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
Identifieur interne : 007363 ( Main/Exploration ); précédent : 007362; suivant : 007364A 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
Auteurs : Aaron H. Wolfson [États-Unis] ; Mark F. Brady [États-Unis] ; Thomas Rocereto [États-Unis] ; Robert S. Mannel [États-Unis] ; Yi-Chun Lee [États-Unis] ; Robert J. Futoran [États-Unis] ; David E. Cohn [États-Unis] ; Olga B. Ioffe [États-Unis]Source :
- Gynecologic oncology [ 0090-8258 ] ; 2007.
Abstract
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.
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).
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).
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.
Url:
DOI: 10.1016/j.ygyno.2007.07.070
PubMed: 17822748
PubMed Central: 2752331
Affiliations:
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Wolfson</name><affiliation wicri:level="2"><nlm:aff id="A1"> Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, FL</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea> Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A2"> Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea> Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo</wicri:cityArea></affiliation></author><author><name sortKey="Rocereto, Thomas" sort="Rocereto, Thomas" uniqKey="Rocereto T" first="Thomas" last="Rocereto">Thomas Rocereto</name><affiliation wicri:level="2"><nlm:aff id="A3"> Cooper University Hospital, Camden, NJ</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea> Cooper University Hospital, Camden</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A4"> University of Oklahoma, Oklahoma City, OK</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oklahoma</region></placeName><wicri:cityArea> University of Oklahoma, Oklahoma City</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A5"> State University of New York Health Science Center, Brooklyn, NY</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea> State University of New York Health Science Center, Brooklyn</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A6"> The University of Nevada School of Medicine/Women’s Cancer Center of Nevada, Las Vegas, NV</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Nevada</region></placeName><wicri:cityArea> The University of Nevada School of Medicine/Women’s Cancer Center of Nevada, Las Vegas</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A7"> Columbus Cancer Council, Columbus, OH</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea> Columbus Cancer Council, Columbus</wicri:cityArea></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 wicri:level="2"><nlm:aff id="A8"> University of Maryland Medical Center, Baltimore, MD</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea> University of Maryland Medical Center, Baltimore</wicri:cityArea></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><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li><li>Maryland</li><li>Nevada</li><li>New Jersey</li><li>Ohio</li><li>Oklahoma</li><li>État de New York</li></region></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Wolfson, Aaron H" sort="Wolfson, Aaron H" uniqKey="Wolfson A" first="Aaron H." last="Wolfson">Aaron H. Wolfson</name></region><name sortKey="Brady, Mark F" sort="Brady, Mark F" uniqKey="Brady M" first="Mark F." last="Brady">Mark F. Brady</name><name sortKey="Cohn, David E" sort="Cohn, David E" uniqKey="Cohn D" first="David E." last="Cohn">David E. Cohn</name><name sortKey="Futoran, Robert J" sort="Futoran, Robert J" uniqKey="Futoran R" first="Robert J." last="Futoran">Robert J. Futoran</name><name sortKey="Ioffe, Olga B" sort="Ioffe, Olga B" uniqKey="Ioffe O" first="Olga B." last="Ioffe">Olga B. Ioffe</name><name sortKey="Lee, Yi Chun" sort="Lee, Yi Chun" uniqKey="Lee Y" first="Yi-Chun" last="Lee">Yi-Chun Lee</name><name sortKey="Mannel, Robert S" sort="Mannel, Robert S" uniqKey="Mannel R" first="Robert S." last="Mannel">Robert S. Mannel</name><name sortKey="Rocereto, Thomas" sort="Rocereto, Thomas" uniqKey="Rocereto T" first="Thomas" last="Rocereto">Thomas Rocereto</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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