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Stein et al.<br />

early after the transplant regimen. Nevertheless, no patient had graft failure as a<br />

consequence of this, <strong>and</strong> all have achieved hematopoietic recovery. Most patients<br />

undergoing <strong>autologous</strong> stem cell transplant in centers around the world received a<br />

regimen of busulfan <strong>and</strong> cyclophosphamide. 1<br />

Whether there are benefits to a<br />

radiation-based regimen compared with one using only chemotherapy cannot be<br />

assessed from this study.<br />

One of the major questions addressed in this pilot study was whether it would<br />

be possible to administer doses of IL-2 that have been reported to induce natural<br />

killer cell activity early after transplant at a time when the disease burden was at a<br />

minimum. The use of IL-2 is designed to treat not only the residual body burden of<br />

tumor not addressed by the preparative regimen but also the leukemia cells that<br />

may have been reinfused with the stem cell graft. This study shows that with proper<br />

use of supportive care, it is possible to administer IL-2 in these doses early after<br />

recovery from <strong>transplantation</strong> with minimal toxicity to the patient. As described<br />

above, no patient required admission to the ICU <strong>and</strong> none suffered respiratory<br />

failure as a consequence, despite fever <strong>and</strong> fluid accumulation, well-recognized<br />

side effects of IL-2.<br />

This study was also designed to assess the incidence of relapse before<br />

<strong>autologous</strong> transplant, the number of patients unable to undergo adequate<br />

collection of peripheral <strong>blood</strong> stem cells, <strong>and</strong> toxicities during consolidation that<br />

precluded proceeding to <strong>autologous</strong> transplant. In this trial, 85% of patients who<br />

were entered on protocol were able to proceed to transplant, with the most common<br />

cause of failure being failure to collect adequate numbers of stem cells. Some<br />

studies suggest that combined cytokine therapy could facilitate stem cell<br />

collection. 20<br />

Trials are now being initiated in the Southwest Oncology Group to<br />

determine whether the addition of thrombopoietin to G-CSF will increase the<br />

quality <strong>and</strong> rate of stem cell procurement after high dose Ara-C consolidation <strong>and</strong><br />

thereby reduce the numbers of patients who are unable to proceed to <strong>autologous</strong><br />

<strong>transplantation</strong> because of inadequate stem cell collections.<br />

In summary, this pilot study indicates that it is feasible to use high-dose IL-2<br />

following a radiation-based <strong>autologous</strong> transplant program <strong>and</strong> that a program of<br />

intensive consolidation, stem cell collection, transplant, <strong>and</strong> DL-2 may improve<br />

disease-free survival for patients with AML in first remission undergoing <strong>transplantation</strong>.<br />

Further studies with larger numbers of patients will help determine the<br />

efficacy of this transplant approach <strong>and</strong> the role of IL-2 in curing patients with AML.<br />

ACKNOWLEDGMENTS<br />

This study was supported in part by U.S. Public Service Grants NCI PPG CA<br />

30206 <strong>and</strong> NCI CA 33572. The authors would like to acknowledge the dedication<br />

of nurses at the City of Hope for the care of patients on this study, the staff of<br />

51

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