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2. Long-term survival following anti-PD-(L)1 monotherapy in advanced urothelial cancer and an assessment of potential prognostic clinical factors: a multicentre observational study

Author

Stockem, Chantal F., Einerhand, Sarah M. H., Rodríguez, Isabel Miras, Salhi, Youssra, Pérez, Esther, Bakaloudi, Dimitra R., Talukder, Rafee, Caramelo, Belen, Morales-Barrera, Rafael, De Meulenaere, Astrid, Rametta, Alessandro, Bottelli, Andrea, Lefort, Felix, Giannatempo, Patrizia, Vulsteke, Christof, Carles, Joan, Duran, Ignacio, Grivas, Petros, de Liaño, Alfonso Gómez, Robbrecht, Debbie G. J., Valderrama, Begoña P., van der Noort, Vincent, and van der Heijden, Michiel S.

Published
2024
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4. The optimal treatment for patients with stage I non-small cell lung cancer: minimally invasive lobectomy versus stereotactic ablative radiotherapy – a nationwide cohort study

Author

Amir, M.I., van Berkum, H., Bertens, H., Bindels, M., Bongers, E.M., Boshuizen, R.C., de Brake-de Jong, K., Braun, J., van den Broek, F.J.C., Bussink, J., Canisius, S., Damhuis, R.A.M., Deelen, M., Deroose, J.P., Dickhoff, C., Dielwart, M.F.H., van Diessen, J.N.A., Dubbelman-Siems, M., van Elst, K., Ghamati, M., Grimme, F.A.B., de Groot, M.A., Halfwerk, F.R., Hartemink, K.J., Hellebrekers, P., Hendriks, L.E.L., Hendriksa, E.R., van Heukelem, S., ten Heuvel, A., Hugen, N., Hutteman, M., Hüyük, M., IJgosse, W.M., de Jaeger, K., de Jong, E.M., van Kampen, D., de Keersmaecker, S., Klomp, H.M., Kouwenhoven, E.A., Krouwels, F.H., Lammers, E., Lastdrager, W.B., van der Leest, K., Liesker, K.R., de Loos, E.R., De Lorenzo, A., Maat, A.P.W.M., Maessen, J.G., Mali, R., Marquenie, N., Marres, G.M.H., Martina, B.G., Masselink, I., Meijer, R.C.A., Mens, D.M., von Meyenfeldt, E.M., Michel, S., van Middendorp, L.B., Moes, J.R., Moons-Pasic, A., Morsink, L., van Nes, J.G.H., van Nistelrooy, M., van der Noort, V., Nuyttens, J.J.M.E., Oosterhuis, J.W.A., Oosthoek, L.W.J., Osté, E., Overhof-Wedick, C., Palamba, H.W., Paulus, G.F., van Putten, J.W.G., van Putten, S.E., Rijna, H., Rikers, C., de Ruiter, J.C., de Ruysscher, D.K., Schiefer, M., Schweitzer, D., Smakman, N., Smit, E.F., Smit, W.G.J.M., Spaans, L.N., Speekenbrink, R.G.H., Stellingwerf, M., Steward, A.J., Susa, D., van Thiel, E., Thönissen, N.M., Veen, E.J., Veenhof, A.A.F.A., van Velthoven-Hoogers, A., Verbogt, N.P.A., Verbruggen, L., Verhagen, A.F.T.M., Verhoeff, J.J.C., van der Voort van Zyp, N.C.M.G., van de Wauwer, C., de Wee, E.M., van der Wekken, A.J., Wener, R.R., Wijsman, R., van den Wildenberg, F.J.H., van der Woude, L., Yang, Z.L., de Ruiter, Julianne Cynthia, van der Noort, Vincent, van Diessen, Judi Nani Annet, Smit, Egbert Frederik, Damhuis, Ronald Alphons Maria, and Hartemink, Koen Johan

Published
2024
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5. Trastuzumab plus pertuzumab for HER2-amplified advanced colorectal cancer: Results from the drug rediscovery protocol (DRUP)

Author

Spiekman, Ilse A.C., Zeverijn, Laurien J., Geurts, Birgit S., Verkerk, Karlijn, Haj Mohammad, Soemeya F., van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W.J., Jansen, Anne M.L., Gootjes, Elske C., de Groot, Derk-Jan A., Kerver, Emile D., van Voorthuizen, Theo, Roodhart, Jeanine M.L., Valkenburg-van Iersel, Liselot B.J., Gelderblom, Hans, Voest, Emile E., and Verheul, Henk M.W.

Published
2024
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6. Cemiplimab in locally advanced or metastatic cutaneous squamous cell carcinoma: prospective real-world data from the DRUG Access Protocol

Author

Verkerk, Karlijn, Geurts, Birgit S., Zeverijn, Laurien J., van der Noort, Vincent, Verheul, Henk M.W., Haanen, John B.A.G., van der Veldt, Astrid A.M., Eskens, Ferry A.L.M., Aarts, Maureen J.B., van Herpen, Carla M.L., Jalving, Mathilde, Gietema, Jourik A., Devriese, Lot A., Labots, Mariette, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Smit, Egbert F., and Bloemendal, Haiko J.

