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In this national study, we have evaluated a new intensive chemotherapy protocol for adult patients with untreated acute lymphoblastic leukaemia (ALL). One hundred and fifty-three patients with median age 42 years received induction therapy with high-dose cytarabine (Ara-C), cyclophosphamide, daunorubicin, vincristine and betamethasone. A high complete remission (CR) rate (90%) was achieved in patients < 60 years compared with 70% in patients > 60 years (P = 0.004). The estimated 3 year overall survival for all patients was 29% (CI 21-36%) and the estimated continuous complete remission (CCR) at 3 years for the patients achieving CR according to the protocol was 36% (CI 27-45%). A favourable pretreatment characteristic was pre-B phenotype, especially for patients < 40 years without any high-risk factor, with an estimated CCR at 3 years of 62% (CI 41-82%). Stem cell transplantation (SCT) as post-remission therapy, mainly for high-risk patients, gave an estimated 3 year disease free survival (DFS) after SCT of 39% (CI 24-54%). No significant differences in DFS could be found between autologous, related or unrelated donor transplantation. We conclude that this intensive protocol resulted in a high CR rate combined with acceptable side-effects and a favourable CCR for patients with pre-B ALL.

In order to further evaluate the effects of rGM-CSF on the reconstituting granulopoiesis, plasma and serum levels of myeloperoxidase (MPO) and lactoferrin (LF), as well as serum levels of eosinophil cationic protein (ECP), were monitored daily during a period of 3-4 weeks following ABMT in a group of 22 patients treated with either rGM-CSF (n = 11) or placebo (n = 11). Despite faster increase in the neutrophil counts in the rGM-CSF group, we did not observe any difference either in P-MPO or in P-LF during the period of early engraftment (days 11-19). This finding indicates that the proliferative effect of rGM-CSF on the neutropoiesis may be overestimated when neutrophil counts alone are taken into consideration, and suggests that other mechanisms may have contributed to the increase in the number of circulating neutrophils. The ratio of the serum to plasma level of LF, but not of MPO, was higher in the rGM-CSF group, probably reflecting a specific in vivo neutrophil priming effect. In the rGM-CSF group there was a clear increase of S-ECP during the second and third week post transplant, corresponding to an increase in eosinophil counts, which indicates that rGM-CSF stimulated eosinophil reconstitution without causing excessive activation of the mature eosinophils.