Previously Treated CLL (REACH)
Proven to drive better outcomes in previously treated chronic lymphocytic leukemia (CLL), as shown in a large Phase III trial1
REACH TRIAL DESIGN: RITUXAN+FC ×6 cycles vs FC ×6
- In the REACH trial, patients who had previously received RITUXAN or both fludarabine and cyclophosphamide, either sequentially or in combination, were excluded from the trial, as were fludarabine-refractory patients; alkylator-refractory patients were permitted and accounted for 26% of the trial population2,3
- FC=fludarabine, dosed at 25 mg/m2/day, and cyclophosphamide, at 250 mg/m2/day, on Days 1 through 3 in both treatment arms; R=RITUXAN, given at a dose of 375 mg/m2 on the day prior to the initiation of the first cycle of FC chemotherapy. In subsequent cycles, RITUXAN was given at a dose of 500 mg/m2 on Day 1 of each cycle. Randomization was stratified by country, type of prior therapy, time from diagnosis to randomization, and β2-microglobulin level.3
- NCI-WG=National Cancer Institute-sponsored Working Group; ECOG=Eastern Cooperative Oncology Group; PFS=progression-free survival.
REACH Trial of Previously Treated CLL: Baseline Patient Characteristics3*
|Baseline patient characteristics||R-FC (n=276)||FC (n=276)|
|Age range (years)||35-83||35-81|
|Binet stage||A B C||
|ECOG performance status||0 1||
- *These patient characteristics are an abbreviated listing of those found in the REACH publication.
The REACH trial was not designed or powered to detect a significant difference in PFS by age category. However, exploratory analysis defined by age suggests no observed benefit with the addition of RITUXAN to FC chemotherapy in previously treated CLL patients 65 years of age or older.
REACH trial—RITUXAN+FC provided significant increases in PFS in previously treated CLL1,2
RITUXAN+FC SIGNIFICANTLY IMPROVED MEDIAN PFS (N=552)1,2
- DoR=duration of response; CI=confidence interval.
- RITUXAN+FC provided a median PFS of 2.2 years in previously treated CLL (p=0.02)1
RITUXAN® (Rituximab) is indicated for the treatment of patients with:
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
RITUXAN is not recommended for use in patients with severe, active infections.
RITUXAN in combination with FC for previously treated CLL
- Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%)
- The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 24.8% and 19.1% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 38.7% and 13.6%, respectively
- Grade 3 or 4 adverse reactions that occurred more frequently in R-FC-treated patients ≥70 years of age compared to younger patients were neutropenia (56% vs. 39%), infections (30% vs. 14%), anemia (21% vs. 10%), thrombocytopenia (19% vs. 8%), and pancytopenia (7% vs. 2%)
- Fifty-nine percent of R-FC–treated patients experienced an infusion reaction
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2013.
- Data on file, Genentech, Inc.
- Robak T, Dmoszynska A, Solal-Céligny P, et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol. 2010;28:1756-1765.