Decreased induction morbidity and mortality following modification to induction therapy in infants with acute lymphoblastic leukemia enrolled on AALL0631: A report from the children's oncology group |
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| Authors: | Wanda L. Salzer MD Tamekia L. Jones PhD Meenakshi Devidas PhD ZoAnn E. Dreyer MD Lia Gore MD Naomi J. Winick MD Lillian Sung MD Elizabeth Raetz MD Mignon L. Loh MD Cindy Y. Wang MPH Paola De Lorenzo PhD Maria Grazia Valsecchi PhD Rob Pieters MD William L. Carroll MD Stephen P. Hunger MD Joanne M. Hilden MD Patrick Brown MD |
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| Affiliation: | 1. U.S. Army Medical Research and Materiel Command, Fort Detrick, Maryland;2. Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, Florida;3. Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas;4. Childrens Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado;5. Division of Pediatric Hematology/Oncology, University of Texas Southwestern School of Medicine, Dallas, Texas;6. Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada;7. Department of Pediatrics and Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah;8. Department of Pediatrics, University of California, San Francisco, California;9. Children's Oncology Group Statistics and Data Center University of Florida, Gainesville, Florida;10. Interfant Trial Data Center, Pediatric Clinic, University of Milano‐Bicocca, Monza, Italy;11. Department of Health Sciences, University of Milano Bicocca, Monza, Italy;12. Princess Maxima Center for Pediatric Oncology, Utrecht, Pediatric Oncology, Erasmus MC ‐ Sophia Children's Hospital, Rotterdam, Netherlands;13. New York University Cancer Institute, New York, New York;14. Oncology and Pediatrics, Johns Hopkins University, Baltimore, Maryland |
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| Abstract: | Background Infants with acute lymphoblastic leukemia (ALL) have a poor prognosis. Intensification of therapy has resulted in fewer relapses but increased early deaths, resulting in failure to improve survival. Procedure AALL0631 is a Phase 3 study for infants (<366 days of age) with newly diagnosed ALL. Induction initially (Cohort 1) consisted of 3 weeks of therapy based on COG P9407. Due to excessive early mortality, induction was amended to a less intensive 5 weeks of therapy based on Interfant‐99. Additionally, enhanced supportive care guidelines were incorporated with hospitalization during induction until evidence of marrow recovery and recommendations for prevention/treatment of infections (Cohort 2). Results Induction mortality was significantly lower for patients in Cohort 2 (2/123, 1.6%) versus Cohort 1 (4/26, 15.4%; P = 0.009). All induction deaths were infection related except one due to progressive disease (Cohort 2). Sterile site infections were lower for patients in Cohort 2 (24/123, 19.5%) versus Cohort 1 (15/26, 57.7%; P = 0.0002), with a significantly lower rate of Gram positive infections during induction for patients in Cohort 2, P = 0.0002. No clinically significant differences in grades 3–5 non‐infectious toxicities were observed between the two cohorts. Higher complete response rates were observed at end induction intensification for Cohort 2 (week 9, 94/100, 94%) versus Cohort 1 (week 7, 17/25, 68%; P = 0.0.0012). Conclusion De‐intensification of induction therapy and enhanced supportive care guidelines significantly decreased induction mortality and sterile site infections, without decreasing complete remission rates. Pediatr Blood Cancer 2015;62:414–418. © 2014 Wiley Periodicals, Inc. |
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| Keywords: | infant acute lymphoblastic leukemia mortality |
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