Results of a BFM-based protocol for the treatment of childhood B-non-Hodgkin's lymphoma and B-acute lymphoblastic leukemia in Argentina.

PURPOSE: To report the feasibility and results of a study based on the BFM-ALL. NHL/86 protocol for B-non-Hodgin's Lymphoma (NHL) and B-Acute Lymphoblastic Leukemia (B-ALL) in Argentina. Design. Prospective, single arm, non-randomized trial.

PATIENTS AND

METHODS

From August 1988 to December 1993, 87 consecutive patients with B-NHL/B-ALL were admitted and 82 were eligible. The therapy was stratified according to stage. All patients received a cytoreductive prephase with cyclophosphamide and prednisone. Those with stage I-II were treated with three 5-day blocks of combined intense chemotherapy including dexamethasone, cyclophosphamidie, ifosfamide, cytarabine, teniposide, doxorabicin, and 500 mg/m2 of methotrexate as a 24 hour continuous infusion. Stage III received 6 blocks and those with stage IV/B-ALL received 6 intensified blocks in which 2 g/m2 of 24 hour continuous infusion methotrexate and vincristine were added. Triple intrathecal therapy was given for CNS prevention. After the first two blocks the response was assessed and those with a partial response were offered optionallya second look surgery or local radiotherapy.

RESULTS

With a median follow-up of 38 (range 16-71) months, the event-free survival (pEFS) for the whole group was 0.69 (Stage I-II n = 16 pEFS = 0.94, stage III n = 50 pEFS = 0.66, Stage IV n = 7 pEFS = 0.43, B-ALL n = 9 pEFS = 0.66). Patients with stage III abdominal tumors who achieved a partial response by imaging studies after induction had a significantly higher risk of relapse than those with a complete response (p = 0.02). Relapse was the most frequent event Toxicity was mainly hematological.

CONCLUSIONS

The application of this protocol was feasible in our setting and its results comparable to the German study. Patients with stage I-II had an excellent outcome. Those with stage III and B-ALL achieved an encouraging event-free survival, however those with abdominal tumors and partial response to induction chemotherapy fared less favourably. This strategy was less effective for patients with initial CNS disease.