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1. Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial

Author

Ngoc H. Tan, Melvin Lafeber, Roos S. G. Sablerolles, Isabelle Veerman Roders, Anna van de Hoef, Karenin van Grafhorst, Leo G. Visser, Douwe F. Postma, Abraham Goorhuis, Wim J. R. Rietdijk, and P. Hugo M. van der Kuy

Subjects
Group, eConsent, Informed consent, Medicine (General), R5-920
Abstract

Abstract Background Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. Methods SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18–65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively. Results Participants found that group eConsent was an efficient method that it allowed them to hear each other’s questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies. Conclusion Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement. Trial registration ClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

Published
2024
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2. Original COVID-19 priming regimen impacts the immunogenicity of bivalent BA.1 and BA.5 boosters

Author

Luca M. Zaeck, Ngoc H. Tan, Wim J. R. Rietdijk, Daryl Geers, Roos S. G. Sablerolles, Susanne Bogers, Laura L. A. van Dijk, Lennert Gommers, Leanne P. M. van Leeuwen, Sharona Rugebregt, Abraham Goorhuis, Douwe F. Postma, Leo G. Visser, Virgil A. S. H. Dalm, Melvin Lafeber, Neeltje A. Kootstra, Anke L. W. Huckriede, Bart L. Haagmans, Debbie van Baarle, Marion P. G. Koopmans, SWITCH-ON Research Group, P. Hugo M. van der Kuy, Corine H. GeurtsvanKessel, and Rory D. de Vries

Subjects
Science
Abstract

Abstract Waning antibody responses after COVID-19 vaccination combined with the emergence of the SARS-CoV-2 Omicron lineage led to reduced vaccine effectiveness. As a countermeasure, bivalent mRNA-based booster vaccines encoding the ancestral spike protein in combination with that of Omicron BA.1 or BA.5 were introduced. Since then, different BA.2-descendent lineages have become dominant, such as XBB.1.5, JN.1, or EG.5.1. Here, we report post-hoc analyses of data from the SWITCH-ON study, assessing how different COVID-19 priming regimens affect the immunogenicity of bivalent booster vaccinations and breakthrough infections (NCT05471440). BA.1 and BA.5 bivalent vaccines boosted neutralizing antibodies and T-cells up to 3 months after boost; however, cross-neutralization of XBB.1.5 was poor. Interestingly, different combinations of prime-boost regimens induced divergent responses: participants primed with Ad26.COV2.S developed lower binding antibody levels after bivalent boost while neutralization and T-cell responses were similar to mRNA-based primed participants. In contrast, the breadth of neutralization was higher in mRNA-primed and bivalent BA.5 boosted participants. Combined, our data further support the current use of monovalent vaccines based on circulating strains when vaccinating risk groups, as recently recommended by the WHO. We emphasize the importance of the continuous assessment of immune responses targeting circulating variants to guide future COVID-19 vaccination policies.

Published
2024
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3. The short- and longer-term effects of brief behavioral parent training versus care as usual in children with behavioral difficulties: study protocol for a randomized controlled trial

Author

Roos S. van Doornik, Saskia van der Oord, Joli Luijckx, Annabeth P. Groenman, Patty Leijten, Marjolein Luman, Pieter J. Hoekstra, Barbara J. van den Hoofdakker, and Tycho J. Dekkers

Subjects
Children, Behavioral difficulties, Brief, Behavioral parent training, Individually tailored, Psychosocial intervention, Psychiatry, RC435-571
Abstract

Abstract Background The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. This protocol paper describes a two-arm, multi-center, randomized controlled trial on the short- and longer-term effectiveness and cost-effectiveness of a brief, individually tailored behavioral parent training program for children with behavioral difficulties. Methods Parents of children aged 2–12 years referred to a child mental healthcare center are randomized to (i) three sessions of behavioral parent training with optional booster sessions or (ii) care as usual. To evaluate effectiveness, our primary outcome is the mean severity of five daily ratings by parents of four selected behavioral difficulties. Secondary outcomes include measures of parent and child behavior, well-being, and parent–child interaction. We explore whether child and parent characteristics moderate intervention effects. To evaluate cost-effectiveness, the use and costs of mental healthcare and utilities are measured. Finally, parents’ and therapists’ satisfaction with the brief program are explored. Measurements take place at baseline (T0), one week after the brief parent training, or eight weeks after baseline (in case of care as usual) (T1), and six months (T2) and twelve months (T3) after T1. Discussion The results of this trial could have meaningful societal implications for children with behavioral difficulties and their parents. If we find the brief behavioral parent training to be more (cost-)effective than care as usual, it could be used in clinical practice to make parent training more accessible. Trial registration The trial is prospectively registered at ClinicalTrials.gov (NCT05591820) on October 24th, 2022 and updated throughout the trial.

Published
2024
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4. Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol

Author

Ngoc H. Tan, Roos S. G. Sablerolles, Wim J. R. Rietdijk, Abraham Goorhuis, Douwe F. Postma, Leo G. Visser, Susanne Bogers, Daryl Geers, Luca M. Zaeck, Marion P. G. Koopmans, Virgil A. S. H. Dalm, Neeltje A. Kootstra, Anke L. W. Huckriede, Debbie van Baarle, Melvin Lafeber, Corine H. GeurtsvanKessel, Rory D. de Vries, and Paul-Hugo Marie van der Kuy

Subjects
COVID-19, immune memory, mRNA vaccine, adenovirus-based vaccine, immune response, Immunologic diseases. Allergy, RC581-607
Abstract

Vaccination against coronavirus disease 2019 (COVID-19) has contributed greatly to providing protection against severe disease, thereby reducing hospital admissions and deaths. Several studies have reported reduction in vaccine effectiveness over time against the Omicron sub-lineages. However, the willingness to receive regular booster doses in the general population is declining. To determine the need for repeated booster vaccinations in healthy individuals and to aid policymakers in future public health interventions for COVID-19, we aim to gain insight into the immunogenicity of the additional bivalent booster vaccination in a representative sample of the healthy Dutch population. The SWITCH ON study was initiated to investigate three main topics: i) immunogenicity of bivalent vaccines after priming with adenovirus- or mRNA-based vaccines, ii) immunological recall responses and reactivity with relevant variants after booster vaccination, and iii) the necessity of booster vaccinations for the healthy population in the future.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05471440.

