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1. p53 immunohistochemistry in endometrial cancer: clinical and molecular correlates in the PORTEC-3 trial

Author

Vermij, Lisa, Léon-Castillo, Alicia, Singh, Naveena, Powell, Melanie E., Edmondson, Richard J., Genestie, Catherine, Khaw, Pearly, Pyman, Jan, McLachlin, C. Meg, Ghatage, Prafull, de Boer, Stephanie M., Nijman, Hans W., Smit, Vincent T.H.B.M., Crosbie, Emma J., Leary, Alexandra, Creutzberg, Carien L., Horeweg, Nanda, Bosse, Tjalling, Horeweg, N., de Boer, S.M., Creutzberg, C.L., Bosse, T., Smit, V.T.H.B.M., Kroep, J., Nout, R.A., Nijman, H.W., de Bruyn, M., Powell, M.E., Singh, N., Kitchener, H.C., Crosbie, E., Edmondson, R., Church, D.N., Leary, A., Mileshkin, L., Pollock, P.M., and MacKay, H.

Published
2022
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2. Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Creutzberg, C, Kim, J, Eminowicz, G, Allanson, E, Eberst, L, Kim, S, Nout, R, Park, J, Lorusso, D, Mileshkin, L, Ottevanger, P, Brand, A, Mezzanzanica, D, Oza, A, Gebski, V, Pothuri, B, Batley, T, Gordon, C, Mitra, T, White, H, Howitt, B, Matias-Guiu, X, Ray-Coquard, I, Gaffney, D, Small, W, Miller, A, Concin, N, Powell, M, Stuart, G, Bookman, M, Barretina-Ginesta, P, Bennett, K, Berek, J, Berger, R, Bjorge, L, Boere, I, Brennan, D, Bruchim, I, Chang, T, Chavez Blanco, A, Chen, X, Colombo, N, Crosbie, E, Denys, H, Duska, L, Fruehauf, F, Gomez Garcia, E, van Gorp, T, Grimm, C, Guitmann, G, Han, K, Hanker, L, Harano, K, Hasegawa, K, Herrington, C, Ip, P, Joly, F, Khaw, P, Kohn, E, Kristeleit, R, Kroep, J, Leary, A, Lee, J, Lheureux, S, Liu, J, Mackay, H, Mahner, S, Mariani, A, Mcalpine, J, Mikami, Y, Mirza, M, Mukhopadhyay, A, Nagao, S, Ng, J, Nogueira-Rodrigues, A, Novak, Z, O'Donnell, J, Osborne, S, Perez-Fidalgo, J, Romeo Marin, M, Roy Chowdhury, R, Sadozye, A, Safra, T, Scott, C, Sehouli, J, Slomovitz, B, Tan, D, Taylor, A, Valabrega, G, Veneziani, A, Verhoeven, K, Vetter, M, Wampfler, J, Westin, S, Wimberger, P, Zola, P, Creutzberg C. L., Kim J. -W., Eminowicz G., Allanson E., Eberst L., Kim S. I., Nout R. A., Park J. -Y., Lorusso D., Mileshkin L., Ottevanger P. B., Brand A., Mezzanzanica D., Oza A., Gebski V., Pothuri B., Batley T., Gordon C., Mitra T., White H., Howitt B., Matias-Guiu X., Ray-Coquard I., Gaffney D., Small W., Miller A., Concin N., Powell M. A., Stuart G., Bookman M. A., Barretina-Ginesta P., Bennett K., Berek J., Berger R., Bjorge L., Boere I., Brennan D., Bruchim I., Chang T. -C., Chavez Blanco A., Chen X., Colombo N., Crosbie E., Denys H., Duska L., Fruehauf F., Gomez Garcia E. M., van Gorp T., Grimm C., Guitmann G., Han K., Hanker L., Harano K., Hasegawa K., Herrington C. S., Ip P., Joly F., Khaw P., Kohn E., Kristeleit R., Kroep