BACKGROUND: Guidelines on the use of haematopoietic colony-stimulating factors for @entity1 having adjuvant chemotherapy for @entity0 are designed to minimize the risk of @entity281 (1-3). Non-randomised data suggest that achievement of planned @entity1213 ( @entity1213 ) may have an important effect on survival. This trial compared the effects of @entity1261 , @entity1261 , against standard management following a first neutropenic event (NE) in achieving planned @entity1213 . @entity1 AND METHODS: Adult @entity1 receiving adjuvant or neo-adjuvant chemotherapy were randomized following a first NE, defined as hospitalisation due to @entity221 , an absolute neutrophil count (ANC)<1  5 x 10(9)/l requiring treatment delay or dose reduction of 15% or more of planned dose.The study was initially planned to enrol 816 @entity1 to detect a difference of 10%. This was difficult to achieve in the time frame and the trial size was amended. Thus 407 @entity1 were randomised to filgrastim for 7 days or pegfilgrastim versus standard care. The amended study was designed to have 80% power to detect an absolute difference of 14% of planned @entity1213 between the two groups. RESULTS: Most regimens were @entity5948 -based many of which included a sequential @entity3907 and /or were in clinical trials. 82  7% had a NE in the first 3 cycles. 401 had calculable relative @entity1213 (RDI) data. A target of 85% planned RDI was achieved in only 50% of @entity1 in the control arm compared with 75% in the @entity1261 arm (p<0  0001). A secondary end-point revealed a reduction in post-randomisation NEs, 65  7% controls versus 18  2% with @entity1261 . CONCLUSIONS: Secondary intervention with @entity1261 showed a statistically significant improvement in the achievement of adequate RDI in non-intensive regimens. This may have important clinical implications for outcome.

A Randomised Trial of Secondary Prophylaxis using XXXX ('SPROG' Trial) for maintaining dose-intensity of standard adjuvant chemotherapy for @entity0 - by the Anglo-Celtic Cooperative Group and NCRN.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity1261 :: ('1440', 'Gene') :: ['GCSF', 'granulocyte colony stimulating factor'] @entity5948 :: ('D018943', 'Chemical') :: ['anthracycline'] @entity3907 :: ('MESH:C080625', 'Chemical') :: ['taxane'] @entity281 :: ('MESH:D007239', 'Disease') :: ['neutropenic infection'] @entity1213 :: ('MESH:D012555', 'Disease') :: ['DI', 'dose intensity'] @entity221 :: ('MESH:D005334', 'Disease') :: ['neutropenic fever']
@entity1261 :: (1440,Gene) :: ['Granulocyte Colony Stimulating Factor']
