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1. Development and Evaluation of an Educational E-Tool to Help Patients With Non-Hodgkin's Lymphoma Manage Their Personal Care Pathway

Author

Stienen, Jozette JC, Ottevanger, Petronella B, Wennekes, Lianne, Dekker, Helena M, van der Maazen, Richard WM, Mandigers, Caroline MPW, van Krieken, Johan HJM, Blijlevens, Nicole MA, and Hermens, Rosella PMG

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundAn overload of health-related information is available for patients on numerous websites, guidelines, and information leaflets. However, the increasing need for personalized health-related information is currently unmet. ObjectiveThis study evaluates an educational e-tool for patients with non-Hodgkin’s lymphoma (NHL) designed to meet patient needs with respect to personalized and complete health-related information provision. The e-tool aims to help NHL patients manage and understand their personal care pathway, by providing them with insight into their own care pathway, the possibility to keep a diary, and structured health-related information. MethodsTogether with a multidisciplinary NHL expert panel, we developed an e-tool consisting of two sections: (1) a personal section for patients’ own care pathway and their experiences, and (2) an informative section including information on NHL. We developed an ideal NHL care pathway based on the available (inter)national guidelines. The ideal care pathway, including date of first consultation, diagnosis, and therapy start, was used to set up the personal care pathway. The informative section was developed in collaboration with the patient association, Hematon. Regarding participants, 14 patients and 6 laymen were asked to evaluate the e-tool. The 24-item questionnaire used discussed issues concerning layout (6 questions), user convenience (3 questions), menu clarity (3 questions), information clarity (5 questions), and general impression (7 questions). In addition, the panel members were asked to give their feedback by email. ResultsA comprehensive overview of diagnostics, treatments, and aftercare can be established by patients completing the questions from the personal section. The informative section consisted of NHL information regarding NHL in general, diagnostics, therapy, aftercare, and waiting times. Regarding participants, 6 patients and 6 laymen completed the questionnaire. Overall, the feedback was positive, with at least 75% satisfaction on each feedback item. Important strengths mentioned were the use of a low health-literacy level, the opportunity to document the personal care pathway and experiences, and the clear overview of the information provided. The added value of the e-tool in general was pointed out as very useful for preparing the consultation with one’s doctor and for providing all information on one website, including the opportunity for a personalized care pathway and diary. The majority of the revisions concerned wording and clarity. In addition, more explicit information on immunotherapy, experimental therapy, and psychosocial support was added. ConclusionsWe have developed a personal care management e-tool for NHL patients. This tool contains a unique way to help patients manage their personal care pathway and give them insight into their NHL by providing health-related information and a personal diary. This evaluation showed that our e-tool meets patients’ needs concerning personalized health-related information, which might serve as a good example for other oncologic diseases. Future research should focus on the possible impact of the e-tool on doctor-patient communication during consultations.

Published
2015
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2. Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Barretina-Ginesta, Pilar, Bennett, Katherine, Berek, Jonathan, Berger, Regina, Bjørge, Line, Boere, Ingrid, Brennan, Donal, Bruchim, Ilan, Chang, Ting-Chang, Chavez Blanco, Adriana, Chen, Xiaojun, Colombo, Nicoletta, Crosbie, Emma, Denys, Hannelore, Duska, Linda, Fruehauf, Filip, Gomez Garcia, Eva Maria, van Gorp, Toon, Grimm, Christoph, Guitmann, Gustavo, Han, Kathy, Hanker, Lars, Harano, Kenichi, Hasegawa, Kosei, Herrington, C Simon, Ip, Philip, Joly, Florence, Khaw, Pearly, Kohn, Elise, Kristeleit, Rebecca, Kroep, Judith, Leary, Alexandra, Lee, Jung-Yun, Lheureux, Stephanie, Liu, Jihong, Mackay, Helen, Mahner, Sven, Mariani, Andrea, McAlpine, Jessica, Mikami, Yoshiki, Mirza, Mansoor Raza, Mukhopadhyay, Asima, Nagao, Shoji, Ng, Joseph, Nogueira-Rodrigues, Angelica, Novák, Zoltán, O'Donnell, Jennifer, Osborne, Sherill, Perez-Fidalgo, J. Alejandro, Romeo Marin, Margarita, Roy Chowdhury, Rahul, Sadozye, Azmat, Safra, Tamar, Scott, Claire, Sehouli, Jalid, Slomovitz, Brian, Tan, David, Taylor, Alexandra, Valabrega, Giorgio, Veneziani, Ana, Verhoeven, Karen, Vetter, Marcus, Wampfler, Julian, Westin, Shannon, Wimberger, Pauline, Zola, Paolo, Creutzberg, Carien L, Kim, Jae-Weon, Eminowicz, Gemma, Allanson, Emma, Eberst, Lauriane, Kim, Se Ik, Nout, Remi A, Park, Jeong-Yeol, Lorusso, Domenica, Mileshkin, Linda, Ottevanger, Petronella B, Brand, Alison, Mezzanzanica, Delia, Oza, Amit, Gebski, Val, Pothuri, Bhavana, Batley, Tania, Gordon, Carol, Mitra, Tina, White, Helen, Howitt, Brooke, Matias-Guiu, Xavier, Ray-Coquard, Isabelle, Gaffney, David, Small, William, Jr, Miller, Austin, Concin, Nicole, Powell, Matthew A, Stuart, Gavin, and Bookman, Michael A

