Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. Export

@article{citeulike:6014152, 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.)}, author = {Perilongo, Giorgio and Maibach, Rudolf and Shafford, Elisabeth and Brugieres, Laurence and Brock, Penelope and Morland, Bruce and de Camargo, Beatriz and Zsiros, Jozsef and Roebuck, Derek and Zimmermann, Arthur and Aronson, Daniel and Childs, Margaret and Widing, Eva and Laithier, Veronique and Plaschkes, Jack and Pritchard, Jon and Scopinaro, Marcello and MacKinlay, Gordon and Czauderna, Piotr}, citeulike-article-id = {6014152}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0810613}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19846851}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19846851}, day = {22}, doi = {10.1056/NEJMoa0810613}, issn = {1533-4406}, journal = {The New England journal of medicine}, keywords = {hepatoblastoma}, month = {October}, number = {17}, pages = {1662--1670}, posted-at = {2009-10-27 05:44:30}, priority = {2}, title = {Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma.}, url = {http://dx.doi.org/10.1056/NEJMoa0810613}, volume = {361}, year = {2009} }

TY - JOUR ID - citeulike:6014152 L3 - citeulike-article-id:6014152 N2 - 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.) IS - 17 JF - The New England journal of medicine SN - 1533-4406 EP - 1670 TI - Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. VL - 361 SP - 1662 KW - hepatoblastoma AU - Perilongo, Giorgio AU - Maibach, Rudolf AU - Shafford, Elisabeth AU - Brugieres, Laurence AU - Brock, Penelope AU - Morland, Bruce AU - de Camargo, Beatriz AU - Zsiros, Jozsef AU - Roebuck, Derek AU - Zimmermann, Arthur AU - Aronson, Daniel AU - Childs, Margaret AU - Widing, Eva AU - Laithier, Veronique AU - Plaschkes, Jack AU - Pritchard, Jon AU - Scopinaro, Marcello AU - MacKinlay, Gordon AU - Czauderna, Piotr PY - 2009/10/22/ UR - http://dx.doi.org/10.1056/NEJMoa0810613 ER -