Published
2024
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7. Cayley algebras give rise to $q$-Fano planes over certain infinite fields and $q$-covering designs over others

Author

van der Noort, Vincent

Subjects
Mathematics - Combinatorics, Mathematics - Rings and Algebras, 51E10, 51D20, 05B25, 17D05
Abstract

Let $F$ be a field. A $2$-$(7, 3, 1)_F$-subspace design, or $q$-Fano plane, over $F$, is a $7$-dimensional vector space $V$ over $F$ together with a collection $\mathfrak{B}$ of three-dimensional subspaces of $V$ such that every two-dimensional subspace of $V$ is contained in exactly one element $B$ of $\mathfrak{B}$. The question of existence of $q$-Fano planes over any field has been open since the 1970s and has attracted considerable attention in the special case that $F$ is finite. Here we show the existence of $2$-$(7, 3, 1)_F$-subspace designs over certain infinite fields $F$, including (among others) $\mathbb{Q}, \mathbb{R}$ and $\mathbb{F}_q(x, y, z)$ for $q$ odd. The space $V$ is the 7-dimensional space of imaginary elements in a Cayley division algebra $O$ over $F$ and $\mathfrak{B}$ consists of the intersections with $V$ of all 4-dimensional subalgebras of $O$. We will present the required background on Cayley algebras in a self-contained fashion. Next we study what happens if we apply the same procedure to split (rather than division) Cayley algebras. By identifying all four-dimensional subalgebras of these, we show that in that case our construction still yields an inclusion minimal $(7, 3, 2)$ $q$-covering design. That is: every two-dimensional subspace of $V$ is contained in at least one element of the resulting set $\mathfrak{B}$ of three-dimensional subspaces of $V$ and no proper subset of $\mathfrak{B}$ has this property. However none of these $q$-covering designs are $q$-Fano planes. In the case that $F$ is finite we compute the number of elements of $\mathfrak{B}$. We also give a purely combinatorial construction of our $q$-Fano planes and $q$-covering designs for an abstract 7-dimensional $F$-vector space $V$ by identifying the collection $\mathfrak{B}$ as a subvariety of the Grassmanian $Gr_3(V)$ defined entirely in terms of the classical Fano plane., Comment: 75 pages, 7 tables, 1 figure

Published
2020

14. Oncologic outcome of response-guided axillary treatment in patients with cN1 breast cancer after primary systemic therapy.

Author

van Hemert, Annemiek, primary, van Loevezijn, Ariane, additional, Baas, Marie-Sophie, additional, Stokkel, Marcel P, additional, Groen, Emilie, additional, van der Noort, Vincent, additional, Loo, Claudette, additional, Sonke, Gabe S., additional, Russell, Nicola, additional, van Duijnhoven, Frederieke H, additional, and Vrancken Peeters, Marie-Jeanne T.F.D, additional

Published
2024
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18. Integrated analysis of pain, health-related quality of life, and analgesic use in patients with metastatic castration-resistant prostate cancer treated with Radium-223

Author

Badrising, Sushil K., Louhanepessy, Rebecca D., van der Noort, Vincent, Kieffer, Jacobien, Coenen, Jules L. L. M., Hamberg, Paul, Beeker, Aart, Wagenaar, Nils, Lam, Marnix, Celik, Filiz, Loosveld, Olaf J. L., Oostdijk, Ad, Zuetenhorst, Hanneke, de Feijter, Jeantine M., Dezentjé, Vincent O., Ras-van Spijk, Suzan, Vegt, Erik, Haanen, John B., van de Poll-Franse, Lonneke V., Zwart, Wilbert, and Bergman, Andries M.

Published
2022
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20. Efficacy of pembrolizumab and biomarker analysis in patients with WGS-based intermediate to high tumor mutational load: results from the Drug Rediscovery Protocol

Author

Geurts, Birgit S., primary, Zeverijn, Laurien J., additional, Leek, Lindsay V.M., additional, van Berge Henegouwen, Jade M., additional, Hoes, Louisa R., additional, van der Wijngaart, Hanneke, additional, van der Noort, Vincent, additional, van de Haar, Joris, additional, van Ommen-Nijhof, Annemiek, additional, Kok, Marleen, additional, Roepman, Paul, additional, Jansen, Anne M.L., additional, de Leng, Wendy W.J., additional, de Jonge, Maja J. A., additional, Hoeben, Ann, additional, van Herpen, Carla M.L., additional, Westgeest, Hans M., additional, Wessels, Lodewyk F.A., additional, Verheul, Henk M.W., additional, Gelderblom, Hans, additional, and Voest, Emile E., additional

Published
2024
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21. Randomized phase III study of docetaxel versus docetaxel plus intercalated erlotinib in patients with relapsed non-squamous non-small cell lung carcinoma

Author

Steendam, Christi M.J., Peric, Robert, van Walree, Nico C., Youssef, Magdolen, Schramel, Franz M.N.H., Brocken, Pepijn, van Putten, John W.G., van der Noort, Vincent, Veerman, G.D. Marijn, Koolen, Stijn L.W., Groen, Harry J.M., Dingemans, Anne-Marie C., Mathijssen, Ron H.J., Smit, Egbert F., and Aerts, Joachim G.J.V.

