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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Gynecologic Oncology Group Randomized Phase III Trial of Whole Abdominal Irradiation (WAI) vs Cisplatin-Ifosfamide and Mesna (CIM) as Post-Surgical Therapy in Stage I-IV Carcinosarcoma (CS) of the Uterus</title><author><name sortKey="Wolfson, Aaron H" sort="Wolfson, Aaron H" uniqKey="Wolfson A" first="Aaron H." last="Wolfson">Aaron H. Wolfson</name><affiliation><nlm:aff id="A1"> Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, FL</nlm:aff></affiliation></author><author><name sortKey="Brady, Mark F" sort="Brady, Mark F" uniqKey="Brady M" first="Mark F." last="Brady">Mark F. Brady</name><affiliation><nlm:aff id="A2"> Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY</nlm:aff></affiliation></author><author><name sortKey="Rocereto, Thomas" sort="Rocereto, Thomas" uniqKey="Rocereto T" first="Thomas" last="Rocereto">Thomas Rocereto</name><affiliation><nlm:aff id="A3"> Cooper University Hospital, Camden, NJ</nlm:aff></affiliation></author><author><name sortKey="Mannel, Robert S" sort="Mannel, Robert S" uniqKey="Mannel R" first="Robert S." last="Mannel">Robert S. Mannel</name><affiliation><nlm:aff id="A4"> University of Oklahoma, Oklahoma City, OK</nlm:aff></affiliation></author><author><name sortKey="Lee, Yi Chun" sort="Lee, Yi Chun" uniqKey="Lee Y" first="Yi-Chun" last="Lee">Yi-Chun Lee</name><affiliation><nlm:aff id="A5"> State University of New York Health Science Center, Brooklyn, NY</nlm:aff></affiliation></author><author><name sortKey="Futoran, Robert J" sort="Futoran, Robert J" uniqKey="Futoran R" first="Robert J." last="Futoran">Robert J. Futoran</name><affiliation><nlm:aff id="A6"> The University of Nevada School of Medicine/Women’s Cancer Center of Nevada, Las Vegas, NV</nlm:aff></affiliation></author><author><name sortKey="Cohn, David E" sort="Cohn, David E" uniqKey="Cohn D" first="David E." last="Cohn">David E. Cohn</name><affiliation><nlm:aff id="A7"> Columbus Cancer Council, Columbus, OH</nlm:aff></affiliation></author><author><name sortKey="Ioffe, Olga B" sort="Ioffe, Olga B" uniqKey="Ioffe O" first="Olga B." last="Ioffe">Olga B. Ioffe</name><affiliation><nlm:aff id="A8"> University of Maryland Medical Center, Baltimore, MD</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">17822748</idno><idno type="pmc">2752331</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2752331</idno><idno type="RBID">PMC:2752331</idno><idno type="doi">10.1016/j.ygyno.2007.07.070</idno><date when="2007">2007</date><idno type="wicri:Area/Pmc/Corpus">002752</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002752</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Gynecologic Oncology Group Randomized Phase III Trial of Whole Abdominal Irradiation (WAI) vs Cisplatin-Ifosfamide and Mesna (CIM) as Post-Surgical Therapy in Stage I-IV Carcinosarcoma (CS) of the Uterus</title><author><name sortKey="Wolfson, Aaron H" sort="Wolfson, Aaron H" uniqKey="Wolfson A" first="Aaron H." last="Wolfson">Aaron H. Wolfson</name><affiliation><nlm:aff id="A1"> Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, FL</nlm:aff></affiliation></author><author><name sortKey="Brady, Mark F" sort="Brady, Mark F" uniqKey="Brady M" first="Mark F." last="Brady">Mark F. Brady</name><affiliation><nlm:aff id="A2"> Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY</nlm:aff></affiliation></author><author><name sortKey="Rocereto, Thomas" sort="Rocereto, Thomas" uniqKey="Rocereto T" first="Thomas" last="Rocereto">Thomas Rocereto</name><affiliation><nlm:aff id="A3"> Cooper University Hospital, Camden, NJ</nlm:aff></affiliation></author><author><name sortKey="Mannel, Robert S" sort="Mannel, Robert S" uniqKey="Mannel R" first="Robert S." last="Mannel">Robert S. Mannel</name><affiliation><nlm:aff id="A4"> University of Oklahoma, Oklahoma City, OK</nlm:aff></affiliation></author><author><name sortKey="Lee, Yi Chun" sort="Lee, Yi Chun" uniqKey="Lee Y" first="Yi-Chun" last="Lee">Yi-Chun Lee</name><affiliation><nlm:aff id="A5"> State University of New York Health Science Center, Brooklyn, NY</nlm:aff></affiliation></author><author><name sortKey="Futoran, Robert J" sort="Futoran, Robert J" uniqKey="Futoran R" first="Robert J." last="Futoran">Robert