Nomograms for Prediction of Outcome With or Without Adjuvant Radiation Therapy for Patients With Endometrial Cancer: A Pooled Analysis of PORTEC-1 and PORTEC-2 Trials

Creutzberg, Carien L.; Stiphout, Ruud G.P.M. van; Nout, Remi A.; Lutgens, Ludy; Jürgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Smit, Vincent T.H.B.M.; Lambin, Philippe

doi:10.1016/j.ijrobp.2014.11.022

Cited by 65 publications

(47 citation statements)

References 26 publications

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“…The question that remains is whether or not an additional BT boost is required. It seems that the incidence of vaginal recurrence after pelvic RT is low being between 1.6 and 2.3 % for early stage intermediate or high risk disease [ 46 , 49 ]. There are currently no randomized trials comparing EBRT vs EBRT with BT.…”

Section: Discussionmentioning

confidence: 99%

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

et al. 2016

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BackgroundTo evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures.MethodsThe records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database.ResultsIn total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %).ConclusionMost clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

et al. 2016

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“…The PORTEC-1 criteria do not incorporate lymphovascular invasion, which has been identified as an independent prognostic factor in numerous studies. [21][22][23][24] Bendifallah et al found that incorporation of lymphovascular invasion significantly improved prognostic accuracy; this was later validated by Korkmaz et al 25 26 Our criteria also include higher-risk grade 2 patients who are omitted by the PORTEC-1 criteria. In comparison with the GOG-99 criteria, our proposed criteria facilitate ease of use and practical application owing to more straightforward age groupings and use of modern FIGO staging.…”

Section: Discussionmentioning

confidence: 75%

A proposal for a new classification of “unfavorable risk criteria” in patients with stage I endometrial cancer

Shinde

Han

et al. 2019

International Journal of Gynecological Cancer

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BackgroundRandomized trials describe differing sets of high–intermediate risk criteria.ObjectiveTo use the National Cancer Database to compare the impact of radiation therapy in patients with stage I endometrial cancer meeting different criteria, and define a classification of “unfavorable risk.”MethodsPatients with stage I endometrial cancer between January 2010 and December 2014 were identified in the National Cancer Database and stratified into two cohorts: (1) patients meeting Gynecologic Oncology Group (GOG)-99 criteria only for high–intermediate risk, but not Post-Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 criteria and (2) those meeting PORTEC-1 criteria only. High-risk stage I patients with both FIGO stage IB (under FIGO 2009 staging) and grade 3 disease were excluded. In each cohort, propensity score-matched survival analyses were performed. Based on these analyses, we propose a new classification of unfavorable risk. We then analyzed the association of adjuvant radiation with survival, stratified by this classification.ResultsWe identified 117,272 patients with stage I endometrial cancer. Of these, 11,207 patients met GOG-99 criteria only and 5,920 patients met PORTEC-1 criteria only. After propensity score matching, adjuvant radiation therapy improved survival (HR=0.73; 95% CI 0.60 to 0.89; p=0.002) in the GOG-99 only cohort. However, there was no benefit of adjuvant radiation (HR=0.89; 95% CI 0.69 to 1.14; p=0.355) in the PORTEC-1 only cohort. We, therefore, defined unfavorable risk stage I endometrial cancer as two or more of the following risk factors: lymphovascular invasion, age ≥70, grade 2–3 disease, and FIGO stage IB. Adjuvant radiation improved survival in stage I patients with adverse risk factors (HR=0.74; 95% CI 0.68 to 0.80; p<0.001), but not in other stage I patients (HR=1.02; 95% CI 0.91 to 1.15; p=0.710; p interaction <0.001).ConclusionOur study showed that adjuvant radiation was associated with an overall survival benefit in patients meeting GOG-99 criteria only; however, no survival benefit was seen in patients meeting PORTEC-1 criteria only. We propose a definition of unfavorable risk stage I endometrial cancer: ≥2 risk factors from among lymphovascular invasion, age ≥70, grade 2–3 disease, and FIGO stage IB disease.

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“…A recently published pooled data from the PORTEC-1 and PORTEC-2 trials incorporate these prospective data, which better elucidate outcomes with and without adjuvant therapy and validate these findings with large retrospective datasets [12]. The final nomogram identified age, FIGO grade, and LVSI as clear prognostic factors in all outcomes.…”

Section: Resultsmentioning

confidence: 86%

Current Concepts in Radiation Therapy for Early-Stage Endometrial Cancer

Gill

Minkoff

Beriwal

2015

Indian J Gynecol Oncolog

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Purpose The present article aims to review current management for early-stage endometrioid carcinomas with a specific focus on adjuvant radiotherapy. Methods A comprehensive literature review was conducted regarding management of early-stage endometrioidtype endometrial cancers. Abstracted information included risk of relapse, treatment approach, and morbidity from treatment. Results A majority of low-risk patients are safely managed with observation, with vaginal cuff brachytherapy (VCBT) reserved for those with multiple other risk factors. Intermediate-risk patients are a heterogeneous group with a variable definition; previous trials have established that VCBT alone is suitable for most patients to avoid morbidity of pelvic external beam radiotherapy (EBRT). Highand high-intermediate risk patients warrant pelvic EBRT ± VCBT with or without sequential chemotherapy. Continued controversy exists regarding the optimal VCBT fractionation regimen, with suggestion that higher dose/ fraction regimens may lead to increased vaginal toxicity. Intensity-modulated radiotherapy is being investigated in an effort to reduce late toxicities. Advanced brachytherapy techniques such as image-guided brachytherapy have improved treatment of salvage and medically inoperable patients.Conclusions Identification of risk groups and toxicity reduction through either appropriate radiotherapy techniques or advanced techniques has enabled optimization of adjuvant management for early-stage endometrial cancer.

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Nomograms for Prediction of Outcome With or Without Adjuvant Radiation Therapy for Patients With Endometrial Cancer: A Pooled Analysis of PORTEC-1 and PORTEC-2 Trials

Cited by 65 publications

References 26 publications

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

A proposal for a new classification of “unfavorable risk criteria” in patients with stage I endometrial cancer

Current Concepts in Radiation Therapy for Early-Stage Endometrial Cancer

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