Table A1.
Reported Response Rates and Adverse Events in Chlorambucil Monotherapy Arms of Various Studies
| Study Treatment | No. of Patients | Median Age (years) | Binet Stage C (%) | Rai Stage III/IV (%) | Dose per Cycle (mg/m2)* | Efficacy |
Safety (%) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia |
Infections (all grades) | Nausea (all grades) | |||||||||||
| ORR (%) | CR (%) | PFS (months) | OS (months) | All Grades | Grade 3/4 | ||||||||
| Fludarabine v chlorambucil v fludarabine plus chlorambucil8 | 193 | 64 | — | 41 | 40 | 37 | 4 | 14.0 | 56 | NR | 19 | NR | NR |
| Chlorambucil v fludarabine v fludarabine plus cyclophosphamide7 | 387 | 65 | 31 | — | 70 | 72 | 7 | 20.0 | Not reached | 28 | NR | NR | NR |
| Alemtuzumab v chlorambucil9 | 148 | 59 | — | 34 | 40 | 55 | 2 | 11.7 | Not reached | NR | 25 | NR | 35 |
| Chlorambucil v fludarabine10 | 100 | 70 | 40 | 43 | 38 | 51 | 0 | 18.0 | 64 | NR | 40 | 32 | NR |
| Bendamustine v chlorambucil11 | 157 | 64 | 29 | — | 60 | 31 | 2 | 8.3 | Not reached | 14 | 11 | 1 | 14 |
Abbreviations: CR, complete response; NR, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.
*
Based on average patient of 70 kg or 1.85 m2.