J. Futoran</name><affiliation><nlm:aff id="A6"> The University of Nevada School of Medicine/Women’s Cancer Center of Nevada, Las Vegas, NV</nlm:aff></affiliation></author><author><name sortKey="Cohn, David E" sort="Cohn, David E" uniqKey="Cohn D" first="David E." last="Cohn">David E. Cohn</name><affiliation><nlm:aff id="A7"> Columbus Cancer Council, Columbus, OH</nlm:aff></affiliation></author><author><name sortKey="Ioffe, Olga B" sort="Ioffe, Olga B" uniqKey="Ioffe O" first="Olga B." last="Ioffe">Olga B. Ioffe</name><affiliation><nlm:aff id="A8"> University of Maryland Medical Center, Baltimore, MD</nlm:aff></affiliation></author></analytic><series><title level="j">Gynecologic oncology</title><idno type="ISSN">0090-8258</idno><idno type="eISSN">1095-6859</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>PURPOSE</title><p id="P2">After initial surgery, there has been no established consensus regarding adjunctive therapy for patients with uterine carcinosarcoma (CS). This study was designed to compare patient outcome following treatment with adjuvant whole abdominal irradiation (WAI) versus (vs) chemotherapy for patients with this rare group of female pelvic malignancies.</p></sec><sec sec-type="methods" id="S2"><title>PATIENTS AND METHODS</title><p id="P3">Eligible, consenting women with stage I-IV uterine CS, no more than 1 cm postsurgical residuum and/or no extra-abdominal spread had their treatments randomly assigned as either WAI or three cycles of cisplatin (C), ifosfamide (I), and mesna (M).</p></sec><sec id="S3"><title>RESULTS</title><p id="P4">232 patients were enrolled, of whom 206 (WAI=105; CIM=101) were deemed eligible. Patient demographics and characteristics were similar between arms. FIGO stage (both arms) was: I=64 (31%); II=26 (13%); III=92 (45%); IV=24 (12%). The estimated crude probability of recurring within 5 years was 58% (WAI) and 52% (CIM). Adjusting for stage and age, the recurrence rate was 21% lower for CIM patients than for WAI patients, (relative hazard [RH] = 0.789, 95% confidence interval [CI]: (0.530 –1.176), p = 0.245, 2-tail test). The estimated death rate was 29% lower among the CIM group (RH = 0.712, 95% CI: 0.484 – 1.048, p = 0.085, 2-tail test).</p></sec><sec id="S4"><title>CONCLUSION</title><p id="P5">We did not find a statistically significant advantage in recurrence rate or survival for adjuvant CIM over WAI in patients with uterine CS. However, the observed differences favor the use of combination chemotherapy in future trials.</p></sec></div></front></TEI><pmc article-type="research-article" xml:lang="EN"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0365304</journal-id><journal-id journal-id-type="pubmed-jr-id">3932</journal-id><journal-id journal-id-type="nlm-ta">Gynecol Oncol</journal-id><journal-title>Gynecologic oncology</journal-title><issn pub-type="ppub">0090-8258</issn><issn pub-type="epub">1095-6859</issn></journal-meta><article-meta><article-id pub-id-type="pmid">17822748</article-id><article-id pub-id-type="pmc">2752331</article-id><article-id pub-id-type="doi">10.1016/j.ygyno.2007.07.070</article-id><article-id pub-id-type="manuscript">NIHMS33375</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>A Gynecologic Oncology Group Randomized Phase III Trial of Whole Abdominal Irradiation (WAI) vs Cisplatin-Ifosfamide and Mesna (CIM) as Post-Surgical Therapy in Stage I-IV Carcinosarcoma (CS) of the Uterus</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Wolfson</surname><given-names>Aaron H.</given-names></name><degrees>MD</degrees><xref rid="A1" ref-type="aff">1</xref></contrib><contrib contrib-type="author"><name><surname>Brady</surname><given-names>Mark F.</given-names></name><degrees>PhD</degrees><xref rid="A2" ref-type="aff">2</xref></contrib><contrib contrib-type="author"><name><surname>Rocereto</surname><given-names>Thomas</given-names></name><degrees>MD</degrees><xref rid="A3" ref-type="aff">3</xref></contrib><contrib contrib-type="author"><name><surname>Mannel</surname><given-names>Robert S.</given-names></name><degrees>MD</degrees><xref rid="A4" ref-type="aff">4</xref></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>Yi-Chun</given-names></name><degrees>MD</degrees><xref rid="A5" ref-type="aff">5</xref></contrib><contrib contrib-type="author"><name><surname>Futoran</surname><given-names>Robert J.