Published
2024
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3. Phenotype-guided targeted therapy based on functional signal transduction pathway activity in recurrent ovarian cancer patients: The STAPOVER study protocol

Author

van der Ploeg, Phyllis, Hendrikse, Cynthia SE., Thijs, Anna MJ., Westgeest, Hans M., Smedts, Huberdina PM., Vos, M Caroline, Jalving, Mathilde, Lok, Christianne AR., Boere, Ingrid A., van Ham, Maaike APC., Ottevanger, Petronella B., Westermann, Anneke M., Mom, Constantijne H., Lalisang, Roy I., Lambrechts, Sandrina, Bekkers, Ruud LM., and Piek, Jurgen MJ.

Published
2024
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7. Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study

Author

Hensley, Martee L, Enserro, Danielle, Hatcher, Helen, Ottevanger, Petronella B, Krarup-Hansen, Anders, Blay, Jean-Yves, Fisher, Cyril, Moxley, Katherine M, Lele, Shashikant B, Lea, Jayanthi S, Tewari, Krishnansu S, Thaker, Premal H, Zivanovic, Oliver, O'Malley, David M, Robison, Katina, and Miller, David S

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe conducted a randomized phase III trial to determine whether adjuvant chemotherapy improves survival in women with uterine leiomyosarcoma.MethodsWomen with uterus-confined, high-grade leiomyosarcoma who were confirmed disease free by imaging were randomly assigned to four cycles of gemcitabine plus docetaxel, followed by four cycles of doxorubicin, or to observation. All were followed for evidence of recurrence. The primary end point was overall survival (OS).ResultsWith international collaboration, 38 of the targeted accrual of 216 patients were enrolled, after which the study was closed by the National Cancer Institute for accrual futility. Twenty patients were assigned to chemotherapy, 18 to observation. Among the 17 patients treated with at least one cycle of chemotherapy, grade 3 or 4 toxicities were observed in 47%; among the 18 patients assigned to observation, one had grade 3 hypertension. There were six deaths (chemotherapy, n = 5; observation, n = 1), all due to disease. The restricted mean survival time for OS was estimated as 34.3 months (95% CI, 25.3 to 43.3 months) in the chemotherapy arm and as 46.4 months (95% CI, 43.6 to 49.1 months) in the observation arm. There were eight recurrences in each arm. The restricted mean survival time for recurrence-free survival was estimated as 18.1 (95% CI, 14.2 to 22.0) months in the chemotherapy arm and as 14.6 months (95% CI, 10.3 to 19.0 months) in the observation arm. Neither survival outcome comparison was considered statistically robust, due to the small sample size.ConclusionDespite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma, this study was closed for accrual futility. Although the sample size precludes robust statistical comparison, observed OS and recurrence-free survival data do not show superior outcomes with adjuvant chemotherapy.

Published
2018

12. Phenotype-guided targeted therapy based on functional signal transduction pathway activity in recurrent ovarian cancer patients:The STAPOVER study protocol

