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1. Association of persistent morbidity after radiotherapy with quality of life in locally advanced cervical cancer survivors

Author

Spampinato, Sofia, Tanderup, Kari, Lindegaard, Jacob C., Schmid, Maximilian P., Sturdza, Alina, Segedin, Barbara, Jürgenliemk-Schulz, Ina M., De Leeuw, Astrid, Bruheim, Kjersti, Mahantshetty, Umesh, Chargari, Cyrus, Rai, Bhavana, Cooper, Rachel, van der Steen-Banasik, Elzbieta, Sundset, Marit, Wiebe, Ericka, Villafranca, Elena, Van Limbergen, Erik, Pieters, Bradley R., Tee Tan, Li, Lutgens, Ludy C.H.W., Hoskin, Peter, Smet, Stéphanie, Pötter, Richard, Nout, Remi, Chopra, Supriya, and Kirchheiner, Kathrin

Published
2023
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2. Risk Factors for Late Persistent Fatigue After Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Analysis From the EMBRACE-I Study

Author

Smet, Stéphanie, Spampinato, Sofia, Pötter, Richard, Jürgenliemk-Schulz, Ina M., Nout, Remi A., Chargari, Cyrus, Mahantshetty, Umesh, Sturdza, Alina, Segedin, Barbara, Bruheim, Kjersti, Hoskin, Peter, Rai, Bhavana, Huang, Fleur, Cooper, Rachel, Van der Steen-Banasik, Elzbieta, Sundset, Marit, Van Limbergen, Erik, Tan, Li Tee, Lutgens, Ludy C.H.W., Villafranca, Elena, Pieters, Bradley R., Tanderup, Kari, and Kirchheiner, Kathrin

Published
2022
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3. Severity and Persistency of Late Gastrointestinal Morbidity in Locally Advanced Cervical Cancer: Lessons Learned From EMBRACE-I and Implications for the Future

Author

Spampinato, Sofia, Jensen, Nina B.K., Pötter, Richard, Fokdal, Lars U., Chargari, Cyrus, Lindegaard, Jacob C., Schmid, Maximilian P., Sturdza, Alina, Jürgenliemk-Schulz, Ina M., Mahantshetty, Umesh, Hoskin, Peter, Segedin, Barbara, Rai, Bhavana, Bruheim, Kjersti, Wiebe, Ericka, Van der Steen-Banasik, Elzbieta, Cooper, Rachel, Van Limbergen, Erik, Sundset, Marit, Pieters, Bradley R., Lutgens, Ludy C.H.W., Tan, Li Tee, Villafranca, Elena, Smet, Stéphanie, Jastaniyah, Noha, Nout, Remi A., Kirisits, Christian, Chopra, Supriya, Kirchheiner, Kathrin, Tanderup, Kari, and EMBRACE Collaborative Group

Published
2022
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4. Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy

Author

Wortman, Bastiaan G., Post, Cathalijne C.B., Powell, Melanie E., Khaw, Pearly, Fyles, Anthony, D'Amico, Romerai, Haie-Meder, Christine, Jürgenliemk-Schulz, Ina M., McCormack, Mary, Do, Viet, Katsaros, Dionyssios, Bessette, Paul, Baron, Marie Hélène, Nout, Remi A., Whitmarsh, Karen, Mileshkin, Linda, Lutgens, Ludy C.H.W., Kitchener, Henry C., Brooks, Susan, Nijman, Hans W., Astreinidou, Eleftheria, Putter, Hein, Creutzberg, Carien L., and de Boer, Stephanie M.

Published
2022
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5. Patients' and clinicians' preferences in adjuvant treatment for high-risk endometrial cancer: Implications for shared decision making

Author

Post, Cathalijne C.B., Mens, Jan Willem M., Haverkort, Marie A.D., Koppe, Friederike, Jürgenliemk-Schulz, Ina M., Snyers, An, Roeloffzen, Ellen M.A., Schaake, Eva E., Slot, Annerie, Stam, Tanja C., Beukema, Jannet C., van den Berg, Hetty A., Lutgens, Ludy C.H.W., Nijman, Hans W., de Kroon, Cornelis D., Kroep, Judith R., Stiggelbout, Anne M., and Creutzberg, Carien L.

Published
2021
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6. MRI-guided adaptive brachytherapy in locally advanced cervical cancer (EMBRACE-I): a multicentre prospective cohort study

Author

Chargari, Cyrus, Dumas, Isabelle, Lowe, Gerry, Swamidas, Jamema, Hudej, Robert, Paulsen Hellebust, Taran, Menon, Geetha, Oinam, Arun S., Bownes, Peter, Christiaens, Melissa, De Brabandere, Marisol, Janssen, Hilde, Oosterveld, Bernard, Koedooder, Kees, Langeland Marthinsen, Anne Beate, Sundset, Marit, Whitney, Diane, Ketelaars, Martijn, Lutgens, Ludy C.H.W., Reinniers, Brigitte, Mora, Itxa, Villafranca, Elena, Antal, Gergely, Hadjiev, Janaki, Bachand, Francois, Batchelar, Deidre, Erickson, Beth, Rownd, Jason, Jacobson, Geraldine, Kim, Yusung, Anttila, Maarit, Palmgren, Jan-Erik, An, Jusheng, Assenholt, Marianne Sanggaard, Banerjee, Susovan, Bentzen, Sören, Berger, Thomas, Dankulchai, Pittaya, Diendorfer, Tamara, Dilworth, Ian, Dimopoulos, Johannes, Dörr, Elke, Ecker, Stefan, Federico, Mario, Fidarova, Elena, Fortin, Israel, Georg, Petra, Gora, Joanna, Hegazy, Neamat, Jastaniyah, Noha, Jensen, Nina Boje Kibsgaard, Liederer, Thomas, Majercakova, Katarina, Misimovic, Dragan, Motisi, Laura, Najjari Jamal, Dina, Nkiwane, Karen, Schwartz-Vittrup, Anders, Serban, Monica, Smet, Stephanie, Spampinato, Sofia, Trnkova, Petra, Valgma, Margit, Westerveld, Henrike, Wong, Joyce Siu Yu, Yoshida, Kenji, Pötter, Richard, Tanderup, Kari, Schmid, Maximilian Paul, Jürgenliemk-Schulz, Ina, Haie-Meder, Christine, Fokdal, Lars Ulrik, Sturdza, Alina Emiliana, Hoskin, Peter, Mahantshetty, Umesh, Segedin, Barbara, Bruheim, Kjersti, Huang, Fleur, Rai, Bhavana, Cooper, Rachel, van der Steen-Banasik, Elzbieta, Van Limbergen, Erik, Pieters, Bradley Rumwell, Tan, Li-Tee, Nout, Remi Abubakar, De Leeuw, Astrid Agatha Catharina, Ristl, Robin, Petric, Primoz, Nesvacil, Nicole, Kirchheiner, Kathrin, Kirisits, Christian, and Lindegaard, Jacob Christian

Published
2021
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7. Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial

Author

Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P.) B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, and Creutzberg, Carien L.