Published
2021
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24. Switch-maintenance gemcitabine after first-line chemotherapy in patients with malignant mesothelioma (NVALT19): an investigator-initiated, randomised, open-label, phase 2 trial

Author

de Gooijer, Cornedine J, van der Noort, Vincent, Stigt, Jos A, Baas, Paul, Biesma, Bonne, Cornelissen, Robin, van Walree, Nico, van Heemst, Robbert C, Soud, Magdolen Youssef-El, Groen, Harry J M, den Brekel, Agnes J Staal-van, Buikhuisen, Wieneke A, Bootsma, Gerben P, Dammeijer, Floris, van Tinteren, Harm, Lalezari, Ferry, Aerts, Joachim G, and Burgers, Jacobus A

Published
2021
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25. Trastuzumab plus pertuzumab for HER2-amplified advanced colorectal cancer: Results from the drug rediscovery protocol (DRUP)

Author

Pathologie Pathologen staf, Cancer, Pathologie Moleculair, MS Medische Oncologie, Spiekman, Ilse A C, Zeverijn, Laurien J, Geurts, Birgit S, Verkerk, Karlijn, Mohammad, Soemeya F Haj, Noort, Vincent van der, Roepman, Paul, de Leng, Wendy W J, Jansen, Anne M L, Gootjes, Elske C, de Groot, Derk-Jan A, Kerver, Emile D, Voorthuizen, Theo van, Roodhart, Jeanine M L, Iersel, Liselot B J Valkenburg-van, Gelderblom, Hans, Voest, Emile E, Verheul, Henk M W, Pathologie Pathologen staf, Cancer, Pathologie Moleculair, MS Medische Oncologie, Spiekman, Ilse A C, Zeverijn, Laurien J, Geurts, Birgit S, Verkerk, Karlijn, Mohammad, Soemeya F Haj, Noort, Vincent van der, Roepman, Paul, de Leng, Wendy W J, Jansen, Anne M L, Gootjes, Elske C, de Groot, Derk-Jan A, Kerver, Emile D, Voorthuizen, Theo van, Roodhart, Jeanine M L, Iersel, Liselot B J Valkenburg-van, Gelderblom, Hans, Voest, Emile E, and Verheul, Henk M W

Published
2024

26. Efficacy of pembrolizumab and biomarker analysis in patients with WGS-based intermediate to high tumor mutational load: results from the Drug Rediscovery Protocol

Author

Palliatieve Zorg, Pathologie Moleculair, Pathologie Pathologen staf, Cancer, Externen Med. Onco, Geurts, Birgit S, Zeverijn, Laurien J, Leek, Lindsay V M, van Berge Henegouwen, Jade M, Hoes, Louisa R, van der Wijngaart, Hanneke, van der Noort, Vincent, van de Haar, Joris, van Ommen-Nijhof, Annemiek, Kok, Marleen, Roepman, Paul, Jansen, Anne M L, de Leng, Wendy W J, de Jonge, Maja J A, Hoeben, Ann, van Herpen, Carla M L, Westgeest, Hans M, Wessels, Lodewyk F A, Verheul, Henk M W, Gelderblom, Hans, Voest, Emile E, Palliatieve Zorg, Pathologie Moleculair, Pathologie Pathologen staf, Cancer, Externen Med. Onco, Geurts, Birgit S, Zeverijn, Laurien J, Leek, Lindsay V M, van Berge Henegouwen, Jade M, Hoes, Louisa R, van der Wijngaart, Hanneke, van der Noort, Vincent, van de Haar, Joris, van Ommen-Nijhof, Annemiek, Kok, Marleen, Roepman, Paul, Jansen, Anne M L, de Leng, Wendy W J, de Jonge, Maja J A, Hoeben, Ann, van Herpen, Carla M L, Westgeest, Hans M, Wessels, Lodewyk F A, Verheul, Henk M W, Gelderblom, Hans, and Voest, Emile E

Published
2024

28. Maximizing treatment opportunities: assessing protocol waivers' impact on safety and outcome in the Drug Rediscovery Protocol

Author

MS Medische Oncologie, Brain, Cancer, van Berge Henegouwen, Jade M, Zeverijn, Laurien J, Geurts, Birgit S, Hoes, Louisa R, van der Wijngaart, Hanneke, van der Noort, Vincent, Huitema, Alwin D R, De Vos, Filip Y F, Grünberg, Katrien, Bloemendal, Haiko J, Verheul, Henk M W, Voest, Emile E, Gelderblom, Hans, MS Medische Oncologie, Brain, Cancer, van Berge Henegouwen, Jade M, Zeverijn, Laurien J, Geurts, Birgit S, Hoes, Louisa R, van der Wijngaart, Hanneke, van der Noort, Vincent, Huitema, Alwin D R, De Vos, Filip Y F, Grünberg, Katrien, Bloemendal, Haiko J, Verheul, Henk M W, Voest, Emile E, and Gelderblom, Hans

Published
2024

29. Efficacy and Safety of Panitumumab in Patients With RAF/RAS-Wild-Type Glioblastoma:Results From the Drug Rediscovery Protocol

Author

Spiekman, Ilse A. C., Geurts, Birgit S., Zeverijn, Laurien J., de Wit, Gijs F., van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W. J., Jansen, Anne M. L., Kusters, Benno, Beerepoot, Laurens, de Vos, Filip Y. F. L., de Groot, Derk-Jan A., de Groot, Jan Willem B., Hoeben, Ann, Buter, Jan, Gelderblom, Hans A. J., Voest, Emile E., Verheul, Henk M. W., Spiekman, Ilse A. C., Geurts, Birgit S., Zeverijn, Laurien J., de Wit, Gijs F., van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W. J., Jansen, Anne M. L., Kusters, Benno, Beerepoot, Laurens, de Vos, Filip Y. F. L., de Groot, Derk-Jan A., de Groot, Jan Willem B., Hoeben, Ann, Buter, Jan, Gelderblom, Hans A. J., Voest, Emile E., and Verheul, Henk M. W.

