Correction: Location of recurrences in high-risk stage I endometrial cancer patients not given postoperative radiotherapy: A Danish gynecological cancer group study

2020 ◽  
Vol 30 (11) ◽  
pp. 1853-1853
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Postoperative Radiotherapy ◽  
Gynecological Cancer ◽  
Stage I ◽  
Not Given ◽  
Cancer Group

Location of recurrences in high-risk stage Iendometrial cancer patients not given postoperative radiotherapy: A Danish gynecological cancer group study

2019 ◽  
Vol 29 (3) ◽  
pp. 497-504 ◽  
Author(s):  
Gitte Ørtoft ◽  
Claus Høgdall ◽  
Caroline Juhl ◽  
Lone K Petersen ◽  
Estrid S Hansen ◽  
...  
Keyword(s):  
High Risk ◽  
Postoperative Radiotherapy ◽  
Gynecological Cancer ◽  
Abdominal Cavity ◽  
Myometrial Invasion ◽  
Stage I ◽  
Not Given ◽  
Recurrence Rates ◽  
Cancer Group ◽  
Grade 3

ObjectivesTo study recurrence rates in Danish high-risk stage I endometrial cancers not given radiotherapy in accordance with the decision of the Danish Gynecological Cancer Group.MethodsThis prospective national cohort study includes all 4707 endometrial carcinomas diagnosed from 2005 to 2012. Of these, 623 patients had grade 3 endometroid adenocarcinoma with >50% myometrial invasion or serous/clear/undifferentiated carcinoma (with any depth of invasion). In 305 patients with high-risk stage I on final pathology, 14.1% received adjuvant external beam radiotherapy and 9.6% adjuvant chemotherapy. No patients received brachytherapy. 5-year Kaplan-Meier survival estimates and actuarial recurrence rates were calculated, and adjusted Cox regression analysis used for comparison. Recurrence rates were compared with historical Danish population data (DEMCA 98–99).ResultsFor non-irradiated patients, 5-year overall survival, cancer-specific survival, and progression-free survival rates in high-risk stage I patients were 65%, 78%, and 73%, respectively. For non-irradiated patients, isolated local recurrences were uncommon (vaginal 3.1%, pelvic 0.4%). Death was mainly due to a high occurrence of non-local recurrences, with 8.8% experiencing a first recurrence in the abdominal cavity (outside the field where radiation traditionally have been given) and 13.0% a distant metastasis outside the abdominal cavity. Grade 3 tumors with >50% myometrial invasion seem to be characterized by a different pattern of recurrences, with significantly more isolated vaginal recurrences (7.9% vs 2.2%) and fewer total number of abdominal recurrences (7.9% vs 15.3%) as compared with unfavorable tumor types.ConclusionIsolated vaginal and pelvic recurrences were rare (3–5%) in patients with a final pathologic diagnosis of high-risk stage I endometrial cancer even after the Danish Gynecological Cancer Group decided to omit all types of postoperative radiotherapy and introduce lymph node staging.

The effect of introducing pelvic lymphadenectomy on survival and recurrence rates in Danish endometrial cancer patients at high risk: a Danish Gynecological Cancer Group study

2019 ◽  
Vol 29 (1) ◽  
pp. 68-76 ◽  
Author(s):  
Gitte Ørtoft ◽  
Claus Høgdall ◽  
Caroline Juhl ◽  
Lone K Petersen ◽  
Estrid S Hansen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Cancer Patients ◽  
Gynecological Cancer ◽  
Stage I ◽  
Cancer Specific Survival ◽  
High Risk Patients ◽  
Risk Patients

ObjectivesTo evaluate the rate of survival and recurrence related to the introduction of pelvic lymphadenectomy in Danish high-risk endometrial cancer patients.Study designData on 713 high-risk patients defined as grade 3 with >50% myometrial invasion or serous/clear/undifferentiated carcinomas stage I–IV endometrial cancer patients diagnosed from 2005 to 2012 were retrieved from the Danish Gynecological Cancer Database. Of these, 305 were high-risk stage I. Five year Kaplan-Meier survival estimates and actuarial recurrence rates were calculated, and adjusted Cox used for comparison. Findings were compared with earlier Danish results.ResultsLymphadenectomy in 390 radically operated high-risk patients resulted in upstaging of 31 patients from stage I to IIIC and 19 patients from stage II to IIIC corresponding to 12.8%. Upstaging from stage I to IIIC had a cancer-specific survival of 77%, almost comparable to lymph node-negative high-risk stage I patients (81%). Lymphadenectomy patients had a significant higher overall survival as compared with non-lymph node resected for all patients, but not for stage I patients. Lymphadenectomy, however, did not significantly affect cancer-specific survival, progression-free survival, recurrence rate or risk of local, distant, or lymph node recurrence. When the survival of high-risk stage I patients was compared with earlier Danish results, a small improvement in overall survival (7%) and cancer-specificsurvival (8%) was demonstrated.ConclusionOnly a small number of high-risk patients were upstaged from stage I to III due to lymphadenectomy. These patients showed a surprisingly good survival possibly due to correct stage identification and subsequent relevant adjuvant therapy. However, even though introduction of lymphadenectomy in the Danish high-risk population seems to increase overall survival, no significant change in cancer-specific survival, progression-free survival or recurrence patterns was demonstrated.

