| Abstract: |
The Children’s Cancer Study Group’s (CCG) clinical trials in acute lymphoblastic leukemia (ALL) prior to 1981 consistently demonstrated that patients presenting with a white blood cell count (WBC) ≥50,000/μl or the “lymphoma syndrome” had a <40% 3-year event-free survival (EFS). The Berlin Frankfurt Munster (BFM) 76/79 study suggested that the prognosis of these patients could be improved. Before testing this therapy in a randomized setting, 29 CCG institutions used it for treatment of 209 newly diagnosed children with ALL and an initial WBC ≥50,000/μl or the lymphoma syndrome. In the intensive phases of therapy, 77% of cumulative parenteral doses and 55% of cumulative oral doses were within 10% of protocol requirements or were modified appropriately for reported toxicity. One hundred ninety-five patients achieved remission (93.3%). Eleven patients died in remission (5.6%)—10 during the intensive reinduction/re-consolidation phase. The 4-year EFS (± 1 SD) was 62% (±3.7%) with a median follow-up of 40 months. Only one patient has had an isolated CNS relapse. These results appear superior to past CCG studies for high-risk patients and extend observations made from studies of similar therapy. © 1988 Raven Press, Ltd., New York. |
| Keywords: |
adolescent; adult; child; child, preschool; major clinical study; prednisone; doxorubicin; cytarabine; bone marrow; antineoplastic combined chemotherapy protocols; drug administration schedule; cyclophosphamide; dexamethasone; vincristine; acute lymphoblastic leukemia; infant; daunorubicin; patient compliance; asparaginase; leukocyte count; clinical trials; intravenous drug administration; mercaptopurine; oral drug administration; fatality; intramuscular drug administration; intensive therapy; protocol compliance; leukemia, lymphocytic, acute; prognosis; human; male; female; support, u.s. gov't, p.h.s.; bfm 76/79; high-risk childhood all
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