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2. 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. Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy

Author

Wortman, B. G., Creutzberg, C. L., Putter, H., Jürgenliemk-Schulz, I. M., Jobsen, J. J., Lutgens, L. C. H. W., van der Steen-Banasik, E. M., Mens, J. W. M., Slot, A., Kroese, M. C. Stenfert, van Triest, B., Nijman, H. W., Stelloo, E., Bosse, T., de Boer, S. M., van Putten, W. L. J., Smit, V. T. H. B. M, Nout, R. A., and for the PORTEC Study Group

Published
2018
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6. Development and validation of prognostic models for anal cancer outcomes using distributed learning: protocol for the international multi-centre atomCAT2 study

Author

Theophanous, S, Lønne, P-I, Choudhury, A, Berbee, M, Dekker, A, Dennis, K, Dewdney, A, Gambacorta, MA, Gilbert, A, Guren, MG, Holloway, L, Jadon, R, Kochhar, R, Mohamed, AA, Muirhead, R, Parés, O, Raszewski, L, Roy, R, Scarsbrook, A, Sebag-Montefiore, D, Spezi, E, Spindler, K-LG, van Triest, B, Vassiliou, V, Malinen, E, Wee, L, Appelt, AL, on behalf of the atomCAT consortium, Radiotherapie, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Radiotherapie OC (9), RS: GROW - R2 - Basic and Translational Cancer Biology, RS: FSE BISS, Adams, Richard, Amin, Muhammad, Capocchiano, Nikola Dino, Colley, Peter, Damiani, Andrea, De Luca, Viola, Deijen, Charlotte, Demetriou, Antri, Eble, Michael J., Field, Matthew, Georgiou, Loukia, Henry, Ann, Lau, Joanna, Lee, Mark, Lilley, John, Lopes, Patricia, Lutz, Christina Maria, Manfrida, Stefania, Marsden, Jenny, Masciocchi, Carlotta, Mercer, Joseph, Nyvang, Lars, Papageorgiou, Elisavet, Price, Gareth, Rackley, Thomas, Savino, Mariachiara, Stroom, Joep, Stylianou, Ioannis, Tambe, Nilesh, Thwaites, David, Trojanowski, Maciej, Valentini, Vincenzo, and Vieira, Sandra

Subjects
Distributed learning, Locoregional control, Freedom from distant metastasis, Squamous cell carcinoma, Federated learning, outcome modelling, Overall survival, Chemoradiotherapy, Anal cancer, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA
Abstract

Diagnostic and prognostic research 6, 14 (2022). doi:10.1186/s41512-022-00128-8, Published by BioMed Central, [London]

Published
2022
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8. PD-0798 Development and results of a patient-reported treatment experience questionnaire on a 1.5 T MR-Linac

Author

Barnes, H., primary, Alexander, S., additional, Bower, L., additional, Ehlers, J., additional, Gani, C., additional, Herbert, T., additional, Lawes, R., additional, Krause, P., additional, øller, M., additional, Morgan, T., additional, Nowee, M., additional, Smith, G., additional, van Triest, B., additional, Tyagi, N., additional, Whiteside, L., additional, and McNair, H., additional

Published
2021
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9. 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

