scholarly journals EP-1489 How effective is adjuvant radiotherapy in the management of stage I high-risk endometrial cancer?

2019 ◽  
Vol 133 ◽  
pp. S807
Author(s):  
J. Song ◽  
T. Le ◽  
M. Gaudet ◽  
C. Ee ◽  
K. Lupe ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Stage I

scholarly journals 117 How Effective is Adjuvant Radiotherapy in the Management of Stage I High-Risk Endometrial Cancer?

2019 ◽  
Vol 139 ◽  
pp. S51
Author(s):  
Jiheon Song ◽  
Tien Le ◽  
Marc Gaudet ◽  
E. Choan ◽  
Krystine Lupe ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Stage I

Is There a Survival Benefit to Adjuvant Radiotherapy in High-Risk Surgical Stage I Endometrial Cancer?

2002 ◽  
Vol 86 (3) ◽  
pp. 259-263 ◽  
Author(s):  
Ali Ayhan ◽  
Cagatay Taskiran ◽  
Cetin Celik ◽  
Inci Guney ◽  
Kunter Yuce ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Survival Benefit ◽  
Stage I

Improved overall survival with adjuvant radiotherapy for high-intermediate and high risk Stage I endometrial cancer

2017 ◽  
Vol 122 (3) ◽  
pp. 452-457 ◽  
Author(s):  
Matthew M. Harkenrider ◽  
William Adams ◽  
Alec M. Block ◽  
Stephanie Kliethermes ◽  
William Small ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Stage I

ENGOT-en11/GOG-3053/KEYNOTE-B21: Phase 3 study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with newly diagnosed high-risk endometrial cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5608-TPS5608
Author(s):  
Toon Van Gorp ◽  
Mansoor Raza Mirza ◽  
Alain Lortholary ◽  
David Cibula ◽  
Axel Walther ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Combination Therapy ◽  
Stage I ◽  
Newly Diagnosed ◽  
Phase 3 ◽  
Eortc Qlq

TPS5608 Background: Pembrolizumab, a selective humanized anti–PD-1 monoclonal antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% ORR as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC. Methods: Eligible patients are ≥18 years old with newly diagnosed, histologically confirmed high-risk (stage I/II non-endometrioid, stage III/IVa, p53 abnormality) EC (carcinoma or carcinosarcoma) following surgery with curative intent with no evidence of disease post-operatively or on imaging, and without prior systemic therapy/radiotherapy. In total, ̃990 patients are randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles + chemotherapy (carboplatin area under the curve [AUC] 5 or 6 + paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 + paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2 per their treatment assignment. At the investigator’s discretion, radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and International Federation of Gynecology and Obstetrics (FIGO) surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS), both estimated by the Kaplan-Meier method, with a stratified log-rank test to assess treatment differences and a Cox proportional hazard model with Efron’s method of tie handling to assess the magnitude of treatment differences. Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). The study began enrollment in December 2020. Clinical trial information: NCT04634877.

Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6)

2021 ◽  
Vol 31 (7) ◽  
pp. 1075-1079
Author(s):  
Günter Emons ◽  
Jae-Weon Kim ◽  
Karin Weide ◽  
Nikolaus de Gregorio ◽  
Pauline Wimberger ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Left Renal Vein ◽  
Stage I ◽  
Open Label ◽  
Risk Of Recurrence ◽  
Gynecology And Obstetrics ◽  
The Impact

BackgroundThe impact of comprehensive pelvic and para-aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident.Primary ObjectiveEvaluation of the effect of comprehensive pelvic and para-aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence.Study HypothesisComprehensive pelvic and para-aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65.Trial DesignOpen label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo-oophorectomy is performed. In arm B, in addition, a systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended.Major Inclusion CriteriaPatients with histologically confirmed endometrial cancer stages pT1b–pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible.Exclusion CriteriaPatients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease.Primary EndpointOverall survival calculated from the date of randomization until death.Sample Size640 patients will be enrolled in the study.Estimated Dates for Completing Accrual and Presenting ResultsAt present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031.Trial RegistrationNCT03438474.

scholarly journals Adjuvant Radiotherapy and/or Chemotherapy for Endometrial Cancer, Status as at 2019

2019 ◽  
Vol 79 (12) ◽  
pp. 1273-1277 ◽  
Author(s):  
Günter Emons ◽  
Clemens Tempfer ◽  
Marco Johannes Battista ◽  
Alexander Mustea ◽  
Dirk Vordermark ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Primary Treatment ◽  
Risk Of Recurrence ◽  
Randomized Controlled ◽  
Randomized Controlled Studies

AbstractThe role of adjuvant radiotherapy and/or chemotherapy in the primary treatment of endometrial cancer with a high risk of recurrence has still not been conclusively determined. The results of 3 large randomized controlled studies on different aspects of this issue have been published in full in recent months, and the relevant results are analyzed here.

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