Author

van der Ploeg, Phyllis, Hendrikse, Cynthia SE, Thijs, Anna MJ, Westgeest, Hans M., Smedts, Huberdina PM, Vos, M. Caroline, Jalving, Mathilde, Lok, Christianne AR, Boere, Ingrid A., van Ham, Maaike APC, Ottevanger, Petronella B., Westermann, Anneke M., Mom, Constantijne H., Lalisang, Roy I., Lambrechts, Sandrina, Bekkers, Ruud LM, Piek, Jurgen MJ, van der Ploeg, Phyllis, Hendrikse, Cynthia SE, Thijs, Anna MJ, Westgeest, Hans M., Smedts, Huberdina PM, Vos, M. Caroline, Jalving, Mathilde, Lok, Christianne AR, Boere, Ingrid A., van Ham, Maaike APC, Ottevanger, Petronella B., Westermann, Anneke M., Mom, Constantijne H., Lalisang, Roy I., Lambrechts, Sandrina, Bekkers, Ruud LM, and Piek, Jurgen MJ

Abstract

Objective: Ovarian cancer is the fifth cause of cancer-related death among women. The benefit of targeted therapy for ovarian cancer patients is limited even if treatment is stratified by molecular signature. There remains a high unmet need for alternative diagnostics that better predict targeted therapy, as current diagnostics are generally inaccurate predictors. Quantitative assessment of functional signal transduction pathway (STP) activity from mRNA measurements of target genes is an alternative approach. Therefore, we aim to identify aberrantly activated STPs in tumour tissue of patients with recurrent ovarian cancer and start phenotype-guided targeted therapy to improve survival without compromising quality of life. Study design: Patients with recurrent ovarian cancer and either 1) have platinum-resistant disease, 2) refrain from standard therapy or 3) are asymptomatic and not yet eligible for standard therapy will be included in this multi-centre prospective cohort study with multiple stepwise executed treatment arms. Targeted therapy will be available for patients with aberrantly high functional activity of the oestrogen receptor, androgen receptor, phosphoinositide 3-kinase or Hedgehog STP. The primary endpoint of this study is the progression-free survival (PFS) ratio (PFS2/PFS1 ratio) according to RECIST 1.1 determined by the PFS on matched targeted therapy (PFS2) compared to PFS on prior therapy (PFS1). Secondary endpoints include among others best overall response, overall survival, side effects, health-related quality of life and cost-effectiveness. Conclusion: The results of this study will show the clinical applicability of STP activity in selecting recurrent ovarian cancer patients for effective therapies.

Published
2024

13. Potential Adverse Outcomes of Shared Decision Making about Palliative Cancer Treatment: A Secondary Analysis of a Randomized Trial

Author

MS Medische Oncologie, Brain, Cancer, van de Water, Loïs F, Bos-van den Hoek, Danique W, Kuijper, Steven C, van Laarhoven, Hanneke W M, Creemers, Geert-Jan, Dohmen, Serge E, Fiebrich, Helle-Brit, Ottevanger, Petronella B, Sommeijer, Dirkje W, de Vos, Filip Y F, Smets, Ellen M A, Henselmans, Inge, MS Medische Oncologie, Brain, Cancer, van de Water, Loïs F, Bos-van den Hoek, Danique W, Kuijper, Steven C, van Laarhoven, Hanneke W M, Creemers, Geert-Jan, Dohmen, Serge E, Fiebrich, Helle-Brit, Ottevanger, Petronella B, Sommeijer, Dirkje W, de Vos, Filip Y F, Smets, Ellen M A, and Henselmans, Inge

Published
2024

15. Potential Adverse Outcomes of Shared Decision Making about Palliative Cancer Treatment: A Secondary Analysis of a Randomized Trial

Author

van de Water, Loïs F., primary, Bos–van den Hoek, Danique W., additional, Kuijper, Steven C., additional, van Laarhoven, Hanneke W. M., additional, Creemers, Geert-Jan, additional, Dohmen, Serge E., additional, Fiebrich, Helle-Brit, additional, Ottevanger, Petronella B., additional, Sommeijer, Dirkje W., additional, de Vos, Filip Y. F., additional, Smets, Ellen M. A., additional, and Henselmans, Inge, additional

Published
2023
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16. Obstetric and maternal outcomes in patients diagnosed with Hodgkin lymphoma during pregnancy: a multicentre, retrospective, cohort study

Author

Maggen, Charlotte, Dierickx, Daan, Lugtenburg, Pieternella, Laenen, Annouschka, Cardonick, Elyce, Smakov, Roman G, Bellido, Mar, Cabrera-Garcia, Alvaro, Gziri, Mina Mhallem, Halaska, Michael J, Ottevanger, Petronella B, Van Calsteren, Kristel, O'Laughlin, Andie, Polushkina, Evgeniya, Van Dam, Laura, Avivi, Irit, Vandenberghe, Peter, Woei-A-Jin, F J Sherida H, and Amant, Frédéric

Published
2019
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18. 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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21. Potential Adverse Outcomes of Shared Decision Making about Palliative Cancer Treatment: A Secondary Analysis of a Randomized Trial.