Published
2021
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8. Persistence of Late Substantial Patient-Reported Symptoms (LAPERS) After Radiochemotherapy Including Image Guided Adaptive Brachytherapy for Locally Advanced Cervical Cancer: A Report From the EMBRACE Study

Author

Vittrup, Anders S., Tanderup, Kari, Bentzen, Søren M., Jensen, Nina B.K., Spampinato, Sofia, Fokdal, Lars U., Lindegaard, Jacob C., Sturdza, Alina, Schmid, Maximilian, Segedin, Barbara, Jürgenliemk-Schulz, Ina M., Bruheim, Kjersti, Mahantshetty, Umesh, Haie-Meder, Christine, Rai, Bhavana, Cooper, Rachel, van der Steen-Banasik, Elzbieta, Sundset, Marit, Huang, Fleur, Nout, Remi A., Villafranca, Elena, Van Limbergen, Erik, Pieters, Bradley R., Tan, Li Tee, Lutgens, Ludy C.H.W., Hoskin, Peter, Pötter, Richard, and Kirchheiner, Kathrin

Published
2021
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9. Prognostic impact and causality of age on oncological outcomes in women with endometrial cancer: a multimethod analysis of the randomised PORTEC-1, -2 and -3 trials

Author

Wakkerman, Famke Charlotte, primary, Wu, Jiqing, additional, Putter, Hein, additional, Jurgenliemk-Schulz, Ina M., additional, Jobsen, Jan J., additional, Lutgens, Ludy C.H.W., additional, Haverkort, Marie A.D., additional, de Jong, Marianne, additional, Mens, Jan Willem M., additional, Wortman, Bastiaan G., additional, Nout, Remi A., additional, Leon-Castillo, Alicia, additional, Powell, Melanie E., additional, Mileshkin, Linda R., additional, Katsaros, Dionyssios, additional, Alfieri, Joanne, additional, Leary, Alexandra, additional, Singh, Naveena, additional, de Boer, Stephanie M., additional, Nijman, Hans W., additional, Smit, Vincent T.H.B.M., additional, Bosse, Tjalling, additional, Koelzer, Viktor H., additional, Creutzberg, Carien L., additional, and Horeweg, Nanda, additional

Published
2023
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10. 919: Randomised trial of nurse-led sexual rehabilitation after radiotherapy for gynaecological cancers

Author

Suvaal, Isabelle, Hummel, Lisanne B., Mens, Jan-Willem M., Tuijnman-Raasveld, Charlotte C., Tsonaka, Roula, Velema, Laura A., Westerveld, Henrike, Cnossen, Jeltsje, Snyers, An, Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Beukema, Jannet C., Haverkort, Dorien, Nowee, Marlies E., de Kroon, Cor D., van den Hout, Wilbert B., Creutzberg, Carien L., van Doorn, Lena E., and Kuile, Moniek M. ter

Published
2024
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11. QPOLE: A Quick, Simple, and Cheap Alternative for POLE Sequencing in Endometrial Cancer by Multiplex Genotyping Quantitative Polymerase Chain Reaction

Author

Van den Heerik, Anne Sophie V.M., primary, Ter Haar, Natalja T., additional, Vermij, Lisa, additional, Jobsen, Jan J., additional, Brinkhuis, Mariel, additional, Roothaan, Suzan M., additional, Leon-Castillo, Alicia, additional, Ortoft, Gitte, additional, Hogdall, Estrid, additional, Hogdall, Claus, additional, Van Wezel, Tom, additional, Lutgens, Ludy C.H.W., additional, Haverkort, Marie A.D., additional, Khattra, Jas, additional, McAlpine, Jessica N., additional, Creutzberg, Carien L., additional, Smit, Vincent T.H.B.M., additional, Gilks, C. Blake, additional, Horeweg, Nanda, additional, and Bosse, Tjalling, additional

Published
2023
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12. Data from Prognostic Integrated Image-Based Immune and Molecular Profiling in Early-Stage Endometrial Cancer

Author

Horeweg, Nanda, primary, de Bruyn, Marco, primary, Nout, Remi A., primary, Stelloo, Ellen, primary, Kedzierska, Katarzyna, primary, León-Castillo, Alicia, primary, Plat, Annechien, primary, Mertz, Kirsten D., primary, Osse, Michelle, primary, Jürgenliemk-Schulz, Ina M., primary, Lutgens, Ludy C.H.W., primary, Jobsen, Jan J., primary, van der Steen-Banasik, Elzbieta M., primary, Smit, Vincent T., primary, Creutzberg, Carien L., primary, Bosse, Tjalling, primary, Nijman, Hans W., primary, Koelzer, Viktor H., primary, and Church, David N., primary

Published
2023
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13. Supplementary Data from Prognostic Integrated Image-Based Immune and Molecular Profiling in Early-Stage Endometrial Cancer

Author

Horeweg, Nanda, primary, de Bruyn, Marco, primary, Nout, Remi A., primary, Stelloo, Ellen, primary, Kedzierska, Katarzyna, primary, León-Castillo, Alicia, primary, Plat, Annechien, primary, Mertz, Kirsten D., primary, Osse, Michelle, primary, Jürgenliemk-Schulz, Ina M., primary, Lutgens, Ludy C.H.W., primary, Jobsen, Jan J., primary, van der Steen-Banasik, Elzbieta M., primary, Smit, Vincent T., primary, Creutzberg, Carien L., primary, Bosse, Tjalling, primary, Nijman, Hans W., primary, Koelzer, Viktor H., primary, and Church, David N., primary

