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1. 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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2. 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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3. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial

Author

McCormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, PJ, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Lutgens, LCHW, Hollema, H, Pras, E, Snyers, A, Westerveld, GH, Jobsen, JJ, Slot, A, Mens, JM, Stam, TC, Van Triest, B, Van der Steen-Banasik, EM, De Winter, KAJ, Quinn, MA, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Colombo, A, Carinelli, S, Ferrero, A, Artioli, G, Davidson, C, McLachlin, CM, Ghatage, P, Rittenberg, PVC, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B, Ledermann, Jonathan A, Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie-Helene, Jürgenliemk-Schulz, Ina M, Kitchener, Henry C, Nijman, Hans W, Wilson, Godfrey, Brooks, Susan, Gribaudo, Sergio, Provencher, Diane, Hanzen, Chantal, Kruitwagen, Roy F, Smit, Vincent T H B M, Singh, Naveena, Do, Viet, Lissoni, Andrea, Nout, Remi A, Feeney, Amanda, Verhoeven-Adema, Karen W, Putter, Hein, and Creutzberg, Carien L

Published
2019
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4. Refinement of high-risk endometrial cancer classification using DNA damage response biomarkers: a TransPORTEC initiative

Author

Auguste, Aurélie, Genestie, Catherine, De Bruyn, Marco, Adam, Julien, Le Formal, Audrey, Drusch, Françoise, Pautier, Patricia, Crosbie, Emma J., MacKay, Helen, Kitchener, Henry C., Powell, Melanie, Pollock, Pamela M., Mileshkin, Linda, Edmondson, Richard J., Nout, Remi, Nijman, Hans W., Creutzberg, Carien L., Bosse, Tjalling, and Leary, Alexandra

Published
2018
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5. 3408: Ten-year results of the PORTEC-3 trial: adjuvant therapy for women with high-risk endometrial cancer

Author

Post, Cathalijne C B, de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Leary, Alexandra, Ottevanger, Nelleke P., McCormack, Mary, Khaw, Pearly, D’Amico, Romerai, Fyles, Anthony, Chargari, Cyrus, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy, Jürgenliemk-Schulz, Ina M., Nout, Remi A., Putter, Hein, Horeweg, Nanda, Bosse, Tjalling, and Creutzberg, Carien L.

Published
2024
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8. Working together to shape the endometrial cancer research agenda: The top ten unanswered research questions

Author

Wan, Y. Louise, Beverley-Stevenson, Rachel, Carlisle, Daloni, Clarke, Sinead, Edmondson, Richard J., Glover, Steve, Holland, Julie, Hughes, Carol, Kitchener, Henry C., Kitson, Sarah, Miles, Tracie, Morley, Richard, Morrison, Jo, Nelson, Linsey, Powell, Melanie, Sadler, Laura, Tomlinson, Anne, Tylko-Hill, Katharine, Whitcombe, Jo, and Crosbie, Emma J.

Published
2016
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9. Table S1 from PROgesterone Therapy for Endometrial Cancer Prevention in Obese Women (PROTEC) Trial: A Feasibility Study

Author

Derbyshire, Abigail E., primary, Allen, Jennifer L., primary, Gittins, Matthew, primary, Lakhiani, Bhavna, primary, Bolton, James, primary, Shaw, Joseph, primary, Pemberton, Philip W., primary, Needham, Michelle, primary, MacKintosh, Michelle L., primary, Edmondson, Richard J., primary, Kitchener, Henry C., primary, and Crosbie, Emma J., primary

Published
2023
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11. Supplementary table 1 from PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial

Author

Kitson, Sarah J., primary, Maskell, Zoe, primary, Sivalingam, Vanitha N., primary, Allen, Jennifer L., primary, Ali, Saad, primary, Burns, Sean, primary, Gilmour, Kyle, primary, Latheef, Rahamatulla, primary, Slade, Richard J., primary, Pemberton, Philip W., primary, Shaw, Joseph, primary, Ryder, W. David, primary, Kitchener, Henry C., primary, and Crosbie, Emma J., primary

Published
2023
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12. Supplementary Data from PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial

Author

Kitson, Sarah J., primary, Maskell, Zoe, primary, Sivalingam, Vanitha N., primary, Allen, Jennifer L., primary, Ali, Saad, primary, Burns, Sean, primary, Gilmour, Kyle, primary, Latheef, Rahamatulla, primary, Slade, Richard J., primary, Pemberton, Philip W., primary, Shaw, Joseph, primary, Ryder, W. David, primary, Kitchener, Henry C., primary, and Crosbie, Emma J., primary