J., Leary A., Lee J. -Y., Lheureux S., Liu J., Mackay H., Mahner S., Mariani A., McAlpine J., Mikami Y., Mirza M. R., Mukhopadhyay A., Nagao S., Ng J., Nogueira-Rodrigues A., Novak Z., O'Donnell J., Osborne S., Perez-Fidalgo J. A., Romeo Marin M., Roy Chowdhury R., Sadozye A., Safra T., Scott C., Sehouli J., Slomovitz B., Tan D., Taylor A., Valabrega G., Veneziani A., Verhoeven K., Vetter M., Wampfler J., Westin S., Wimberger P., Zola P., Creutzberg, C, Kim, J, Eminowicz, G, Allanson, E, Eberst, L, Kim, S, Nout, R, Park, J, Lorusso, D, Mileshkin, L, Ottevanger, P, Brand, A, Mezzanzanica, D, Oza, A, Gebski, V, Pothuri, B, Batley, T, Gordon, C, Mitra, T, White, H, Howitt, B, Matias-Guiu, X, Ray-Coquard, I, Gaffney, D, Small, W, Miller, A, Concin, N, Powell, M, Stuart, G, Bookman, M, Barretina-Ginesta, P, Bennett, K, Berek, J, Berger, R, Bjorge, L, Boere, I, Brennan, D, Bruchim, I, Chang, T, Chavez Blanco, A, Chen, X, Colombo, N, Crosbie, E, Denys, H, Duska, L, Fruehauf, F, Gomez Garcia, E, van Gorp, T, Grimm, C, Guitmann, G, Han, K, Hanker, L, Harano, K, Hasegawa, K, Herrington, C, Ip, P, Joly, F, Khaw, P, Kohn, E, Kristeleit, R, Kroep, J, Leary, A, Lee, J, Lheureux, S, Liu, J, Mackay, H, Mahner, S, Mariani, A, Mcalpine, J, Mikami, Y, Mirza, M, Mukhopadhyay, A, Nagao, S, Ng, J, Nogueira-Rodrigues, A, Novak, Z, O'Donnell, J, Osborne, S, Perez-Fidalgo, J, Romeo Marin, M, Roy Chowdhury, R, Sadozye, A, Safra, T, Scott, C, Sehouli, J, Slomovitz, B, Tan, D, Taylor, A, Valabrega, G, Veneziani, A, Verhoeven, K, Vetter, M, Wampfler, J, Westin, S, Wimberger, P, Zola, P, Creutzberg C. L., Kim J. -W., Eminowicz G., Allanson E., Eberst L., Kim S. I., Nout R. A., Park J. -Y., Lorusso D., Mileshkin L., Ottevanger P. B., Brand A., Mezzanzanica D., Oza A., Gebski V., Pothuri B., Batley T., Gordon C., Mitra T., White H., Howitt B., Matias-Guiu X., Ray-Coquard I., Gaffney D., Small W., Miller A., Concin N., Powell M. A., Stuart G., Bookman M. A., Barretina-Ginesta P., Bennett K., Berek J., Berger R., Bjorge L., Boere I., Brennan D., Bruchim I., Chang T. -C., Chavez Blanco A., Chen X., Colombo N., Crosbie E., Denys H., Duska L., Fruehauf F., Gomez Garcia E. M., van Gorp T., Grimm C., Guitmann G., Han K., Hanker L., Harano K., Hasegawa K., Herrington C. S., Ip P., Joly F., Khaw P., Kohn E., Kristeleit R., Kroep J., Leary A., Lee J. -Y., Lheureux S., Liu J., Mackay H., Mahner S., Mariani A., McAlpine J., Mikami Y., Mirza M. R., Mukhopadhyay A., Nagao S., Ng J., Nogueira-Rodrigues A., Novak Z., O'Donnell J., Osborne S., Perez-Fidalgo J. A., Romeo Marin M., Roy Chowdhury R., Sadozye A., Safra T., Scott C., Sehouli J., Slomovitz B., Tan D., Taylor A., Valabrega G., Veneziani A., Verhoeven K., Vetter M., Wampfler J., Westin S., Wimberger P., and Zola P.