Author

van de Water, Loïs F., Bos–van den Hoek, Danique W., Kuijper, Steven C., van Laarhoven, Hanneke W. M., Creemers, Geert-Jan, Dohmen, Serge E., Fiebrich, Helle-Brit, Ottevanger, Petronella B., Sommeijer, Dirkje W., de Vos, Filip Y. F., Smets, Ellen M. A., and Henselmans, Inge

Abstract

Background: While shared decision making (SDM) is advocated for ethical reasons and beneficial outcomes, SDM might also negatively affect patients with incurable cancer. The current study explored whether SDM, and an oncologist training in SDM, are associated with adverse outcomes (i.e., patient anxiety, tension, helplessness/hopelessness, decisional uncertainty, and reduced fighting spirit). Design: A secondary analysis of a randomized clinical trial investigating the effects of SDM interventions in the context of advanced cancer. The relations between observed SDM (OPTION12), specific SDM elements (4SDM), oncologist SDM training, and adverse outcomes were analyzed. We modeled adverse outcomes as a multivariate phenomenon, followed by univariate regressions if significant. Results: In total, 194 patients consulted by 31 oncologists were included. In a multivariate analysis, observed SDM and adverse outcomes were significantly related. More specifically, more observed SDM in the consultation was related to patients reporting more tension (P = 0.002) and more decisional uncertainty (P = 0.004) at 1 wk after the consultation. The SDM element "informing about the options" was especially found to be related to adverse outcomes, specifically to more helplessness/hopelessness (P = 0.002) and more tension (P = 0.016) at 1 wk after the consultation. Whether the patient consulted an oncologist who had received SDM training or not was not significantly related to adverse outcomes. No relations with long-term adverse outcomes were found. Conclusions: It is important for oncologists to realize that for some patients, SDM may temporarily be associated with negative emotions. Further research is needed to untangle which, when, and how adverse outcomes might occur and whether and how burden may be minimized for patients. Highlights: Observed shared decision making was related to more tension and uncertainty postconsultation in advanced cancer patients However, training oncologists in SDM did not affect adverse outcomes. Further research is needed to untangle which, when, and how adverse outcomes might occur and how burden may be minimized [ABSTRACT FROM AUTHOR]

Published
2024
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22. Pharmacokinetic boosting of olaparib:A randomised, cross-over study (PROACTIVE-study)

Author

Overbeek, Joanneke K., Guchelaar, Niels A.D., Mohmaed Ali, Ma Ida, Ottevanger, Petronella B., Bloemendal, Haiko J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Boere, Ingrid A., Hamberg, Paul, Huitema, Alwin D.R., Sonke, Gabe S., Opdam, Frans L., ter Heine, Rob, van Erp, Nielka P., Overbeek, Joanneke K., Guchelaar, Niels A.D., Mohmaed Ali, Ma Ida, Ottevanger, Petronella B., Bloemendal, Haiko J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Boere, Ingrid A., Hamberg, Paul, Huitema, Alwin D.R., Sonke, Gabe S., Opdam, Frans L., ter Heine, Rob, and van Erp, Nielka P.

Abstract

Background: Pharmacokinetic (PK) boosting is the intentional use of a drug-drug interaction to enhance systemic drug exposure. PK boosting of olaparib, a CYP3A-substrate, has the potential to reduce PK variability and financial burden. The aim of this study was to investigate equivalence of a boosted, reduced dose of olaparib compared to the non-boosted standard dose. Methods: This cross-over, multicentre trial compared olaparib 300 mg twice daily (BID) with olaparib 100 mg BID boosted with the strong CYP3A-inhibitor cobicistat 150 mg BID. Patients were randomised to the standard therapy followed by the boosted therapy, or vice versa. After seven days of each therapy, dense PK sampling was performed for noncompartmental PK analysis. Equivalence was defined as a 90% Confidence Interval (CI) of the geometric mean ratio (GMR) of the boosted versus standard therapy area under the plasma concentration-time curve (AUC0–12 h) within no-effect boundaries. These boundaries were set at 0.57–1.25, based on previous pharmacokinetic studies with olaparib capsules and tablets. Results: Of 15 included patients, 12 were eligible for PK analysis. The GMR of the AUC0–12 h was 1.45 (90% CI 1.27–1.65). No grade ≥3 adverse events were reported during the study. Conclusions: Boosting a 100 mg BID olaparib dose with cobicistat increases olaparib exposure 1.45-fold, compared to the standard dose of 300 mg BID. Equivalence of the boosted olaparib was thus not established. Boosting remains a promising strategy to reduce the olaparib dose as cobicistat increases olaparib exposure Adequate tolerability of the boosted therapy with higher exposure should be established.

