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Intensification of Therapy for Children With Lower-Risk Acute Lymphoblastic Leukemia: Long-Term Follow-Up of Patients Treated on Children’s Cancer Group Trial 1881

Raymond J. Hutchinson, Paul S. Gaynon, Harland Sather, Salvatore J. Bertolone, Herbert A. Cooper, Raymond Tannous, Linda M. Wells, Nyla A. Heerema, Scott Sailer, Michael E. Trigg for the Children’s Cancer Group/Children’s Oncology Group

From the University of Michigan Health System, Ann Arbor, MI; Childrens Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, CA; University of Louisville, Louisville, KY; University of North Carolina, Chapel Hill, NC; University of Iowa Hospital and Clinics, Iowa City, IA; Richland Memorial Hospital, Columbia, SC; Ohio State University, Columbus, OH; and Alfred I. DuPont Hospital for Children, Wilmington, DE.

Address reprint requests to Raymond J. Hutchinson, MD, C.S. Mott Children’s Hospital, Bone Marrow Transplant Unit, 1500 E Medical Ctr Dr, CCGC-B1-207, Ann Arbor, MI 48109-0914; email: rhutchin{at}umich.edu.

Purpose: From December 1988 through December 1992, the Children’s Cancer Group (CCG) conducted a randomized trial (CCG-1881) designed to evaluate the impact of adding a single delayed intensification phase of therapy to standard therapy for patients with newly diagnosed low-risk acute lymphoblastic leukemia (ALL).

Patients and Methods: Patients (n = 778) with newly diagnosed ALL, 2 to 9 years of age at diagnosis with an initial WBC count less than 10,000/µL, were eligible for this protocol. All patients received induction, consolidation, and interim maintenance phases of therapy over the first 16 weeks. At week 16, patients remaining in remission were randomly assigned to receive or not receive a single 7-week delayed intensification (DI) phase of therapy. Maintenance therapy was given in lieu of or after DI, with total duration of therapy approximately 3 years for boys and 2 years for girls.

Results: Patients randomized to receive DI experienced fewer relapse events in all categories. Kaplan-Meier life-table estimates for continuous complete remission (CCR) at 7 years for the randomized regimens were 77% (SE, 2.4%) for the standard regimen and 83% (SE, 2.7%) for the DI regimen (P = .072). The only prognostic factor of significance postrandomization in this selected low-risk population was the day 14 marrow response (P = .0001).

Conclusion: The addition of a single DI phase of therapy was well tolerated and augmented 7-year CCR by 6% (SE of the difference, 3.3%), resulting in 26% fewer adverse events. Overall survival for eligible patients at 7 years is 90% (SE, 1.2%).

Supported in part by the Children’s Cancer Group Chairman’s grant no. CA-13539 from the National Cancer Institute, National Institutes of Health.

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