Abstract

The Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Consensus Conference on Clinical Research (ECCC) was held in Incheon, South Korea, Nov 2–3, 2023. The aims were to develop consensus statements for future trials in endometrial cancer to achieve harmonisation on design elements, select important questions, and identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and finalisation of 18 statements within four topic groups, addressing adjuvant treatment in high-risk disease; treatment for metastatic and recurrent disease; trial designs for rare endometrial cancer subgroups and special circumstances; and specific methodology and adaptation for trials in low-resource settings. In addition, eight areas of unmet need were identified. This was the first GCIG Consensus Conference to include patient advocates and an expert on inclusion, diversity, equity, and access to take part in all aspects of the process and output. Four early-career investigators were also selected for participation, ensuring that they represented different GCIG member groups and regions. Unanimous consensus was obtained for 16 of the 18 statements, with 97% concordance for the remaining two. Using the described methodology from previous Ovarian Cancer Consensus Conferences, this conference did not require even one minority statement. The high acceptance rate following active involvement in the preparation, discussion, and refinement of the statements by all representatives confirmed the consensus progress within a global academic setting, and the expectation that the ECCC will lead to greater harmonisation, actualisation, inclusion, and resolution of unmet needs in clinical research for individuals living with and beyond endometrial cancer worldwide.

Published
2024

3. Author Correction: Prediction of recurrence risk in endometrial cancer with multimodal deep learning.

Author

Volinsky-Fremond, S, Horeweg, N, Andani, S, Barkey Wolf, J, Lafarge, MW, de Kroon, CD, Ørtoft, G, Høgdall, E, Dijkstra, J, Jobsen, JJ, Lutgens, LCHW, Powell, ME, Mileshkin, LR, Mackay, H, Leary, A, Katsaros, D, Nijman, HW, de Boer, SM, Nout, RA, de Bruyn, M, Church, D, Smit, VTHBM, Creutzberg, CL, Koelzer, VH, Bosse, T, Volinsky-Fremond, S, Horeweg, N, Andani, S, Barkey Wolf, J, Lafarge, MW, de Kroon, CD, Ørtoft, G, Høgdall, E, Dijkstra, J, Jobsen, JJ, Lutgens, LCHW, Powell, ME, Mileshkin, LR, Mackay, H, Leary, A, Katsaros, D, Nijman, HW, de Boer, SM, Nout, RA, de Bruyn, M, Church, D, Smit, VTHBM, Creutzberg, CL, Koelzer, VH, and Bosse, T

Published
2024

6. Tranexamic acid in coronary artery surgery: One-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial

Author

Myles, Paul, Smith, Julian, Cooper, D. James, Silbert, Brendan, McNeil, John, Marasco, Silvana, Esmore, Donald, Krum, Henry, Tonkin, A., Buxton, B., Heritier, S., Merry, A., Liew, D., McNeil, J., Forbes, A., Cooper, D.J., Wallace, S., Meehan, A., Myles, P., Galagher, W., Farrington, C., Ditoro, A., Wutzlhofer, L., Story, D., Peyton, P., Baulch, S., Sidiropoulos, S., Potgieter, D., Baker, R.A., Pesudovs, B., O'Loughlin J Wells, E., Coutts, P., Bolsin, S., Osborne, C., Ives, K., Smith, J., Hulley, A., Christie-Taylor, G., Painter, T., Lang, S., Mackay, H., Cokis, C., March, S., Bannon, P.G., Wong, C., Turner, L., Scott, D., Silbert, B., Said, S., Corcoran, P., de Prinse, L., Bussières, J.S., Gagné, N., Lamy, A., Semelhago, L., Chan, M.T.V., Underwood, M., Choi, G.S.Y., Fung, B., Landoni, G., Lembo, R., Monaco, F., Simeone, F., Marianello, D., Alvaro, G., De Vuono, G., van Dijk, D., Dieleman, J., Numan, S., McGuinness, S., Parke, R., Raudkivi, P., Gilder, E., Byrne, K., Dunning, J., Termaat, J., Mans, G., Jayarajah, M., Alderton, J., Waugh, D., Platt, M.J., Pai, A., Sevillano, A., Lal, A., Sinclair, C., Kunst, G., Knighton, A., Cubas, G.M., Saravanan, P., Millner, R., Vasudevan, V., Patteril, M., Lopez, E., Basu, R., Lu, J., Myles, Paul S., Smith, Julian A., Kasza, Jessica, Jayarajah, Mohandas, Painter, Thomas, Bussières, Jean S., McGuinness, Shay, Byrne, Kelly, Chan, Matthew T.V., Landoni, Giovanni, Wallace, Sophie, and Forbes, Andrew

Published
2019
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9. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, Lorusso, Domenica, Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, and Lorusso, Domenica

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023

10. Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program

Author

Bosse, T., Creutzberg, C.L., Crosbie, E.J., Han, K., Horeweg, N., Leary, A., Kroep, J.R., McAlpine, J.N., Powell, M.E., Blanc-Durand, F., Bruyn, M. de, Church, D.N., Koelzer, V.H., Kommoss, S., Singh, N., Bardet, A., Counsell, N., Putter, H., Tu, D., Edmondson, R., Gordon, C., Ledermann, J., Morice, P., MacKay, H., Nijman, H., Nout, R.A., Smit, V.T.H.B.M., White, H., Alexandre, J., Boer, S.M. de, Boere, I., Cooper, R., Ethier, J.L., Frenel, J.S., McGrane, J., Taylor, A., Welch, S., Westermann, A.M., Linden, H.D. van der, Farrelly, L., Feeney, A., Kaya, M., Liu, W., Melis, A., Ngadjeua-Tchouatieu, F., Parulekar, W., Verhoeven-Adema, K., and RAINBO Res Consortium

