scholarly journals A Phase III Trial of Postoperative Chemotherapy or No Further Treatment for Patients with Node- Negative Stage I-Ii Intermediate or High Risk Endometrial Cancer. Engot-En2-Dgcg / Eortc 55102

2014 ◽  
Vol 25 ◽  
pp. iv324
Author(s):  
F. Amant ◽  
C. Lundgren ◽  
F. Kridelka ◽  
A. Ferrero ◽  
S. Greggi ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Stage I ◽  
Postoperative Chemotherapy ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Node Negative

scholarly journals Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early-Stage Endometrial Cancer

2019 ◽  
Vol 37 (21) ◽  
pp. 1810-1818 ◽  
Author(s):  
Marcus E. Randall ◽  
Virginia Filiaci ◽  
D. Scott McMeekin ◽  
Vivian von Gruenigen ◽  
Helen Huang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Confidence Limit ◽  
Clear Cell ◽  
Early Stage ◽  
Stage I ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Pelvic Radiation

PURPOSE The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma. PATIENTS AND METHODS A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33–based high-intermediate–risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m2 (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles. RESULTS The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9% v 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated. CONCLUSION Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.

A randomized phase III trial of docetaxel plus cisplatin or paclitaxel plus carboplatin compared with doxorubicin plus cisplatin as adjuvant chemotherapy for endometrial cancer at high risk of recurrence: Japanese Gynecologic Oncology Group study (JGOG2043).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5503-5503 ◽  
Author(s):  
Hiroyuki Nomura ◽  
Daisuke Aoki ◽  
Hirofumi Michimae ◽  
Mika Mizuno ◽  
Hidekatsu Nakai ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Phase Iii Trial ◽  
Risk Of Recurrence ◽  
Significant Difference ◽  
Platinum Agent

5503 Background: The superiority of chemotherapy regimens employing a taxane plus a platinum agent over standard therapy with doxorubicin plus cisplatin (AP) was recently demonstrated for advanced or recurrent endometrial cancer. This multicenter phase III trial evaluated the clinical benefit of taxane plus platinum agent regimens as adjuvant chemotherapy compared with AP for endometrial cancer patients at high risk of recurrence after surgery. Methods: Endometrial cancer patients having a high risk of recurrence and postoperative residual disease < 2 cm were randomly assigned (1:1:1) with stratification by FIGO stage and histologic grade to receive 6 cycles of doxorubicin (60 mg/m2) plus cisplatin (50 mg/m2) on day 1 (AP), docetaxel (70 mg/m2) plus cisplatin (60 mg/m2) on day 1 (DP) or paclitaxel (180 mg/m2) plus carboplatin (AUC 6.0 mg/mL x minute) on day 1 (TC) every 3 weeks as adjuvant chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), adverse events, and tolerability. Results: From November 2006 to January 2011, 788 patients were enrolled from 118 institutions in Japan and were eligible for evaluation. The proportion of patients receiving 6 cycles was 80% for AP, 83% for DP, and 76% for TC, and tolerability of the regimens showed no significant difference. After a median follow-up period of 7.0 years, there was no statistical difference of PFS (P=0.1246) or OS (P=0.6734) among the 3 groups. The 5-year PFS rate was 74.9% for AP, 80.9% for DP, and 74.7% for TC, while the 5-year OS rates were 84.3%, 89.3%, and 88.4%, respectively. Conclusions: There was no significant difference of survival among patients receiving AP, DP, or TC as adjuvant chemotherapy for endometrial cancer. Since each regimen showed adequate tolerability, taxane plus platinum agent regimens may be a reasonable alternative to AP. Clinical trial information: UMIN000000522.

Cost-effectiveness analysis of p53 immunohistochemical testing in stage I and II high-risk endometrial cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18838-e18838
Author(s):  
Taylor Orellana ◽  
Jessica L. Berger ◽  
Michelle M. Boisen ◽  
Ronald J. Buckanovich ◽  
Lan Gardner Coffman ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Cost Effectiveness ◽  
High Risk ◽  
Molecular Analysis ◽  
Stage I ◽  
Phase Iii ◽  
Sensitivity Analyses ◽  
Model Parameters ◽  
P53 Mutations ◽  
Markov Decision Model

e18838 Background: PORTEC-3, a phase III clinical trial comparing adjuvant radiation alone (RT) to combined chemoradiation therapy (CTRT) in patients with high-risk endometrial cancer (EC), demonstrated no benefit with CTRT compared to RT for patients with stage I and II EC. However, a subsequent tumor molecular analysis revealed that individuals with stage I and II high-risk EC with p53 mutations had statistically significantly improved progression-free survival (PFS) and clinically significantly improved overall survival (OS) with combined CTRT. As p53 immunohistochemical (IHC) testing and CTRT adds to cost and toxicity, we sought to evaluate the cost-effectiveness of p53 IHC tumor testing in patients with stage I and II high-risk EC. Methods: A Markov decision model was developed to compare two testing strategies in patients with stage I and II high-risk EC: p53 IHC testing vs. no IHC testing. IHC staining for p53 is an accurate and validated surrogate for TP53 mutational status. As a result, p53 IHC testing alone was used in the decision analysis. Data from PORTEC-3 and the subsequent molecular analysis were used for the base case model parameters, including treatment regimen, PFS, OS, and incidence of p53-mutated tumors. Cost and utility data were derived from the Federal Supply Schedule, the Centers for Medicare and Medicaid Services (CMS) Fee Schedules, the Tufts CEA registry, peer-reviewed literature, and expert input. Data analysis was performed using TreeAge Pro Software, 2021. Effectiveness outcomes included quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed in order to identify the influence of individual variables on the overall model. Results: When compared to no testing, p53 IHC testing resulted in a cost savings of $471 per patient while providing an additional 0.310 QALYs. Therefore, p53 IHC testing was less expensive and more effective than no IHC testing and was a dominant strategy in this model. In one-way sensitivity analyses, CTRT and RT costs, discount rate, and percentage of p53 mutations detected had the most impact on the model; however, p53 IHC testing remained a cost-saving strategy over all parameter ranges examined. Conclusions: For patients with high-risk stage I and II EC, this analysis suggests that p53 IHC testing is cost-effective compared to no testing in determining the costs and benefits of adjuvant chemotherapy. Although additional studies are warranted, this data provides further support for the role of molecular-based treatment decisions for high-risk stage I and II endometrial cancer.

Sign in / Sign up

Export Citation Format

Share Document