de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, P, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Jurgenliemk-Schulz, I, Kitchener, H, Nijman, H, Wilson, G, Brooks, S, Gribaudo, S, Provencher, D, Hanzen, C, Kruitwagen, R, Smit, V, Singh, N, Do, V, Lissoni, A, Nout, R, Feeney, A, Verhoeven-Adema, K, Putter, H, Creutzberg, C, Mccormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, P, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Lutgens, L, Hollema, H, Pras, E, Snyers, A, Westerveld, G, Jobsen, J, Slot, A, Mens, J, Stam, T, Van Triest, B, Van der Steen-Banasik, E, De Winter, K, Quinn, M, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Colombo, A, Carinelli, S, Ferrero, A, Artioli, G, Davidson, C, Mclachlin, C, Ghatage, P, Rittenberg, P, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer S. M., Powell M. E., Mileshkin L., Katsaros D., Bessette P., Haie-Meder C., Ottevanger P. B., Ledermann J. A., Khaw P., D'Amico R., Fyles A., Baron M. -H., Jurgenliemk-Schulz I. M., Kitchener H. C., Nijman H. W., Wilson G., Brooks S., Gribaudo S., Provencher D., Hanzen C., Kruitwagen R. F., Smit V. T. H. B. M., Singh N., Do V., Lissoni A., Nout R. A., Feeney A., Verhoeven-Adema K. W., Putter H., Creutzberg C. L., McCormack M., Whitmarsh K., Allerton R., Gregory D., Symonds P., Hoskin P. J., Adusumalli M., Anand A., Wade R., Stewart A., Taylor W., Lutgens L. C. H. W., Hollema H., Pras E., Snyers A., Westerveld G. H., Jobsen J. J., Slot A., Mens J. M., Stam T. C., Van Triest B., Van der Steen-Banasik E. M., De Winter K. A. J., Quinn M. A., Kolodziej I., Pyman J., Johnson C., Capp A., Fossati R., Colombo A., Carinelli S., Ferrero A., Artioli G., Davidson C., McLachlin C. M., Ghatage P., Rittenberg P. V. C., Souhami L., Thomas G., Duvillard P., Berton-Rigaud D., Tubiana-Mathieu N., de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, P, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Jurgenliemk-Schulz, I, Kitchener, H, Nijman, H, Wilson, G, Brooks, S, Gribaudo, S, Provencher, D, Hanzen, C, Kruitwagen, R, Smit, V, Singh, N, Do, V, Lissoni, A, Nout, R, Feeney, A, Verhoeven-Adema, K, Putter, H, Creutzberg, C, Mccormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, P, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Lutgens, L, Hollema, H, Pras, E, Snyers, A, Westerveld, G, Jobsen, J, Slot, A, Mens, J, Stam, T, Van Triest, B, Van der Steen-Banasik, E, De Winter, K, Quinn, M, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Colombo, A, Carinelli, S, Ferrero, A, Artioli, G, Davidson, C, Mclachlin, C, Ghatage, P, Rittenberg, P, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer S. M., Powell M. E., Mileshkin L., Katsaros D., Bessette P., Haie-Meder C., Ottevanger P. B., Ledermann J. A., Khaw P., D'Amico R., Fyles A., Baron M. -H., Jurgenliemk-Schulz I. M., Kitchener H. C., Nijman H. W., Wilson G., Brooks S., Gribaudo S., Provencher D., Hanzen C., Kruitwagen R. F., Smit V. T. H. B. M., Singh N., Do V., Lissoni A., Nout R. A., Feeney A., Verhoeven-Adema K. W., Putter H., Creutzberg C. L., McCormack M., Whitmarsh K., Allerton R., Gregory D., Symonds P., Hoskin P. J., Adusumalli M., Anand A., Wade R., Stewart A., Taylor W., Lutgens L. C. H. W., Hollema H., Pras E., Snyers A., Westerveld G. H., Jobsen J. J., Slot A., Mens J. M., Stam T. C., Van Triest B., Van der Steen-Banasik E. M., De Winter K. A. J., Quinn M. A., Kolodziej I., Pyman J., Johnson C., Capp A., Fossati R., Colombo A., Carinelli S., Ferrero A., Artioli G., Davidson C., McLachlin C. M., Ghatage P., Rittenberg P. V. C., Souhami L., Thomas G., Duvillard P., Berton-Rigaud D., and Tubiana-Mathieu N.

Abstract

Background: The PORTEC-3 trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We updated the analysis to investigate patterns of recurrence and did a post-hoc survival analysis. Methods: In the multicentre randomised phase 3 PORTEC-3 trial, women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO) 2009 stage I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I–III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0–2. Participants were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2 given intravenously), by use of a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage, and histological type. The co-primary endpoints were overall survival and failure-free survival. Secondary endpoints of vaginal, pelvic, and distant recurrence were analysed according to the first site of recurrence. Survival endpoints were analysed by intention-to-treat, and adjusted for stratification factors. Competing risk methods were used for failure-free survival and recurrence. We did a post-hoc analysis to analyse patterns of recurrence with 1 additional year of follow-up. The study was closed on Dec 20, 2013; follow-up is ongoing. This study is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. Findings: Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the rad