Published
2023
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14. QPOLE:A Quick, Simple, and Cheap Alternative for POLE Sequencing in Endometrial Cancer by Multiplex Genotyping Quantitative Polymerase Chain Reaction

Author

Van den Heerik, Anne Sophie V.M., Ter Haar, Natalja T., Vermij, Lisa, Jobsen, Jan J., Brinkhuis, Mariel, Roothaan, Suzan M., Leon-Castillo, Alicia, Ortoft, Gitte, Hogdall, Estrid, Hogdall, Claus, Van Wezel, Tom, Lutgens, Ludy C.H.W., Haverkort, Marie A.D., Khattra, Jas, McAlpine, Jessica N., Creutzberg, Carien L., Smit, Vincent T.H.B.M., Gilks, C. Blake, Horeweg, Nanda, Bosse, Tjalling, Van den Heerik, Anne Sophie V.M., Ter Haar, Natalja T., Vermij, Lisa, Jobsen, Jan J., Brinkhuis, Mariel, Roothaan, Suzan M., Leon-Castillo, Alicia, Ortoft, Gitte, Hogdall, Estrid, Hogdall, Claus, Van Wezel, Tom, Lutgens, Ludy C.H.W., Haverkort, Marie A.D., Khattra, Jas, McAlpine, Jessica N., Creutzberg, Carien L., Smit, Vincent T.H.B.M., Gilks, C. Blake, Horeweg, Nanda, and Bosse, Tjalling

Abstract

PURPOSE: Detection of 11 pathogenic variants in the POLE gene in endometrial cancer (EC) is critically important to identify women with a good prognosis and reduce overtreatment. Currently, POLE status is determined by DNA sequencing, which can be expensive, relatively time-consuming, and unavailable in hospitals without specialized equipment and personnel. This may hamper the implementation of POLE-testing in clinical practice. To overcome this, we developed and validated a rapid, low-cost POLE hotspot test by a quantitative polymerase chain reaction (qPCR) assay, QPOLE. MATERIALS AND METHODS: Primer and fluorescence-labeled 5'-nuclease probe sequences of the 11 established pathogenic POLE mutations were designed. Three assays, QPOLE-frequent for the most common mutations and QPOLE-rare-1 and QPOLE-rare-2 for the rare variants, were developed and optimized using DNA extracted from formalin-fixed paraffin-embedded tumor tissues. The simplicity of the design enables POLE status assessment within 4-6 hours after DNA isolation. An interlaboratory external validation study was performed to determine the practical feasibility of this assay. RESULTS: Cutoffs for POLE wild-type, POLE-mutant, equivocal, and failed results were predefined on the basis of a subset of POLE mutants and POLE wild-types for the internal and external validation. For equivocal cases, additional DNA sequencing is recommended. Performance in 282 EC cases, of which 99 were POLE-mutated, demonstrated an overall accuracy of 98.6% (95% CI, 97.2 to 99.9), a sensitivity of 95.2% (95% CI, 90.7 to 99.8), and a specificity of 100%. After DNA sequencing of 8.8% equivocal cases, the final sensitivity and specificity were 96.0% (95% CI, 92.1 to 99.8) and 100%. External validation confirmed feasibility and accuracy. CONCLUSION: QPOLE is a qPCR assay that is a quick, simple, and reliable alternative for DNA sequencing. QPOLE detects all pathogenic variants in the exonuclease domain of the POLE gene. QPOLE will

Published
2023

15. Interpretable deep learning model to predict the molecular classification of endometrial cancer from haematoxylin and eosin-stained whole-slide images: a combined analysis of the PORTEC randomised trials and clinical cohorts

Author

MS Radiotherapie, Cancer, Fremond, Sarah, Andani, Sonali, Barkey Wolf, Jurriaan, Dijkstra, Jouke, Melsbach, Sinéad, Jobsen, Jan J., Brinkhuis, Mariel, Roothaan, Suzan, Jurgenliemk-Schulz, Ina, Lutgens, Ludy C.H.W., Nout, Remi A., van der Steen-Banasik, Elzbieta M., de Boer, Stephanie M., Powell, Melanie E., Singh, Naveena, Mileshkin, Linda R., Mackay, Helen J., Leary, Alexandra, Nijman, Hans W., Smit, Vincent T.H.B.M., Creutzberg, Carien L., Horeweg, Nanda, Koelzer, Viktor H., Bosse, Tjalling, MS Radiotherapie, Cancer, Fremond, Sarah, Andani, Sonali, Barkey Wolf, Jurriaan, Dijkstra, Jouke, Melsbach, Sinéad, Jobsen, Jan J., Brinkhuis, Mariel, Roothaan, Suzan, Jurgenliemk-Schulz, Ina, Lutgens, Ludy C.H.W., Nout, Remi A., van der Steen-Banasik, Elzbieta M., de Boer, Stephanie M., Powell, Melanie E., Singh, Naveena, Mileshkin, Linda R., Mackay, Helen J., Leary, Alexandra, Nijman, Hans W., Smit, Vincent T.H.B.M., Creutzberg, Carien L., Horeweg, Nanda, Koelzer, Viktor H., and Bosse, Tjalling

Published
2023

17. Health-Related Quality of Life in Locally Advanced Cervical Cancer Patients After Definitive Chemoradiation Therapy Including Image Guided Adaptive Brachytherapy: An Analysis From the EMBRACE Study

Author

Lindegaard, Jacob, Tanderup, Kari, Fokdal, Lars, Van Der Steen Banasik, Elzbieta, Haie-Meder, Christine, Dumas, Isabelle, Chargari, Cyrus, Nout, Remi A., Van Limbergen, Erik, Petrič, Primož, Segedin, Barbara, Hudej, Robert, Erickson, Beth, Hoskin, Peter, Lowe, Gerry, Mahantshetty, Umesh, Swamidas, Jamema, Shrivastava, Shyam Kishore, Jürgenliemk-Schulz, Ina M., De Leeuw, Astrid, Kirchheiner, Kathrin, Dörr, Wolfgang, Pötter, Richard, Lutgens, Ludy C.H.W., Hadjiev, Janaki, Cooper, Rachel, Bownes, Peter, Sundset, Marit, Bruheim, Kjersti, Hellebust, Taran Paulsen, Huang, Fleur, Menon, Geetha, Villafranca, Elena, Rai, Bhavana, Oinam, Arun S., Tan, Li Tee, Bachand, Francois, Jacobson, Geraldine, Anttila, Maarit, Pieters, Bradley, and Lindegaard, Jacob C.