Published
2022
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5. Heterologous Ad26.COV2.S Prime and mRNA-Based Boost COVID-19 Vaccination Regimens: The SWITCH Trial Protocol

Author

Roos S. G. Sablerolles, Abraham Goorhuis, Corine H. GeurtsvanKessel, Rory D. de Vries, Anke L. W. Huckriede, Marion P. G. Koopmans, Melvin Lafeber, Douwe F. Postma, Debbie van Baarle, Leo G. Visser, Virgil A. S. H. Dalm, Neeltje A. Kootstra, Wim J. R. Rietdijk, and P. Hugo M. van der Kuy

Subjects
SARS-CoV-2, COVID-19, Homologous vaccination regimen, Heterologous vaccine regimen, randomized clinical trial, Ad26.Cov2.S, Immunologic diseases. Allergy, RC581-607
Published
2021
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6. Association between Clinical Frailty Scale score and hospital mortality in adult patients with COVID-19 (COMET): an international, multicentre, retrospective, observational cohort study

Author

Roos S G Sablerolles, MD, Melvin Lafeber, MD, Janneke A L van Kempen, MD, Bob P A van de Loo, Msc, Eric Boersma, ProfPhD, Wim J R Rietdijk, PhD, Harmke A Polinder-Bos, MD, Simon P Mooijaart, MD, Hugo van der Kuy, ProfPharmD, Jorie Versmissen, MD, Miriam C Faes, MD, LA Agnoletto, J Aleman, S Andreassi, LM Andrews, L Ashfield, H Bell, AKB Bengaard, SB Berlinghini, KB Bini, ZB Bisoffi, KB Blum, E Boemaars, GB Boni, TM Bosch, BE Bosma, F Boutkourt, C Bufarini, A Bulsink, RC Cabuk, GC Callens, MC Candela, MC Canonici, EC Capone, IC Carmo, FC Caruso, PC Chessa, GC Cohet, I Cornelissen-Wesseling, KML Crommentuijn, FM de Stoppelaar, HAJM de Wit, DS Deben, LJJ Derijks, MDC Di Carlo, J Diepstraten, B Dilek, DMK Duchek-Mann, MM Ebbens, LJ Ellerbroek, M Ezinga, MF Falcao, FF Falcao, LF Fantini, HF Farinha, PMG Filius, NJ Fitzhugh, G Fleming, TF Forsthuber, GG Gambarelli, MG Gambera, CGY García Yubero, Z Getrouw, CN Ghazarian, N Goodfellow, MQG Gorgas, RG Grinta, K Guda, DH Haider, J Hanley, KH Heitzeneder, WL Hemminga, LC Hendriksen, DL Hilarius, FEF Hogenhuis, IC Hoogendoorn-de Graaf, MBH Houlind, MAH Huebler, KPGM Hurkens, PKC Janssen, E Jong, MHW Kappers, KFM Keijzers, MK Kemogni, EM Kemper, RA Kranenburg, LL Krens, JL G Le Grand, J Liang, S Lim, NL Lindner, EL Loche, AL Lubich, B Maat, CM Maesano, AM Maiworm, M Maragna, FM Marchesini, IM Martignoni, G M Martini, CM Masini, R Mc Menamin, DM Mendes, M Miarons, R Moorlag, MR Müller, FN Nagele, KN Nemec, GO Oka, AG Otten-Helmers, SP Pagliarino, FP Pappalardo, M Patel, PM Peverini, FP Pieraccini, EMP Platania, NPK Pons-Kerjean, LPH Portillo Horcajada, GR Rametta, JR Rijo, EE Roelofsen, E Roobol-Meuwese, LR Rossi, SAH Russel, Z Safipour, FS Salaffi, L Saleh, AMS Schimizzi, JMGA Schols, MS Schwap, MG Scott, EAM Slijfer, EMA Slob, JS Soares, MS Solano, F Sombogaard, GS Stemer, MT Tardella, PGJ ter Horst, RT Tessari, J Tournoy, RB van den Berg, L Van der Linden, PD van der Linden, SC van Dijk, RW Van Etten, IMM van Haelst, M van Heuckelum, HJM van Kan, C van Nieuwkoop, HAW van Onzenoort, P van Wijngaarden, JDJ Verdonk, Fv Verri, JAMC Verstijnen, MV Veyrier, EV Viegas, LE Visser, A Vos, MAM Vromen, PC Wierenga, DR Wong, CZ Zenico, and TZ Zuppini

Subjects
Geriatrics, RC952-954.6, Medicine
Abstract

Summary: Background: During the COVID-19 pandemic, the scarcity of resources has necessitated triage of critical care for patients with the disease. In patients aged 65 years and older, triage decisions are regularly based on degree of frailty measured by the Clinical Frailty Scale (CFS). However, the CFS could also be useful in patients younger than 65 years. We aimed to examine the association between CFS score and hospital mortality and between CFS score and admission to intensive care in adult patients of all ages with COVID-19 across Europe. Methods: This analysis was part of the COVID Medication (COMET) study, an international, multicentre, retrospective observational cohort study in 63 hospitals in 11 countries in Europe. Eligible patients were aged 18 years and older, had been admitted to hospital, and either tested positive by PCR for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or were judged to have a high clinical likelihood of having SARS-CoV-2 infection by the local COVID-19 expert team. CFS was used to assess level of frailty: fit (CFS1–3), mildly frail (CFS4–5), or frail (CFS6–9). The primary outcome was hospital mortality. The secondary outcome was admission to intensive care. Data were analysed using a multivariable binary logistic regression model adjusted for covariates (age, sex, number of drugs prescribed, and type of drug class as a proxy for comorbidities). Findings: Between March 30 and July 15, 2020, 2434 patients (median age 68 years [IQR 55–77]; 1480 [61%] men, 954 [30%] women) had CFS scores available and were included in the analyses. In the total sample and in patients aged 65 years and older, frail patients and mildly frail patients had a significantly higher risk of hospital mortality than fit patients (total sample: CFS6–9 vs CFS1–3 odds ratio [OR] 2·71 [95% CI 2·04–3·60], p

Published
2021
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8. Original COVID-19 priming regimen impacts the immunogenicity of bivalent BA.1 and BA.5 boosters

Author

Zaeck, Luca M., Tan, Ngoc H., Rietdijk, Wim J. R., Geers, Daryl, Sablerolles, Roos S. G., Bogers, Susanne, van Dijk, Laura L. A., Gommers, Lennert, van Leeuwen, Leanne P. M., Rugebregt, Sharona, Goorhuis, Abraham, Postma, Douwe F., Visser, Leo G., Dalm, Virgil A. S. H., Lafeber, Melvin, Kootstra, Neeltje A., Huckriede, Anke L. W., Haagmans, Bart L., van Baarle, Debbie, Koopmans, Marion P. G., van der Kuy, P. Hugo M., GeurtsvanKessel, Corine H., and de Vries, Rory D.