Published
2019

12. PD-0071: The MOMENTUM study, an international registry of patients treated on an MR-linac: 9-month experience

Author

Van Otterloo, S. De Mol, primary, Blezer, E.L.A., additional, Fuller, C.D., additional, Faivre-Finn, C., additional, Sahgal, A., additional, Van der Heide, U.A., additional, Christodouleas, J.P., additional, Akhiat, H., additional, Mook, S., additional, Intven, M.P.W., additional, Van Triest, B., additional, Tree, A.C., additional, Kirby, A.M., additional, Lalondrelle, S., additional, Schultz, C., additional, Erickson, B., additional, Emma, H., additional, Nowee, M.E., additional, Hafeez, S., additional, Oelfke, U., additional, Tersteeg, R.H.A., additional, Eggert, D., additional, Hall, W.A., additional, and Verkooijen, H.M., additional

Published
2020
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17. The Patterns of Care, Tolerability and Safety in the First Year of a Novel High Field MR-Linac

Author

de Mol van Otterloo, S.R., primary, Christodouleas, J.P., additional, Blezer, E.L.A., additional, Cobben, D., additional, Erickson, B.A., additional, Fuller, C.D., additional, Hafeez, S., additional, Kirby, A., additional, Lalondrelle, S., additional, Mook, S., additional, Nowee, M.E., additional, Orrling, K., additional, Philippens, M., additional, Sahgal, A., additional, Schultz, C.J., additional, Tree, A., additional, van Triest, B., additional, Tseng, C.L., additional, Hall, W.A., additional, and Verkooijen, H., additional

Published
2020
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18. 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, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, P, Ledermann, J, Khaw, P, Colombo, A, Fyles, A, Baron, M, Jurgenliemk-Schulz, I, Kitchener, H, Nijman, H, Wilson, G, Brooks, S, Carinelli, S, Provencher, D, Hanzen, C, Lutgens, L, Smit, V, Singh, N, Do, V, D'Amico, R, Nout, R, Feeney, A, Verhoeven-Adema, K, Putter, H, Creutzberg, C, Mccormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, P, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Kruitwagen, R, Hollema, H, Pras, E, Snyers, A, Stalpers, L, Jobsen, J, Slot, A, Mens, J, Stam, T, Van Triest, B, Van der Steen - Banasik, E, De Winter, K, Quinn, M, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Gribaudo, S, Lissoni, A, Ferrero, A, Artioli, G, Davidson, C, Mclachlin, C, Ghatage, P, Rittenberg, P, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer S. M., Powell M. E., Mileshkin L., Katsaros D., Bessette P., Haie-Meder C., Ottevanger P. B., Ledermann J. A., Khaw P., Colombo A., Fyles A., Baron M. -H., Jurgenliemk-Schulz I. M., Kitchener H. C., Nijman H. W., Wilson G., Brooks S., Carinelli S., Provencher D., Hanzen C., Lutgens L. C. H. W., Smit V. T. H. B. M., Singh N., Do V., D'Amico R., Nout R. A., Feeney A., Verhoeven-Adema K. W., Putter H., Creutzberg C. L., McCormack M., Whitmarsh K., Allerton R., Gregory D., Symonds P., Hoskin P. J., Adusumalli M., Anand A., Wade R., Stewart A., Taylor W., Kruitwagen R. F. P. M., Hollema H., Pras E., Snyers A., Stalpers L., Jobsen J. J., Slot A., Mens J. -W. M., Stam T. C., Van Triest B., Van der Steen - Banasik E. M., De Winter K. A. J., Quinn M. A., Kolodziej I., Pyman J., Johnson C., Capp A., Fossati R., Gribaudo S., Lissoni A. A., Ferrero A., Artioli G., Davidson C., McLachlin C. M., Ghatage P., Rittenberg P. V. C., Souhami L., Thomas G., Duvillard P., Berton-Rigaud D., Tubiana-Mathieu N., de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, P, Ledermann, J, Khaw, P, Colombo, A, Fyles, A, Baron, M, Jurgenliemk-Schulz, I, Kitchener, H, Nijman, H, Wilson, G, Brooks, S, Carinelli, S, Provencher, D, Hanzen, C, Lutgens, L, Smit, V, Singh, N, Do, V, D'Amico, R, Nout, R, Feeney, A, Verhoeven-Adema, K, Putter, H, Creutzberg, C, Mccormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, P, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Kruitwagen, R, Hollema, H, Pras, E, Snyers, A, Stalpers, L, Jobsen, J, Slot, A, Mens, J, Stam, T, Van Triest, B, Van der Steen - Banasik, E, De Winter, K, Quinn, M, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Gribaudo, S, Lissoni, A, Ferrero, A, Artioli, G, Davidson, C, Mclachlin, C, Ghatage, P, Rittenberg, P, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer S. M., Powell M. E., Mileshkin L., Katsaros D., Bessette P., Haie-Meder C., Ottevanger P. B., Ledermann J. A., Khaw P., Colombo A., Fyles A., Baron M. -H., Jurgenliemk-Schulz I. M., Kitchener H. C., Nijman H. W., Wilson G., Brooks S., Carinelli S., Provencher D., Hanzen C., Lutgens L. C. H. W., Smit V. T. H. B. M., Singh N., Do V., D'Amico R., Nout R. A., Feeney A., Verhoeven-Adema K. W., Putter H., Creutzberg C. L., McCormack M., Whitmarsh K., Allerton R., Gregory D., Symonds P., Hoskin P. J., Adusumalli M., Anand A., Wade R., Stewart A., Taylor W., Kruitwagen R. F. P. M., Hollema H., Pras E., Snyers A., Stalpers L., Jobsen J. J., Slot A., Mens J. -W. M., Stam T. C., Van Triest B., Van der Steen - Banasik E. M., De Winter K. A. J., Quinn M. A., Kolodziej I., Pyman J., Johnson C., Capp A., Fossati R., Gribaudo S., Lissoni A. A., Ferrero A., Artioli G., Davidson C., McLachlin C. M., Ghatage P., Rittenberg P. V. C., Souhami L., Thomas G., Duvillard P., Berton-Rigaud D., and Tubiana-Mathieu N.