Abstract

BACKGROUND: The prognosis of malignant primary high-grade brain tumors, predominantly glioblastomas, is poor despite intensive multimodality treatment options. In more than 50% of patients with glioblastomas, potentially targetable mutations are present, including rearrangements, altered splicing, and/or focal amplifications of epidermal growth factor receptor (EGFR) by signaling through the RAF/RAS pathway. We studied whether treatment with the clinically available anti-EGFR monoclonal antibody panitumumab provides clinical benefit for patients with RAF/RAS-wild-type (wt) glioblastomas in the Drug Rediscovery Protocol (DRUP). METHODS: Patients with progression of treatment refractory RAF/RASwt glioblastoma were included for treatment with panitumumab in DRUP when measurable according to RANO criteria. The primary endpoints of this study are clinical benefit (CB: defined as confirmed objective response [OR] or stable disease [SD] ≥ 16 weeks) and safety. Patients were enrolled using a Simon-like 2-stage model, with 8 patients in stage 1 and up to 24 patients in stage 2 if at least 1 in 8 patients had CB in stage 1. RESULTS: Between 03-2018 and 02-2022, 24 evaluable patients were treated. CB was observed in 5 patients (21%), including 2 patients with partial response (8.3%) and 3 patients with SD ≥ 16 weeks (12.5%). After median follow-up of 15 months, median progression-free survival and overall survival were 1.7 months (95% CI 1.6-2.1 months) and 4.5 months (95% CI 2.9-8.6 months), respectively. No unexpected toxicities were observed. CONCLUSIONS: Panitumumab treatment provides limited CB in patients with recurrent RAF/RASwt glioblastoma precluding further development of this therapeutic strategy.

Published
2024

30. Efficacy and Safety of Panitumumab in Patients With RAF/RAS-Wild-Type Glioblastoma: Results From the Drug Rediscovery Protocol

Author

Pathologie Pathologen staf, Cancer, Pathologie Moleculair, MS Medische Oncologie, Brain, Spiekman, Ilse A C, Geurts, Birgit S, Zeverijn, Laurien J, de Wit, Gijs F, van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W J, Jansen, Anne M L, Kusters, Benno, Beerepoot, Laurens V, de Vos, Filip Y F L, de Groot, Derk-Jan A, de Groot, Jan Willem B, Hoeben, Ann, Buter, Jan, Gelderblom, Hans A J, Voest, Emile E, Verheul, Henk M W, Pathologie Pathologen staf, Cancer, Pathologie Moleculair, MS Medische Oncologie, Brain, Spiekman, Ilse A C, Geurts, Birgit S, Zeverijn, Laurien J, de Wit, Gijs F, van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W J, Jansen, Anne M L, Kusters, Benno, Beerepoot, Laurens V, de Vos, Filip Y F L, de Groot, Derk-Jan A, de Groot, Jan Willem B, Hoeben, Ann, Buter, Jan, Gelderblom, Hans A J, Voest, Emile E, and Verheul, Henk M W

Published
2024

31. Cemiplimab in locally advanced or metastatic cutaneous squamous cell carcinoma: prospective real-world data from the DRUG Access Protocol

Author

MS Medische Oncologie, Cancer, Verkerk, Karlijn, Geurts, Birgit S, Zeverijn, Laurien J, van der Noort, Vincent, Verheul, Henk M W, Haanen, John B A G, van der Veldt, Astrid A M, Eskens, Ferry A L M, Aarts, Maureen J B, van Herpen, Carla M L, Jalving, Mathilde, Gietema, Jourik A, Devriese, Lot A, Labots, Mariette, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Smit, Egbert F, Bloemendal, Haiko J, MS Medische Oncologie, Cancer, Verkerk, Karlijn, Geurts, Birgit S, Zeverijn, Laurien J, van der Noort, Vincent, Verheul, Henk M W, Haanen, John B A G, van der Veldt, Astrid A M, Eskens, Ferry A L M, Aarts, Maureen J B, van Herpen, Carla M L, Jalving, Mathilde, Gietema, Jourik A, Devriese, Lot A, Labots, Mariette, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Smit, Egbert F, and Bloemendal, Haiko J

Published
2024

32. Trastuzumab plus pertuzumab for HER2-amplified advanced colorectal cancer:Results from the drug rediscovery protocol (DRUP)

Author

Spiekman, Ilse A.C., Zeverijn, Laurien J., Geurts, Birgit S., Verkerk, Karlijn, Mohammad, Soemeya F.Haj, Noort, Vincent van der, Roepman, Paul, de Leng, Wendy W.J., Jansen, Anne M.L., Gootjes, Elske C., de Groot, Derk Jan A., Kerver, Emile D., Voorthuizen, Theo van, Roodhart, Jeanine M.L., Iersel, Liselot B.J.Valkenburg van, Gelderblom, Hans, Voest, Emile E., Verheul, Henk M.W., Spiekman, Ilse A.C., Zeverijn, Laurien J., Geurts, Birgit S., Verkerk, Karlijn, Mohammad, Soemeya F.Haj, Noort, Vincent van der, Roepman, Paul, de Leng, Wendy W.J., Jansen, Anne M.L., Gootjes, Elske C., de Groot, Derk Jan A., Kerver, Emile D., Voorthuizen, Theo van, Roodhart, Jeanine M.L., Iersel, Liselot B.J.Valkenburg van, Gelderblom, Hans, Voest, Emile E., and Verheul, Henk M.W.

