178 pts, age <65, fit without del (17p), enrolled -November 2007 and January 2009.

Randomized to 6 courses of FCR (n=83) or FCCam arm (n=82).

Primary endpoint: 3-year progression-free survival (PFS).

Secondary endpoints: safety, response to treatment, overall survival (OS) and MRD.

PFS and OS in two arms not significantly different.

At median follow-up 55.5 months, 57 pts (FCCam arm) vs 50 in FCR arm free of disease progression .3-year estimated PFS at 81% in both arms (p=0.80).

14 died in FCCam arm -7 progression, 7 toxicity. 9 died in the FCR arm - all progression. 3-year estimated survival at 90% vs. 88% (p=0.85).

Significant impact of IGHV mutational status, Binet stage, MRD level on PFS.

OS -no significant difference .

Confirm absence of superiority of the FCCam regimen on OS and PFS.

Longer follow-up: no higher rate of late toxicity in FCCam arm, especially secondary malignancies.

Late adverse events mainly infectious.

MRD significant prognostic factor.

Early results implied that FCCam regimen associated with unfavourable safety profile.

Extended follow-up confirms absence of superiority of FCCam.