Published
2023

23. Pharmacokinetic boosting of olaparib: A randomised, cross-over study (PROACTIVE-study)

Author

Medisch Oncologische Disciplines, Apotheek O&O&O, Cancer, Overbeek, Joanneke K., Guchelaar, Niels A.D., Mohmaed Ali, Ma Ida, Ottevanger, Petronella B., Bloemendal, Haiko J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Boere, Ingrid A., Hamberg, Paul, Huitema, Alwin D.R., Sonke, Gabe S., Opdam, Frans L., ter Heine, Rob, van Erp, Nielka P., Medisch Oncologische Disciplines, Apotheek O&O&O, Cancer, Overbeek, Joanneke K., Guchelaar, Niels A.D., Mohmaed Ali, Ma Ida, Ottevanger, Petronella B., Bloemendal, Haiko J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Boere, Ingrid A., Hamberg, Paul, Huitema, Alwin D.R., Sonke, Gabe S., Opdam, Frans L., ter Heine, Rob, and van Erp, Nielka P.

Published
2023

25. 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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28. Real‐life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study ( RESPONSE trial)

Author

Marth, Christian, primary, Abreu, Miguel Henriques, additional, Andersen, Klaus Kaae, additional, Aro, Karoliina M., additional, de Lurdes Batarda, Maria, additional, Boll, Dorry, additional, Ekmann‐Gade, Anne Weng, additional, Haltia, Ulla‐Maija, additional, Hansen, Jesper, additional, Haug, Ala Jabri, additional, Høgdall, Claus, additional, Korach, Jacob, additional, Lassus, Heini, additional, Lindemann, Kristina, additional, Van Nieuwenhuysen, Els, additional, Ottevanger, Petronella B., additional, Polterauer, Stephan, additional, and Schnack, Tine Henrichsen, additional

Published
2022
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30. Angiotensin II–Receptor Inhibition With Candesartan to Prevent Trastuzumab-Related Cardiotoxic Effects in Patients With Early Breast Cancer: A Randomized Clinical Trial

Author

Boekhout, Annelies H., Gietema, Jourik A., Milojkovic Kerklaan, Bojana, van Werkhoven, Erik D., Altena, Renske, Honkoop, Aafke, Los, Maartje, Smit, Willem M., Nieboer, Peter, Smorenburg, Carolien H., Mandigers, Caroline M. P. W., van der Wouw, Agnes J., Kessels, Lonneke, van der Velden, Annette W. G., Ottevanger, Petronella B., Smilde, Tineke, de Boer, Jaap, van Veldhuisen, Dirk J., Kema, Ido P., de Vries, Elisabeth G. E., and Schellens, Jan H. M.

Published
2016
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31. Distinct Genomic Profiles Are Associated with Treatment Response and Survival in Ovarian Cancer

Author

de Witte, Chris J., Kutzera, Joachim, van Hoeck, Arne, Nguyen, Luan, Boere, Ingrid A., Jalving, Mathilde, Ottevanger, Petronella B., van Schaik-Van de Mheen, Christa, Stevense, Marion, Kloosterman, Wigard P., Zweemer, Ronald P., Cuppen, Edwin, Witteveen, Petronella O., de Witte, Chris J., Kutzera, Joachim, van Hoeck, Arne, Nguyen, Luan, Boere, Ingrid A., Jalving, Mathilde, Ottevanger, Petronella B., van Schaik-Van de Mheen, Christa, Stevense, Marion, Kloosterman, Wigard P., Zweemer, Ronald P., Cuppen, Edwin, and Witteveen, Petronella O.

Abstract

The majority of patients with ovarian cancer ultimately develop recurrent chemotherapy-resistant disease. Treatment stratification is mainly based on histological subtype and stage, prior response to platinum-based chemotherapy, and time to recurrent disease. Here, we integrated clinical treatment, treatment response, and survival data with whole-genome sequencing profiles of 132 solid tumor biopsies of metastatic epithelial ovarian cancer to explore genome-informed stratification opportunities. Samples from primary and recurrent disease harbored comparable numbers of single nucleotide variants and structural variants. Mutational signatures represented platinum exposure, homologous recombination deficiency, and aging. Unsupervised hierarchical clustering based on genomic input data identified specific ovarian cancer subgroups, characterized by homologous recombination deficiency, genome stability, and duplications. The clusters exhibited distinct response rates and survival probabilities which could thus potentially be used for genome-informed therapy stratification for more personalized ovarian cancer treatment.