Published
2016
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18. Interpretable deep learning model to predict the molecular classification of endometrial cancer from haematoxylin and eosin-stained whole-slide images: a combined analysis of the PORTEC randomised trials and clinical cohorts

Author

Fremond, Sarah, Andani, Sonali, Wolf, Jurriaan Barkey, Dijkstra, Jouke, Melsbach, Sinéad, Jobsen, Jan J., Brinkhuis, Mariel, Roothaan, Suzan, Jurgenliemk-Schulz, Ina, Lutgens, Ludy C.H.W., Nout, Remi A ., van der Steen-Banasik, Elzbieta M., de Boer, Stephanie M., Singh, Naveena, Mileshkin, Linda R., Mackay, Helen J., Leary, Alexandra, Nijman, Hans W., Smit, Vincent T.H.B.M, Creutzberg, Carien L., Horeweg, Nanda, Koelzer, Viktor H., and Bosse, Tjalling

Abstract

Background Endometrial cancer can be molecularly classified into POLEmut, mismatch repair deficient (MMRd), p53 abnormal (p53abn), and no specific molecular profile (NSMP) subgroups. We aimed to develop an interpretable deep learning pipeline for whole-slide-image-based prediction of the four molecular classes in endometrial cancer (im4MEC), to identify morpho-molecular correlates, and to refine prognostication. Methods This combined analysis included diagnostic haematoxylin and eosin-stained slides and molecular and clinicopathological data from 2028 patients with intermediate-to-high-risk endometrial cancer from the PORTEC-1 (n=466), PORTEC-2 (n=375), and PORTEC-3 (n=393) randomised trials and the TransPORTEC pilot study (n=110), the Medisch Spectrum Twente cohort (n=242), a case series of patients with POLEmut endometrial cancer in the Leiden Endometrial Cancer Repository (n=47), and The Cancer Genome Atlas-Uterine Corpus Endometrial Carcinoma cohort (n=395). PORTEC-3 was held out as an independent test set and a four-fold cross validation was performed. Performance was measured with the macro and class-wise area under the receiver operating characteristic curve (AUROC). Whole-slide images were segmented into tiles of 360 μm resized to 224 × 224 pixels. im4MEC was trained to learn tile-level morphological features with self-supervised learning and to molecularly classify whole-slide images with an attention mechanism. The top 20 tiles with the highest attention scores were reviewed to identify morpho-molecular correlates. Predictions of a nuclear classification deep learning model serve to derive interpretable morphological features. We analysed 5-year recurrence-free survival and explored prognostic refinement by molecular class using the Kaplan-Meier method. Findings im4MEC attained macro-average AUROCs of 0·874 (95% CI 0·856–0·893) on four-fold cross-validation and 0·876 on the independent test set. The class-wise AUROCs were 0·849 for POLEmut (n=51), 0·844 for MMRd (n=134), 0·883 for NSMP (n=120), and 0·928 for p53abn (n=88). POLEmut and MMRd tiles had a high density of lymphocytes, p53abn tiles had strong nuclear atypia, and the morphology of POLEmut and MMRd endometrial cancer overlapped. im4MEC highlighted a low tumour-to-stroma ratio as a potentially novel characteristic feature of the NSMP class. 5-year recurrence-free survival was significantly different between im4MEC predicted molecular classes in PORTEC-3 (log-rank p, The Lancet Digital Health, 5 (2), ISSN:2589-7500

Published
2023

19. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

Author

de Boer, Stephanie M., Nout, Remi A., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Lutgens, Ludy C.H.W., van der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W., and Creutzberg, Carien L.

Published
2015
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20. Molecular Classification Predicts Response to Radiotherapy in the Randomized PORTEC-1 and PORTEC-2 Trials for Early-Stage Endometrioid Endometrial Cancer.

Author

Horeweg, Nanda, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., Haverkort, Marie A.D., Mens, Jan Willem M., Slot, Annerie, Wortman, Bastiaan G., de Boer, Stephanie M., Stelloo, Ellen, Verhoeven-Adema, Karen W., Putter, Hein, Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., Creutzberg, C.L., Koper, P.C.M., van Putten, W.L.J., and Dercksen, R.

Published
2023
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22. Automated causal inference in application to randomized controlled clinical trials

Author

Wu, Ji Q., Horeweg, Nanda, de Bruyn, Marco, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., van der Steen-Banasik, Elzbieta M., Nijman, Hans W., Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., Koelzer, Viktor H., Wu, Ji Q., Horeweg, Nanda, de Bruyn, Marco, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., van der Steen-Banasik, Elzbieta M., Nijman, Hans W., Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., and Koelzer, Viktor H.

Abstract

Randomized controlled trials (RCTs) are considered the gold standard for testing causal hypotheses in the clinical domain; however, the investigation of prognostic variables of patient outcome in a hypothesized cause–effect route is not feasible using standard statistical methods. Here we propose a new automated causal inference method (AutoCI) built on the invariant causal prediction (ICP) framework for the causal reinterpretation of clinical trial data. Compared with existing methods, we show that the proposed AutoCI allows one to clearly determine the causal variables of two real-world RCTs of patients with endometrial cancer with mature outcome and extensive clinicopathological and molecular data. This is achieved via suppressing the causal probability of non-causal variables by a wide margin. In ablation studies, we further demonstrate that the assignment of causal probabilities by AutoCI remains consistent in the presence of confounders. In conclusion, these results confirm the robustness and feasibility of AutoCI for future applications in real-world clinical analysis.