Published
2024
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10. Suture versus open mesh repair for small umbilical hernia: Results of a propensity-matched cohort study

Author

Antor, M., Beck, M., Barrat, C., Berney, C., Binot, D., Bousquet, J., Blazquez, D., Bonan, A., Cas, O., Champault-Fezais, A., Chastan, P., Chollet, J.-M., Cossa, J.-P., Dabrowski, A., Delaunay, T., Démaret, S., Drissi, F., Demian, H., Dubuisson, V., Dugue, T., Fromont, G., Gillion, J.-F., Jacquin, C., Jurczak, F., Khalil, H., Launay-Savary, M., Lepère, M., Lépront, D., Longeville, J.H., Le Toux, N., Loriau, J., Magne, E., Ngo, P., Oberlin, O., Passot, G., Pavis d’Escurac, X., Putinier, J.B., Renard, Y., Romain, B., Soler, M., Roos, S., Thillois, J.-M., Tiry, P., Vu, P., Verhaeghe, R., Warlaumont, M., Zaranis, C., Frey, Samuel, Beauvais, Adrien, Soler, Marc, Beck, Mathieu, Dugué, Timothée, Pavis d’Escurac, Xavier, Dabrowski, André, Jurczak, Florent, and Gillion, Jean-François

Published
2023
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11. Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON): results from the direct boost group of an open-label, multicentre, randomised controlled trial

Author

Tan, Ngoc H, Geers, Daryl, Sablerolles, Roos S G, Rietdijk, Wim J R, Goorhuis, Abraham, Postma, Douwe F, Visser, Leo G, Bogers, Susanne, van Dijk, Laura L A, Gommers, Lennert, van Leeuwen, Leanne P M, Boerma, Annemarie, Nijhof, Sander H, van Dort, Karel A, Koopmans, Marion P G, Dalm, Virgil A S H, Lafeber, Melvin, Kootstra, Neeltje A, Huckriede, Anke L W, van Baarle, Debbie, Zaeck, Luca M, GeurtsvanKessel, Corine H, de Vries, Rory D, and van der Kuy, P Hugo M

Published
2023
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14. Age Moderates the Effect of Obesity on Mortality Risk in Critically Ill Patients With COVID-19: A Nationwide Observational Cohort Study*

Author

den Uil, Corstiaan A., Termorshuizen, Fabian, Rietdijk, Wim J. R., Sablerolles, Roos S. G., van der Kuy, Hugo P. M., Haas, Lenneke E. M., van der Voort, Peter H. J., de Lange, Dylan W., Pickkers, Peter, de Keizer, Nicolette F., Arbous, M. S., Barnas, M. G. W., Boer, D. P., Bosman, R. J., Brunnekreef, G. B., de Bruin, M. Th., de Graaff, M. J., de Jong, R. M., de Meijer, A. R., de Ruijter, W., de Waal, R., Dijkhuizen, A., Dongelmans, D. A., Dormans, T. P. J., Draisma, A., Drogt, I., Eikemans, B. J. W., Elbers, P. W. G., Epker, J. L., Erkamp, M. L., Festen-Spanjer, B., Frenzel, T., Georgieva, L., Gritters, N. C., Hené, I. Z., Hoeksema, M., Holtkamp, J. W. M., Hoogendoorn, M. E., Jacobs, C. J. G. M., Janssen, I. T. A., Kieft, H., Koetsier, M. P., Koning, T. J. J., Kreeftenberg, H., Kusadasi, N., Lens, J. A., Lutisan, J. G., Mehagnoul-Schipper, D. J., Moolenaar, D., Nooteboom, F., Postma, N., Pruijsten, R. V., Ramnarain, D., Reidinga, A. C., Rengers, E., Rijkeboer, A. A., Rijpstra, T., Rozendaal, F. W., Schnabel, R. M., Silderhuis, V. M., Spijkstra, J. J., Spronk, P. E., te Velde, L. F., Urlings-Strop, L. C., van den Berg, A. E., van den Berg, R., van der Horst, I. C. C., van Driel, E. M., van Gulik, L., van Iersel, F. M., van Lieshout, M., van Oers, J. A. H., van Slobbe-Bijlsma, E. R., van Tellingen, M., Vandeputte, J., Verbiest, D. P., Versluis, D. J., Verweij, E., Vrolijk-de Mos, M., and Wesselink, R. M. J.

Published
2023
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15. Adjuvant treatment for melanoma in clinical practice – Trial versus reality

Author

de Meza, Melissa M., Ismail, Rawa K., Rauwerdink, Daan, van Not, Olivier J., van Breeschoten, Jesper, Blokx, Willeke A.M., de Boer, Anthonius, van Dartel, Maaike, Hilarius, Doranne L., Ellebaek, Eva, Bonenkamp, Han J., Blank, Christian U., Aarts, Maureen J.B., van Akkooi, Alexander C.J., van den Berkmortel, Franchette W.P.J., Boers-Sonderen, Marye J., de Groot, Jan Willem B., Haanen, John B., Hospers, Geke A.P., Kapiteijn, Ellen W., Piersma, Djura, van Rijn, Roos S., van der Veldt, Astrid A.M., Vreugdenhil, Art, Westgeest, Hans M., van den Eertwegh, Alfons J.M., Suijkerbuijk, Karijn P.M., and Wouters, Michel W.J.M.

Published
2021
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16. Association between Clinical Frailty Scale score and hospital mortality in adult patients with COVID-19 (COMET): an international, multicentre, retrospective, observational cohort study