Abstract

Background: In 2–5% of patients with colorectal cancer (CRC), human epidermal growth factor 2 (HER2) is amplified or overexpressed. Despite prior evidence that anti-HER2 therapy confers clinical benefit (CB) in one-third of these patients, it is not approved for this indication in Europe. In the Drug Rediscovery Protocol (DRUP), patients are treated with off-label drugs based on their molecular profile. Here, we present the results of the cohort ‘trastuzumab/pertuzumab for treatment-refractory patients with RAS/BRAF-wild-type HER2amplified metastatic CRC (HER2+mCRC)’. Methods: Patients with progressive treatment-refractory RAS/BRAF-wild-type HER2+mCRC with measurable disease were included for trastuzumab plus pertuzumab treatment. Primary endpoints of DRUP are CB (defined as confirmed objective response (OR) or stable disease (SD) ≥ 16 weeks) and safety. Patients were enrolled using a Simon-like 2-stage model, with 8 patients in stage 1 and 24 patients in stage 2 if at least 1/8 patients had CB. To identify biomarkers for response, whole genome sequencing (WGS) was performed on pre-treatment biopsies. Results: CB was observed in 11/24 evaluable patients (46%) with HER2+mCRC, seven patients achieved an OR (29%). Median duration of response was 8.4 months. Patients had undergone a median of 3 prior treatment lines. Median progression-free survival and overall survival were 4.3 months (95% CI 1.9–10.3) and 8.2 months (95% CI 7.2–14.7), respectively. No unexpected toxicities were observed. WGS provided potential explanations for resistance in 3/10 patients without CB, for whom WGS was available. Conclusions: The results of this study confirm a clinically significant benefit of trastuzumab plus pertuzumab treatment in patients with HER2+mCRC.

Published
2024

33. Cemiplimab in locally advanced or metastatic cutaneous squamous cell carcinoma:prospective real-world data from the DRUG Access Protocol

Author

Verkerk, Karlijn, Geurts, Birgit S., Zeverijn, Laurien J., van der Noort, Vincent, Verheul, Henk M.W., Haanen, John B.A.G., van der Veldt, Astrid A.M., Eskens, Ferry A.L.M., Aarts, Maureen J.B., van Herpen, Carla M.L., Jalving, Mathilde, Gietema, Jourik A., Devriese, Lot A., Labots, Mariette, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Smit, Egbert F., Bloemendal, Haiko J., Verkerk, Karlijn, Geurts, Birgit S., Zeverijn, Laurien J., van der Noort, Vincent, Verheul, Henk M.W., Haanen, John B.A.G., van der Veldt, Astrid A.M., Eskens, Ferry A.L.M., Aarts, Maureen J.B., van Herpen, Carla M.L., Jalving, Mathilde, Gietema, Jourik A., Devriese, Lot A., Labots, Mariette, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Smit, Egbert F., and Bloemendal, Haiko J.

Abstract

Background: The DRUG Access Protocol provides patients with cancer access to registered anti-cancer drugs that are awaiting reimbursement in the Netherlands and simultaneously collects prospective real-world data (RWD). Here, we present RWD from PD-1 blocker cemiplimab in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (laCSCC; mCSCC). Methods: Patients with laCSCC or mCSCC received cemiplimab 350 mg fixed dose every three weeks. Primary endpoints were objective clinical benefit rate (CBR), defined as objective response (OR) or stable disease (SD) at 16 weeks, physician-assessed CBR, defined as clinician's documentation of improved disease or SD based on evaluation of all available clinical parameters at 16 weeks, objective response rate (ORR), and safety, defined as grade ≥ 3 treatment related adverse events (TRAEs) occurring up to 30 days after last drug administration. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), and overall survival (OS). Findings: Between February 2021 and December 2022, 151 patients started treatment. Objective and physician-assessed CBR were 54.3% (95% CI, 46.0–62.4) and 59.6% (95% CI, 51.3–67.5), respectively. ORR was 35.1% (95% CI, 27.5–43.3). After a median follow-up of 15.2 months, median DoR was not reached. Median PFS and OS were 12.2 (95% CI, 7.0-not reached) and 24.2 months (95% CI, 18.8-not reached), respectively. Sixty-eight TRAEs occurred in 29.8% of patients. Most commonly reported TRAE was a kidney transplant rejection (9.5%). Interpretation: Cemiplimab proved highly effective and safe in this real-world cohort of patients with laCSCC or mCSCC, confirming its therapeutic value in the treatment of advanced CSCC in daily clinical practice. Funding: The DRUG Access Protocol is supported by all participating pharmaceutical companies: Bayer, Janssen, Lilly, Merck, Novartis, Roche, and Sanofi.

Published
2024

34. Head-to-head comparison of composite and individual biomarkers to predict clinical benefit to PD-1 blockade in non-small cell lung cancer.