Subjects
endometrial neoplasms, Oncology, Obstetrics and Gynecology
Abstract

BackgroundThe endometrial cancer molecular classification has been integrated into the 2020 World Health Organization (WHO) diagnostic classification and European treatment guidelines, and provides direction towards more effective and less toxic adjuvant treatment strategies for women with endometrial cancer.Primary Objective(s)The RAINBO program of clinical trials will investigate four molecular class-directed adjuvant treatment strategies following surgical resection to either increase cure rates through the addition of novel targeted therapies or safely reduce toxicity and improve quality of life through treatment de-escalation.Study HypothesisMolecular-directed adjuvant treatment strategies will improve clinical outcomes and reduce toxicity of unwarranted therapies in women with endometrial cancer. The overarching and translational research RAINBO program will advance knowledge of predictive and prognostic (bio)markers that will improve prognostication and treatment allocation.Trial DesignThe RAINBO program is a platform of four international clinical trials and an overarching research program. The randomized phase III p53abn-RED trial for women with invasive stage I–III p53abn endometrial cancer compares adjuvant chemoradiation followed by olaparib for 2 years with adjuvant chemoradiation alone. The randomized phase III MMRd-GREEN trial for women with stage II (with lymphovascular space invasion (LVSI)) or stage III mismatch repair-deficient (MMRd) endometrial cancer compares adjuvant radiotherapy with concurrent and adjuvant durvalumab for 1 year to radiotherapy alone. The randomized phase III NSMP-ORANGE trial is a treatment de-escalation trial for women with estrogen receptor positive stage II (with LVSI) or stage III no specific molecular profile (NSMP) endometrial cancer comparing radiotherapy followed by progestin for 2 years to adjuvant chemoradiation. ThePOLEmut-BLUE trial is a phase II trial in which the safety of de-escalation of adjuvant therapy is investigated for women with stage I–IIIPOLEmut endometrial cancer: no adjuvant therapy for lower-risk disease and no adjuvant therapy or radiotherapy alone for higher-risk disease. The overarching RAINBO program will combine data and tumor material of all participants to perform translational research and evaluate molecular class-based adjuvant therapy in terms of efficacy, toxicity, quality of life, and cost-utility.Major Inclusion/Exclusion CriteriaInclusion criteria include a histologically confirmed diagnosis of endometrial cancer treated by hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel lymph node biopsy, with no macroscopic residual disease after surgery and no distant metastases, and molecular classification according to the WHO 2020 algorithm.Primary Endpoint(s)Recurrence-free survival at 3 years in the p53abn-RED, MMRd-GREEN, and NSMP-ORANGE trials and pelvic recurrence at 3 years in thePOLEmut-BLUE trial.Sample SizeThe p53abn-RED trial will include 554 patients, the MMRd-GREEN trial 316, the NSMP-ORANGE trial 600, and thePOLEmut-BLUE trial 145 (120 for lower-risk disease and approximately 25 for higher-risk disease). The overarching research program will pool the four sub-trials resulting in a total sample size of around 1600.Estimated Dates for Completing Accrual and Presenting ResultsThe four clinical trials will have different completion dates; main results are expected from 2028.Trial Registration NumberThe RAINBO program is registered at clinicaltrials.gov (NCT05255653).

Published
2023

11. pSESYNTH project: Community mobilization for a multi-disciplinary paleo database of the Global South

Author

Kulkarni, C., Jara, I. A., Chevalier, M., Isa, A. A., Alinezhad, K., Brugger, S. O., Bunbury, M. M. E., Cordero-Oviedo, C., Courtney-Mustaphi, C., Echeverría-Galindo, P., Ensafi Moghaddam, T., Ferrara, V., Garcia-Rodriguez, F., Gitau, P., Hannaford, M., Herbert, A., Hernández, A., Jalali, B., Jha, D. K., Kinyanjui, R. N., Koren, G., Mackay, H., Mansilla, C. A., Margalef, O., Mukhopadhyay, S., Onafeso, O., Riris, P., Rodriguez-Abaunza, A., Rodríguez-Zorro, P., Saeidi, S., Ratnayake, S., Seitz, C., Spate, M., Vásquez, C., and Benito, X.

Abstract

How to enhance paleoscientific research, collaboration and application in the Global South? The INQUA-funded multi-year pSESYNTH project envisions the first multi-disciplinary Holocene paleo database through a collaborative vision for past human-environmental systems in the Global South, and their future sustainability.

