Prognostic implications of cytogenetics in adults with acute lymphoblastic leukemia treated with inotuzumab ozogamicin |
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| Authors: | Elias Jabbour Anjali S. Advani Matthias Stelljes Wendy Stock Michaela Liedtke Nicola Gökbuget Giovanni Martinelli Susan O'Brien Jane Liang White Tao Wang M. Luisa Paccagnella Barbara Sleight Erik Vandendries Daniel J. DeAngelo Hagop M. Kantarjian |
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| Affiliation: | 1. Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas;2. Department of Medicine A, Hematology and Oncology, University of Muenster, Muenster, Germany;3. Department of Hematology/Oncology, University of Chicago, Chicago, Illinois;4. Divisions of Hematology and Oncology, Stanford Cancer Institute, Stanford, California;5. Department of Medicine, Goethe University, Frankfurt, Germany;6. Division of Hematology/Oncology, Chao Family Comprehensive Cancer Center, University of California, Orange, California;7. Pfizer Inc, Groton, Connecticut;8. Pfizer Inc, Cambridge, Massachusetts;9. Department of Medical Oncology/Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts |
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| Abstract: | Karyotype is frequently used to predict response and outcome in leukemia. This post hoc exploratory analysis evaluated the relationship between baseline cytogenetics and outcome in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) treated with inotuzumab ozogamicin (InO), a humanized CD22 antibody conjugated to calicheamicin, in the phase 3, open-label, randomized INO-VATE trial. Data as of March 8, 2016, are presented in this analysis. Of the 326 patients randomized, 284 had screening karyotyping data (144 in the InO arm and 140 in the standard care [SC] arm). With InO, complete remission or complete remission with incomplete hematologic recovery (CR/CRi), minimal residual disease negativity rates, and overall survival (OS) were not significantly different between cytogenetic subgroups. CR/CRi rates favored InO over SC in the diploid with ≥20 metaphases, complex, and “other” cytogenetic subgroups. The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups. Generally, InO is effective and provides substantial clinical benefit in patients with R/R ALL who have specific baseline karyotypes. |
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