.7 mo | |
| G-B | ||||||||
| Brown22 | 20 | 62 | NR | NR | 45 | 90 | 100% at a median follow-up of 23.5 mo |
| Regimen and trial . | No. of patients . | Median age (y) . | Older patents (%) . | Creatinine clearance <70 mL/min (%) . | CR% . | ORR% . | PFS (mo) . | Comments . |
|---|---|---|---|---|---|---|---|---|
| FCR | ||||||||
| MDACC12,13 | 300 | 57 | 14% (≥70 y) | NR (creatinine ≥2 excluded) | 72 | 95 | 80 | Lower CR rate in older patients |
| CLL8 trial (FCR arm)14 | 408 | 61 | 11% (≥70 y) | Excluded | 44 | 90 | 52 | Patients (≥65 y) had similar CR and PFS as younger patients; however, there was more hematologic toxicity and bacterial infections in older patients |
| 31% (≥65 y) | ||||||||
| CLL10 trial (FCR arm)16 | 282 | 61 | 31% (≥65 y) | Excluded | 40 | 95 | 55 | |
| FCR-lite25,26 | 63 | 58 | 15% (≥70 y) | NR (creatinine ≥1.8 excluded) | 73 | 94 | 70 | |
| BR | ||||||||
| GCLLSG phase 215 | 117 | 64 | 26% (>70 y) | 35% | 23 | 88 | 34 | ORR inferior for older patients but similar PFS; patients with lower GFR had a response and PFS similar to those with GFR ≥70 mL/min |
| CLL10 trial (BR arm)16 | 279 | 62 | 39% (≥65 y) | Excluded | 31 | 96 | 42 | |
| FR | ||||||||
| CALGB 971223,24 | 104 | 63 | NR | NR (creatinine >1.5 × ULN excluded) | 47 | 84 | 42 | |
| PCR | ||||||||
| Kay27,28 | 64 | 63 | 28% (≥70 y) | 40% | 41 | 91 | 33 | No difference in PFS between older and younger or between those with poor renal function and normal renal function |
| FCO | ||||||||
| Wierda29 | 61 | 56 | 18% (≥65 y) | NR (creatinine > 1.5 × ULN excluded) | 41 | 75 | ∼70% at 1 y | |
| PCO | ||||||||
| Shanafelt30 | 48 | 65 | 38% (≥70 y) | NR (creatinine > 1.5 × ULN excluded) | 46 | 96 | NR | |
| G-FC | ||||||||
| Brown22 | 21 | 58 | NR | NR (creatinine clearance ≤ 60 mL/min excluded) | 24 | 62 | 100% at a median follow-up of 20.7 mo | |
| G-B | ||||||||
| Brown22 | 20 | 62 | NR | NR | 45 | 90 | 100% at a median follow-up of 23.5 mo |
FCO, fludarabine, cyclophosphamide, and ofatumumab; FR, fludarabine and rituximab; GFR, glomerular filtration rate; NR, not reported; PCO, pentostatin, cyclophosphamide, and ofatumumab; PCR, pentostatin, cyclophosphamide, and rituximab; ULN, upper limit of normal.