Published
2023

13. 525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775

Author

Makker, V., primary, Colombo, N., additional, Casado Herraez, A., additional, Monk, B.J., additional, Mackay, H., additional, Santin, A.D., additional, Miller, D.S., additional, Moore, R.G., additional, Baron-Hay, S.E., additional, Ray-Coquard, I.L., additional, Shapira-Frommer, R., additional, Ushijima, K., additional, Yonemori, K., additional, Kim, Y.M., additional, Guerra Alia, E.M., additional, Sanli, U.A., additional, Huang, J., additional, McKenzie, J., additional, Barresi, G., additional, and Lorusso, D., additional

Published
2022
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16. LBA33 ICON9: International phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy

Author

Nicum, S., Ledermann, J.A., Mileshkin, L., Jayson, G.C., Gourley, C., Michael, A., Lord, R., Mackay, H., Hall, M., Tookman, L., Banerjee, S., Harnett, P., Macdonald, I., Lee, Y.C., Elyashiv, O., Wilkinson, K., Farrelly, L., and Counsell, N.

Published
2024
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18. A Survey of 14 to 16 Year Olds as to Their Attitude toward and Use of Sunbeds

Author

Mackay, H., Lowe, D., Edwards, D., and Rogers, S. N.

Abstract

Objective: Sunbeds pose a potential risk to health. Although not recommended for children under 16 years of age they are used by this age group. The purpose of this study was to assess the awareness of suntanning guidelines, the use of sunbeds and the attitude towards tanning in children aged between 14 and 16 years. Design and method: 499 pupils aged 14 to 16 years responded to a questionnaire survey in two schools in a mixed urban part of Merseyside. Results: Overall, sunbeds had been used by 43 per cent of pupils. Girls had used them much more than boys with use increasing by age for both sexes. Overall, 65 per cent said they were aware of guidelines. About half thought that guidelines advising people how often to use a sunbed were a good thing. One in 10 of those using a sunbed also said they had had problems with their eyes or skin. Most boy and girl users thought using sunbeds made them look healthy, made them more attractive and confident, that they created a base tan before a holiday and that they were a good treatment for spots. Conclusion: There is considerable awareness of sunbed guidelines; however, sunbed use in the under 16 year age group remains high. This poses a public health issue and better education and enforcement strategies are required. (Contains 4 tables.)

Published
2007
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19. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer

Author

Provencher, D M, Gallagher, C J, Parulekar, W R, Ledermann, J A, Armstrong, D K, Brundage, M, Gourley, C, Romero, I, Gonzalez-Martin, A, Feeney, M, Bessette, P, Hall, M, Weberpals, J I, Hall, G, Lau, S K, Gauthier, P, Fung-Kee-Fung, M, Eisenhauer, E A, Winch, C, Tu, D, and MacKay, H J

Published
2018
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20. Tertiary lymphoid structures critical for prognosis in endometrial cancer patients

Author

Horeweg, N, Workel, HH, Loiero, D, Church, DN, Vermij, L, Leon-Castillo, A, Krog, RT, de Boer, SM, Nout, RA, Powell, ME, Mileshkin, LR, MacKay, H, Leary, A, Singh, N, Juergenliemk-Schulz, IM, Smit, VTHBM, Creutzberg, CL, Koelzer, VH, Nijman, HW, Bosse, T, de Bruyn, M, Horeweg, N, Workel, HH, Loiero, D, Church, DN, Vermij, L, Leon-Castillo, A, Krog, RT, de Boer, SM, Nout, RA, Powell, ME, Mileshkin, LR, MacKay, H, Leary, A, Singh, N, Juergenliemk-Schulz, IM, Smit, VTHBM, Creutzberg, CL, Koelzer, VH, Nijman, HW, Bosse, T, and de Bruyn, M

Abstract

B-cells play a key role in cancer suppression, particularly when aggregated in tertiary lymphoid structures (TLS). Here, we investigate the role of B-cells and TLS in endometrial cancer (EC). Single cell RNA-sequencing of B-cells shows presence of naïve B-cells, cycling/germinal center B-cells and antibody-secreting cells. Differential gene expression analysis shows association of TLS with L1CAM overexpression. Immunohistochemistry and co-immunofluorescence show L1CAM expression in mature TLS, independent of L1CAM expression in the tumor. Using L1CAM as a marker, 378 of the 411 molecularly classified ECs from the PORTEC-3 biobank are evaluated, TLS are found in 19%. L1CAM expressing TLS are most common in mismatch-repair deficient (29/127, 23%) and polymerase-epsilon mutant EC (24/47, 51%). Multivariable Cox regression analysis shows strong favorable prognostic impact of TLS, independent of clinicopathological and molecular factors. Our data suggests a pivotal role of TLS in outcome of EC patients, and establishes L1CAM as a simple biomarker.