</given-names></name><degrees>MD</degrees><xref rid="A6" ref-type="aff">6</xref></contrib><contrib contrib-type="author"><name><surname>Cohn</surname><given-names>David E.</given-names></name><degrees>MD</degrees><xref rid="A7" ref-type="aff">7</xref></contrib><contrib contrib-type="author"><name><surname>Ioffe</surname><given-names>Olga B.</given-names></name><degrees>MD</degrees><xref rid="A8" ref-type="aff">8</xref></contrib></contrib-group><aff id="A1"><label>1</label> Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, FL</aff><aff id="A2"><label>2</label> Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY</aff><aff id="A3"><label>3</label> Cooper University Hospital, Camden, NJ</aff><aff id="A4"><label>4</label> University of Oklahoma, Oklahoma City, OK</aff><aff id="A5"><label>5</label> State University of New York Health Science Center, Brooklyn, NY</aff><aff id="A6"><label>6</label> The University of Nevada School of Medicine/Women’s Cancer Center of Nevada, Las Vegas, NV</aff><aff id="A7"><label>7</label> Columbus Cancer Council, Columbus, OH</aff><aff id="A8"><label>8</label> University of Maryland Medical Center, Baltimore, MD</aff><author-notes><corresp id="FN1">Corresponding author: Aaron H. Wolfson, M.D., 1475 NW 12<sup>th</sup> Avenue, D-31, Miami, FL 33136, Telephone 305-243-4210, FAX 305-243-4363, <email>awolfson@med.miami.edu</email></corresp><fn id="FN2"><p>For reprint information: Ms. Denise Mackey, Gynecologic Oncology Group, Administrative Office, Four Penn Center, 1600 JKF Blvd., Suite 1020, Philadelphia, PA 19102, Phone: 215-854-0770</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>14</day><month>5</month><year>2009</year></pub-date><pub-date pub-type="epub"><day>5</day><month>9</month><year>2007</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2007</year></pub-date><pub-date pub-type="pmc-release"><day>25</day><month>9</month><year>2009</year></pub-date><volume>107</volume><issue>2</issue><fpage>177</fpage><lpage>185</lpage><related-article journal-id-type="nlm-ta" journal-id="Gynecol Oncol" related-article-type="commentary" page="166" id="N0x1e122a0N0x28f5e10" xlink:href="17950382" ext-link-type="pubmed" vol="107"></related-article><abstract><sec id="S1"><title>PURPOSE</title><p id="P2">After initial surgery, there has been no established consensus regarding adjunctive therapy for patients with uterine carcinosarcoma (CS). This study was designed to compare patient outcome following treatment with adjuvant whole abdominal irradiation (WAI) versus (vs) chemotherapy for patients with this rare group of female pelvic malignancies.</p></sec><sec sec-type="methods" id="S2"><title>PATIENTS AND METHODS</title><p id="P3">Eligible, consenting women with stage I-IV uterine CS, no more than 1 cm postsurgical residuum and/or no extra-abdominal spread had their treatments randomly assigned as either WAI or three cycles of cisplatin (C), ifosfamide (I), and mesna (M).</p></sec><sec id="S3"><title>RESULTS</title><p id="P4">232 patients were enrolled, of whom 206 (WAI=105; CIM=101) were deemed eligible. Patient demographics and characteristics were similar between arms. FIGO stage (both arms) was: I=64 (31%); II=26 (13%); III=92 (45%); IV=24 (12%). The estimated crude probability of recurring within 5 years was 58% (WAI) and 52% (CIM). Adjusting for stage and age, the recurrence rate was 21% lower for CIM patients than for WAI patients, (relative hazard [RH] = 0.789, 95% confidence interval [CI]: (0.530 –1.176), p = 0.245, 2-tail test). The estimated death rate was 29% lower among the CIM group (RH = 0.712, 95% CI: 0.484 – 1.048, p = 0.085, 2-tail test).</p></sec><sec id="S4"><title>CONCLUSION</title><p id="P5">We did not find a statistically significant advantage in recurrence rate or survival for adjuvant CIM over WAI in patients with uterine CS. However, the observed differences favor the use of combination chemotherapy in future trials.</p></sec></abstract><contract-num rid="CA1">U10 CA037517-15</contract-num><contract-num rid="CA1">U10 CA027469-19</contract-num><contract-sponsor id="CA1">National Cancer Institute : NCI</contract-sponsor></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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