Author

Agnoletto, LA, Aleman, J, Andreassi, S, Andrews, LM, Ashfield, L, Bell, H, Bengaard, AKB, Berlinghini, SB, Bini, KB, Bisoffi, ZB, Blum, KB, Boemaars, E, Boni, GB, Bosch, TM, Bosma, BE, Boutkourt, F, Bufarini, C, Bulsink, A, Cabuk, RC, Callens, GC, Candela, MC, Canonici, MC, Capone, EC, Carmo, IC, Caruso, FC, Chessa, PC, Cohet, GC, Cornelissen-Wesseling, I, Crommentuijn, KML, de Stoppelaar, FM, de Wit, HAJM, Deben, DS, Derijks, LJJ, Di Carlo, MDC, Diepstraten, J, Dilek, B, Duchek-Mann, DMK, Ebbens, MM, Ellerbroek, LJ, Ezinga, M, Falcao, MF, Falcao, FF, Fantini, LF, Farinha, HF, Filius, PMG, Fitzhugh, NJ, Fleming, G, Forsthuber, TF, Gambarelli, GG, Gambera, MG, García Yubero, CGY, Getrouw, Z, Ghazarian, CN, Goodfellow, N, Gorgas, MQG, Grinta, RG, Guda, K, Haider, DH, Hanley, J, Heitzeneder, KH, Hemminga, WL, Hendriksen, LC, Hilarius, DL, Hogenhuis, FEF, Hoogendoorn-de Graaf, IC, Houlind, MBH, Huebler, MAH, Hurkens, KPGM, Janssen, PKC, Jong, E, Kappers, MHW, Keijzers, KFM, Kemogni, MK, Kemper, EM, Kranenburg, RA, Krens, LL, Le Grand, JL G, Liang, J, Lim, S, Lindner, NL, Loche, EL, Lubich, AL, Maat, B, Maesano, CM, Maiworm, AM, Maragna, M, Marchesini, FM, Martignoni, IM, Martini, G M, Masini, CM, Mc Menamin, R, Mendes, DM, Miarons, M, Moorlag, R, Müller, MR, Nagele, FN, Nemec, KN, Oka, GO, Otten-Helmers, AG, Pagliarino, SP, Pappalardo, FP, Patel, M, Peverini, PM, Pieraccini, FP, Platania, EMP, Pons-Kerjean, NPK, Portillo Horcajada, LPH, Rametta, GR, Rijo, JR, Roelofsen, EE, Roobol-Meuwese, E, Rossi, LR, Russel, SAH, Safipour, Z, Salaffi, FS, Saleh, L, Schimizzi, AMS, Schols, JMGA, Schwap, MS, Scott, MG, Slijfer, EAM, Slob, EMA, Soares, JS, Solano, MS, Sombogaard, F, Stemer, GS, Tardella, MT, ter Horst, PGJ, Tessari, RT, Tournoy, J, van den Berg, RB, Van der Linden, L, van der Linden, PD, van Dijk, SC, Van Etten, RW, van Haelst, IMM, van Heuckelum, M, van Kan, HJM, van Nieuwkoop, C, van Onzenoort, HAW, van Wijngaarden, P, Verdonk, JDJ, Verri, Fv, Verstijnen, JAMC, Veyrier, MV, Viegas, EV, Visser, LE, Vos, A, Vromen, MAM, Wierenga, PC, Wong, DR, Zenico, CZ, Zuppini, TZ, Sablerolles, Roos S G, Lafeber, Melvin, van Kempen, Janneke A L, van de Loo, Bob P A, Boersma, Eric, Rietdijk, Wim J R, Polinder-Bos, Harmke A, Mooijaart, Simon P, van der Kuy, Hugo, Versmissen, Jorie, and Faes, Miriam C

Published
2021
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17. Original COVID-19 priming regimen impacts the immunogenicity of bivalent BA.1 and BA.5 boosters

Author

Zaeck, Luca M, Tan, Ngoc H, Rietdijk, Wim J R, Geers, Daryl, Sablerolles, Roos S G, Bogers, Susanne, van Dijk, Laura L A, Gommers, Lennert, van Leeuwen, Leanne P M, Rugebregt, Sharona, Goorhuis, Abraham, Postma, Douwe F, Visser, Leo G, Dalm, Virgil A S H, Lafeber, Melvin, Kootstra, Neeltje A, Huckriede, Anke L W, Haagmans, Bart L, van Baarle, Debbie, Koopmans, Marion P G, van der Kuy, P Hugo M, GeurtsvanKessel, Corine H, de Vries, Rory D, Zaeck, Luca M, Tan, Ngoc H, Rietdijk, Wim J R, Geers, Daryl, Sablerolles, Roos S G, Bogers, Susanne, van Dijk, Laura L A, Gommers, Lennert, van Leeuwen, Leanne P M, Rugebregt, Sharona, Goorhuis, Abraham, Postma, Douwe F, Visser, Leo G, Dalm, Virgil A S H, Lafeber, Melvin, Kootstra, Neeltje A, Huckriede, Anke L W, Haagmans, Bart L, van Baarle, Debbie, Koopmans, Marion P G, van der Kuy, P Hugo M, GeurtsvanKessel, Corine H, and de Vries, Rory D

Abstract

Waning antibody responses after COVID-19 vaccination combined with the emergence of the SARS-CoV-2 Omicron lineage led to reduced vaccine effectiveness. As a countermeasure, bivalent mRNA-based booster vaccines encoding the ancestral spike protein in combination with that of Omicron BA.1 or BA.5 were introduced. Since then, different BA.2-descendent lineages have become dominant, such as XBB.1.5, JN.1, or EG.5.1. Here, we report post-hoc analyses of data from the SWITCH-ON study, assessing how different COVID-19 priming regimens affect the immunogenicity of bivalent booster vaccinations and breakthrough infections (NCT05471440). BA.1 and BA.5 bivalent vaccines boosted neutralizing antibodies and T-cells up to 3 months after boost; however, cross-neutralization of XBB.1.5 was poor. Interestingly, different combinations of prime-boost regimens induced divergent responses: participants primed with Ad26.COV2.S developed lower binding antibody levels after bivalent boost while neutralization and T-cell responses were similar to mRNA-based primed participants. In contrast, the breadth of neutralization was higher in mRNA-primed and bivalent BA.5 boosted participants. Combined, our data further support the current use of monovalent vaccines based on circulating strains when vaccinating risk groups, as recently recommended by the WHO. We emphasize the importance of the continuous assessment of immune responses targeting circulating variants to guide future COVID-19 vaccination policies.

Published
2024

18. Functional outcomes in symptomatic versus asymptomatic patients undergoing incisional hernia repair: Replacing one problem with another? A prospective cohort study in 1312 patients

Author

Abet, E., Ain, J.-F., Arnalsteen, L., Baraket, O., Beck, M., Bellouard, A., Benizri, E., Berney, C., Bilem, D., Binot, D., Blanc, B., Blazquez, D., Bonan, A., Boukortt, T., Brehant, O., Cas, O., Champault-Fezais, A., Chau, A., Chollet, J.-M., Constantin, M., Cossa, J.-P., Dabrowski, A., David, A., Demaret, S., Dubuisson, V., Dugue, T., El Nakadi, I., Faure, J.-P., Frileux, P., Fromont, G., Gadiri, N., Gillion, J.-F., Glehen, O., Hennequin, S., Isambert, M., Jurczak, F., Khalil, H., Lamblin, A., Largenton, C., Lavy, M., Lepère, M., Le Toux, N., Magne, E., Manfredelli, S., Mariette, C., Marion, Y., Mercoli, H.-A., Mesli Smain, N., Moszkowicz, D., Najim, M., Oberlin, O., Odet, E., Ortega Deballon, P., Pavis d’Escurac, X., Pichot Delahaye, V., Putinier, J.B., Regimbeau, J.M., Renard, Y., Romain, B., Rouquie, D., Soler, M., Soufron, J., Roos, S., Thillois, J.-M., Tiry, P., Vauchaussade De Chaumont, A., Vinatier, E., Vu, P., Verhaeghe, R., Zaranis, C., Zeineb, M., de Smet, Gijs H.J., Sneiders, Dimitri, Yurtkap, Yagmur, Menon, Anand G., Jeekel, Johannes, Kleinrensink, Gert-Jan, Lange, Johan F., and Gillion, Jean-François

