CYCLOPHOSPHAMIDE DOXORUBICIN VS CISPLATIN TENIPOSIDE IN THE TREATMENTOF CHILDREN OLDER THAN 12 MONTHS OF AGE WITH DISSEMINATED NEUROBLASTOMA - A PEDIATRIC-ONCOLOGY-GROUP RANDOMIZED PHASE-II STUDY

This prospective study was designed to estimate the response rates and to compare two drug pairs, cyclophosphamide/doxorubicin (Cy/A) and ci splatin/teniposide (P1/VM) in previously untreated patients with disse minated neuroblastoma >12 months of age at diagnosis. Estimated comple te clinical response rates after five courses of therapy were 13% (70 patients) and 22% (64 patients) for Cy/A and P1/VM, respectively (P = 0.17). After surgical removal of residual tumors in patients with part ial response, the complete response rates were 27% and 34% (P = 0.50), respectively. The overall CR/PR rates after induction and surgery wer e 59% and 73% (P = 0.077). There was no significant difference in even t free survival (P = 0.48) or survival (P = 0.40). Five year survival on the two arms were 14% (SE = 5%) and 12% (SE = 4%), respectively. To xicity was significant but manageable. The Cy/A arm had significantly higher hematopoietic toxicity but significantly lower GI toxicity. Sig nificant allergic reactions were seen with the P1/VM arm, none in the Cy/A arm. Given the activity of these two regimens, further therapy wi th a combination of these regimens is suggested. (C) 1995 Wiley-Liss, Inc.