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

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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.

    Results

  • 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)

    Author's Conclusions

  • 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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