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 Predictors of Survival in Women with High-Risk Endometrial Cancer and Comparisons of Sandwich versus Concurrent Adjuvant Chemotherapy and Radiotherapy

2020 ◽  
Vol 17 (16) ◽  
pp. 5941
Author(s):  
Hui-Hua Chen ◽  
Wan-Hua Ting ◽  
Hsu-Dong Sun ◽  
Ming-Chow Wei ◽  
Ho-Hsiung Lin ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Endometrial Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Lymph Node Metastasis ◽  
Cancer Patients ◽  
Body Mass ◽  
Paraaortic Lymph Node ◽  
Node Metastasis ◽  
Paraaortic Lymph Node Metastasis

Background: to elucidate the predictors of progression-free survival (PFS) and overall survival (OS) in high-risk endometrial cancer patients. Methods: the medical records of all consecutivewomen with high-risk endometrial cancer were reviewed. Results: among 92 high-risk endometrial cancer patients, 30 women experienced recurrence, and 21 women died. The 5-year PFS and OS probabilities were 65.3% and 75.9%, respectively. Multivariable Cox regression revealed that body mass index (hazard ratio (HR) = 1.11), paraaortic lymph node metastasis (HR = 11.11), lymphovascular space invasion (HR = 5.61), and sandwich chemoradiotherapy (HR = 0.15) were independently predictors of PFS. Body mass index (HR = 1.31), paraaortic lymph node metastasis (HR = 32.74), non-endometrioid cell type (HR = 11.31), and sandwich chemoradiotherapy (HR = 0.07) were independently predictors of OS. Among 51 women who underwent sandwich (n = 35) or concurrent (n = 16) chemoradiotherapy, the use of sandwich chemoradiotherapy were associated with better PFS (adjusted HR = 0.26, 95% CI = 0.08–0.87, p = 0.03) and OS (adjusted HR = 0.11, 95% CI = 0.02–0.71, p = 0.02) compared with concurrent chemoradiotherapy. Conclusion: compared with concurrent chemoradiotherapy, sandwich chemoradiotherapy was associated with better PFS and OS in high-risk endometrial cancer patients. In addition, high body mass index, paraaortic lymph node metastasis, and non-endometrioid cell type were also predictors of poor OS in high-risk endometrial cancer patients.

Significance of morphometric, DNA cytometric features, and other prognostic markers on survival of endometrial cancer patients in northern Norway

2002 ◽  
Vol 12 (1) ◽  
pp. 49-56 ◽  
Author(s):  
A Ørbo ◽  
M Rydningen ◽  
B Straume ◽  
S Lysne
Keyword(s):  
Endometrial Cancer ◽  
Cancer Patients ◽  
Vascular Invasion ◽  
Prognostic Markers ◽  
Dna Ploidy ◽  
Prognostic Significance ◽  
Figo Stage ◽  
Stage I ◽  
Northern Norway

Abstract.Ørbo A, Rydningen M, Straume B, Lysne S. Significance of morphometric, DNA cytometric features, and other prognostic markers on survival of endometrial cancer patients in northern Norway.The objective of this study was to evaluate the prognostic value of nuclear morphometric features and DNA ploidy by flow cytometry next to depth of myometrial invasion and vascular invasion in endometrial cancer of all FIGO stages.A total of 123 women (103 FIGO stage I, eight stage II, and 12 stage III and IV) from northern Norway were studied. The follow-up period was between 7 and 19 years. The median age of patients was 62 years. The primary surgery was performed in the University Hospital of Tromsø or in the seven different reference hospitals in the northern part of Norway after an endometrial cancer diagnosis. The histologic, morphometric, flowcytometric and immunohistochemical investigations were based on archival paraffin-embedded material. The information regarding the follow-up data and clinical information were obtained from the medical records.Thirteen (10.6%) patients from the entire group (all stages) but only three (2.7%) of the FIGO stage I and II patients died from locally recurrent or metastatic disease. FIGO substage (P = 0.0006; odds ratio [OR] = 16.44, 95% confidence interval [CI] = 3.36–80.45), vascular invasion (P = 0.01, OR = 6.42, CI = 1.57–26.34) and nuclear size (P = 0.025, 0 R = 1.3, CI = 1.05–1.61) were independently correlated with recurrence in a multivariate analysis but histologic grade and DNA ploidy were not. Vascular invasion was poorly reproducible both between and within the same observer, however.In this retrospective study of all stages of endometrial carcinoma with long follow-up periods the primary tumor characteristics nuclear perimeter and FIGO stage were of prognostic significance in addition to the poorly reproducible vessel invasion.

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
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