Abstract | BACKGROUND: METHODS: Children with standard-risk hepatoblastoma who were younger than 16 years of age were eligible for inclusion in the study. After they received one cycle of cisplatin (80 mg per square meter of body-surface area per 24 hours), we randomly assigned patients to receive cisplatin (every 14 days) or cisplatin plus doxorubicin administered in three preoperative cycles and two postoperative cycles. The primary outcome was the rate of complete resection, and the trial was powered to test the noninferiority of cisplatin alone (<10% difference in the rate of complete resection). RESULTS: Between June 1998 and December 2006, 126 patients were randomly assigned to receive cisplatin and 129 were randomly assigned to receive cisplatin plus doxorubicin. The rate of complete resection was 95% in the cisplatin-alone group and 93% in the cisplatin- doxorubicin group in the intention-to-treat analysis (difference, 1.4%; 95% confidence interval [CI], -4.1 to 7.0); these rates were 99% and 95%, respectively, in the per-protocol analysis. Three-year event-free survival and overall survival were, respectively, 83% (95% CI, 77 to 90) and 95% (95% CI, 91 to 99) in the cisplatin group, and 85% (95% CI, 79 to 92) and 93% (95% CI, 88 to 98) in the cisplatin- doxorubicin group (median follow-up, 46 months). Acute grade 3 or 4 adverse events were more frequent with combination therapy (74.4% vs. 20.6%). CONCLUSIONS:
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Authors | Giorgio Perilongo, Rudolf Maibach, Elisabeth Shafford, Laurence Brugieres, Penelope Brock, Bruce Morland, Beatriz de Camargo, Jozsef Zsiros, Derek Roebuck, Arthur Zimmermann, Daniel Aronson, Margaret Childs, Eva Widing, Veronique Laithier, Jack Plaschkes, Jon Pritchard, Marcello Scopinaro, Gordon MacKinlay, Piotr Czauderna |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 361
Issue 17
Pg. 1662-70
(Oct 22 2009)
ISSN: 1533-4406 [Electronic] United States |
PMID | 19846851
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2009 Massachusetts Medical Society |
Chemical References |
- Antineoplastic Agents
- Doxorubicin
- Cisplatin
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Topics |
- Antineoplastic Agents
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Biopsy
- Chemotherapy, Adjuvant
- Child
- Child, Preschool
- Cisplatin
(administration & dosage, adverse effects)
- Disease Progression
- Doxorubicin
(administration & dosage, adverse effects)
- Female
- Hepatoblastoma
(drug therapy, mortality, surgery)
- Humans
- Infant
- Liver Neoplasms
(drug therapy, mortality, surgery)
- Male
- Neoplasm Recurrence, Local
- Survival Analysis
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