Author

Hummelink, Karlijn, van der Noort, Vincent, Muller, Mirte, Schouten, Robert D., van den Heuvel, Michel M., Thommen, Daniela S., Smit, Egbert F., Meijer, Gerrit A., and Monkhorst, Kim

Subjects
*NON-small-cell lung carcinoma, *TUMOR-infiltrating immune cells, *PROGRAMMED cell death 1 receptors, *TERTIARY structure, *BIOMARKERS
Abstract

Background: The efficacy of PD-1 blocking agents in advanced NSCLC has shown prolonged effectiveness, but only in a minority of patients. Multiple biomarkers have been explored to predict treatment benefit, yet their combined performance remains inadequately examined. In this study, we assessed the combined predictive performance of multiple biomarkers in NSCLC patients treated with nivolumab. Methods: Pretreatment samples from 135 patients receiving nivolumab were used to evaluate the predictive performance of CD8 tumor-infiltrating lymphocytes (TILs), intratumoral (IT) localization of CD8 TILs, PD-1 high expressing TILs (PD1T TILs), CD3 TILs, CD20 B-cells, tertiary lymphoid structures (TLS), PD-L1 tumor proportion score (TPS) and the Tumor Inflammation score (TIS). Patients were randomly assigned to a training (n = 55) and validation cohort (n = 80). The primary outcome measure was Disease Control at 6 months (DC 6m) and the secondary outcome measure was DC at 12 months (DC 12m). Results: In the validation cohort, the two best performing composite biomarkers (i.e. CD8+IT-CD8 and CD3+IT-CD8) demonstrated similar or lower sensitivity (64% and 83%) and NPV (76% and 85%) compared to individual biomarkers PD-1T TILs and TIS (sensitivity: 72% and 83%, NPV: 86% and 84%) for DC 6m, respectively. Additionally, at 12 months, both selected composite biomarkers (CD8+IT-CD8 and CD8+TIS) demonstrated inferior predictive performance compared to PD-1T TILs and TIS alone. PD-1T TILs and TIS showed high sensitivity (86% and 100%) and NPV (95% and 100%) for DC 12m. PD-1T TILs could more accurately discriminate patients with no long-term benefit, as specificity was substantially higher compared to TIS (74% versus 39%). Conclusion: Composite biomarkers did not show improved predictive performance compared to PD-1T TILs and TIS alone for both the 6- and 12-month endpoints. PD-1T TILs and TIS identified patients with DC 12m with high sensitivity. Patients with no long-term benefit to PD-1 blockade were most accurately identified by PD-1T TILs. [ABSTRACT FROM AUTHOR]

Published
2024
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35. Design, validation and performance of aspartate aminotransferase- and lactate dehydrogenase-reporting algorithms for haemolysed specimens including correction within quality specifications.

Author

Colak, Selcuk, Tasdemir, Onur, van der Schaaf, Marianne, Opdam, Frans, van den Noort, Vincent, van den Broek, Daan, and van Rossum, Huub H

Subjects
CORRECTION factors, MEDICAL laboratories, ASPARTIC acid, EXPERIMENTAL design, ALGORITHMS
Abstract

Background: In vitro haemolysis is a major operational challenge for medical laboratories. A new experimental design was used to investigate under what conditions algorithms could be designed to report either quantitative or qualitative aspartate aminotransferase and lactate dehydrogenase results outside the manufacturer's haemolysis specifications. Quantitative corrections were required to meet prespecified quality specifications. Methods: Twenty-five patient samples were used to design reporting algorithms and another 41 patient samples were used to validate the algorithms. Aspartate aminotransferase, lactate dehydrogenase and haemolysis index were determined using a Cobas 6000 analyser (Roche diagnostics, Mannheim, Germany). Correction factors were determined, and the accuracy of the correction was investigated. Reporting algorithms were designed based on (i) the manufacturer's cut-off for the haemolysis index, (ii) corrections within the total allowable error specification and (iii) qualitative reporting based on obtained results. The impact of the reporting algorithms was retrospectively determined by recalculating six months of aspartate aminotransferase and lactate dehydrogenase results. Results: No correction for aspartate aminotransferase/lactate dehydrogenase was possible for results below the upper reference interval limit, while results equal to or greater than the upper reference interval limit could, up to mild haemolysis, be corrected within the total error criterion. All samples generated from the validated patient cohort fulfilled the set criteria. The algorithms allowed reporting 88.5% and 85.9% of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results, respectively. Conclusions: An approach is presented that allows to generate and validate reporting algorithms for aspartate aminotransferase and lactate dehydrogenase compatible with prespecified quality specifications. The designed algorithms resulted in a significant reduction of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma

Author

Vos, Joris L., Elbers, Joris B. W., Krijgsman, Oscar, Traets, Joleen J. H., Qiao, Xiaohang, van der Leun, Anne M., Lubeck, Yoni, Seignette, Iris M., Smit, Laura A., Willems, Stefan M., van den Brekel, Michiel W. M., Dirven, Richard, Baris Karakullukcu, M., Karssemakers, Luc, Klop, W. Martin C., Lohuis, Peter J. F. M., Schreuder, Willem H., Smeele, Ludi E., van der Velden, Lilly-Ann, Bing Tan, I., Onderwater, Suzanne, Jasperse, Bas, Vogel, Wouter V., Al-Mamgani, Abrahim, Keijser, Astrid, van der Noort, Vincent, Broeks, Annegien, Hooijberg, Erik, Peeper, Daniel S., Schumacher, Ton N., Blank, Christian U., de Boer, Jan Paul, Haanen, John B. A. G., and Zuur, Charlotte L.