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/m2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2) 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

Published
2018

19. Study protocols of three parallel phase 1 trials combining radical radiotherapy with the PARP inhibitor olaparib

Author

de Haan, R, van Werkhoven, E, van den Heuvel, M M, Peulen, H M U, Sonke, G S, Elkhuizen, P, van den Brekel, M W M, Tesselaar, M E T, Vens, C, Schellens, J H M, van Triest, B, Verheij, M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Arbeids- en Organisatie Psychologie (Psychologie, FMG), FMG, MKA AMC (OII, ACTA), Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, CCA - Cancer Treatment and quality of life, Academic Medical Center, and Maxillofacial Surgery (AMC)

Subjects
0301 basic medicine, Oncology, Cancer Research, Lung Neoplasms, medicine.medical_treatment, Piperazines, Study Protocol, chemistry.chemical_compound, Olaparib, 0302 clinical medicine, TITE-CRM, Surgical oncology, Carcinoma, Non-Small-Cell Lung, Neoplasms, Doselimiting toxicity, Dose limiting toxicity, Common Terminology Criteria for Adverse Events, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Tolerability, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, PARP inhibitor, Carcinoma, Squamous Cell, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], medicine.medical_specialty, Maximum Tolerated Dose, Antineoplastic Agents, Breast Neoplasms, Phase 1, Poly(ADP-ribose) Polymerase Inhibitors, Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9], lcsh:RC254-282, 03 medical and health sciences, Breast cancer, SDG 3 - Good Health and Well-being, Internal medicine, Genetics, medicine, Humans, Radiotherapy, Dose escalation, business.industry, Radiosensitisation, medicine.disease, Head and neck squamous-cell carcinoma, Radiation therapy, 030104 developmental biology, chemistry, Phthalazines, Radiotherapy, Adjuvant, business
Abstract