Published
2020
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19. The Short- and Longer-Term Effects of Brief Behavioral Parent Training Versus Care as Usual in Children with Behavioral Difficulties: Study Protocol for a Randomized Controlled Trial

Author

Doornik, Roos S. van, primary, Oord, Saskia van der, additional, Luijckx, Joli, additional, Groenman, Annabeth P., additional, Leijten, Patty, additional, Luman, Marjolein, additional, Hoekstra, Pieter J., additional, Hoofdakker, Barbara J. van den, additional, and Dekkers, Tycho J., additional

Published
2024
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20. First-line BRAF/MEK inhibitors versus anti-PD-1 monotherapy in BRAFV600-mutant advanced melanoma patients: a propensity-matched survival analysis

Author

van Breeschoten, Jesper, Wouters, Michel W. J. M., Hilarius, Doranne L., Haanen, John B., Blank, Christian U., Aarts, Maureen J. B., van den Berkmortel, Franchette W. P. J., de Groot, Jan-Willem B., Hospers, Geke A. P., Kapiteijn, Ellen, Piersma, Djura, van Rijn, Roos S., Suijkerbuijk, Karijn P. M., Blokx, Willeke A. M., Tije, Bert-Jan J. ten, Veldt, Astrid A. M. van der, Vreugdenhil, Art, Boers-Sonderen, Marye J., and van den Eertwegh, Alfonsus J. M.

Published
2021
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23. List of Contributors

Author

Arputharaj, A., primary, Das, Subrata, additional, Gobalakrishnan, M., additional, Hildenbrand, J., additional, Ivy, Nishita, additional, Jönsson, C., additional, Krishnaprasad, G., additional, Maity, Subhankar, additional, Manickam, Parthiban, additional, Pandit, Pintu, additional, Patil, P.G., additional, Prasannamedha, G., additional, Raja, A.S.M., additional, Roos, S., additional, Saravanan, D., additional, Saxena, Sujata, additional, Senthilkumar, P., additional, Singha, Kunal, additional, and Vijay, Deepthi, additional

Published
2021
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27. External Validation of the European Hernia Society Classification for Postoperative Complications after Incisional Hernia Repair: A Cohort Study of 2,191 Patients

Author

Ain, J.-F., Beck, M., Barrat, C., Berney, C., Berrod, J.-L., Binot, D., Boudet, M.-J., Bousquet, J., Blazquez, D., Bonan, A., Cas, O., Champault-Fezais, A., Chastan, P., Cardin, J.-L., Chollet, J.-M., Cossa, J.-P., Dabrowski, A., Démaret, S., Drissi, F., Durou, J., Dugue, T., Faure, J.-P., Framery, D., Fromont, G., Gainant, A., Gauduchon, L., Genser, L., Gillion, J.-F., Guillaud, A., Jacquin, C., Jurczak, F., Khalil, H., Lacroix, A., Ledaguenel, P., Lepère, M., Lépront, D., Letoux, N., Loriau, J., Magne, E., Ngo, P., Oberlin, O., Paterne, D., Pavis d'Escurac, X., Potiron, L., Renard, Y., Soler, M., Rignier, P., Roos, S., Thillois, J.-M., Tiry, P., Verhaeghe, R., Vu, P., Zaranis, C., Kroese, Leonard F., Kleinrensink, Gert-Jan, Lange, Johan F., and Gillion, Jean-Francois

Published
2018
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28. Correction: First-line BRAF/MEK inhibitors versus anti-PD-1 monotherapy in BRAFV600-mutant advanced melanoma patients: a propensity-matched survival analysis

Author

van Breeschoten, Jesper, Wouters, Michel W. J. M., Hilarius, Doranne L., Haanen, John B., Blank, Christian U., Aarts, Maureen J. B., van den Berkmortel, Franchette W. P. J., de Groot, Jan-Willem B., Hospers, Geke A. P., Kapiteijn, Ellen, Piersma, Djura, van Rijn, Roos S., Suijkerbuijk, Karijn P. M., Blokx, Willeke A. M., Tije, Bert-Jan J. ten, Veldt, Astrid A. M. van der, Vreugdenhil, Art, Boers-Sonderen, Marye J., and van den Eertwegh, Alfonsus J. M.

Published
2022
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30. ALL-tRNAseq enables robust tRNA profiling in tissue samples

Author

Chantal Scheepbouwer, Ernesto Aparicio-Puerta, Cristina Gomez-Martin, Heleen Verschueren, Monique van Eijndhoven, Laurine E. Wedekind, Stavros Giannoukakos, Nathalie Hijmering, Lisa Gasparotto, Hilde T. van der Galien, Roos S. van Rijn, Eleonora Aronica, Robby Kibbelaar, Vivi M. Heine, Pieter Wesseling, David P. Noske, W. Peter Vandertop, Daphne de Jong, D. Michiel Pegtel, Michael Hackenberg, Tom Wurdinger, Alan Gerber, Danijela Koppers-Lalic, Pathology, AII - Inflammatory diseases, ANS - Cellular & Molecular Mechanisms, Child and Adolescent Psychiatry & Psychosocial Care, Neurosurgery, ANS - Neurovascular Disorders, ANS - Systems & Network Neuroscience, CCA - Cancer Treatment and Quality of Life, Human genetics, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Amsterdam Neuroscience - Compulsivity, Impulsivity & Attention, AII - Cancer immunology, CCA - Cancer biology and immunology, CCA - Imaging and biomarkers, Amsterdam Neuroscience - Neurovascular Disorders, Amsterdam Neuroscience - Systems & Network Neuroscience, and AII - Infectious diseases

Subjects
tissue samples, Genetics, cancer, high-throughput sequencing, transfer RNA, Developmental Biology
Abstract