Published
2021
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41. Efficacy and Safety of Panitumumab in Patients With RAF/RAS-Wild-Type Glioblastoma: Results From the Drug Rediscovery Protocol.

Author

Spiekman, Ilse A C, Geurts, Birgit S, Zeverijn, Laurien J, Wit, Gijs F de, van der Noort, Vincent, Roepman, Paul, Leng, Wendy W J de, Jansen, Anne M L, Kusters, Benno, Beerepoot, Laurens V, Vos, Filip Y F L de, Groot, Derk-Jan A de, Groot, Jan Willem B de, Hoeben, Ann, Buter, Jan, Gelderblom, Hans A J, Voest, Emile E, and Verheul, Henk M W

Subjects
PROTEIN metabolism, THERAPEUTIC use of monoclonal antibodies, GLIOMAS, PATIENT safety, CLINICAL trials, DESCRIPTIVE statistics, PANITUMUMAB, LONGITUDINAL method, DRUG efficacy, RESEARCH, TRANSFERASES, SURVIVAL analysis (Biometry), CONFIDENCE intervals, EPIDERMAL growth factor receptors, EVALUATION
Abstract

Background The prognosis of malignant primary high-grade brain tumors, predominantly glioblastomas, is poor despite intensive multimodality treatment options. In more than 50% of patients with glioblastomas, potentially targetable mutations are present, including rearrangements, altered splicing, and/or focal amplifications of epidermal growth factor receptor (EGFR) by signaling through the RAF / RAS pathway. We studied whether treatment with the clinically available anti- EGFR monoclonal antibody panitumumab provides clinical benefit for patients with RAF/RAS -wild-type (wt) glioblastomas in the Drug Rediscovery Protocol (DRUP). Methods Patients with progression of treatment refractory RAF / RASwt glioblastoma were included for treatment with panitumumab in DRUP when measurable according to RANO criteria. The primary endpoints of this study are clinical benefit (CB: defined as confirmed objective response [OR] or stable disease [SD] ≥ 16 weeks) and safety. Patients were enrolled using a Simon-like 2-stage model, with 8 patients in stage 1 and up to 24 patients in stage 2 if at least 1 in 8 patients had CB in stage 1. Results Between 03-2018 and 02-2022, 24 evaluable patients were treated. CB was observed in 5 patients (21%), including 2 patients with partial response (8.3%) and 3 patients with SD ≥ 16 weeks (12.5%). After median follow-up of 15 months, median progression-free survival and overall survival were 1.7 months (95% CI 1.6-2.1 months) and 4.5 months (95% CI 2.9-8.6 months), respectively. No unexpected toxicities were observed. Conclusions Panitumumab treatment provides limited CB in patients with recurrent RAF / RAS wt glioblastoma precluding further development of this therapeutic strategy. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Penile cancer care in the Netherlands: increased incidence, centralisation, and improved survival.

Author

Vreeburg, Manon T.A., de Vries, Hielke‐Martijn, van der Noort, Vincent, Horenblas, Simon, van Rhijn, Bas W.G., Hendricksen, Kees, Graafland, Niels, van der Poel, Henk G., and Brouwer, Oscar R.

Subjects
PENILE cancer, CANCER treatment, SQUAMOUS cell carcinoma, TUMOR classification, REGRESSION analysis, SURVIVAL rate
Abstract

Objective: To evaluate penile squamous cell carcinoma (PSCC) incidence and centralisation trends in the Netherlands over the past three decades, as well as the effect of centralisation of PSCC care on survival. Patients and methods: In the Netherlands PSCC care is largely centralised in one national centre of expertise (Netherlands Cancer Institute [NCI], Amsterdam). For this study, the Netherlands Cancer Registry, an independent nationwide cancer registry, provided per‐patient data on age, clinical and pathological tumour staging, follow‐up, and vital status. Patients with treatment at the NCI were identified and compared to patients who were treated at all other centres. The age‐standardised incidence rate was calculated with the European Standard Population. The probability of death due to PSCC was estimated using the relative survival. Multivariable Cox regression analysis was performed to evaluate predictors of survival. Results: A total of 3160 patients were diagnosed with PSCC between 1990 and 2020, showing a rising incidence (P < 0.001). Annual caseload increased at the NCI (1% in 1990, 65% in 2020) and decreased at other (regional) centres (99% to 35%). Despite a relatively high percentage of patients with T2–4 (64%) and N+ (33%) at the NCI, the 5‐year relative survival was higher (86%, 95% confidence interval [CI] 82–91%) compared to regional centres (76%, 95% CI 73–80%, P < 0.001). Patients with a pathological T2 tumour were treated with glans‐sparing treatment more often at the reference centre than at the regional centres (16% vs 5.0%, P < 0.001). After adjusting for age, histological grading, T‐stage, presence of lymph node involvement and year of diagnosis, treatment at regional centres remained a predictor for worse survival (hazard ratio 1.22, 95% CI 1.05–1.39; P = 0.006). Conclusion: The incidence of PSCC in the Netherlands has been gradually increasing over the past three decades, with a noticeable trend towards centralisation of PSCC care and improved relative survival rate. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Optimising primary molecular profiling in non-small cell lung cancer

Author

Schouten, Robert Dirk, primary, Schouten, Irene, additional, Schuurbiers, Milou, additional, Van der Noort, Vincent, additional, Damhuis, Ronald, additional, Van der Heijden, Erik, additional, Burgers, Sjaak, additional, Barlo, Nicole, additional, Van Lindert, Anne, additional, Maas, Klaar, additional, Van den Brand, Joop, additional, Smit, Arthur, additional, Van Haarst, Jan-Maarten, additional, Van der Maat, Bas, additional, Schuuring, Ed, additional, Blaauwgeers, Hans, additional, Willems, Stefan, additional, Monkhorst, Kim, additional, Van den Broek, Daan, additional, and Van den Heuvel, Michel, additional

Published
2023
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45. Blood platelet RNA profiles do not enable for nivolumab response prediction at baseline in patients with non-small cell lung cancer.