BackgroundPoly (ADP-ribose) Polymerase (PARP) inhibitors are promising novel radiosensitisers. Pre-clinical models have demonstrated potent and tumour-specific radiosensitisation by PARP inhibitors. Olaparib is a PARP inhibitor with a favourable safety profile in comparison to clinically used radiosensitisers including cisplatin when used as single agent. However, data on safety, tolerability and efficacy of olaparib in combination with radiotherapy are limited.MethodsOlaparib is dose escalated in combination with radical (chemo-)radiotherapy regimens for non-small cell lung cancer (NSCLC), breast cancer and head and neck squamous cell carcinoma (HNSCC) in three parallel single institution phase 1 trials. All trials investigate a combination treatment of olaparib and radiotherapy, the NSCLC trial also investigates a triple combination of olaparib, radiotherapy and concurrent low dose cisplatin. The primary objective is to identify the maximum tolerated dose of olaparib in these combination treatments, defined as the dose closest to but not exceeding a 15% probability of dose limiting toxicity. Each trial has a separate dose limiting toxicity definition, taking into account incidence, duration and severity of expected toxicities without olaparib. Dose escalation is performed using a time-to-event continual reassessment method (TITE-CRM). TITE-CRM enables the incorporation of late onset toxicity until one year after treatment in the dose limiting toxicity definition while maintaining an acceptable trial duration. Olaparib treatment starts two days before radiotherapy and continues during weekends until two days after radiotherapy. Olaparib will also be given two weeks and one week before radiotherapy in the breast cancer trial and HNSCC trial respectively to allow for translational research. Toxicity is scored using common terminology criteria for adverse events (CTCAE) version 4.03. Blood samples, and tumour biopsies in the breast cancer trial, are collected for pharmacokinetic and pharmacodynamic analyses.DiscussionWe designed three parallel phase 1 trials to assess the safety and tolerability of the PARP inhibitor olaparib in combination with radical (chemo-)radiotherapy treatment regimens. PARP inhibitors have the potential to improve outcomes in patients treated with radical (chemo-)radiotherapy, by achieving higher locoregional control rates and/or less treatment associated toxicity.Trial registrationClinicalTrials.govIdentifiers: NCT01562210 (registered March 23, 2012), NCT02227082 (retrospectively registered August 27, 2014), NCT02229656 (registered September 1, 2014).

Published
2019
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21. First system for fully-automated multi-criterial treatment planning for a high-magnetic field MR-Linac applied to rectal cancer

Author

Bijman, R. (Renate), Rossi, L. (Linda), Janssen, T. (Tessa), Ruiter, P.E. (Petra) de, Carbaat, C., van Triest, B., Breedveld, S. (Sebastiaan), Sonke, J.J., Heijmen, B.J.M. (Ben), Bijman, R. (Renate), Rossi, L. (Linda), Janssen, T. (Tessa), Ruiter, P.E. (Petra) de, Carbaat, C., van Triest, B., Breedveld, S. (Sebastiaan), Sonke, J.J., and Heijmen, B.J.M. (Ben)

Abstract

Background and purpose: In this study we developed a workflow for fully-automated generation of deliverable IMRT plans for a 1.5 T MR-Linac (MRL) based on contoured CT scans, and we evaluated automated MRL planning for rectal cancer. Methods: The Monte Carlo dose calculation engine used in the clinical MRL TPS (Monaco, Elekta AB, Stockholm, Sweden), suited for high accuracy dose calculations in a 1.5 T magnetic field, was coupled to our in-house developed Erasmus-iCycle optimizer. Clinically deliverable plans for 23 rectal cancer patients were automatically generated in a two-step process, i.e., multi-criterial fluence map optimization with Erasmus-iCycle followed by a conversion into a deliverable IMRT plan in the clinical TPS. Automatically generated plans (AUTOplans) were compared to plans that were manually generated with the clinical TPS (MANplans). Results: With AUTOplanning large reductions in planning time and workload were obtained; 4–6 h mainly hands-on planning for MANplans vs 1 h of mainly computer computation time for AUTOplans. For equal target coverage, the bladder and bowel bag Dmean was reduced in the AUTOplans by 1.3 Gy (6.9%) on average with a maximum reduction of 4.5 Gy (23.8%). Dosimetric measurements at the MRL demonstrated clinically acceptable delivery accuracy for the AUTOplans. Conclusions: A system for fully automated multi-criterial planning for a 1.5 T MR-Linac was developed and tested for rectal cancer patients. Automated planning resulted in major reductions in planning workload and time, while plan quality improved. Negative impact of the high magnetic field on the dose distributions could be avoided.

