Treatment of children with acute lymphoblastic leukemia in India using a BFM protocol.

Background: Limited data exists on the long-term treatment outcome and prognosis of childhood ALL in India.

Procedure: Three hundred and seven children (1-14 years) with acute lymphoblastic leukemia (ALL) were treated with a modified BFM protocol 76/79 between 1985 and 2003. Treatment outcome and prognostic factors were evaluated.

Results: The median age was 6 years; 78% had B lineage acute lymphoblastic leukemia and 22% had T lineage disease. Good prednisolone response was observed in 82% of cases. Two hundred and seventy-three children (91.6%) achieved complete remission; with 2% induction-related mortality and 6.4% having resistant disease. 52% of all evaluable patients and 56.8% of complete responders are in continuous complete remission (CCR) at a median follow up of 62 months (30-194 months). The median event free survival (EFS) was 114 months. The estimated 5 year overall survival, EFS and disease free survival was 59.8%, 56%, and 53.9%, respectively. The prognostic factors adversely affecting the EFS were poor prednisolone response, resistant disease and WBC count greater than 20 x 10(9)/L at diagnosis. The 5 year EFS in the favorable risk group (age 1-9 years, WBC count less than 20 x 10(9)/L and prednisolone good response) was 73.1 +/- 4.9%.

Conclusion: This report examines a cohort of children with ALL treated with a BFM protocol in India with adequate follow up and demonstrates the need for cost effective improvements.