Requestioning the Role of Prolonged Maintenance Chemotherapy in AML: Randomized Trial by the German AML Cooperative Group Updated.
Reviewer: Mary Kara Bucci, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 10, 2001
Presenter: Thomas Buechner
Presenter's Affiliation: German AML Cooperative Group
Type of Session: Scientific
Background The German AML Cooperative Group (GAMLCG) has previously reported a survival advantage to 3 years of montly maintenance chemotherapy after standard dose thioguanine/araC/daunorubicin (TAD) vs. no further treatment. This was initially reported in 1985 (JCO 3:1583, 1985). Ten-year update of the previously reported GAMLCG trial of TAD+maintenance vs. TAD alone shows a continued benefit in the maintenance arm, 18% relapse-free survival (RFS) vs 6% in the TAD-alone arm. Based on these results, the GAMLCG performed new randomized trial of 3 years of maintenance chemotherapy vs. no further treatment following a new chemotherapy regimen.
Materials and Methods
817 patients (pts) were randomized to one of two treatment arms.
Arm 1: TAD + high-dose araC/mitox(HAM) followed by TAD consolidation and monthly, low dose TAD maintenance.
Arm 2: TAD-HAM-TAD + one course of HAM with adjusted dose araC (S-HAM) and no maintenance chemotherapy.
Median pt age was 54 (range, 16-82), with 35% over age 60.
Patient characteristics were evenly balances between the two groups.
Response to induction was not different between the two arms; complete response of 69% vs. 70% and partial response of 19% vs 18%.
64% of pts in the maintenance arm received the intended treatment (full doses) and 44% of pts in the no-maintenance arm received full-dose treatment.
5-year relapse-free survival (RFS) is 31% in the patients treated according to the maintenance arm vs 24% in the patients treated according to the no-maintenance arm, p=.014.
Survival at 5 years from treatment start is 27% (no difference between the two arms); survival 5 years from complete remission is 37% (no difference between the two groups)
By analysis according to treatment received, 5-year RFS is significantly higher in the maintenance arm.
There is no difference in the survival of the two groups.
Overall survival includes patients treated with second-line chemotherapy; the difference in RFS implies a greater chance of cure from first-line treatment alone in the maintenance group.
Clinical/Scientific Implications The GAMLCG considers the maintenance regimen superior to the no-maintenance arm because of increased chance of cure from the first-line treatment alone. Currently, a trial is underway comparing maintenance chemotherapy as standard therapy vs. autologous bone marrow transplant.
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Apr 9, 2012 - For patients with untreated de novo acute myeloid leukemia, the addition of gemtuzumab ozogamicin to standard frontline chemotherapy improves event-free, overall, and relapse-free survival, without causing excessive toxicity, according to a phase 3 study published online April 5 in The Lancet.