Published
2020
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23. 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 S. M., Powell M. E., Mileshkin L., Katsaros D., Bessette P., Haie-Meder C., Ottevanger P. B., Ledermann J. A., Khaw P., Colombo A., Fyles A., Baron M. -H., Jurgenliemk-Schulz I. M., Kitchener H. C., Nijman H. W., Wilson G., Brooks S., Carinelli S., Provencher D., Hanzen C., Lutgens L. C. H. W., Smit V. T. H. B. M., Singh N., Do V., D'Amico R., Nout R. A., Feeney A., Verhoeven-Adema K. W., Putter H., Creutzberg C. L., McCormack M., Whitmarsh K., Allerton R., Gregory D., Symonds P., Hoskin P. J., Adusumalli M., Anand A., Wade R., Stewart A., Taylor W., Kruitwagen R. F. P. M., Hollema H., Pras E., Snyers A., Stalpers L., Jobsen J. J., Slot A., Mens J. -W. M., Stam T. C., Van Triest B., Van der Steen - Banasik E. M., De Winter K. A. J., Quinn M. A., Kolodziej I., Pyman J., Johnson C., Capp A., Fossati R., Gribaudo S., Lissoni A. A., Ferrero A., Artioli G., Davidson C., McLachlin C. M., Ghatage P., Rittenberg P. V. C., Souhami L., Thomas G., Duvillard P., Berton-Rigaud D., Tubiana-Mathieu N., de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, P, Ledermann, J, Khaw, P, Colombo, A, Fyles, A, Baron, M, Jurgenliemk-Schulz, I, Kitchener, H, Nijman, H, Wilson, G, Brooks, S, Carinelli, S, Provencher, D, Hanzen, C, Lutgens, L, Smit, V, Singh, N, Do, V, D'Amico, R, Nout, R, Feeney, A, Verhoeven-Adema, K, Putter, H, Creutzberg, C, Mccormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, P, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Kruitwagen, R, Hollema, H, Pras, E, Snyers, A, Stalpers, L, Jobsen, J, Slot, A, Mens, J, Stam, T, Van Triest, B, Van der Steen - Banasik, E, De Winter, K, Quinn, M, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Gribaudo, S, Lissoni, A, Ferrero, A, Artioli, G, Davidson, C, Mclachlin, C, Ghatage, P, Rittenberg, P, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, and Tubiana-Mathieu, N

Subjects
Canada, Antineoplastic Combined Chemotherapy Protocol, Paclitaxel, Time Factor, Risk Factor, Australia, Chemoradiotherapy, Adjuvant, Middle Aged, Carboplatin, Europe, Treatment Outcome, Gynecologic Surgical Procedures, Lymph Node Excision, Endometrial Neoplasm, Female, Radiotherapy, Adjuvant, Dose Fractionation, Radiation, Cisplatin, Neoplasm Grading, Carcinoma, Endometrioid, Aged, Human, Neoplasm Staging, 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/m2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2) 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

28. 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

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

Published
2019
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31. Study protocols of three parallel phase 1 trials combining radical radiotherapy with the PARP inhibitor olaparib

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Haan, R, van Werkhoven, E, van den Heuvel, M M, Peulen, H M U, Sonke, G S, Elkhuizen, P, van den Brekel, M W M, Tesselaar, M E T, Vens, C, Schellens, J H M, van Triest, B, Verheij, M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Haan, R, van Werkhoven, E, van den Heuvel, M M, Peulen, H M U, Sonke, G S, Elkhuizen, P, van den Brekel, M W M, Tesselaar, M E T, Vens, C, Schellens, J H M, van Triest, B, and Verheij, M

Published
2019

35. OC-0608: Radiotherapy quality assurance program for the STAR-TReC trial; planning results of Dutch centers

Author

Peters, F.P., primary, Kerkhof, E.M., additional, Rutten, H., additional, Intven, M., additional, Berbee, M., additional, Theuws, J., additional, Van Triest, B., additional, Reerink, O., additional, Rozema, T., additional, Van Leeuwen, R.H.G., additional, Tijssen, R.N.H., additional, Van den Boogaard, J., additional, Murrer, L., additional, Van Haaren, P., additional, Van der Heide, U.A., additional, Stoian, G., additional, Jansen, R., additional, Raaijmakers, E., additional, Van Weerd, E., additional, and Marijnen, C.A.M., additional

Published
2018
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38. Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy

Author

Wortman, B.G. (B. G.), Creutzberg, C.L. (Carien), Putter, H. (Hein), Jürgenliemk-Schulz, I.-M. (Ina-M.), Jobsen, J.J. (Jan), Lutgens, L.C. (Ludy), Steen-Banasik, E.M. (Elzbieta) van der, Mens, J.W.M. (J. W.M.), Slot, A. (Annerie), Kroese, M.S. (Stenfert), van Triest, B. (B.), Nijman, H.W. (Hans), Stelloo, E. (E.), Bosse, T. (Tjalling), Boer, S.M. (Stephanie) de, Putten, W.L.J. (Wim) van, Smit, V.T.H.B.M. (Vincent), Nout, R.A., Wortman, B.G. (B. G.), Creutzberg, C.L. (Carien), Putter, H. (Hein), Jürgenliemk-Schulz, I.-M. (Ina-M.), Jobsen, J.J. (Jan), Lutgens, L.C. (Ludy), Steen-Banasik, E.M. (Elzbieta) van der, Mens, J.W.M. (J. W.M.), Slot, A. (Annerie), Kroese, M.S. (Stenfert), van Triest, B. (B.), Nijman, H.W. (Hans), Stelloo, E. (E.), Bosse, T. (Tjalling), Boer, S.M. (Stephanie) de, Putten, W.L.J. (Wim) van, Smit, V.T.H.B.M. (Vincent), and Nout, R.A.

