The prophylactic use of granulocyte-colony stimulating factor during remission induction is associated with increased leukaemia-free survival of adults with acute lymphoblastic leukaemia: A joint analysis of five randomised trials on behalf of the EWALL

Background: Granulocyte-colony stimulating factor (G-CSF) is used to prevent febrile neutropenia and support intense chemotherapy. However, its impact on long-term outcome in oncological patients including adults with acute lymphoblastic leukaemia (ALL) has not been determined so far. Methods: In the current study follow-up data from individual patients recruited in five multicentre, prospective, randomised trials were pooled to perform a joint analysis. Among 347 adults and adolescents with ALL, 185 were assigned to receive prophylactically G-CSF along with induction chemotherapy while 162 patients were treated without G-CSF support. Results: With the median follow-up of 5.3 years, there was a tendency towards increased 5 year probability of the overall survival for the G-CSF arm compared to the controls (32% +/- 4% versus 23% +/- 4%, p = .07), which reached statistical significance in a subgroup of T-ALL (51% +/- 8% versus 29% +/- 9%, p = .01) and among patients aged 21-40 years (44% +/- 6% versus 27% +/- 6%, p = .03). The probability of leukaemia-free survival was 38% +/- 4% and 24% +/- 4% (p = .01) while the median remission duration equalled 33 and 17 months (p = .007), respectively. In a multivariate analysis the prophylactic use of G-CSF was independently associated with reduced risk of relapse (hazard ratio (HR) = .64, p = .007) and treatment failure (HR = .67, p = .02). Conclusions: The prophylactic use of G-CSF during induction of ALL is associated with improved long-term outcome and should be recommended especially in a setting of T-ALL and in 'young adults'. Our analysis provides the first direct evidence coming from prospective trials for the impact of primary G-CSF prophylaxis on disease-free survival of oncological patients. (C) 2011 Elsevier Ltd. All rights reserved.