Transfer RNAs (tRNAs) are small adaptor RNAs essential for mRNA translation. Alterations in the cellular tRNA population can directly affect mRNA decoding rates and translational efficiency during cancer development and progression. To evaluate changes in the composition of the tRNA pool, multiple sequencing approaches have been developed to overcome reverse transcription blocks caused by the stable structures of these molecules and their numerous base modifications. However, it remains unclear whether current sequencing protocols faithfully capture tRNAs existing in cells or tissues. This is specifically challenging for clinical tissue samples that often present variable RNA qualities. For this reason, we developed ALL-tRNAseq, which combines the highly processive MarathonRT and RNA demethylation for the robust assessment of tRNA expression, together with a randomized adapter ligation strategy prior to reverse transcription to assess tRNA fragmentation levels in both cell lines and tissues. Incorporation of tRNA fragments not only informed on sample integrity but also significantly improved tRNA profiling of tissue samples. Our data showed that our profiling strategy effectively improves classification of oncogenic signatures in glioblastoma and diffuse large B-cell lymphoma tissues, particularly for samples presenting higher levels of RNA fragmentation, further highlighting the utility of ALL-tRNAseq for translational research.

Published
2023
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31. Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases

Author

Ismail, Rawa K., Sikkes, Nienke O., Wouters, Michel W.J.M., Hilarius, Doranne L., Pasmooij, Anna M.G., van den Eertwegh, Alfonsus J.M., Aarts, Maureen J.B., van den Berkmortel, Franchette W.P.J., Boers-Sonderen, Marye J., de Groot, Jan Willem B., Haanen, John B.A.G., Hospers, Geke A.P., Kapiteijn, Ellen, Piersma, Djura, van Rijn, Roos S., Suijkerbuijk, Karijn P.M., ten Tije, Bert-Jan, van der Veldt, Astrid A.M., Vreugdenhil, Art, van Dartel, Maaike, and de Boer, Anthonius

Published
2021
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32. Suture versus open mesh repair for small umbilical hernia: Results of a propensity-matched cohort study

Author

Frey, Samuel, primary, Beauvais, Adrien, additional, Soler, Marc, additional, Beck, Mathieu, additional, Dugué, Timothée, additional, Pavis d’Escurac, Xavier, additional, Dabrowski, André, additional, Jurczak, Florent, additional, Gillion, Jean-François, additional, Antor, M., additional, Beck, M., additional, Barrat, C., additional, Berney, C., additional, Binot, D., additional, Bousquet, J., additional, Blazquez, D., additional, Bonan, A., additional, Cas, O., additional, Champault-Fezais, A., additional, Chastan, P., additional, Chollet, J.-M., additional, Cossa, J.-P., additional, Dabrowski, A., additional, Delaunay, T., additional, Démaret, S., additional, Drissi, F., additional, Demian, H., additional, Dubuisson, V., additional, Dugue, T., additional, Fromont, G., additional, Gillion, J.-F., additional, Jacquin, C., additional, Jurczak, F., additional, Khalil, H., additional, Launay-Savary, M., additional, Lepère, M., additional, Lépront, D., additional, Longeville, J.H., additional, Le Toux, N., additional, Loriau, J., additional, Magne, E., additional, Ngo, P., additional, Oberlin, O., additional, Passot, G., additional, Pavis d’Escurac, X., additional, Putinier, J.B., additional, Renard, Y., additional, Romain, B., additional, Soler, M., additional, Roos, S., additional, Thillois, J.-M., additional, Tiry, P., additional, Vu, P., additional, Verhaeghe, R., additional, Warlaumont, M., additional, and Zaranis, C., additional

Published
2023
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34. Fabricated Flips: Poisoning Federated Learning without Data

Author

Huang, J. (author), Zhao, Z. (author), Chen, Lydia Y. (author), Roos, S. (author), Huang, J. (author), Zhao, Z. (author), Chen, Lydia Y. (author), and Roos, S. (author)

Abstract

Attacks on Federated Learning (FL) can severely reduce the quality of the generated models and limit the usefulness of this emerging learning paradigm that enables on-premise decentralized learning. However, existing untargeted attacks are not practical for many scenarios as they assume that i) the attacker knows every update of benign clients, or ii) the attacker has a large dataset to locally train updates imitating benign parties. In this paper, we propose a data-free untargeted attack (DFA) that synthesizes malicious data to craft adversarial models without eavesdropping on the transmission of benign clients at all or requiring a large quantity of task-specific training data. We design two variants of DFA, namely DFA-R and DFA-G, which differ in how they trade off stealthiness and effectiveness. Specifically, DFA-R iteratively optimizes a malicious data layer to minimize the prediction confidence of all outputs of the global model, whereas DFA-G interactively trains a malicious data generator network by steering the output of the global model toward a particular class. Experimental results on Fashion-MNIST, Cifar-10, and SVHN show that DFA, despite requiring fewer assumptions than existing attacks, achieves similar or even higher attack success rate than state-of-the-art untargeted attacks against various state-of-the-art defense mechanisms. Concretely, they can evade all considered defense mechanisms in at least 50% of the cases for CIFAR-10 and often reduce the accuracy by more than a factor of 2. Consequently, we design REFD, a defense specifically crafted to protect against data-free attacks. REFD leverages a reference dataset to detect updates that are biased or have a low confidence. It greatly improves upon existing defenses by filtering out the malicious updates and achieves high global model accuracy., Green Open Access added to TU Delft Institutional Repository 'You share, we take care!' - Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public., Data-Intensive Systems

Published
2023
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35. A Deployment-First Methodology to Mechanism Design and Refinement in Distributed Systems

Author

de Vos, M.A. (author), Ishmaev, G. (author), Pouwelse, J.A. (author), Roos, S. (author), de Vos, M.A. (author), Ishmaev, G. (author), Pouwelse, J.A. (author), and Roos, S. (author)

Abstract

Catalyzed by the popularity of blockchain technology, there has recently been a renewed interest in the design, implementation and evaluation of decentralized systems. Most of these systems are intended to be deployed at scale and in heterogeneous environments with real users and unpredictable workloads. Nevertheless, most research in this field evaluates such systems in controlled environments that poorly reflect the complex conditions of real-world environments. In this work, we argue that deployment is crucial to understanding decentralized mechanisms in a real-world environment and an enabler to building more robust and sustainable systems. We highlight the merits of deployment by comparing this approach with other experimental setups and show how our lab applied a deployment-first methodology. We then outline how we use Tribler, our peer-to-peer file-sharing application, to deploy and monitor decentralized mechanisms at scale. We illustrate the application of our methodology by describing a deployment trial in experimental tokenomics. Finally, we summarize four lessons learned from multiple deployment trials where we applied our methodology., Green Open Access added to TU Delft Institutional Repository 'You share, we take care!' - Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public., Data-Intensive Systems

