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 Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. 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. NIH Public Access

Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib–II endometrial cancer: An Italian multicenter retrospective study (CTF study)

“…The pooled data meta-analyses showed a significant improvement in terms of progression-free survival (HR = 0.80; 95%CI = 0.66-0.97) and overall survival (HR = 0.76, 95% CI = 0.62-0.92) for chemotherapy arm [24]. The HR for death was the same if the analysis excluded the trial enrolling carcinosarcomas [30]. However, GOG122 included patients with stage III-IV endometrial cancer with residual disease b 2 cm [29].…”

“…Therefore VBT could be the adjuvant treatment of choice in this clinical setting. Four randomized trials compared adjuvant platinum based chemotherapy to radiotherapy in high-risk endometrial cancer [22,23,29,30]. The pooled data meta-analyses showed a significant improvement in terms of progression-free survival (HR = 0.80; 95%CI = 0.66-0.97) and overall survival (HR = 0.76, 95% CI = 0.62-0.92) for chemotherapy arm [24].…”

Molecular markers and clinical behavior of uterine carcinosarcomas: focus on the epithelial tumor component

“…Treatment with adjuvant combined chemotherapy seems the most promising compared with single-agent chemotherapy 14,15 or radiotherapy. 16 However, more research is needed to develop the most effective treatment for patients with uterine carcinosarcomas.…”

Impact of Treatment Strategies on Local Control and Survival in Uterine Carcinosarcomas in Turkey

“…Data on the efficacy of PC regimen in uterine carcinosarcoma is limited. Among patients with advanced or recurrent disease, 54% response rate was achieved in a GOG study (Wolfson et al, 2007). Response rates were similar in another study and median PFS was 16 and 12 months in chemo naive and previously treated patients, respectively (Hoskins et al, 2008).…”

“…On the other hand, data in the adjuvant treatment is more scarce. GOG0150 compared adjuvant ifosfamide and cisplatin to whole abdominal radiotherapy and found similar outcomes but a trend towards superior survival with chemotherapy (Wolfson et al, 2007). The role of radiotherapy after surgery has shown an increased local control with no significant effect on overall survival (Ferrer et al, 1999;Denschlag et al, 2007).…”