In 1971, Cancer and Leukemia Group B (CALGB) mounted a study of acute lymphocytic leukemia (ALL) that compared the effects of the two steroid hormones dexamethasone and prednisone. Six-hundred-forty-six children and adolescents with ALL were randomized to receive either prednisone or dexamethasone as part of their remission induction therapy. The 493 evaluable patients who achieved complete remission received the same steroid as pulses throughout remission. Specific central nervous system (CNS) therapy was randomized to either six injections of intrathecal methotrexate (IT MTX) alone or to six injections of IT MTX with cranial radiation (2,400 cGy). Both cranial radiation and dexamethasone offered increased protection against CNS relapse as the first site of failure over IT MTX alone. There were 30 CNS relapses among 238 patients (12.6%) receiving cranial radiation plus IT MTX, whereas there were 70 CNS relapses among 225 (P less than 0.001) (22.5%) in those who received IT MTX alone. Similarly, there were 33 CNS relapses among 231 (14.3%) children treated with dexamethasone, whereas there were 67 CNS relapses among 262 (25.6%) treated with prednisone (P = 0.017). Both steroids appeared equal in protecting the bone marrow. Recent national studies have shown significant improvements in preventing CNS relapse over the results in the present report. However, this finding warrants further investigation and, with further documentation, could lead to the substitution of prednisone by dexamethasone to aid further in preventing CNS relapse. This may be particularly important in patients at higher risk for CNS relapse.
Between 1971 and 1974, 646 evaluable patients under 20 years of age with previously untreated acute lymphocytic leukemia were treated according to Cancer and Leukemia Group B (formerly Acute Leukemia Group B) Protocol 7111. On a random basis, they received a 10‐day course of 1,000 units/kg/day of L‐asparaginase before, during, or after a 3‐week course of vincristine and corticosteroid. A control group received vincristine and corticosteroid for 4 weeks but no asparaginase. The overall complete remission rate was 85%, which was not altered significantly by any of the induction variables. Patients who received asparaginase for 10 days subsequent to vincristine and corticosteroid had a significantly longer complete remission duration with an estimated median of 45 months, compared to 20 months for the group receiving no asparaginase and 27 months for the other 2 asparaginase regimens. The beneficial effect of asparaginase was noted, irrespective of which 1 of the 2 intensification and maintenance programs the patients received. The 5‐year projection indicates a complete remission rate of 50% for those patients receiving subsequent asparaginase as compared to 41% of those induced on other regimens in this study and thus is superior to the use of only vincristine and corticosteroid.
Two hundred and twenty-seven children with recurrent acute lymphoblastic leukemia were treated with various combinations of vincristine, prednisone, cyclophosphamide and L-asparaginase in an approach to the induction of remission. The combination of L-asparaginase 1,000 mu/kg iv q.d. x 10, vincristine 2.0 mg/m2iv q.w. x 4 and prednisone 40 mg/m2 p.o.q.d. x 28 days was found to be highly effective. The incidence of remission was 73%. No significant improvement was achieved when cyclophosphamide was added to this regimen. Various combinations of cytosine arabinoside, cyclophosphamide, vincristine, prednisone, BCNU or CCNU failed to maintain remission duration for more than two or three months. Neither BCNU nor CCNU prevented the development of CNS leukemia.
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