Published
2023
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13. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an 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, Kitchener, Henry C, Nijman, Hans W, Kruitwagen, Roy F, Nout, Remi A, Verhoeven-Adema, Karen W, Smit, Vincent T, Putter, Hein, and Creutzberg, Carien L

Published
2016
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18. Cervical Cancer: A Global Health Crisis

Author

Small, William, Jr, Bacon, Monica A., Bajaj, Amishi, Chuang, Linus T., Fisher, Brandon J., Harkenrider, Matthew M., Jhingran, Anuja, Kitchener, Henry C., Mileshkin, Linda R., Viswanathan, Akila N., and Gaffney, David K.

Published
2017
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20. 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, Jurgenliemk-Schulz, Ina M., McCormack, Mary, Do, Viet, Katsaros, Dionyssios, Bessette, Paul, Baron, Marie Helene, 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., Wortman, Bastiaan G., Post, Cathalijne C. B., Powell, Melanie E., Khaw, Pearly, Fyles, Anthony, D'Amico, Romerai, Haie-Meder, Christine, Jurgenliemk-Schulz, Ina M., McCormack, Mary, Do, Viet, Katsaros, Dionyssios, Bessette, Paul, Baron, Marie Helene, 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.

Abstract

Purpose: Radiation therapy techniques have developed from 3-dimensional conformal radiation therapy (3DCRT) to intensity modulated radiation therapy (IMRT), with better sparing of the surrounding normal tissues. The current analysis aimed to investigate whether IMRT, compared to 3DCRT, resulted in fewer adverse events (AEs) and patient-reported symptoms in the randomized PORTEC-3 trial for high-risk endometrial cancer. Methods and Materials: Data on AEs and patient-reported quality of life (QoL) of the PORTEC-3 trial were available for analysis. Physician-reported AEs were graded using Common Terminology Criteria for Adverse Events v3.0. QoL was assessed by the European Organisation for Research and Treatment of Cancer QLQC30, CX24, and OV28 questionnaires. Data were compared between 3DCRT and IMRT. A P value of ≤ .01 was considered statistically significant due to the risk of multiple testing. For QoL, combined scores 1 to 2 (“not at all” and “a little”) versus 3 to 4 (“quite a bit” and “very much”) were compared between the techniques. Results: Of 658 evaluable patients, 559 received 3DCRT and 99 IMRT. Median follow-up was 74.6 months. During treatment no significant differences were observed, with a trend for more grade ≥3 AEs, mostly hematologic and gastrointestinal, after 3DCRT (37.7% vs 26.3%, P = .03). During follow-up, 15.4% (vs 4%) had grade ≥2 diarrhea, and 26.1% (vs 13.1%) had grade ≥2 hematologic AEs after 3DCRT (vs IMRT) (both P < .01). Among 574 (87%) patients evaluable for QoL, 494 received 3DCRT and 80 IMRT. During treatment, 37.5% (vs 28.6%) reported diarrhea after 3DCRT (vs IMRT) (P = .125); 22.1% (versus 10.0%) bowel urgency (P = 0039), and 18.2% and 8.6% abdominal cramps (P = .058). Other QoL scores showed no differences. Conclusions: IMRT resulted in fewer grade ≥3 AEs during treatment and significantly lower rates of grade ≥2 diarrhea and hematologic AEs during follow-up. Trends toward fewer patient-reported bowel urgency and abdominal cr

Published
2022

21. 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. Mortality Associated with Oral Contraceptive Use

Author

Szarewski, Anne, Kitchener, Henry C., Horowitz, Joseph, Kahlenborn, Chris, Grant, Ellen C. G., Steel, C. Michael, Price, Elizabeth H., Anthony, Honor M., Downing, Damien, Radcliffe, Michael J., and Myhill, Sarah

Published
1999

28. Long-term toxicity and health-related quality of life after adjuvant chemoradiotherapy or radiotherapy alone for high-risk endometrial cancer in the randomised PORTEC-3 trial