Published
2022

21. Neolithic Human Diet Based on Studies of Coprolites from the Swifterbant Culture Sites, the Netherlands: Synthesis - Human versus community diet

Author

Kubiak-Martens, L. (author), van der Linden, M. (author), Hardy, K. (author), Mackay, H. (author), Ngan-Tillard, D.J.M. (author), Shillito, L.- M. (author), Zeiler, J.T. (author), Kubiak-Martens, L. (author), van der Linden, M. (author), Hardy, K. (author), Mackay, H. (author), Ngan-Tillard, D.J.M. (author), Shillito, L.- M. (author), and Zeiler, J.T. (author)

Abstract

The aim of this final chapter is to integrate the results obtained from the multi-disciplinary study applied to a series of coprolites from the Late Mesolithic and Early Neolithic Swifterbant Culture sites, to determine their role as a source of information about the prehistoric dietary tradition and health. The study of coprolites provides a unique opportunity to reconstruct the most complete spectrum of the foods that were consumed in the past, both as cooked meals as well as foods that were eaten raw. In addition to the food remains, coprolites also contain intestinal parasites which affected the health of prehistoric populations. Coprolite studies can also provide information about palaeoenvironmental conditions through the types of microfossils and macrofossils they contain., Geo-engineering

Published
2022

22. p53 immunohistochemistry in endometrial cancer:clinical and molecular correlates in the PORTEC-3 trial

Author

Vermij, Lisa, Léon-Castillo, Alicia, Singh, Naveena, Powell, M. E., Edmondson, Richard J., Genestie, Catherine, Khaw, Pearly, Pyman, Jan, McLachlin, C. Meg, Ghatage, Prafull, de Boer, Stephanie M., Nijman, H. W., Smit, V. T.H.B.M., Crosbie, Emma J., Leary, Alexandra, Creutzberg, Carien L., Horeweg, Nanda, Bosse, Tjalling, de Boer, S. M., Creutzberg, C. L., Bosse, T., Kroep, J., Nout, R. A., de Bruyn, M., Singh, N., Kitchener, H. C., Crosbie, E., Edmondson, R., Church, D. N., Leary, A., Mileshkin, L., Pollock, P. M., MacKay, H., Vermij, Lisa, Léon-Castillo, Alicia, Singh, Naveena, Powell, M. E., Edmondson, Richard J., Genestie, Catherine, Khaw, Pearly, Pyman, Jan, McLachlin, C. Meg, Ghatage, Prafull, de Boer, Stephanie M., Nijman, H. W., Smit, V. T.H.B.M., Crosbie, Emma J., Leary, Alexandra, Creutzberg, Carien L., Horeweg, Nanda, Bosse, Tjalling, de Boer, S. M., Creutzberg, C. L., Bosse, T., Kroep, J., Nout, R. A., de Bruyn, M., Singh, N., Kitchener, H. C., Crosbie, E., Edmondson, R., Church, D. N., Leary, A., Mileshkin, L., Pollock, P. M., and MacKay, H.

Abstract

Standard molecular classification of endometrial cancers (EC) is now endorsed by the WHO and identifies p53-abnormal (p53abn) EC as the subgroup with the poorest prognosis and the most likely to benefit from adjuvant chemo(radio)therapy. P53abn EC are POLE wildtype, mismatch repair proficient and show abnormal immunohistochemical (IHC) staining for p53. Correct interpretation of routinely performed p53 IHC has therefore become of paramount importance. We aimed to comprehensively investigate abnormal p53 IHC patterns and their relation to clinicopathological and molecular features. Tumor material of 411 molecularly classified high-risk EC from consenting patients from the PORTEC-3 clinical trial were collected. p53 IHC was successful in 408 EC and was considered abnormal when the tumor showed a mutant expression pattern (including subclonal): overexpression, null or cytoplasmic. The presence of pathogenic mutations was determined by next generation sequencing (NGS). Abnormal p53 expression was observed in 131/408 (32%) tumors. The most common abnormal p53 IHC pattern was overexpression (n = 89, 68%), followed by null (n = 12, 9%) and cytoplasmic (n = 3, 2%). Subclonal abnormal p53 staining was observed in 27 cases (21%), which was frequently but not exclusively, associated with POLE mutations and/or MMRd (n = 22/27; p < 0.001). Agreement between p53 IHC and TP53 NGS was observed in 90.7%, resulting in a sensitivity and specificity of 83.6% and 94.3%, respectively. Excluding POLEmut and MMRd EC, as per the WHO-endorsed algorithm, increased the accuracy to 94.5% with sensitivity and specificity of 95.0% and 94.1%, respectively. Our data shows that awareness of the abnormal p53 IHC patterns are prerequisites for correct EC molecular classification. Subclonal abnormal p53 expression is a strong indicator for POLEmut and/or MMRd EC. No significant differences in clinical outcomes were observed among the abnormal p53 IHC patterns. Our data support use of the WHO-endo

Published
2022

23. Updated efficacy and safety of lenvatinib (LEN) plus pembrolizumab (pembro) vs treatment of physician's choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775

Author

Makker, V., Colombo, N., Casado Herraez, A., Monk, B. J., Mackay, H., Santin, A. D., and Miller, D. S.