Published
2022

23. Defining Substantial Lymphovascular Space Invasion in Endometrial Cancer

Author

Peters, Elke E.M., León-Castillo, Alicia, Smit, Vincent T.H.B.M., Boennelycke, Marie, Hogdall, Estrid, Hogdall, Claus, Creutzberg, Carien, Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Ortoft, Gitte, Bosse, Tjalling, Nout, Remi, Peters, Elke E.M., León-Castillo, Alicia, Smit, Vincent T.H.B.M., Boennelycke, Marie, Hogdall, Estrid, Hogdall, Claus, Creutzberg, Carien, Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Ortoft, Gitte, Bosse, Tjalling, and Nout, Remi

Abstract

Lymphovascular space invasion (LVSI) occurs in a minority of endometrial cancer (EC) cases, and the extent of LVSI is an important risk factor for recurrence and/or metastases. Our aim was to improve the reproducibility of measuring clinically meaningful LVSI by performing a quantitative analysis of the correlation between LVSI and the risk of pelvic lymph node recurrence in EC. EC samples from PORTEC-1 and PORTEC-2 trials were retrieved and used to collect quantitative data, including the number of LVSI-positive vessels per H&E-stained slide. Using a predefined threshold for clinical relevance, the risk of pelvic lymph node recurrence risk was calculated (Kaplan-Meier method, with Cox regression) using a stepwise adjustment for the number of LVSI-positive vessels. This analysis was then repeated in the Danish Gynecological Cancer Database (DGCD) cohort. Among patients in PORTEC-1 and PORTEC-2 trials who did not receive external beam radiotherapy, the 5-yr pelvic lymph node recurrence risk was 3.3%, 6.7% (P=0.51), and 26.3% (P<0.001), respectively when 0, 1 to 3, or ≥4 vessels had LVSI involvement; similar results were obtained for the DGCD cohort. Furthermore, both the average number of tumor cells in the largest embolus and the number of LVSI-positive H&E slides differed significantly between focal LVSI and substantial LVSI. On the basis of these results, we propose a numeric threshold (≥4 LVSI-involved vessels in at least one H&E slide) for defining clinically relevant LVSI in EC, thereby adding supportive data to the semiquantitative approach. This will help guide gynecologic pathologists to differentiate between focal and substantial LVSI, especially in borderline cases.

Published
2022

24. Defining Substantial Lymphovascular Space Invasion in Endometrial Cancer

Author

MS Radiotherapie, Cancer, Peters, Elke E.M., León-Castillo, Alicia, Smit, Vincent T.H.B.M., Boennelycke, Marie, Hogdall, Estrid, Hogdall, Claus, Creutzberg, Carien, Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Ortoft, Gitte, Bosse, Tjalling, Nout, Remi, MS Radiotherapie, Cancer, Peters, Elke E.M., León-Castillo, Alicia, Smit, Vincent T.H.B.M., Boennelycke, Marie, Hogdall, Estrid, Hogdall, Claus, Creutzberg, Carien, Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Ortoft, Gitte, Bosse, Tjalling, and Nout, Remi

Published
2022

25. Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy

Author

MS Radiotherapie, Cancer, Wortman, Bastiaan G., Post, Cathalijne C.B., Powell, Melanie E., Khaw, Pearly, Fyles, Anthony, D'Amico, Romerai, Haie-Meder, Christine, Jürgenliemk-Schulz, Ina M., McCormack, Mary, Do, Viet, Katsaros, Dionyssios, Bessette, Paul, Baron, Marie Hélène, Nout, Remi A., Whitmarsh, Karen, Mileshkin, Linda, Lutgens, Ludy C.H.W., Kitchener, Henry C., Brooks, Susan, Nijman, Hans W., Astreinidou, Eleftheria, Putter, Hein, Creutzberg, Carien L., de Boer, Stephanie M., MS Radiotherapie, Cancer, Wortman, Bastiaan G., Post, Cathalijne C.B., Powell, Melanie E., Khaw, Pearly, Fyles, Anthony, D'Amico, Romerai, Haie-Meder, Christine, Jürgenliemk-Schulz, Ina M., McCormack, Mary, Do, Viet, Katsaros, Dionyssios, Bessette, Paul, Baron, Marie Hélène, Nout, Remi A., Whitmarsh, Karen, Mileshkin, Linda, Lutgens, Ludy C.H.W., Kitchener, Henry C., Brooks, Susan, Nijman, Hans W., Astreinidou, Eleftheria, Putter, Hein, Creutzberg, Carien L., and de Boer, Stephanie M.

Published
2022

26. Risk Factors for Late Persistent Fatigue After Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Analysis From the EMBRACE-I Study

Author

MS Radiotherapie, Cancer, Smet, Stéphanie, Spampinato, Sofia, Pötter, Richard, Jürgenliemk-Schulz, Ina M., Nout, Remi A., Chargari, Cyrus, Mahantshetty, Umesh, Sturdza, Alina, Segedin, Barbara, Bruheim, Kjersti, Hoskin, Peter, Rai, Bhavana, Huang, Fleur, Cooper, Rachel, Van der Steen-Banasik, Elzbieta, Sundset, Marit, Van Limbergen, Erik, Tan, Li Tee, Lutgens, Ludy C.H.W., Villafranca, Elena, Pieters, Bradley R., Tanderup, Kari, Kirchheiner, Kathrin, MS Radiotherapie, Cancer, Smet, Stéphanie, Spampinato, Sofia, Pötter, Richard, Jürgenliemk-Schulz, Ina M., Nout, Remi A., Chargari, Cyrus, Mahantshetty, Umesh, Sturdza, Alina, Segedin, Barbara, Bruheim, Kjersti, Hoskin, Peter, Rai, Bhavana, Huang, Fleur, Cooper, Rachel, Van der Steen-Banasik, Elzbieta, Sundset, Marit, Van Limbergen, Erik, Tan, Li Tee, Lutgens, Ludy C.H.W., Villafranca, Elena, Pieters, Bradley R., Tanderup, Kari, and Kirchheiner, Kathrin

Published
2022

27. Automated causal inference in application to randomized controlled clinical trials

Author

MS Radiotherapie, Cancer, Wu, Ji Q., Horeweg, Nanda, de Bruyn, Marco, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., van der Steen-Banasik, Elzbieta M., Nijman, Hans W., Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., Koelzer, Viktor H., MS Radiotherapie, Cancer, Wu, Ji Q., Horeweg, Nanda, de Bruyn, Marco, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., van der Steen-Banasik, Elzbieta M., Nijman, Hans W., Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., and Koelzer, Viktor H.