Published
2023
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36. Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON):results from the direct boost group of an open-label, multicentre, randomised controlled trial

Author

Tan, Ngoc H., Geers, Daryl, Sablerolles, Roos S G, Rietdijk, Wim J R, Goorhuis, Abraham, Postma, Douwe F, Visser, Leo G, Bogers, Susanne, van Dijk, Laura L A, Gommers, Lennert, van Leeuwen, Leanne P M, Boerma, Annemarie, Nijhof, Sander H, van Dort, Karel A, Koopmans, Marion P G, Dalm, Virgil A S H, Lafeber, Melvin, Kootstra, Neeltje A, Huckriede, Anke L W, van Baarle, Debbie, Zaeck, Luca M, Geurts van Kessel, Corine H., de Vries, Rory D, van der Kuy, P Hugo M, Tan, Ngoc H., Geers, Daryl, Sablerolles, Roos S G, Rietdijk, Wim J R, Goorhuis, Abraham, Postma, Douwe F, Visser, Leo G, Bogers, Susanne, van Dijk, Laura L A, Gommers, Lennert, van Leeuwen, Leanne P M, Boerma, Annemarie, Nijhof, Sander H, van Dort, Karel A, Koopmans, Marion P G, Dalm, Virgil A S H, Lafeber, Melvin, Kootstra, Neeltje A, Huckriede, Anke L W, van Baarle, Debbie, Zaeck, Luca M, Geurts van Kessel, Corine H., de Vries, Rory D, and van der Kuy, P Hugo M

Abstract

Background: Bivalent mRNA-based COVID-19 vaccines encoding the ancestral and omicron spike (S) protein were developed as a countermeasure against antigenically distinct SARS-CoV-2 variants. We aimed to assess the (variant-specific) immunogenicity and reactogenicity of mRNA-based bivalent omicron (BA.1) vaccines in individuals who were primed with adenovirus-based or mRNA-based vaccines encoding the ancestral spike protein. Methods: We analysed results of the direct boost group of the SWITCH ON study, an open-label, multicentre, randomised controlled trial. Health-care workers from four academic hospitals in the Netherlands aged 18–65 years who had completed a primary COVID-19 vaccination regimen and received one booster of an mRNA-based vaccine, given no later than 3 months previously, were eligible. Participants were randomly assigned (1:1) using computer software in block sizes of 16 and 24 to receive an omicron BA.1 bivalent booster straight away (direct boost group) or a bivalent omicron BA.5 booster, postponed for 90 days (postponed boost group), stratified by priming regimen. The BNT162b2 OMI BA.1 boost was given to participants younger than 45 years, and the mRNA-1273.214 boost was given to participants 45 years or older, as per Dutch guidelines. The direct boost group, whose results are presented here, were divided into four subgroups for analysis: (1) Ad26.COV2.S (Johnson & Johnson) prime and BNT162b2 OMI BA.1 (BioNTech–Pfizer) boost (Ad/P), (2) mRNA-based prime and BNT162b2 OMI BA.1 boost (mRNA/P), (3) Ad26.COV2.S prime and mRNA-1273.214 (Moderna) boost (Ad/M), and (4) mRNA-based prime and mRNA-1273.214 boost (mRNA/M). The primary outcome was fold change in S protein S1 subunit-specific IgG antibodies before and 28 days after booster vaccination. The primary outcome and safety were assessed in all participants except those who withdrew, had a SARS-CoV-2 breakthrough infection, or had a missing blood sample at day 0 or day 28. This tria

Published
2023

37. Maverick Matters: Client Contribution and Selection in Federated Learning

Author

Huang, J. (author), Hong, C. (author), Liu, Yang (author), Chen, Lydia Y. (author), Roos, S. (author), Huang, J. (author), Hong, C. (author), Liu, Yang (author), Chen, Lydia Y. (author), and Roos, S. (author)

Abstract

Federated learning (FL) enables collaborative learning between parties, called clients, without sharing the original and potentially sensitive data. To ensure fast convergence in the presence of such heterogeneous clients, it is imperative to timely select clients who can effectively contribute to learning. A realistic but overlooked case of heterogeneous clients are Mavericks, who monopolize the possession of certain data types, e.g., children hospitals possess most of the data on pediatric cardiology. In this paper, we address the importance and tackle the challenges of Mavericks by exploring two types of client selection strategies. First, we show theoretically and through simulations that the common contribution-based approach, Shapley Value, underestimates the contribution of Mavericks and is hence not effective as a measure to select clients. Then, we propose FedEMD, an adaptive strategy with competitive overhead based on the Wasserstein distance, supported by a proven convergence bound. As FedEMD adapts the selection probability such that Mavericks are preferably selected when the model benefits from improvement on rare classes, it consistently ensures the fast convergence in the presence of different types of Mavericks. Compared to existing strategies, including Shapley Value-based ones, FedEMD improves the convergence speed of neural network classifiers with FedAvg aggregation by 26.9% and its performance is consistent across various levels of heterogeneity., Data-Intensive Systems

Published
2023
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38. Age Moderates the Effect of Obesity on Mortality Risk in Critically Ill Patients With COVID-19:A Nationwide Observational Cohort Study*

Author

den Uil, Corstiaan A, Termorshuizen, Fabian, Rietdijk, Wim J R, Sablerolles, Roos S G, van der Kuy, Hugo P M, Haas, Lenneke E M, van der Voort, Peter H J, de Lange, Dylan W, Pickkers, Peter, de Keizer, Nicolette F, den Uil, Corstiaan A, Termorshuizen, Fabian, Rietdijk, Wim J R, Sablerolles, Roos S G, van der Kuy, Hugo P M, Haas, Lenneke E M, van der Voort, Peter H J, de Lange, Dylan W, Pickkers, Peter, and de Keizer, Nicolette F

Abstract

OBJECTIVES: A high body mass index (BMI) is associated with an unfavorable disease course in COVID-19, but not among those who require admission to the ICU. This has not been examined across different age groups. We examined whether age modifies the association between BMI and mortality among critically ill COVID-19 patients.DESIGN: An observational cohort study.SETTING: A nationwide registry analysis of critically ill patients with COVID-19 registered in the National Intensive Care Evaluation registry.PATIENTS: We included 15,701 critically ill patients with COVID-19 (10,768 males [68.6%] with median [interquartile range] age 64 yr [55-71 yr]), of whom 1,402 (8.9%) patients were less than 45 years.INTERVENTIONS: None.MEASUREMENTS AND MAIN RESULTS: In the total sample and after adjustment for age, gender, Acute Physiology and Chronic Health Evaluation IV, mechanical ventilation, and use of vasoactive drugs, we found that a BMI greater than or equal to 30 kg/m2 does not affect hospital mortality (adjusted odds ratio [ORadj] = 0.98; 95% CI, 0.90-1.06; p = 0.62). For patients less than 45 years old, but not for those greater than or equal to 45 years old, a BMI greater than or equal to 30 kg/m2 was associated with a lower hospital mortality (ORadj = 0.59; 95% CI, 0.36-0.96; p = 0.03).CONCLUSIONS: A higher BMI may be favorably associated with a lower mortality among those less than 45 years old. This is in line with the so-called "obesity paradox" that was established for other groups of critically ill patients in broad age ranges. Further research is needed to understand this favorable association in young critically ill patients with COVID-19.