Abstract

Annual Meeting of the European-Society-for-Medical-Oncology (ESMO) -- SEP 09-13, 2022 -- ELECTR NETWORK, [No Abstract Available], European Soc Med Oncol, Eisai Inc., Nutley, NJ, USA; Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Published
2022

24. Neolithic Human Diet Based on Studies of Coprolites from the Swifterbant Culture Sites, the Netherlands: Synthesis - Human versus community diet

Author

Kubiak-Martens, L., van der Linden, M., Hardy, K., Mackay, H., Ngan-Tillard, D.J.M., Shillito, L.- M., Zeiler, J.T., Kubiak-Martens, Lucy, and van der Linden, Marjolein

Abstract

The aim of this final chapter is to integrate the results obtained from the multi-disciplinary study applied to a series of coprolites from the Late Mesolithic and Early Neolithic Swifterbant Culture sites, to determine their role as a source of information about the prehistoric dietary tradition and health.The study of coprolites provides a unique opportunity to reconstruct the most complete spectrum of the foods that were consumed in the past, both as cooked meals as well as foods that were eaten raw. In addition to the food remains, coprolites also contain intestinal parasites which affected the health of prehistoric populations. Coprolite studies can also provide information about palaeoenvironmental conditions through the types of microfossils and macrofossils they contain.

Published
2022

26. Racism : undoing the damage.

Author

Ang, I., Hamilton, P., Kowalski, S., McFarlane, H., Petersen, M., Hickey, C., MacKay, H., Manne, R., and Vince, M.

Published
2002

30. News and Letters

Author

Kandall, Geoffrey A., Lindstrom, Peter A., MacKay, H., Sokolowsky, Daniel, Johnsonbaugh, Richard, Schattschneider, Doris, Meyers, Victor, and Blockton, Connie

Published
1977

33. O002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors

Author

Makker, V, primary, Colombo, N, additional, Casado Herráez, A, additional, Santin, A, additional, Colomba, E, additional, Miller, D, additional, Fujiwara, K, additional, Pignata, S, additional, Banerjee, S, additional, Monk, B, additional, Ushijima, K, additional, Penson, R, additional, Kristeleit, R, additional, Fabbro, M, additional, Orlando, M, additional, Mackay, H, additional, Ren, M, additional, Orlowski, R, additional, Dutta, L, additional, and Lorusso, D, additional

Published
2021
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34. Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus (SPARTACUS): A Multicenter Prospective Trial Evaluating Acute Toxicities and Patient Reported Outcomes

Author

Leung, E.W., primary, Gladwish, A.P., additional, Davidson, M.T.M., additional, Taggar, A., additional, Barnes, E., additional, Donovan, E., additional, Gien, L.T., additional, Covens, A., additional, Vicus, D., additional, Kupets, R., additional, Han, K., additional, Velker, V., additional, Mendez, L., additional, MacKay, H., additional, Cheung, P., additional, Loblaw, D.A., additional, and D'Souza, D.P., additional

Published
2021
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35. 397 Molecular profiling of NSMP high-risk endometrial cancers of the PORTEC-3 trial – prognostic refinement and druggable targets

Author

Vermij, L, primary, Powell, M, additional, Leon-Castillo, A, additional, De Boer, S, additional, Mileshkin, L, additional, Mackay, H, additional, Leary, A, additional, Nijman, HW, additional, Singh, N, additional, Pollock, P, additional, Bessette, P, additional, Haie-Meder, C, additional, Smit, V, additional, Edmondson, R, additional, Crosbie, E, additional, Nout, R, additional, Horeweg, N, additional, Creutzberg, CL, additional, and Bosse, T, additional

Published
2021
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36. 595 Implementation of collaborative translational research (TransPORTEC) findings in an international endometrial cancer clinical trials program (RAINBO)

Author

Bosse, T, primary, Powell, M, additional, Crosbie, E, additional, Leary, A, additional, Kroep, J, additional, Han, K, additional, Mcalpine, J, additional, Horeweg, N, additional, De Boer, S, additional, De Bruyn, M, additional, Nout, R, additional, Smit, V, additional, Nijman, HW, additional, Singh, N, additional, Mackay, H, additional, Edmondson, R, additional, Mileshkin, L, additional, Church, D, additional, Kitchener, H, additional, and Creutzberg, CL, additional

