Research article summary (published 20 Oct 2009):

Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma.

Full Abstract

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.) 2009 Massachusetts Medical Society

Author information

Author/s: Perilongo, Giorgio (G); Maibach, Rudolf (R); Shafford, Elisabeth (E); Brugieres, Laurence (L); Brock, Penelope (P); Morland, Bruce (B); de Camargo, Beatriz (B); Zsiros, Jozsef (J); Roebuck, Derek (D); Zimmermann, Arthur (A); Aronson, Daniel (D); Childs, Margaret (M); Widing, Eva (E); Laithier, Veronique (V); Plaschkes, Jack (J); Pritchard, Jon (J); Scopinaro, Marcello (M); MacKinlay, Gordon (G); Czauderna, Piotr (P);

Affiliation: Division of Hematology-Oncology, Department of Pediatrics, University Hospital of Padua, Padua, Italy. giorgio.perilongo(-atsign-)unipd.it

Grants: (Agency:Cancer Research UK)

Journal and publication information

Publication Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: The New England journal of medicine (N Engl J Med), published in United States. (Language: eng)

Reference: 2009-Oct; vol 361 (issue 17) : pp 1662-70

Dates: Created 2009/10/22; Completed 2009/10/29;

PMID: 19846851, status: MEDLINE (last retrieval date: 10/29/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

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

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

Associated Chemicals: Antineoplastic Agents (0) ; Cisplatin (15663-27-1) ; Doxorubicin (23214-92-8)

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