Chemoimmunotherapy With Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR)
Eichhorst B, Fink A, Busch R et al.
Key Points:
- Investigators present interim data of CLL10 Trial comparing BR vs FCR in terms of non-inferiority and better tolerability in first-line therapy of physically fit pts without del(17p)
- Dose reduction >10%: FCR 27.3% vs BR 31.6% (p = 0.012)
- Complete response rate (CRR): FCR 47.4% vs BR 38.1% (p=0.031)
- Two years PFS: FCR 85.0% vs BR 78.2% (p=0.041)
- No difference in OS rate for the FCR vs BR arm (94.2% vs 95.8% at 2 years p=0.593)
- Hazard Ratio: PFS=1.385, EFS=1.375 and OS=0.842
- Significant difference in median PFS BR 36.5 mo vs not reached for FCR (p=0.016) in pts <65 yrs; disappeared in elderly pts
- CTC grade 3 to 5 adverse events: FCR 90.8% vs BR 78.5% (p<0.001)
- Treatment related mortality: FCR 3.9% (n=11) vs BR 2.1% (n=6).
Implications:
- Interim analysis of CLL10 Trial shows: FCR more efficient than BR in first-line treatment of fit CLL pts (higher CRR, longer PFS and EFS); however, with higher rate of severe adverse events, in particular neutropenia and infections.
View the original abstract on the ASH website.