Published
2021
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38. 482 Tertiary lymphoid structures as markers of anti-tumor immunity with independent prognostic value in the PORTEC-3 trial of high-risk endometrial cancer

Author

Horeweg, N, primary, Workel, H, additional, Loiero, D, additional, Church, D, additional, Vermij, L, additional, Leon-Castillo, A, additional, De Boer, S, additional, Nout, R, additional, Powell, M, additional, Mileshkin, L, additional, Mackay, H, additional, Leary, A, additional, Singh, N, additional, Jürgenliemk-Schulz, I, additional, Creutzberg, CL, additional, Kölzer, V, additional, Nijman, HW, additional, Bosse, T, additional, and De Bruyn, M, additional

Published
2021
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42. 726MO Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer (Study 309/KEYNOTE-775)

Author

Colombo, N., primary, Lorusso, D., additional, Herráez, A. Casado, additional, Santin, A.D., additional, Colomba, E., additional, Miller, D.S., additional, Fujiwara, K., additional, Pignata, S., additional, Floquet, A., additional, Monk, B.J., additional, Banerjee, S., additional, Penson, R.T., additional, Kristeleit, R., additional, Fabbro, M., additional, Orlando, M., additional, Mackay, H., additional, Jensen, E., additional, Dutta, L., additional, Orlowski, R., additional, and Makker, V., additional

Published
2021
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47. Increasing Tephra Deposition in Northeastern North America Points to Atmospheric Circulation Changes at the Early Mid Holocene Transition

Author

Monteath, A. J., Jensen, B. J. L., Davies, L. J., Bolton, M. S. M., Hughes, P. D. M., Mackay, H., Edwards, M. E., Finkenbinder, M., Booth, R. K., Cwynar, L. C., Harvey, J., Pyne‐O’Donnell, S., Papp, C. N., Froese, D. G., Mallon, G., Amesbury, M. J., and Mayfield, R. J.

Abstract

The number of cryptotephra (non‐visible volcanic ash) records from northeastern North America is unique in the continent. The resulting tephrostratigraphic framework includes ash deposits sourced from volcanic arcs across the Northern Hemisphere and is an exceptional resource for correlating and dating paleoenvironmental records. It also provides an opportunity to explore more novel questions regarding the controls on ultra‐distal tephra (volcanic ash >3,000 km from source) dispersal and deposition. Here, we examine temporal patterns in the tephrostratigraphy of northeastern North America to test the legitimacy of a previously noted change in ash deposition frequency at the Early Mid Holocene transition. We integrate five new cryptotephra records into the existing framework to improve its temporal and spatial extent and report further occurrences of widespread cryptotephra deposits including Mt. St. Helens We, Jala pumice, White River Ash east, Ruppert tephra, Mt. St. Helens Yn and Mazama Ash. Reexamination of the combined tephrostratigraphy using breakpoint analysis shows a significant increase in the frequency of ashfall after ca. 9,000 (7,860–9,650) cal yr BP (calendar years before C.E. 1950). We discuss this change in relation to volcanic and environmental controls of fine ash dispersal and preservation. We reject hypotheses relating to eruption frequency or depositional processes in favor of changing atmospheric transport patterns and tephra dispersal—possibly caused by the retreat of the Laurentide Ice Sheet. Our study is a novel example of how tephrostratigraphy can be used beyond traditional correlative and dating studies, in this case indicating large‐scale changes in atmospheric circulation through time. Microscopic volcanic ash beds can be traced across continents and in northeastern North America have been extensively studied to form a stratigraphic framework of ashfall spanning the last 16,000 years. In this study, we extend the spatial and temporal extent of this framework and use statistical breakpoint analysis to look for patterns in ashfall frequency through time. We find that there is a sustained increase in the frequency of ashfall around 9,000 years ago. This pattern is inconsistent with wider records of volcanism and depositional processes and can only be explained by changes in atmospheric circulation. Paleoenvironmental records also show evidence for atmospheric changes that were driven by the collapse of the North American ice sheets. Our findings show that distal records of ashfall are sensitive to long‐term atmospheric change and can provide new data for testing paleoclimate simulations. New records and statistical reanalysis reveal an increase in tephra deposition frequency over northeastern North America ca. 9,000 years agoThis increase likely reflects changing atmospheric circulation associated with the collapse of the Laurentide ice sheet New records and statistical reanalysis reveal an increase in tephra deposition frequency over northeastern North America ca. 9,000 years ago This increase likely reflects changing atmospheric circulation associated with the collapse of the Laurentide ice sheet

Published
2025
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