Toxicity Assessment of Molecularly Targeted Drugs Incorporated into Multiagent Chemotherapy Regimens for Pediatric Acute Lymphocytic Leukemia (ALL): Review From an International Consensus Conference

TM Horton, R Sposto, P Brown, CP Reynolds, SP Hunger, NJ Winick, EA Raetz, WL Carroll, RJ Arceci, MJ Borowitz, PS Gaynon, L Gore, S Jeha, BJ Maurer, SE Siegel, A Biondi, Pamela Kearns, A Narendran, LB Silverman, MA SmithCM Zwaan, JA Whitlock

Research output: Contribution to journalReview article

16 Citations (Scopus)

Abstract

One of the challenges of incorporating molecularly targeted drugs into multi-agent chemotherapy (backbone) regimens is defining dose-limiting toxicities (DLTs) of the targeted agent against the background of toxicities of the backbone regimen. An international panel of 22 pediatric acute lymphocytic leukemia (ALL) experts addressed this issue (www.ALLNA.org). Two major questions surrounding DLT assessment were explored: (1) how toxicities can be best defined, assessed, and attributed; and (2) how effective dosing of new agents incorporated into multi-agent ALL clinical trials can be safely established in the face of disease- and therapy-related systemic toxicities. The consensus DLT definition incorporates tolerance of resolving Grade 3 and some resolving Grade 4 toxicities with stringent safety monitoring. This functional DLT definition is being tested in two Children's Oncology Group (COG) ALL clinical trials. Pediatr Blood Cancer 2010;54:872-878. (C) 2010 Wiley-Liss, Inc.
Original languageEnglish
Pages (from-to)872-878
Number of pages7
JournalPediatric Blood & Cancer
Volume54
Issue number7
DOIs
Publication statusPublished - 1 Jul 2010

Keywords

  • maximum tolerated dose
  • dose-limiting toxicity
  • ALL relapse
  • developmental therapeutics
  • ALL

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