Published
2022

28. Severity and Persistency of Late Gastrointestinal Morbidity in Locally Advanced Cervical Cancer: Lessons Learned From EMBRACE-I and Implications for the Future

Author

MS Radiotherapie, Cancer, Spampinato, Sofia, Jensen, Nina B.K., Pötter, Richard, Fokdal, Lars U., Chargari, Cyrus, Lindegaard, Jacob C., Schmid, Maximilian P., Sturdza, Alina, Jürgenliemk-Schulz, Ina M., Mahantshetty, Umesh, Hoskin, Peter, Segedin, Barbara, Rai, Bhavana, Bruheim, Kjersti, Wiebe, Ericka, Van der Steen-Banasik, Elzbieta, Cooper, Rachel, Van Limbergen, Erik, Sundset, Marit, Pieters, Bradley R., Lutgens, Ludy C.H.W., Tan, Li Tee, Villafranca, Elena, Smet, Stéphanie, Jastaniyah, Noha, Nout, Remi A., Kirisits, Christian, Chopra, Supriya, Kirchheiner, Kathrin, Tanderup, Kari, EMBRACE Collaborative Group, Collaborative Group, MS Radiotherapie, Cancer, Spampinato, Sofia, Jensen, Nina B.K., Pötter, Richard, Fokdal, Lars U., Chargari, Cyrus, Lindegaard, Jacob C., Schmid, Maximilian P., Sturdza, Alina, Jürgenliemk-Schulz, Ina M., Mahantshetty, Umesh, Hoskin, Peter, Segedin, Barbara, Rai, Bhavana, Bruheim, Kjersti, Wiebe, Ericka, Van der Steen-Banasik, Elzbieta, Cooper, Rachel, Van Limbergen, Erik, Sundset, Marit, Pieters, Bradley R., Lutgens, Ludy C.H.W., Tan, Li Tee, Villafranca, Elena, Smet, Stéphanie, Jastaniyah, Noha, Nout, Remi A., Kirisits, Christian, Chopra, Supriya, Kirchheiner, Kathrin, Tanderup, Kari, and EMBRACE Collaborative Group, Collaborative Group

Published
2022

29. Defining Substantial Lymphovascular Space Invasion in Endometrial Cancer

Author

Peters, Elke E.M., primary, León-Castillo, Alicia, additional, Smit, Vincent T.H.B.M., additional, Boennelycke, Marie, additional, Hogdall, Estrid, additional, Hogdall, Claus, additional, Creutzberg, Carien, additional, Jürgenliemk-Schulz, Ina M., additional, Jobsen, Jan J., additional, Mens, Jan Willem M., additional, Lutgens, Ludy C.H.W., additional, van der Steen-Banasik, Elzbieta M., additional, Ortoft, Gitte, additional, Bosse, Tjalling, additional, and Nout, Remi, additional

Published
2021
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30. Patients' and clinicians' preferences in adjuvant treatment for high-risk endometrial cancer:Implications for shared decision making

Author

Post, Cathalijne C.B., Mens, Jan Willem M., Haverkort, Marie A.D., Koppe, Friederike, Jürgenliemk-Schulz, Ina M., Snyers, An, Roeloffzen, Ellen M.A., Schaake, Eva E., Slot, Annerie, Stam, Tanja C., Beukema, Jannet C., van den Berg, Hetty A., Lutgens, Ludy C.H.W., Nijman, Hans W., de Kroon, Cornelis D., Kroep, Judith R., Stiggelbout, Anne M., Creutzberg, Carien L., Post, Cathalijne C.B., Mens, Jan Willem M., Haverkort, Marie A.D., Koppe, Friederike, Jürgenliemk-Schulz, Ina M., Snyers, An, Roeloffzen, Ellen M.A., Schaake, Eva E., Slot, Annerie, Stam, Tanja C., Beukema, Jannet C., van den Berg, Hetty A., Lutgens, Ludy C.H.W., Nijman, Hans W., de Kroon, Cornelis D., Kroep, Judith R., Stiggelbout, Anne M., and Creutzberg, Carien L.

Abstract

Background: Decision making regarding adjuvant therapy for high-risk endometrial cancer is complex. The aim of this study was to determine patients' and clinicians' minimally desired survival benefit to choose chemoradiotherapy over radiotherapy alone. Moreover, influencing factors and importance of positive and negative treatment effects (i.e. attribute) were investigated. Methods: Patients with high-risk endometrial cancer treated with adjuvant pelvic radiotherapy with or without chemotherapy and multidisciplinary gynaecologic oncology clinicians completed a trade-off questionnaire based on PORTEC-3 trial data. Results: In total, 171 patients and 63 clinicians completed the questionnaire. Median minimally desired benefit to make chemoradiotherapy worthwhile was significantly higher for patients versus clinicians (10% vs 5%, p = 0.02). Both patients and clinicians rated survival benefit most important during decision making, followed by long-term symptoms. Older patients (OR 0.92 [95%CI 0.87–0.97]; p = 0.003) with comorbidity (OR 0.34 [95% CI 0.12–0.89]; p = 0.035) had lower preference for chemoradiotherapy, while patients with better numeracy skills (OR 1.2 [95%CI 1.05–1.36], p = 0.011) and chemoradiotherapy history (OR 25.0 [95%CI 8.8–91.7]; p < 0.001) had higher preference for chemoradiotherapy. Conclusions: There is a considerable difference in minimally desired survival benefit of chemoradiotherapy in high-risk endometrial cancer among and between patients and clinicians. Overall, endometrial cancer patients needed higher benefits than clinicians before preferring chemoradiotherapy.

Published
2021

31. Patients' and clinicians' preferences in adjuvant treatment for high-risk endometrial cancer: Implications for shared decision making

Author

MS Radiotherapie, Cancer, Post, Cathalijne C.B., Mens, Jan Willem M., Haverkort, Marie A.D., Koppe, Friederike, Jürgenliemk-Schulz, Ina M., Snyers, An, Roeloffzen, Ellen M.A., Schaake, Eva E., Slot, Annerie, Stam, Tanja C., Beukema, Jannet C., van den Berg, Hetty A., Lutgens, Ludy C.H.W., Nijman, Hans W., de Kroon, Cornelis D., Kroep, Judith R., Stiggelbout, Anne M., Creutzberg, Carien L., MS Radiotherapie, Cancer, Post, Cathalijne C.B., Mens, Jan Willem M., Haverkort, Marie A.D., Koppe, Friederike, Jürgenliemk-Schulz, Ina M., Snyers, An, Roeloffzen, Ellen M.A., Schaake, Eva E., Slot, Annerie, Stam, Tanja C., Beukema, Jannet C., van den Berg, Hetty A., Lutgens, Ludy C.H.W., Nijman, Hans W., de Kroon, Cornelis D., Kroep, Judith R., Stiggelbout, Anne M., and Creutzberg, Carien L.