Published
2022

32. Real-life data on treatment and outcomes in advanced ovarian cancer:An observational, multinational cohort study (RESPONSE trial)

Author

Marth, Christian, Abreu, Miguel Henriques, Andersen, Klaus Kaae, Aro, Karoliina M., de Lurdes Batarda, Maria, Boll, Dorry, Ekmann-Gade, Anne Weng, Haltia, Ulla-Maija, Hansen, Jesper, Haug, Ala Jabri, Høgdall, Claus, Korach, Jacob, Lassus, Heini, Lindemann, Kristina, Van Nieuwenhuysen, Els, Ottevanger, Petronella B, Polterauer, Stephan, Schnack, Tine Henrichsen, Marth, Christian, Abreu, Miguel Henriques, Andersen, Klaus Kaae, Aro, Karoliina M., de Lurdes Batarda, Maria, Boll, Dorry, Ekmann-Gade, Anne Weng, Haltia, Ulla-Maija, Hansen, Jesper, Haug, Ala Jabri, Høgdall, Claus, Korach, Jacob, Lassus, Heini, Lindemann, Kristina, Van Nieuwenhuysen, Els, Ottevanger, Petronella B, Polterauer, Stephan, and Schnack, Tine Henrichsen

Abstract

Background: This study aimed to describe the treatment strategies and outcomes for women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer (OC). Methods: This observational study collected real-world medical record data from eight Western countries on the diagnostic workup, clinical outcomes, and treatment of adult women with newly diagnosed advanced (Stage III–IV) high-grade serous or endometrioid OC. Patients were selected backward in time from April 1, 2018 (the index date), with a target of 120 patients set per country, followed for ≥20 months. Results: Of the 1119 women included, 66.9% had Stage III disease, 11.7% had a deleterious BRCA mutation, and 26.6% received bevacizumab; 40.8% and 39.3% underwent primary debulking surgery (PDS) and interval debulking surgery (IDS), respectively. Of the patients who underwent PDS, 55.5% had no visible residual disease (VRD); 63.9% of the IDS patients had no VRD. According to physician-assessed responses (at the first assessment after diagnosis and treatment), 53.2% of the total population had a complete response and 25.7% had a partial response to first-line chemotherapy after surgery. After ≥20 months of follow-up, 32.9% of the patients were disease-free, 46.4% had progressive disease, and 20.6% had died. Bevacizumab use had a significant positive effect on overall survival (hazard ratio [HR], 0.62; 95% CI, 0.42–0.91; p =.01). A deleterious BRCA status had a significant positive effect on progression-free survival (HR, 0.60; 95% CI, 0.41–0.84; p <.01). Conclusions: Women with advanced high-grade serous or endometrioid OC have a poor prognosis. Bevacizumab use and a deleterious BRCA status were found to improve survival in this real-world population. Lay summary: Patients with advanced (Stage III or IV) ovarian cancer (OC) have a poor prognosis. The standard treatment options of surgery and chemotherapy extend life beyond diagnosis for 5 years or more in only approximately 45% of patient

Published
2022

33. Attitudes Toward Striving for Quality and Length of Life Among Patients With Advanced Cancer and a Poor Prognosis

Author

MS Medische Oncologie, Cancer, van der Velden, Naomi C A, van Laarhoven, Hanneke W M, Nieuwkerk, Pythia T, Kuijper, Steven C, Sommeijer, Dirkje W, Ottevanger, Petronella B, Fiebrich, Helle-Brit, Dohmen, Serge E, Creemers, Geert-Jan, de Vos, Filip Y F L, Smets, Ellen M A, Henselmans, Inge, MS Medische Oncologie, Cancer, van der Velden, Naomi C A, van Laarhoven, Hanneke W M, Nieuwkerk, Pythia T, Kuijper, Steven C, Sommeijer, Dirkje W, Ottevanger, Petronella B, Fiebrich, Helle-Brit, Dohmen, Serge E, Creemers, Geert-Jan, de Vos, Filip Y F L, Smets, Ellen M A, and Henselmans, Inge

