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

Wanda L. Salzer, Tamekia L. Jones, Meenakshi Devidas, Zoann E. Dreyer, Lia Gore, Naomi J. Winick, Lillian Sung, Elizabeth Raetz, Mignon L. Loh, Cindy Y. Wang, Paola De Lorenzo, Maria Grazia Valsecchi, Rob Pieters, William L. Carroll, Stephen P. Hunger, Joanne M. Hilden, Patrick Brown

Research output: Contribution to journalArticle

14 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)414-418
Number of pages5
JournalPediatric Blood and Cancer
Volume62
Issue number3
DOIs
StatePublished - Mar 1 2015

Keywords

  • Infant acute lymphoblastic leukemia
  • Mortality

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

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    Salzer, W. L., Jones, T. L., Devidas, M., Dreyer, Z. E., Gore, L., Winick, N. J., Sung, L., Raetz, E., Loh, M. L., Wang, C. Y., De Lorenzo, P., Valsecchi, M. G., Pieters, R., Carroll, W. L., Hunger, S. P., Hilden, J. M., & Brown, P. (2015). 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. Pediatric Blood and Cancer, 62(3), 414-418. https://doi.org/10.1002/pbc.25311