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dc.contributor.authorSkapek, Stephen X.
dc.contributor.authorAnderson, James R.
dc.contributor.authorHill, D. Ashley
dc.contributor.authorHenry, David
dc.contributor.authorSpunt, Sheri L.
dc.contributor.authorMeyer, William
dc.contributor.authorKao, Simon
dc.contributor.authorHoffer, Fredric A.
dc.contributor.authorGrier, Holcombe E.
dc.contributor.authorHawkins, Douglas S.
dc.contributor.authorRaney, R. Beverly
dc.date2022-08-11T08:10:32.000
dc.date.accessioned2022-08-23T17:12:18Z
dc.date.available2022-08-23T17:12:18Z
dc.date.issued2013-07-01
dc.date.submitted2017-04-13
dc.identifier.citationPediatr Blood Cancer. 2013 Jul;60(7):1108-12. doi: 10.1002/pbc.24457. Epub 2012 Dec 31. <a href="https://doi.org/10.1002/pbc.24457">Link to article on publisher's site</a>
dc.identifier.issn1545-5009 (Linking)
dc.identifier.doi10.1002/pbc.24457
dc.identifier.pmid23281268
dc.identifier.urihttp://hdl.handle.net/20.500.14038/46474
dc.description.abstractBACKGROUND: Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children's Oncology Group. PROCEDURES: Eligible patients were (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging. RESULTS: Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10-18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23-0.48) and 96%, respectively. All three deaths were due to progressive DT. CONCLUSIONS: Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=23281268&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4646066/
dc.subjectHealth Services Administration
dc.subjectNeoplasms
dc.subjectOncology
dc.subjectPediatrics
dc.subjectRadiology
dc.titleSafety and efficacy of high-dose tamoxifen and sulindac for desmoid tumor in children: results of a Children's Oncology Group (COG) phase II study
dc.typeJournal Article
dc.source.journaltitlePediatric blood and cancer
dc.source.volume60
dc.source.issue7
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/qarc/27
dc.identifier.contextkey10017781
html.description.abstract<p>BACKGROUND: Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children's Oncology Group.</p> <p>PROCEDURES: Eligible patients were (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging.</p> <p>RESULTS: Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10-18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23-0.48) and 96%, respectively. All three deaths were due to progressive DT.</p> <p>CONCLUSIONS: Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates.</p>
dc.identifier.submissionpathqarc/27
dc.contributor.departmentQuality Assurance Review Center
dc.source.pages1108-12


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