Published
2023

42. Response to immune checkpoint inhibitors in acral melanoma

Author

Olivier J. van Not, Melissa M. de Meza, Alfons J.M. van den Eertwegh, John B. Haanen, Christian U. Blank, Maureen J.B. Aarts, Franchette W.P.J. van den Berkmortel, Jesper van Breeschoten, Jan-Willem B. de Groot, Geke A.P. Hospers, Rawa K. Ismail, Ellen Kapiteijn, Djura Piersma, Roos S. van Rijn, Marion A.M. Stevense-den Boer, Astrid A.M. van der Veldt, Gerard Vreugdenhil, Han J. Bonenkamp, Marye J. Boers-Sonderen, Willeke A.M. Blokx, Michel W.J.M. Wouters, Karijn P.M. Suijkerbuijk, Medical Oncology, Radiology & Nuclear Medicine, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Internal medicine, Medical oncology, AII - Cancer immunology, CCA - Cancer Treatment and quality of life, Obstetrics and gynaecology, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Cancer Research, Skin Neoplasms, Survival, Melanoma/mortality, THERAPY, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], SUBTYPES, Cohort Studies, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Immune checkpoint inhibitors, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, Skin Neoplasms/drug therapy, Humans, Prospective Studies, Melanoma, OUTCOMES, Response, KIT, EFFICACY, Nivolumab/adverse effects, Ipilimumab, Immune Checkpoint Inhibitors/therapeutic use, MUCOSAL, Nivolumab, Oncology, ARM, Immunotherapy, Ipilimumab/therapeutic use
Abstract

Background: Recent reports suggest the limited efficacy of immune checkpoints inhibitors in advanced acral melanoma (AM). This study aims to investigate the clinical outcomes of immune checkpoint inhibitors in patients with stage III and IV AM and compare them to cutaneous melanoma (CM). Methods: We included patients with advanced AM and CM treated with first-line anti -programmed cell death (PD)-1 monotherapy or ipilimumab-nivolumab registered in the prospective nationwide Dutch Melanoma Treatment Registry. Objective response rates, progression free survival (PFS) and overall survival (OS) were calculated. A Cox proportional hazard model was used to assess the prognostic factors with PFS and OS. Results: In total, 2058 patients (88 AM and 1970 CM) with advanced melanoma were included. First-line objective response rates were 34% for AM versus 54% for CM in the advanced anti-PD-1 cohort and 33% for AM versus 53% for CM in the advanced ipilimumab-nivolumab cohort. The Median PFS was significantly shorter for anti-PD-1 treated AM patients (3.1 months; 95%CI: 2.8-5.6) than patients with CM (10.1 months; 95%CI: 8.5-12.2) (P < 0.001). In patients with advanced melanoma, AM was significantly associated with a higher risk of progression (HRadj 1.63; 95%CI: 1.26-2.11 ; P < 0.001) and death (HRadj 1.54; 95%CI: 1.15-2.06; P Z 0.004) than CM. Conclusions: This study shows lower effectiveness of anti-PD-1 monotherapy and ipilimumab-nivolumab in AM, with lower response rates, PFS and OS than CM. This group of patients should be prioritised in the development of alternative treatment strategies. 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Published
2022
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43. Correction: First-line BRAF/MEK inhibitors versus anti-PD-1 monotherapy in BRAFV600-mutant advanced melanoma patients: a propensity-matched survival analysis

Author

van Breeschoten, Jesper, Wouters, Michel W. J. M., Hilarius, Doranne L., Haanen, John B., Blank, Christian U., Aarts, Maureen J. B., van den Berkmortel, Franchette W. P. J., de Groot, Jan-Willem B., Hospers, Geke A. P., Kapiteijn, Ellen, Piersma, Djura, van Rijn, Roos S., Suijkerbuijk, Karijn P. M., Blokx, Willeke A. M., ten Tije, Bert-Jan J., van der Veldt, Astrid A. M., Vreugdenhil, Art, Boers-Sonderen, Marye J., and van den Eertwegh, Alfonsus J. M.

Published
2021
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44. ALL-tRNAseq enables robust tRNA profiling in tissue samples

Author

Scheepbouwer, Chantal, primary, Aparicio-Puerta, Ernesto, additional, Gomez-Martin, Cristina, additional, Verschueren, Heleen, additional, van Eijndhoven, Monique, additional, Wedekind, Laurine E., additional, Giannoukakos, Stavros, additional, Hijmering, Nathalie, additional, Gasparotto, Lisa, additional, van der Galien, Hilde T., additional, van Rijn, Roos S., additional, Aronica, Eleonora, additional, Kibbelaar, Robby, additional, Heine, Vivi M., additional, Wesseling, Pieter, additional, Noske, David P., additional, Vandertop, W. Peter, additional, de Jong, Daphne, additional, Pegtel, D. Michiel, additional, Hackenberg, Michael, additional, Wurdinger, Tom, additional, Gerber, Alan, additional, and Koppers-Lalic, Danijela, additional

Published
2023
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48. Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol

Author

Tan, Ngoc H., primary, Sablerolles, Roos S. G., additional, Rietdijk, Wim J. R., additional, Goorhuis, Abraham, additional, Postma, Douwe F., additional, Visser, Leo G., additional, Bogers, Susanne, additional, Geers, Daryl, additional, Zaeck, Luca M., additional, Koopmans, Marion P. G., additional, Dalm, Virgil A. S. H., additional, Kootstra, Neeltje A., additional, Huckriede, Anke L. W., additional, van Baarle, Debbie, additional, Lafeber, Melvin, additional, GeurtsvanKessel, Corine H., additional, de Vries, Rory D., additional, and van der Kuy, Paul-Hugo Marie, additional

Published
2022
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