Author

Muller, Mirte, Best, Myron G., van der Noort, Vincent, Hiltermann, T. Jeroen N., Niemeijer, Anna-Larissa N., Post, Edward, Sol, Nik, In 't Veld, Sjors G.J.G., Nogarede, Tineke, Visser, Lisanne, Schouten, Robert D., van den Broek, Daan, Hummelink, Karlijn, Monkhorst, Kim, de Langen, Adrianus J., Schuuring, Ed, Smit, Egbert F., Groen, Harry J.M., Wurdinger, Thomas, and van den Heuvel, Michel M.

Subjects
NON-small-cell lung carcinoma, BLOOD platelets, NIVOLUMAB, RNA, SUPPORT vector machines
Abstract

BACKGROUND: Anti-PD-(L)1 immunotherapy has emerged as a promising treatment approach for non-small cell lung cancer (NSCLC), though the response rates remain low. Pre-treatment response prediction may improve patient allocation for immunotherapy. Blood platelets act as active immune-like cells, thereby constraining T-cell activity, propagating cancer metastasis, and adjusting their spliced mRNA content. OBJECTIVE: We investigated whether platelet RNA profiles before start of nivolumab anti-PD1 immunotherapy may predict treatment responses. METHODS: We performed RNA-sequencing of platelet RNA samples isolated from stage III-IV NSCLC patients before treatment with nivolumab. Treatment response was scored by the RECIST-criteria. Data were analyzed using a predefined thromboSeq analysis including a particle-swarm-enhanced support vector machine (PSO/SVM) classification algorithm. RESULTS: We collected and processed a 286-samples cohort, separated into a training/evaluation and validation series and subjected those to training of the PSO/SVM-classification algorithm. We observed only low classification accuracy in the 107-samples validation series (area under the curve (AUC) training series: 0.73 (95% -CI: 0.63–0.84, n = 88 samples), AUC evaluation series: 0.64 (95% -CI: 0.51–0.76, n = 91 samples), AUC validation series: 0.58 (95% -CI: 0.45–0.70, n = 107 samples)), employing a five-RNAs biomarker panel. CONCLUSIONS: We concluded that platelet RNA may have minimally discriminative capacity for anti-PD1 nivolumab response prediction, with which the current methodology is insufficient for diagnostic application. [ABSTRACT FROM AUTHOR]

Published
2024
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48. External validation of the Rotterdam Prostate Cancer Risk Calculator within a Dutch high-risk clinical cohort

Author

Hagens, Marinus J., primary, Stelwagen, Piter J., additional, Veerman, Hans, additional, Rynja, Sybren P., additional, Smeenge, Martijn, additional, van der Noort, Vincent, additional, Roeleveld, Ton A., additional, van Kesteren, Jolien, additional, Remmers, Sebastiaan, additional, Roobol, Monique J., additional, van Leeuwen, Pim J., additional, and van der Poel, Henk G., additional

Published
2023
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49. Supplementary Figure from PD-1T TILs as a Predictive Biomarker for Clinical Benefit to PD-1 Blockade in Patients with Advanced NSCLC

Author

Hummelink, Karlijn, primary, van der Noort, Vincent, primary, Muller, Mirte, primary, Schouten, Robert D., primary, Lalezari, Ferry, primary, Peters, Dennis, primary, Theelen, Willemijn S.M.E., primary, Koelzer, Viktor H., primary, Mertz, Kirsten D., primary, Zippelius, Alfred, primary, van den Heuvel, Michel M., primary, Broeks, Annegien, primary, Haanen, John B.A.G., primary, Schumacher, Ton N., primary, Meijer, Gerrit A., primary, Smit, Egbert F., primary, Monkhorst, Kim, primary, and Thommen, Daniela S., primary

Published
2023
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50. Supplementary Data from PD-1T TILs as a Predictive Biomarker for Clinical Benefit to PD-1 Blockade in Patients with Advanced NSCLC

Author

Hummelink, Karlijn, primary, van der Noort, Vincent, primary, Muller, Mirte, primary, Schouten, Robert D., primary, Lalezari, Ferry, primary, Peters, Dennis, primary, Theelen, Willemijn S.M.E., primary, Koelzer, Viktor H., primary, Mertz, Kirsten D., primary, Zippelius, Alfred, primary, van den Heuvel, Michel M., primary, Broeks, Annegien, primary, Haanen, John B.A.G., primary, Schumacher, Ton N., primary, Meijer, Gerrit A., primary, Smit, Egbert F., primary, Monkhorst, Kim, primary, and Thommen, Daniela S., primary

Published
2023
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