Published
2022

34. Distinct Genomic Profiles Are Associated with Treatment Response and Survival in Ovarian Cancer

Author

CMM Groep Cuppen, CMM Groep De Ridder, Cancer, Child Health, MS Gynaecologische Oncologie, MS Medische Oncologie, de Witte, Chris J, Kutzera, Joachim, van Hoeck, Arne, Nguyen, Luan, Boere, Ingrid A, Jalving, Mathilde, Ottevanger, Petronella B, van Schaik-van de Mheen, Christa, Stevense, Marion, Kloosterman, Wigard P, Zweemer, Ronald P, Cuppen, Edwin, Witteveen, Petronella O, CMM Groep Cuppen, CMM Groep De Ridder, Cancer, Child Health, MS Gynaecologische Oncologie, MS Medische Oncologie, de Witte, Chris J, Kutzera, Joachim, van Hoeck, Arne, Nguyen, Luan, Boere, Ingrid A, Jalving, Mathilde, Ottevanger, Petronella B, van Schaik-van de Mheen, Christa, Stevense, Marion, Kloosterman, Wigard P, Zweemer, Ronald P, Cuppen, Edwin, and Witteveen, Petronella O

Published
2022

36. Distinct Genomic Profiles Are Associated with Treatment Response and Survival in Ovarian Cancer

Author

de Witte, Chris J., primary, Kutzera, Joachim, additional, van Hoeck, Arne, additional, Nguyen, Luan, additional, Boere, Ingrid A., additional, Jalving, Mathilde, additional, Ottevanger, Petronella B., additional, van Schaik-van de Mheen, Christa, additional, Stevense, Marion, additional, Kloosterman, Wigard P., additional, Zweemer, Ronald P., additional, Cuppen, Edwin, additional, and Witteveen, Petronella O., additional

Published
2022
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38. Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

Author

Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klaus, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Tomas, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, Bois, Du, Andreas, Ferrandina, Ferrandina, Maria Gabriella, AGO Study Group-led GCIG/ENGOT Intergroup Consortium, Ray-Coquard, I, Cibula, D, Mirza, M, Reuss, A, Ricci, C, Colombo, N, Koch, H, Goffin, F, González-Martin, A, Ottevanger, P, Baumann, K, Bjørge, L, Lesoin, A, Burges, A, Rosenberg, P, Gropp-Meier, M, Harrela, M, Harter, P, Frenel, J, Minarik, T, Pisano, C, Hasenburg, A, Merger, M, and du Bois, A

Subjects
Cancer Research, Indoles, medicine.medical_treatment, Gastroenterology, Carboplatin, Placebos, chemistry.chemical_compound, tyrosine kinase inhibitor, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, nintedanib, Clinical endpoint, anti-angiogenic, Aged, 80 and over, Ovarian Neoplasms, Hazard ratio, Area under the curve, Cytoreduction Surgical Procedures, Middle Aged, Progression-Free Survival, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], ovarian cancer, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Nintedanib, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Placebo, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Chemotherapy, business.industry, Ovary, antiangiogenic, medicine.disease, Settore MED/40 - GINECOLOGIA E OSTETRICIA, chemistry, Ovarian cancer, business, Follow-Up Studies
Abstract

Contains fulltext : 218867.pdf (Publisher’s version ) (Closed access) AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB-IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m(2) ) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2-21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83-1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

Published
2020

39. Erratum to: Effect of a Skills Training for Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment: A Randomized Clinical Trial (The Oncologist, (2020), 25, 3, 10.1634/theoncologist.2019-0453)

Author

Henselmans, Inge, van Laarhoven, Hanneke W. M., van Maarschalkerweerd, Pomme, de Haes, Hanneke C. J. M., Dijkgraaf, Marcel G. W., Sommeijer, Dirkje W., Ottevanger, Petronella B., Fiebrich, Helle-Brit, Dohmen, Serge, Creemers, Geert-Jan, de Vos, Filip Y. F. L., Smets, Ellen M. A., Medical Psychology, APH - Personalized Medicine, APH - Quality of Care, CCA - Cancer Treatment and Quality of Life, Oncology, Amsterdam Gastroenterology Endocrinology Metabolism, Epidemiology and Data Science, and APH - Methodology

