Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma

Perilongo, Giorgio; Maibach, Rudolf; Shafford, Elisabeth; Brugieres, Laurence; Brock, Penelope; Morland, Bruce; de Camargo, Beatriz; Zsiros, Jozsef; Roebuck, Derek; Zimmermann, Arthur; Aronson, Daniel; Childs, Margaret; Widing, Eva; Laithier, Veronique; Plaschkes, Jack; Pritchard, Jon; Scopinaro, Marcello; MacKinlay, Gordon; Czauderna, Piotr (2009). Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. New England journal of medicine NEJM, 361(17), pp. 1662-70. Waltham, Mass.: Massachusetts Medical Society MMS 10.1056/NEJMoa0810613

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BACKGROUND: Preoperative cisplatin alone may be as effective as cisplatin plus doxorubicin in standard-risk hepatoblastoma (a tumor involving three or fewer sectors of the liver that is associated with an alpha-fetoprotein level of >100 ng per milliliter). 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: As compared with cisplatin plus doxorubicin, cisplatin monotherapy achieved similar rates of complete resection and survival among children with standard-risk hepatoblastoma. Doxorubicin can be safely omitted from the treatment of standard-risk hepatoblastoma. (ClinicalTrials.gov number, NCT00003912.)

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Service Sector > Institute of Pathology

UniBE Contributor:

Zimmermann, Arthur

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 15:11

Last Modified:

16 Jul 2018 14:58

Publisher DOI:

10.1056/NEJMoa0810613

PubMed ID:

19846851

Web of Science ID:

000270977400008

URI:

https://boris.unibe.ch/id/eprint/31443 (FactScience: 195975)

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