Table 2.
Randomized phase 3 clinical trials evaluating chemotherapy with or without rituximab for the treatment of chronic lymphocytic leukemia.5–22–44
| Study | Patient population | Arm (number of patients) |
Treatment* (mg/m2) |
Response†: ORR (CR) (%) |
Progression free survival (months) |
Overall survival |
|---|---|---|---|---|---|---|
| Hallek22 | Treatment naive CLL and an indication for therapy physically fit patients of any age with normal kidney function were enrolled | Chemotherapy arm-FC (409) | Fludarabine 25 d 1–3×6 cycles | 80 (22) | Median 32.8 | 83% at 3 yrs |
| CLL08 | Cyclophosphamide 250 d 1–3×6 cycles | (95% CI 29.6–36) 45 % at 3 yrs | ||||
| Chemoimmunotherapy arm-FCR (408) | FC same as chemotherapy arm | 90 (44) | Median 51.8 | 87% at 3 yrs | ||
| Rituximab 375 d 0 cycle 1, 500 mgd 1cycle 2–6 | (95% CI 46.2- 57.6) 65% at 3 yrs | |||||
| Reynolds44 | 80% previously untreated and 20% relapsed-”minimally treated” patients | PCR (92) | Pentostatin 4 d 1 × 8 cycles Cyclophosphamide 600 d 1 × 8 cycles | 45(7) | Not reported | Not reported |
| US oncology | Rituximab 375 (split dose d 8 and 9 of cycle 1, d 1 cycles 2–8) Cycles administered every 21 d | |||||
| FCR (92) | Fludarabine 20 d 1–5×6 cycles | 58(17) | Not reported | Not reported | ||
| Cyclophosphamide 600 d 1 × 6 cycles | ||||||
| Rituximab 375 (split dose d 8 & 9 cycle 1, d 1 cycles 2–6) | ||||||
| Robak5 | Previously treated patients with an indication for therapy | Chemotherapy arm-FC (276) | 58(13) | 20.6 | 52 mo | |
| REACH | Chemoimmunotherapy arm-FCR (276) | 70 (24) | 30.6 | Not reached |
*
Cycles are 28 days unless otherwise noted.
†
All responses were assessed by National Cancer Institute-working group (NCI-WG) criteria.
CI=confidence interval; CR=complete response; d=day(s); FC=fludarabine and cyclophosphamide; FCR=FC and rituximab; mo=month(s); ORR=overall response rate; pt(s)=patients; PCR=pentostatin, cyclophosphamide, and rituximab.