Published
2021

32. Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial

Author

MS Radiotherapie, Cancer, Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P ).B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, Creutzberg, Carien L., MS Radiotherapie, Cancer, Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P ).B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, and Creutzberg, Carien L.

Published
2021

33. Prevalence and Prognosis of Lynch Syndrome and Sporadic Mismatch Repair Deficiency in Endometrial Cancer

Author

MS Radiotherapie, Cancer, Post, Cathalijne C.B., Stelloo, Ellen, Smit, Vincent T.H.B.M., Ruano, Dina, Tops, Carli M., Vermij, Lisa, Rutten, Tessa A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., Nout, Remi A., Crosbie, Emma J., Powell, Melanie E., Mileshkin, Linda, Leary, Alexandra, Bessette, Paul, Putter, Hein, de Boer, Stephanie M., Horeweg, Nanda, Nielsen, Maartje, Wezel, Tom van, Bosse, Tjalling, Creutzberg, Carien L., MS Radiotherapie, Cancer, Post, Cathalijne C.B., Stelloo, Ellen, Smit, Vincent T.H.B.M., Ruano, Dina, Tops, Carli M., Vermij, Lisa, Rutten, Tessa A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., Nout, Remi A., Crosbie, Emma J., Powell, Melanie E., Mileshkin, Linda, Leary, Alexandra, Bessette, Paul, Putter, Hein, de Boer, Stephanie M., Horeweg, Nanda, Nielsen, Maartje, Wezel, Tom van, Bosse, Tjalling, and Creutzberg, Carien L.

Published
2021

34. MRI-guided adaptive brachytherapy in locally advanced cervical cancer (EMBRACE-I): a multicentre prospective cohort study

Author

Pötter, Richard, primary, Tanderup, Kari, additional, Schmid, Maximilian Paul, additional, Jürgenliemk-Schulz, Ina, additional, Haie-Meder, Christine, additional, Fokdal, Lars Ulrik, additional, Sturdza, Alina Emiliana, additional, Hoskin, Peter, additional, Mahantshetty, Umesh, additional, Segedin, Barbara, additional, Bruheim, Kjersti, additional, Huang, Fleur, additional, Rai, Bhavana, additional, Cooper, Rachel, additional, van der Steen-Banasik, Elzbieta, additional, Van Limbergen, Erik, additional, Pieters, Bradley Rumwell, additional, Tan, Li-Tee, additional, Nout, Remi Abubakar, additional, De Leeuw, Astrid Agatha Catharina, additional, Ristl, Robin, additional, Petric, Primoz, additional, Nesvacil, Nicole, additional, Kirchheiner, Kathrin, additional, Kirisits, Christian, additional, Lindegaard, Jacob Christian, additional, Chargari, Cyrus, additional, Dumas, Isabelle, additional, Lowe, Gerry, additional, Swamidas, Jamema, additional, Hudej, Robert, additional, Paulsen Hellebust, Taran, additional, Menon, Geetha, additional, Oinam, Arun S., additional, Bownes, Peter, additional, Christiaens, Melissa, additional, De Brabandere, Marisol, additional, Janssen, Hilde, additional, Oosterveld, Bernard, additional, Koedooder, Kees, additional, Langeland Marthinsen, Anne Beate, additional, Sundset, Marit, additional, Whitney, Diane, additional, Ketelaars, Martijn, additional, Lutgens, Ludy C.H.W., additional, Reinniers, Brigitte, additional, Mora, Itxa, additional, Villafranca, Elena, additional, Antal, Gergely, additional, Hadjiev, Janaki, additional, Bachand, Francois, additional, Batchelar, Deidre, additional, Erickson, Beth, additional, Rownd, Jason, additional, Jacobson, Geraldine, additional, Kim, Yusung, additional, Anttila, Maarit, additional, Palmgren, Jan-Erik, additional, An, Jusheng, additional, Assenholt, Marianne Sanggaard, additional, Banerjee, Susovan, additional, Bentzen, Sören, additional, Berger, Thomas, additional, Dankulchai, Pittaya, additional, Diendorfer, Tamara, additional, Dilworth, Ian, additional, Dimopoulos, Johannes, additional, Dörr, Elke, additional, Ecker, Stefan, additional, Federico, Mario, additional, Fidarova, Elena, additional, Fortin, Israel, additional, Georg, Petra, additional, Gora, Joanna, additional, Hegazy, Neamat, additional, Jastaniyah, Noha, additional, Jensen, Nina Boje Kibsgaard, additional, Liederer, Thomas, additional, Majercakova, Katarina, additional, Misimovic, Dragan, additional, Motisi, Laura, additional, Najjari Jamal, Dina, additional, Nkiwane, Karen, additional, Schwartz-Vittrup, Anders, additional, Serban, Monica, additional, Smet, Stephanie, additional, Spampinato, Sofia, additional, Trnkova, Petra, additional, Valgma, Margit, additional, Westerveld, Henrike, additional, Wong, Joyce Siu Yu, additional, and Yoshida, Kenji, additional

Published
2021
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35. Prognostic Integrated Image-Based Immune and Molecular Profiling in Early-Stage Endometrial Cancer

Author

Horeweg, Nanda, primary, de Bruyn, Marco, additional, Nout, Remi A., additional, Stelloo, Ellen, additional, Kedzierska, Katarzyna, additional, León-Castillo, Alicia, additional, Plat, Annechien, additional, Mertz, Kirsten D., additional, Osse, Michelle, additional, Jürgenliemk-Schulz, Ina M., additional, Lutgens, Ludy C.H.W., additional, Jobsen, Jan J., additional, van der Steen-Banasik, Elzbieta M., additional, Smit, Vincent T., additional, Creutzberg, Carien L., additional, Bosse, Tjalling, additional, Nijman, Hans W., additional, Koelzer, Viktor H., additional, and Church, David N., additional

Published
2020
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36. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial

Author

de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., and Stam, Tanja C.