Author

Post, C, de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, N, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Kitchener, H, Nijman, H, Lutgens, L, Brooks, S, Jürgenliemk-Schulz, I, Feeney, A, Goss, G, Fossati, R, Ghatage, P, Leary, A, Do, V, Lissoni, A, Mccormack, M, Nout, R, Verhoeven-Adema, K, Smit, V, Putter, H, Creutzberg, C, 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, Post, C, de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, N, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Kitchener, H, Nijman, H, Lutgens, L, Brooks, S, Jürgenliemk-Schulz, I, Feeney, A, Goss, G, Fossati, R, Ghatage, P, Leary, A, Do, V, Lissoni, A, Mccormack, M, Nout, R, Verhoeven-Adema, K, Smit, V, Putter, H, Creutzberg, C, 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

Abstract

Background: The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiotherapy versus pelvic radiotherapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL). Patients and methods: 660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiotherapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiotherapy alone. Toxicity was graded using CTCAE v3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28-subscales and compared to normative-data. An as-treated analysis was performed. Results: Median follow up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiotherapy versus 46 (24%) who had received radiotherapy (p=0.008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, p=0.18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiotherapy in 6% (vs 0% after radiotherapy, p<0.001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, p<0.001 at 3 years; 24% vs 9%, p=0.002 at 5 years). Until 3 years, more patients who had chemoradiotherapy reported limb weakness (21% vs 5%, p<0.001) and lower physical (79 vs 87, p<0.001) and role functioning (78 vs 88, p<0.001) scores. Both treatment groups reported similar long-term global health/QOL scores, which were better than those of the normative-population. Conclusion: This study shows a long-lasting, clinically relevant, negative impact of chemoradiotherapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and

Published
2021

29. 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

32. PROgesterone Therapy for Endometrial Cancer Prevention in Obese Women (PROTEC) Trial: A Feasibility Study

Author

Derbyshire, Abigail E., primary, Allen, Jennifer L., additional, Gittins, Matthew, additional, Lakhiani, Bhavna, additional, Bolton, James, additional, Shaw, Joseph, additional, Pemberton, Philip W., additional, Needham, Michelle, additional, MacKintosh, Michelle L., additional, Edmondson, Richard J., additional, Kitchener, Henry C., additional, and Crosbie, Emma J., additional

Published
2021
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34. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial

Author

Paavonen, Jorma, Jenkins, David, Bosch, F Xavier, Naud, Paulo, Salmerón, Jorge, Wheeler, Cosette M, Chow, Song-Nan, Apter, Dan L, Kitchener, Henry C, Castellsague, Xavier, de Carvalho, Newton S, Skinner, S Rachel, Harper, Diane M, Hedrick, James A, Jaisamrarn, Unnop, Limson, Genara AM, Dionne, Marc, Quint, Wim, Spiessens, Bart, Peeters, Pascal, Struyf, Frank, Wieting, Susan L, Lehtinen, Matti O, and Dubin, Gary

Published
2007
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36. Molecular classification of the PORTEC-3 trial for high-risk endometrial cancer: Impact on prognosis and benefit from adjuvant therapy

Author

Leon-Castillo, Alicia, De Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda R., Mackay, Helen J., Leary, Alexandra, Nijman, Hans W., Singh, Naveena, Pollock, Pamela M., Bessette, Paul, Fyles, Anthony, Haie-Meder, Christine, Smit, Vincent T.H.B.M., Edmondson, Richard J., Putter, Hein, Kitchener, Henry C., Crosbie, Emma J., De Bruyn, Marco, Nout, Remi A., Horeweg, Nanda, Creutzberg, Carien L., Bosse, Tjalling, Leon-Castillo, Alicia, De Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda R., Mackay, Helen J., Leary, Alexandra, Nijman, Hans W., Singh, Naveena, Pollock, Pamela M., Bessette, Paul, Fyles, Anthony, Haie-Meder, Christine, Smit, Vincent T.H.B.M., Edmondson, Richard J., Putter, Hein, Kitchener, Henry C., Crosbie, Emma J., De Bruyn, Marco, Nout, Remi A., Horeweg, Nanda, Creutzberg, Carien L., and Bosse, Tjalling