Abstract

The Oncologist 2020;25:e578–e588; first published on November 26, 2019; doi: 10.1634/theoncologist.2019-0453 The authors regret that there is an error in the results reflecting the effect of the interventions on patient-reported decisional conflict post-consultation. We used the Dutch version of the Decisional Conflict Scale (DCS) as translated and validated by Koedoot and colleagues in 2001 [1]. This Dutch version was based on the DCS published in 1995 [2]; however, this version appears different from the version presented in the current manual of the DCS, first published in 1993 but updated in 2010 [3]. The item content is comparable, yet the version we used contains five items that need to be reverse coded. We calculated sum scores in accordance with the current manual and, hence, did not reverse code any of the items. This resulted in incorrect sum scores. The corrected results are presented in Tables 2 and 3, shown here and corresponding to the numbered tables in the original article. On page e584 of the original article, the correct figures should be described as follows: Condition did not affect patients’ decisional conflict (F(3,145) = 1.99, p =.12). 2 Table Raw means with standard deviations of decisional conflict for total sample and each condition (Table presented.) a Patients were instructed to skip the items of the Decisional Conflict Scale if, in their view, a decision was not or not yet made (n = 23 patients skipped all or > 2 items of the scale). 3 Table Bootstrapped parameter estimates and 95% CIs of the fixed effects in the Mixed Linear Model (Table presented.) a Difference in estimated marginal means (‘no training, no aid’ concerns the comparison group) divided by the pooled standard deviation calculated from the standard errors √(((se1 * √n1)2 * (n1-1) + (se2 * √n2)2 * (n2-1)/(n1+n2-2)). The corrected results did not affect any of the conclusions of our study. Nevertheless, the authors would like to apologize for any inconvenience caused. References 1. Koedoot N, Molenaar S, Oosterveld P et al. The decisional conflict scale: Further validation in two samples of Dutch oncology patients. Patient Educ Couns 2001;45:187-193. 2. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995;15:25-30. 3. O'Connor AM. User manual Decisional Conflict Scale 2010. Available from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_decisional_conflict.pdf.

Published
2021

42. Association of Chemotherapy Timing in Pregnancy With Congenital Malformation

Author

van Gerwen, Mathilde, primary, Maggen, Charlotte, additional, Cardonick, Elyce, additional, Verwaaijen, Emma J., additional, van den Heuvel-Eibrink, Marry, additional, Shmakov, Roman G., additional, Boere, Ingrid, additional, Gziri, Mina M., additional, Ottevanger, Petronella B., additional, Lok, Christianne A. R., additional, Halaska, Michael, additional, Shao, Long Ting, additional, Struys, Ilana, additional, van Dijk-Lokkart, Elisabeth M., additional, Van Calsteren, Kristel, additional, Fruscio, Robert, additional, Zola, Paolo, additional, Scarfone, Giovanna, additional, and Amant, Frédéric, additional

Published
2021
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43. Early prediction of post-molar gestational trophoblastic neoplasia and resistance to methotrexate, based on a single serum human chorionic gonadotropin measurement

Author

Hoeijmakers, Yvonne M., primary, Eysbouts, Yalck K., additional, Massuger, Leon F.A.G., additional, Dandis, Rana, additional, Inthout, Joanna, additional, van Trommel, N.E., additional, Ottevanger, Petronella B., additional, Thomas, Chris M.G., additional, and Sweep, Fred C.G.J., additional

Published
2021
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45. Assessing the safety, tolerability and efficacy of PLGA-based immunomodulatory nanoparticles in patients with advanced NY-ESO-1-positive cancers: a first-in-human phase I open-label dose-escalation study protocol

Author

Creemers, Jeroen H A, primary, Pawlitzky, Inka, additional, Grosios, Konstantina, additional, Gileadi, Uzi, additional, Middleton, Mark R, additional, Gerritsen, Winald R, additional, Mehra, Niven, additional, Rivoltini, Licia, additional, Walters, Ian, additional, Figdor, Carl G, additional, Ottevanger, Petronella B, additional, and de Vries, I Jolanda M, additional

Published
2021
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48. Effect of a Skills Training for Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment: A Randomized Clinical Trial

Author

Henselmans, Inge, primary, Laarhoven, Hanneke W.M., additional, Maarschalkerweerd, Pomme, additional, Haes, Hanneke C.J.M., additional, Dijkgraaf, Marcel G.W., additional, Sommeijer, Dirkje W., additional, Ottevanger, Petronella B., additional, Fiebrich, Helle-Brit, additional, Dohmen, Serge, additional, Creemers, Geert-Jan, additional, Vos, Filip Y.F.L., additional, and Smets, Ellen M.A., additional

Published
2021
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