Interim Analysis of Multicenter AML Trial, "HOGS", based on Cytogenetic risk

초록

We studied complete remission, relapse, toxic death, DFS and OS. HDAC, auto PBPCT and allogeneic BMT after 1 or 2 times of post remission therapy based on 4 prognostic groups(APL, Acute promyelocytic leukemia: GPG, Good prognosis group; IPG, Intermediate prognosis group; PPG, Poor prognosis group by MRC definition) based on cytogenetics. Three plus seven(Idarubicin 12mg/m2, D1-D3; Ara-C 100mg/m2, D1-D7) were given to de novo AML, secondary AML and RAEB-T. HDAC or auto PBPCT was given followed by intermediate dose(8gm/m2) of Ara-C to the patients with GPG(ie, t(8:21), inv(16)). Three times of post remission therapy including HDAC, or auto PBPCT followed by two times of post remission therapy was given to IPG or PPG(ie, -5, -7, del 5q, complex). In cases of APL, three times of post-remission therapy with idarubicin only was performed. ATRA were given to APL group during remission induction therapy and after post-remission maintenance period. Up to June, 2003, 255 patients(19 centers) were enrolled. Median follow-up was 37months. Among them, 92.9% was de novo AML, and APL, GPG, IPG and PPG was, 14.9%, 20.8%, 51.4%, and 12.2% respectively. Over all remission rate after 1st induction(3+7) was 71.4%(APL: 86.8%, GPG: 86.8%, IPG: 65.6%, PPG: 51.6%, P<0.001). Relapse rate after induction was 15.8%(APL), 39.6%(GPG), 50.4%(IPG) and 71%(PPG)(P<0.001). During this trial, 62 patients were excluded from the cohort(Remission induction failure;51, Death due to toxicities and PD;39). Toxicities profiles including mucositis hepatic, cardiac and bleeding episodes are similar on 4 different therapy modalities(HDAC, auto PBPCT and allo BMT). Among IPG, Auto arm was superior to HDAC and Allo arm in terms of OS(P:004) and LFS(P:003). However, among PPG, there were no significant statistical differences on OS and LFS in all the therapy modalities(ie, HDAC, Auto, Allo).