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Sustained Complete Molecular Remissions After Treatment With Imatinib-Mesylate in Patients With Failure After Allogeneic Stem Cell Transplantation for Chronic Myelogenous...
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Titel: |
Sustained Complete Molecular Remissions After Treatment With Imatinib-Mesylate in Patients With Failure After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia: Results of a Prospective Phase II Open-Label Multicenter Study |
In: | Journal of Clinical Oncology, 23, 2005, 30, S. 7583-7593 |
veröffentlicht: |
American Society of Clinical Oncology (ASCO)
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Umfang: | 7583-7593 |
ISSN: |
0732-183X 1527-7755 |
DOI: | 10.1200/jco.2005.01.3110 |
Zusammenfassung: | <jats:sec><jats:title>Purpose</jats:title><jats:p> In the era of molecular therapy of chronic myelogenous leukemia (CML) applying BCR-ABL tyrosine kinase inhibitors, the usefulness of molecular end points, in particular, quantitative polymerase chain reaction (PCR) for BCR-ABL in monitoring responses has been broadly accepted. Therefore, we have designed a prospective phase II trial in CML, which, for the first time, evaluated the feasibility and safety of molecular end points as surrogate markers to guide through a stratified treatment algorithm within a multicenter trial. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> As a clinical model, we adopted minimal residual disease (MRD) found in relapse after allogeneic stem cell transplantation (SCT) in CML. Forty-four patients were enrolled and received the BCR-ABL tyrosine kinase inhibitor imatinib (IM) at a starting dose of 400 mg/d. The quality of molecular responses achieved then decided on discontinuation of IM or dose escalation up to 800 mg/d, and finally, on application of donor lymphocyte infusions. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Seventy percent of patients achieved a complete molecular response (CMR), defined as nested PCR-negativity for BCR-ABL in three consecutive samples. Interestingly, in four out of 10 patients who discontinued IM, CMR was durable even after cessation of IM with a median follow-up of 494 days. This suggests the possibility of long-term tumor control in a subset of patients. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The treatment strategy showed that IM treatment was well-tolerated and highly efficacious in MRD after allogeneic SCT. Moreover, this study demonstrated that evaluation of a molecular end point within a multicenter trial can be a safe and effective tool for clinical decision making. </jats:p></jats:sec> |
Format: | E-Article |
Quelle: | American Society of Clinical Oncology (ASCO) (CrossRef) |
Sprache: | Englisch |