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

Aaron Wolfson, Mark F. Brady, Thomas Rocereto, Robert S. Mannel, Yi Chun Lee, Robert J. Futoran, David E. Cohn, Olga B. Ioffe

Research output: Contribution to journalArticle

183 Citations (Scopus)

Abstract

Purpose: 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. Patients and methods: 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). Results: 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, two-tail test). Conclusion: 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.

Original languageEnglish
Pages (from-to)177-185
Number of pages9
JournalGynecologic Oncology
Volume107
Issue number2
DOIs
StatePublished - Nov 1 2007

Fingerprint

Mesna
Carcinosarcoma
Ifosfamide
Cisplatin
Uterus
Therapeutics
Confidence Intervals
Recurrence
Combination Drug Therapy
Survival Rate
Demography
Drug Therapy

Keywords

  • Carcinosarcoma
  • Whole body irradiation

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

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. / Wolfson, Aaron; Brady, Mark F.; Rocereto, Thomas; Mannel, Robert S.; Lee, Yi Chun; Futoran, Robert J.; Cohn, David E.; Ioffe, Olga B.

In: Gynecologic Oncology, Vol. 107, No. 2, 01.11.2007, p. 177-185.

Research output: Contribution to journalArticle

Wolfson, Aaron ; Brady, Mark F. ; Rocereto, Thomas ; Mannel, Robert S. ; Lee, Yi Chun ; Futoran, Robert J. ; Cohn, David E. ; Ioffe, Olga B. / 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. In: Gynecologic Oncology. 2007 ; Vol. 107, No. 2. pp. 177-185.
@article{5c287177994f44aa9fc4b776d48130a3,
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",
abstract = "Purpose: 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. Patients and methods: 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). Results: 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, two-tail test). Conclusion: 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.",
keywords = "Carcinosarcoma, Whole body irradiation",
author = "Aaron Wolfson and Brady, {Mark F.} and Thomas Rocereto and Mannel, {Robert S.} and Lee, {Yi Chun} and Futoran, {Robert J.} and Cohn, {David E.} and Ioffe, {Olga B.}",
year = "2007",
month = "11",
day = "1",
doi = "10.1016/j.ygyno.2007.07.070",
language = "English",
volume = "107",
pages = "177--185",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "2",

}

TY - JOUR

T1 - 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

AU - Wolfson, Aaron

AU - Brady, Mark F.

AU - Rocereto, Thomas

AU - Mannel, Robert S.

AU - Lee, Yi Chun

AU - Futoran, Robert J.

AU - Cohn, David E.

AU - Ioffe, Olga B.

PY - 2007/11/1

Y1 - 2007/11/1

N2 - Purpose: 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. Patients and methods: 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). Results: 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, two-tail test). Conclusion: 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.

AB - Purpose: 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. Patients and methods: 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). Results: 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, two-tail test). Conclusion: 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.

KW - Carcinosarcoma

KW - Whole body irradiation

UR - http://www.scopus.com/inward/record.url?scp=35348917431&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=35348917431&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2007.07.070

DO - 10.1016/j.ygyno.2007.07.070

M3 - Article

C2 - 17822748

AN - SCOPUS:35348917431

VL - 107

SP - 177

EP - 185

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 2

ER -