Abstract

PURPOSE: The randomized Adjuvant Chemoradiotherapy Versus Radiotherapy Alone in Women With High-Risk Endometrial Cancer (PORTEC-3) trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy (CTRT) versus radiotherapy alone (RT) for women with high-risk endometrial cancer (EC). Because The Cancer Genome Atlas defined an EC molecular classification with strong prognostic value, we investigated prognosis and impact of chemotherapy for each molecular subgroup using tissue samples from PORTEC-3 trial participants. METHODS: Paraffin-embedded tissues of 423 consenting patients were collected. Immunohistochemistry for p53 and mismatch repair (MMR) proteins, and DNA sequencing for POLE exonuclease domain were done to classify tumors as p53 abnormal (p53abn), POLE-ultramutated (POLEmut), MMR-deficient (MMRd), or no specific molecular profile (NSMP). The primary end point was recurrence-free survival (RFS). Kaplan-Meier method, log-rank test, and Cox model were used for analysis. RESULTS: Molecular analysis was successful in 410 high-risk EC (97%), identifying the 4 subgroups: P53abn EC (n = 93; 23%), POLEmut (n = 51; 12%), MMRd (n = 137; 33%), and NSMP (n = 129; 32%). Five-year RFS was 48% for patients with p53abn EC, 98% for POLEmut EC, 72% for MMRd EC, and 74% for NSMP EC (P <001). The 5-year RFS with CTRT versus RT for p53abn EC was 59% versus 36% (P =019); 100% versus 97% for patients with POLEmut EC (P =637); 68% versus 76% (P =428) for MMRd EC; and 80% versus 68% (P =243) for NSMP EC. CONCLUSION: Molecular classification has strong prognostic value in high-risk EC, with significantly improved RFS with adjuvant CTRT for p53abn tumors, regardless of histologic type. Patients with POLEmut EC had an excellent RFS in both trial arms. EC molecular classification should be incorporated in the risk stratification of these patients as well as in future trials to target specific subgrou

Published
2020

43. The Manchester International Consensus Group recommendations for the management of gynecological cancers in Lynch syndrome

Author

Crosbie, Emma J, Ryan, Neil AJ, Arends, Mark J, Bosse, Tjalling, Burn, John, Cornes, Joanna M, Crawford, Robin, Eccles, Diana, Frayling, Ian M, Ghaem-Maghami, Sadaf, Hampel, Heather, Kauff, Noah D, Kitchener, Henry C, Kitson, Sarah J, Manchanda, Ranjit, McMahon, Raymond FT, Monahan, Kevin J, Menon, Usha, Møller, Pål, Möslein, Gabriela, Rosenthal, Adam, Sasieni, Peter, Seif, Mourad W, Singh, Naveena, Skarrott, Pauline, Snowsill, Tristan M, Steele, Robert, Tischkowitz, Marc, Manchester International Consensus Group, Evans, D Gareth, Crosbie, Emma J [0000-0003-0284-8630], Evans, D Gareth [0000-0002-8482-5784], and Apollo - University of Cambridge Repository

Subjects
Ovarian Neoplasms, congenital, hereditary, and neonatal diseases and abnormalities, Consensus, Genital Neoplasms, Female, screening, nutritional and metabolic diseases, Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms, Europe, Lynch syndrome, endometrial cancer, North America, surveillance, Humans, Mass Screening, Female, guidance, Early Detection of Cancer
Abstract

PURPOSE: There are no internationally agreed upon clinical guidelines as to which women with gynecological cancer would benefit from Lynch syndrome screening or how best to manage the risk of gynecological cancer in women with Lynch syndrome. The Manchester International Consensus Group was convened in April 2017 to address this unmet need. The aim of the Group was to develop clear and comprehensive clinical guidance regarding the management of the gynecological sequelae of Lynch syndrome based on existing evidence and expert opinion from medical professionals and patients. METHODS: Stakeholders from Europe and North America worked together over a two-day workshop to achieve consensus on best practice. RESULTS: Guidance was developed in four key areas: (1) whether women with gynecological cancer should be screened for Lynch syndrome and (2) how this should be done, (3) whether there was a role for gynecological surveillance in women at risk of Lynch syndrome, and (4) what preventive measures should be recommended for women with Lynch syndrome to reduce their risk of gynecological cancer. CONCLUSION: This document provides comprehensive clinical guidance that can be referenced by both patients and clinicians so that women with Lynch syndrome can expect and receive appropriate standards of care.

Published
2019

49. 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

50. Preferences for interventions designed to increase cervical screening uptake in non‐attending young women: How findings from a discrete choice experiment compare with observed behaviours in a trial

Author

Campbell, Helen E., primary, Gray, Alastair M., additional, Watson, Judith, additional, Jackson, Cath, additional, Moseley, Carly, additional, Cruickshank, Margaret E., additional, Kitchener, Henry C., additional, and Rivero‐Arias, Oliver, additional

Published
2019
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