Subjects
Canada, Time Factors, Endometrial Neoplasms/mortality, Clinical Trial, Phase III, Risk Factors, Paclitaxel/administration & dosage, Journal Article, Humans, Comparative Study, Aged, Neoplasm Staging, Gynecologic Surgical Procedures/adverse effects, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Research Support, Non-U.S. Gov't, Australia, Carboplatin/administration & dosage, Chemoradiotherapy, Adjuvant/adverse effects, Middle Aged, Europe, Multicenter Study, Treatment Outcome, Oncology, Randomized Controlled Trial, Carcinoma, Endometrioid/mortality, Lymph Node Excision, Female, Radiotherapy, Adjuvant, Dose Fractionation, Radiation, Neoplasm Grading, Cisplatin/administration & dosage, New Zealand
Abstract

BACKGROUND: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m 2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m 2) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. RESULTS: 686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1-73·1). 5-year overall survival was 81·8% (95% CI 77·5-86·2) with chemoradiotherapy versus 76·7% (72·1-81·6) with radiotherapy (adjusted hazard ratio [HR] 0·76, 95% CI 0·54-1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3-79·9) versus 68·6% (63·1-73·4; HR 0·71, 95% CI 0·53-0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p

Published
2018

37. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial

Author

MS Radiotherapie, Cancer, de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., Stam, Tanja C., PORTEC study group, MS Radiotherapie, Cancer, de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., Stam, Tanja C., and PORTEC study group

Published
2018

38. Health-Related Quality of Life in Locally Advanced Cervical Cancer Patients After Definitive Chemoradiation Therapy Including Image Guided Adaptive Brachytherapy: An Analysis From the EMBRACE Study

Author

Kirchheiner, Kathrin, primary, Pötter, Richard, additional, Tanderup, Kari, additional, Lindegaard, Jacob C., additional, Haie-Meder, Christine, additional, Petrič, Primož, additional, Mahantshetty, Umesh, additional, Jürgenliemk-Schulz, Ina M., additional, Rai, Bhavana, additional, Cooper, Rachel, additional, Dörr, Wolfgang, additional, Nout, Remi A., additional, Lindegaard, Jacob, additional, Fokdal, Lars, additional, Van Der Steen Banasik, Elzbieta, additional, Dumas, Isabelle, additional, Chargari, Cyrus, additional, Van Limbergen, Erik, additional, Segedin, Barbara, additional, Hudej, Robert, additional, Erickson, Beth, additional, Hoskin, Peter, additional, Lowe, Gerry, additional, Swamidas, Jamema, additional, Shrivastava, Shyam Kishore, additional, De Leeuw, Astrid, additional, Kirchheiner, Kathrin, additional, Lutgens, Ludy C.H.W., additional, Hadjiev, Janaki, additional, Bownes, Peter, additional, Sundset, Marit, additional, Bruheim, Kjersti, additional, Hellebust, Taran Paulsen, additional, Huang, Fleur, additional, Menon, Geetha, additional, Villafranca, Elena, additional, Oinam, Arun S., additional, Tan, Li Tee, additional, Bachand, Francois, additional, Jacobson, Geraldine, additional, Anttila, Maarit, additional, and Pieters, Bradley, additional

Published
2016
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39. Substantial lymph-vascular space invasion (LVSI) is a significant risk factor for recurrence in endometrial cancer - A pooled analysis of PORTEC 1 and 2 trials

Author

Bosse, Tjalling, Peters, Elke E.M., Creutzberg, Carien L., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Smit, Vincent T.H.B.M., Nout, Remi A., Bosse, Tjalling, Peters, Elke E.M., Creutzberg, Carien L., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Smit, Vincent T.H.B.M., and Nout, Remi A.

Published
2015

40. Substantial lymph-vascular space invasion (LVSI) is a significant risk factor for recurrence in endometrial cancer - A pooled analysis of PORTEC 1 and 2 trials

Author

MS Radiotherapie, Cancer, Bosse, Tjalling, Peters, Elke E.M., Creutzberg, Carien L., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Smit, Vincent T.H.B.M., Nout, Remi A., MS Radiotherapie, Cancer, Bosse, Tjalling, Peters, Elke E.M., Creutzberg, Carien L., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Mens, Jan Willem M., Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Smit, Vincent T.H.B.M., and Nout, Remi A.

Published
2015

41. 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

Author

MS Radiotherapie, Cancer, Creutzberg, Carien L., Van Stiphout, Ruud G.P.M., Nout, Remi A., Lutgens, Ludy C.H.W., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Smit, Vincent T.H.B.M., Lambin, Philippe, MS Radiotherapie, Cancer, Creutzberg, Carien L., Van Stiphout, Ruud G.P.M., Nout, Remi A., Lutgens, Ludy C.H.W., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J, Smit, Vincent T.H.B.M., and Lambin, Philippe

Published
2015

42. Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship: Results from the randomized PORTEC-2 trial

Author

MS Radiotherapie, Cancer, De Boer, Stephanie M., Nout, Remi A., Jurgenliemk-Schulz, Ina M., Jobsen, Jan J, Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W, Creutzberg, Carien L., MS Radiotherapie, Cancer, De Boer, Stephanie M., Nout, Remi A., Jurgenliemk-Schulz, Ina M., Jobsen, Jan J, Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W, and Creutzberg, Carien L.

Published
2015

43. Substantial lymph-vascular space invasion (LVSI) is a significant risk factor for recurrence in endometrial cancer – A pooled analysis of PORTEC 1 and 2 trials

Author

Bosse, Tjalling, primary, Peters, Elke E.M., additional, Creutzberg, Carien L., additional, Jürgenliemk-Schulz, Ina M., additional, Jobsen, Jan J., additional, Mens, Jan Willem M., additional, Lutgens, Ludy C.H.W., additional, van der Steen-Banasik, Elzbieta M., additional, Smit, Vincent T.H.B.M., additional, and Nout, Remi A., additional

Published
2015
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