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Original Article
A phase II study of topotecan with vincristine and doxorubicin in children with recurrent/refractory neuroblastoma
Article first published online: 16 OCT 2003
DOI: 10.1002/cncr.11797
Copyright © 2003 American Cancer Society
Additional Information
How to Cite
Garaventa, A., Luksch, R., Biasotti, S., Severi, G., Pizzitola, M. R., Viscardi, E., Prete, A., Mastrangelo, S., Podda, M., Haupt, R. and De Bernardi, B. (2003), A phase II study of topotecan with vincristine and doxorubicin in children with recurrent/refractory neuroblastoma. Cancer, 98: 2488–2494. doi: 10.1002/cncr.11797
Publication History
- Issue published online: 17 NOV 2003
- Article first published online: 16 OCT 2003
- Manuscript Accepted: 25 AUG 2003
- Manuscript Revised: 19 AUG 2003
- Manuscript Received: 11 JUN 2003
Funded by
- Italian National Research Council, Project Consiglio Nazionale della Ricerca-Ministero dell'Istruzione, dell'Università e della Ricerca (CNR-MIUR)
- Minister of Health-Special Programs Research “Finalizzata 2000” and “Finalizzata 2002”
- Italian Neuroblastoma Association (Genoa, Italy)
- Abstract
- Article
- References
- Cited By
Keywords:
- Phase II;
- neuroblastoma;
- topotecan;
- vincristine;
- doxorubicin
Abstract
BACKGROUND
A Phase II trial in children with advanced neuroblastoma was carried out in five Italian institutions to evaluate the antitumor activity and tolerability of topotecan followed by vincristine and doxorubicin.
METHODS
Children older than age 1 year with Stage III or Stage IV neuroblastoma, all of whom had been treated previously with chemotherapy and were diagnosed with either refractory or recurrent disease, were treated with topotecan at an intravenous dose of 1.5 mg/m2 (the dose was 0.75 mg/m2 for patients who were treated within 1 year of previous megatherapy) per day for 5 days followed by 48-hour intravenous infusions of 2 mg/m2 vincristine and 45 mg/m2 doxorubicin. Cycles of therapy were repeated every 3 weeks.
RESULTS
Twenty-five patients (2 with Stage III disease and 23 with Stage IV disease; 19 with refractory disease and 6 with recurrent disease) were treated with a total of 115 cycles. Four patients had complete responses, 12 patients had partial responses, 4 patients had minor responses or stable disease, and 5 patients had tumor progression. The overall response rate (including complete and partial responses) was 64% (95% confidence interval, 43–82%). Fifteen patients were alive at the time of the current report and were progression free at 4–16 months (median, 9 months) after the first course of this treatment. Toxicity generally was limited to the hematopoietic system. Dose-limiting toxicity was observed in only 1 patient (Grade 4 liver toxicity). There were no deaths due to infectious or toxic causes.
CONCLUSIONS
The topotecan-vincristine-doxorubicin combination was active and well tolerated in previously treated patients with advanced neuroblastoma. Cancer 2003. © 2003 American Cancer Society.

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