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Med. Pediatr. Oncol. · Jan 2001
Clinical TrialN7: a novel multi-modality therapy of high risk neuroblastoma (NB) in children diagnosed over 1 year of age.
- N K Cheung, B H Kushner, M LaQuaglia, K Kramer, S Gollamudi, G Heller, W Gerald, S Yeh, R Finn, S M Larson, D Wuest, M Byrnes, E Dantis, J Mora, I Y Cheung, N Rosenfield, S Abramson, and R J O'Reilly.
- Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA. Cheungn@MSKCC.org
- Med. Pediatr. Oncol. 2001 Jan 1; 36 (1): 227-30.
BackgroundThe N7 protocol for poor-risk neuroblastoma uses dose-intensive chemotherapy (as in N6 protocol [Kushner et al.: J Clin Oncol 12:2607-2613, 1994] but with lower dosing of vincristine) for induction, surgical resection and 2100 cGy hyperfractionated radiotherapy for local control, and for consolidation, targeted radioimmunotherapy with 131I-labeled anti-GD2 3F8 monoclonal antibody and immunotherapy with unlabeled/unmodified 3F8 (400 mg/m2).ProcedureThe chemotherapy consists of: cyclophosphamide 70 mg/kg/d x 2 and a 72-hr infusion of doxorubicin 75 mg/m2 plus vincristine 2 mg/m2, for courses 1, 2, 4, and 6; and cisplatin 50 mg/m2/d x 4 and etoposide 200 mg/m2/d x 3, for courses 3, 5, and 7. 131I-3F8 is dosed at 20 mCi/kg, which is myeloablative and therefore necessitates stem-cell support.ResultsOf the first 24 consecutive previously untreated patients more than 1 year old at diagnosis, 22 were stage 4 and two were unresectable stage 3 with MYCN amplification. Chemotherapy achieved CR/VGPR in 21 of 24 patients. Twenty patients to date have completed treatment with 131I-3F8, and 15 patients have completed all treatment. With a median follow-up of 19 months, 18 of 24 patients remain progression-free.ConclusionsMajor toxicities were grade 4 myelosuppression and mucositis during chemotherapy, and self-limited pain and urticaria during antibody treatment. Late effects include hearing deficits and hypothyroidism.
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