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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EResults from the Combination Therapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma trial [EURAMOS-1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00134030\u0026amp;atom=%2Fspmdc%2F13%2F6%2F25.atom\u0022\u003ENCT00134030\u003C\/a\u003E; \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA10504)] show that maintenance therapy with pegylated interferon a-2b (PEG IFN-a-2b) after surgery and chemotherapy does not improve event-free survival in patients with high-grade osteosarcoma and good response to preoperative methotrexate, doxorubicin, and cisplatin (regimen collectively called MAP).\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMetabolic Bone Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESoft Tissue Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMetabolic Bone Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESoft Tissue Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EResults from the Combination Therapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma trial [EURAMOS-1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00134030\u0026amp;atom=%2Fspmdc%2F13%2F6%2F25.atom\u0022\u003ENCT00134030\u003C\/a\u003E; \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA10504)] show that maintenance therapy with pegylated interferon \u03b1-2b (PEG IFN-\u03b1-2b) after surgery and chemotherapy does not improve event-free survival (EFS) in patients with high-grade osteosarcoma and good response to preoperative methotrexate, doxorubicin, and cisplatin (regimen collectively called MAP).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EEURAMOS-1 is a randomized controlled trial from the European and American Osteosarcoma Study Group that investigated the efficacy of maintenance therapy with PEG IFN-\u03b1-2b in patients with resectable osteosarcoma and \u201cgood response\u201d (\u0026lt;10% viable tumor at surgery) to preoperative chemotherapy. The results were presented by Stefan S. Bielack, MD, PhD, Klinikum Stuttgart Olgahospital, Stuttgart, Germany.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EOsteosarcoma is a rare cancer, with 2 to 3 cases per million per year, in which histologic response is a prognostic factor for survival. Poor responders are generally considered to have a 3-year EFS and 5-year overall survival (OS) rate of 45% each [Ritter J, Bielack SS. \u003Cem\u003EAnn Oncol\u003C\/em\u003E 2010]. Among good responders, those rates climb to 70%. IFN-\u03b1 has shown growth inhibition in osteosarcoma cell lines, animal studies have extensively studied it in other tumors as maintenance therapy, and its safety in children is well established. These factors combined with the relatively favorable prognosis for patients with good histologic response may make IFN-\u03b1 a reasonable option for maintenance therapy.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients aged \u226440 years who had resectable localized or primary metastatic high-grade extremity or axial osteosarcoma were eligible for registration at diagnosis, provided they had no pretreatment for osteosarcoma and no prior chemotherapy. All patients received 2 cycles of MAP induction followed by surgical resection. Good histologic responders were then randomized to 4 cycles of MAP alone (MAP group) or 4 cycles of MAP followed by PEG IFN-\u03b1-2b weekly from Week 30 to Week 104 (MAP-IFN group). The starting dose of PEG IFN-\u03b1-2b was 0.5 \u03bcg\/kg\/week (maximum of 50 \u03bcg) given subcutaneously for 4 weeks. If the drug was well tolerated, the dose could be escalated to 1.0 \u03bcg\/kg\/week (maximum of 100 \u03bcg). The primary study endpoint was EFS, defined as death, local recurrence, new metastatic disease, progression, or secondary malignancy. Secondary endpoints were OS, toxicity, and quality of life.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EA total of 2260 patients were registered between April 2005 and November 2011, which makes it the largest trial studying this rare cancer. Good response was confirmed in 1041 patients, of which 715 (male, 59%; median age, 14 years) consented to randomization (MAP, n=358; MAP-IFN, n=357). Of the 357 patients randomized to the MAP-IFN group, 271 (76%) started treatment with PEG IFN-\u03b1-2b at a median of 5.4 months after randomization. The primary reason for not starting PEG IFN-\u03b1-2b was refusal (66\/86 patients).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EGrade 0 to 2 toxicities were reported by 70% (n=187) of patients receiving PEG IFN-\u03b1-2b while 30% (n=81) reported Grade 3 or 4 toxicities. Grade 4 toxicities included 13 hematologic, 3 cardiac, and 1 each dyspnea, mood alteration, and amylase. At study end, 37 were still receiving PEG IFN-\u03b1-2b while 234 subjects had stopped it (128 had completed therapy; 106 terminated early). Reasons for early termination were toxicity (n=44), disease progression (n=25), and refusal\/other (n=37). The median duration of PEG IFN-\u03b1-2b therapy was 14.9 months. After a median follow-up of 3 years following randomization, there was no significant difference in EFS between the MAP and MAP-IFN groups (74% vs 77%; HR, 0.82; 95% CI, 0.61 to 1.11; p=0.201).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn conclusion, MAP plus maintenance therapy with PEG IFN-\u03b1-2b was not superior to MAP alone, but it should be noted that the results may have been influenced by the failure of 24% of patients to start PEG IFN-\u03b1-2b treatment. Further follow-up for events and survival is ongoing.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/13\/6\/25.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznwc2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}