Childrens Cancer Group 3891

The Children's Cancer Group (CCG) 3891 study has provided the largest phase III experience in NB to date. This study employed a 2x2 factorial design. Patients were randomized to consolidation with HDC/SCR vs continuation chemotherapy after induction. Bone marrow purged using immunomag-netic method (see 11.6.3.6) was the stem cell source for HDC/SCR. After completion of consolidation, patients in both groups were randomized to 13-ris retinoic acid or no further therapy (Matthay et al. 1999). Patients randomized to HDC/SCR +13-ris retinoic acid showed improved EFS compared with those treated with conventional chemotherapy without 13-ris retinoic acid. Note that the survival curves (Chap. 15, Fig. 15.5.) start at the time of the second randomization (after HDC/SCR), and not at diagnosis. This study also highlighted the challenges of a 2x2 design and a complex treatment plan: of 579

Table 11.6.2 Results from large studies of HDC/SCR in high-risk neuroblastoma. C carboplatin, E etoposide, M melphalan, Ctx cyclophosphamide, T thiotepa, TBI total body irradiation

Group

Number

Study type

EFS from

EFS (%)

Myeloablative regimen(s)

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