BACKGROUND: Infants (<366 days of age) with acute lymphoblastic leukemia (ALL) have a poor prognosis. Most treatment failures occur within 6-9 months of diagnosis, primarily from relapse. PROCEDURE: The Children's Oncology Group P9407 study was designed to test if early intensified treatment would improve outcome for infants with ALL. Due to a significant number of early deaths (< 90 days from enrollment), Induction therapy was amended three times. Cohorts 1 + 2 (n = 68), received identical Induction therapy except for reduced daunorubicin dose in Cohort 2. Cohort 3 (n = 141) received prednisone (40 mg/m(2)/day) instead of dexamethasone (10 mg/m(2)/day) and short infusion daunorubicin (30 minutes) instead of continuous infusion (48 hours), as well as additional supportive care measures throughout therapy. RESULTS: Early deaths occurred in 17/68 (25%) infants in Cohorts 1 + 2 and 8/141 (5.7%) infants in Cohort 3 (P < 0.0001). Among infants ≤90 days of age at diagnosis, early death occurred in 10/17 (58.8%) in Cohorts 1 + 2 and 4/27 (14.8%) in Cohort 3 (P = 0.006). Among infants >90 days of age at diagnosis, early death occurred in 7/51 (13.7%) in Cohorts 1 + 2 and 4/114 (3.5%) in Cohort 3 (P = 0.036). Bacterial, viral, and fungal infections were more common in Cohorts 1 + 2 versus Cohort 3. CONCLUSIONS: Early morbidity and mortality for infants with ALL were reduced by substitution of prednisone (40 mg/m(2)/day) for dexamethasone (10 mg/m(2)/day), the delivery of daunorubicin over 30 minutes instead of a continuous infusion for 48 hours, and the provision of more specific supportive care measures.
BACKGROUND:Infants (<366 days of age) with acute lymphoblastic leukemia (ALL) have a poor prognosis. Most treatment failures occur within 6-9 months of diagnosis, primarily from relapse. PROCEDURE: The Children's Oncology Group P9407 study was designed to test if early intensified treatment would improve outcome for infants with ALL. Due to a significant number of early deaths (< 90 days from enrollment), Induction therapy was amended three times. Cohorts 1 + 2 (n = 68), received identical Induction therapy except for reduced daunorubicin dose in Cohort 2. Cohort 3 (n = 141) received prednisone (40 mg/m(2)/day) instead of dexamethasone (10 mg/m(2)/day) and short infusion daunorubicin (30 minutes) instead of continuous infusion (48 hours), as well as additional supportive care measures throughout therapy. RESULTS: Early deaths occurred in 17/68 (25%) infants in Cohorts 1 + 2 and 8/141 (5.7%) infants in Cohort 3 (P < 0.0001). Among infants ≤90 days of age at diagnosis, early death occurred in 10/17 (58.8%) in Cohorts 1 + 2 and 4/27 (14.8%) in Cohort 3 (P = 0.006). Among infants >90 days of age at diagnosis, early death occurred in 7/51 (13.7%) in Cohorts 1 + 2 and 4/114 (3.5%) in Cohort 3 (P = 0.036). Bacterial, viral, and fungal infections were more common in Cohorts 1 + 2 versus Cohort 3. CONCLUSIONS: Early morbidity and mortality for infants with ALL were reduced by substitution of prednisone (40 mg/m(2)/day) for dexamethasone (10 mg/m(2)/day), the delivery of daunorubicin over 30 minutes instead of a continuous infusion for 48 hours, and the provision of more specific supportive care measures.
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Authors: Steven E Lipshultz; Amy L Giantris; Stuart R Lipsitz; Virginia Kimball Dalton; Barbara L Asselin; Ronald D Barr; Luis A Clavell; Craig A Hurwitz; Albert Moghrabi; Yvan Samson; Marshall A Schorin; Richard D Gelber; Stephen E Sallan; Steven D Colan Journal: J Clin Oncol Date: 2002-03-15 Impact factor: 44.544
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Authors: S S Legha; R S Benjamin; B Mackay; M Ewer; S Wallace; M Valdivieso; S L Rasmussen; G R Blumenschein; E J Freireich Journal: Ann Intern Med Date: 1982-02 Impact factor: 25.391
Authors: ZoAnn E Dreyer; Joanne M Hilden; Tamekia L Jones; Meenakshi Devidas; Naomi J Winick; Cheryl L Willman; Richard C Harvey; I-Ming Chen; Fred G Behm; Jeanette Pullen; Brent L Wood; Andrew J Carroll; Nyla A Heerema; Carolyn A Felix; Blaine Robinson; Gregory H Reaman; Wanda L Salzer; Stephen P Hunger; William L Carroll; Bruce M Camitta Journal: Pediatr Blood Cancer Date: 2014-11-14 Impact factor: 3.167
Authors: 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 Journal: Pediatr Blood Cancer Date: 2014-11-18 Impact factor: 3.167
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Authors: P De Lorenzo; A V Moorman; R Pieters; Z E Dreyer; N A Heerema; A J Carroll; S P Hunger; R Harvey; C L Willman; M Devidas; M-G Valsecchi; C J Harrison Journal: Leukemia Date: 2013-09-27 Impact factor: 11.528
Authors: Karen A Urtishak; Alena Y Z Edwards; Li-San Wang; Amanda Hudome; Blaine W Robinson; Jeffrey S Barrett; Kajia Cao; Lori Cory; Jonni S Moore; Andrew D Bantly; Qian-Chun Yu; I-Ming L Chen; Susan R Atlas; Cheryl L Willman; Mondira Kundu; Andrew J Carroll; Nyla A Heerema; Meenakshi Devidas; Joanne M Hilden; ZoAnn E Dreyer; Stephen P Hunger; Gregory H Reaman; Carolyn A Felix Journal: Blood Date: 2013-02-07 Impact factor: 22.113
Authors: K Koh; D Tomizawa; A Moriya Saito; T Watanabe; T Miyamura; M Hirayama; Y Takahashi; A Ogawa; K Kato; K Sugita; T Sato; T Deguchi; Y Hayashi; J Takita; Y Takeshita; M Tsurusawa; K Horibe; S Mizutani; E Ishii Journal: Leukemia Date: 2014-06-03 Impact factor: 11.528
Authors: Azada Ibrahimova; Lena E Winestone; Tamara P Miller; Kyle Kettler; Alix E Seif; Yuan-Shung Huang; Caitlin W Elgarten; Regina M Myers; Brian T Fisher; Richard Aplenc; Kelly D Getz Journal: Pediatr Blood Cancer Date: 2021-03-11 Impact factor: 3.167