Abstract

Background: PORTEC-2 was a randomised trial for women with high-intermediate risk (HIR) endometrial cancer, comparing pelvic external beam radiotherapy (EBRT) with vaginal brachytherapy (VBT). We evaluated long-term outcomes combined with the results of pathology review and molecular analysis. Methods: 427 women with HIR endometrial cancer were randomised between 2002–2006 to VBT or EBRT. Primary endpoint was vaginal recurrence (VR). Pathology review was done in 97.4%, combined with molecular analysis. Results: Median follow-up was 116 months; 10-year VR was 3.4% versus 2.4% for VBT vs. EBRT (p = 0.55). Ten-year pelvic recurrence (PR) was more frequent in the VBT group (6.3% vs. 0.9%, p = 0.004), mostly combined with distant metastases (DM). Ten-year isolated PR was 2.5% vs. 0.5%, p = 0.10, and DM 10.4 vs. 8.9% (p = 0.45). Overall survival for VBT vs. EBRT was 69.5% vs. 67.6% at 10 years (p = 0.72). L1CAM and p53-mutant expression and substantial lymph-vascular space invasion were risk factors for PR and DM. EBRT reduced PR in cases with these risk factors. Conclusion: Long-term results of the PORTEC-2 trial confirm VBT as standard adjuvant treatment for HIR endometrial cancer. Molecular risk assessment has the potential to guide adjuvant therapy. EBRT provided better pelvic control in patients with unfavourable risk factors.

Published
2018
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39. Radiotherapy quality assurance program for the STAR-TReC trial; planning results of Dutch centers

Author

MMB Research line 1, PMC Medisch specialisten, MS Radiotherapie, Cancer, Klinische Fysica RT, Circulatory Health, Arts Assistenten Cardiologie, Peters, F. P., Kerkhof, E. M., Rutten, H., Intven, M., Berbee, M., Theuws, J., Van Triest, B., Reerink, O., Rozema, T., Van Leeuwen, R. H. G., Tijssen, R. N. H., Van den Boogaard, J., Murrer, L., Van Haaren, P., Van der Heide, U. A., Stoian, G., Jansen, R., Raaijmakers, E., Van Weerd, E., Marijnen, C. A. M., MMB Research line 1, PMC Medisch specialisten, MS Radiotherapie, Cancer, Klinische Fysica RT, Circulatory Health, Arts Assistenten Cardiologie, Peters, F. P., Kerkhof, E. M., Rutten, H., Intven, M., Berbee, M., Theuws, J., Van Triest, B., Reerink, O., Rozema, T., Van Leeuwen, R. H. G., Tijssen, R. N. H., Van den Boogaard, J., Murrer, L., Van Haaren, P., Van der Heide, U. A., Stoian, G., Jansen, R., Raaijmakers, E., Van Weerd, E., and Marijnen, C. A. M.

Published
2018

40. Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy

Author

Wortman, BG, Creutzberg, CL, Putter, H, Jurgenliemk-Schulz, IM, Jobsen, JJ, Lutgens, L, van de Steen-Banasik, EM, Mens, Jan Willem, Slot, A, Kroese, MCS, van Triest, B, Nijman, HW, Stelloo, E, Bosse, T, Boer, SM, van Putten, WLJ, Smit, V, Nout, RA, Wortman, BG, Creutzberg, CL, Putter, H, Jurgenliemk-Schulz, IM, Jobsen, JJ, Lutgens, L, van de Steen-Banasik, EM, Mens, Jan Willem, Slot, A, Kroese, MCS, van Triest, B, Nijman, HW, Stelloo, E, Bosse, T, Boer, SM, van Putten, WLJ, Smit, V, and Nout, RA

Published
2018

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