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123 results on '"Sinnige, Harm"'

1. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Published
2022
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2. Improving the identification of frail elderly newly diagnosed multiple myeloma patients

Author

Stege, Claudia A. M., Nasserinejad, Kazem, Klein, Saskia K., Timmers, Gert-Jan, Hoogendoorn, Mels, Ypma, Paula F., Nijhof, Inger S., Velders, Gerjo A., Strobbe, Leonie, Durdu-Rayman, Nazik, Westerman, Matthijs, Davidis-van Schoonhoven, Marjan A., van Kampen, Roel J. W., Beeker, Aart, Koster, Ad, Dijk, Amanda C., van de Donk, Niels W. C. J., van der Spek, Ellen, Leys, Rineke B. L., Silbermann, Matthijs H., Groen, Kaz, van der Burg-de Graauw, Nicole C. H. P., Sinnige, Harm A. M., van der Hem, Klaas G., Levenga, Henriette, Bilgin, Yavuz M., Sonneveld, Pieter, Levin, Mark-David, and Zweegman, Sonja

Published
2021
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3. Thalidomide before and after autologous stem cell transplantation in recently diagnosed multiple myeloma (HOVON-50): long-term results from the phase 3, randomised controlled trial

Author

van de Donk, Niels WCJ, van der Holt, Bronno, Minnema, Monique C, Vellenga, Edo, Croockewit, Sandra, Kersten, Marie José, von dem Borne, Peter A, Ypma, Paula, Schaafsma, Ron, de Weerdt, Okke, Klein, Saskia K, Delforge, Michel, Levin, Mark-David, Bos, Gerard M, Jie, Kon-Siong G, Sinnige, Harm, Coenen, Jules LLM, de Waal, Esther G, Zweegman, Sonja, Sonneveld, Pieter, and Lokhorst, Henk M

Published
2018
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4. Melphalan, prednisone, and lenalidomide versus melphalan, prednisone, and thalidomide in untreated multiple myeloma

Author

Zweegman, Sonja, van der Holt, Bronno, Mellqvist, Ulf-Henrik, Salomo, Morten, Bos, Gerard M.J., Levin, Mark-David, Visser-Wisselaar, Heleen, Hansson, Markus, van der Velden, Annette W.G., Deenik, Wendy, Gruber, Astrid, Coenen, Juleon L.L.M., Plesner, Torben, Klein, Saskia K., Tanis, Bea C., Szatkowski, Damian L., Brouwer, Rolf E., Westerman, Matthijs, Leys, M.(Rineke) B.L., Sinnige, Harm A.M., Haukås, Einar, van der Hem, Klaas G., Durian, Marc F., Mattijssen, E.(Vera)J.M., van de Donk, Niels W.C.J., Stevens-Kroef, Marian J.P.L., Sonneveld, Pieter, and Waage, Anders

Published
2016
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6. Addition of the nuclear export inhibitor selinexor to standard intensive treatment for elderly patients with AML and high risk MDS

Author

Janssen, Jeroen, primary, Löwenberg, Bob, additional, Manz, Markus, additional, Biemond, Bart, additional, Westerweel, Peter, additional, Klein, Saskia, additional, Fehr, Martin, additional, Sinnige, Harm, additional, Efthymiou, Anna, additional, Legdeur, M, additional, Pabst, Thomas, additional, Gregor, Michael, additional, Poel, Marjolein van der, additional, Deeren, Dries, additional, Tick, Lidwine, additional, Jongen-Lavrencic, Mojca, additional, Obbergh, Florence, additional, Boersma, Rinske, additional, de Weerdt, Okke, additional, Chalandon, Yves, additional, Heim, Dominik, additional, spertini, Olivier, additional, Sluis, Geerte van, additional, Graux, Carlos, additional, Stuessi, Georg., additional, Norden, Yvette van, additional, and Ossenkoppele, Gert, additional

Published
2022
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7. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial.

Author

UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - (SLuc) Service d'hématologie, Rijneveld, Anita W, van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J, van de Loosdrecht, Arjen A, van der Wagen, Lotte E, Bellido, Mar, van Gelder, Michel, van der Velden, Walter J F M, Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J M, Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L, Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A M, Breems, Dimitri A, Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E, Boersma, Rinske S, Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W, Beel, Karolien, Maertens, Johan A, Beverloo, H Berna, Bakkus, Marleen, Homburg, Christa H E, de Haas, Valerie, van der Velden, Vincent H J, Cornelissen, Jan J, Dutch-Belgian HOVON Cooperative group, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - (SLuc) Service d'hématologie, Rijneveld, Anita W, van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J, van de Loosdrecht, Arjen A, van der Wagen, Lotte E, Bellido, Mar, van Gelder, Michel, van der Velden, Walter J F M, Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J M, Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L, Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A M, Breems, Dimitri A, Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E, Boersma, Rinske S, Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W, Beel, Karolien, Maertens, Johan A, Beverloo, H Berna, Bakkus, Marleen, Homburg, Christa H E, de Haas, Valerie, van der Velden, Vincent H J, Cornelissen, Jan J, and Dutch-Belgian HOVON Cooperative group

Abstract

Clofarabine (CLO) is a nucleoside analog with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase 3 study aimed to evaluate whether CLO added to induction and whether consolidation would improve outcome in adults with newly diagnosed ALL. Treatment of younger (18-40 years) patients consisted of a pediatric-inspired protocol, and for older patients (41-70 years), a semi-intensive protocol was used. Three hundred and forty patients were randomized. After a median follow-up of 70 months, 5-year event-free survival (EFS) was 50% and 53% for arm A and B (CLO arm). For patients ≤40 years, EFS was 58% vs 65% in arm A vs B, whereas in patients >40 years, EFS was 43% in both arms. Complete remission (CR) rate was 89% in both arms and similar in younger and older patients. Minimal residual disease (MRD) was assessed in 200 patients (60%). Fifty-four of 76 evaluable patients (71%) were MRD- after consolidation 1 in arm A vs 75/81 (93%) in arm B (P = .001). Seventy (42%) patients proceeded to allogeneic hematopoietic stem cell transplantation in both arms. Five-year overall survival (OS) was similar in both arms: 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and nonrelapse mortality was 16% vs 17% after CR. CLO-treated patients experienced more serious adverse events, more infections, and more often went off protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity. This trial was registered at www.trialregister.nl as #NTR2004.

Published
2022

8. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL:the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Danie€lle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurelie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., Cornelissen, Jan J., Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Danie€lle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurelie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Abstract

Clofarabine (CLO) is a nucleoside analog with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase 3 study aimed to evaluate whether CLO added to induction and whether consolidation would improve outcome in adults with newly diagnosed ALL. Treatment of younger (18-40 years) patients consisted of a pediatric-inspired protocol, and for older patients (41-70 years), a semi-intensive protocol was used. Three hundred and forty patients were randomized. After a median follow-up of 70 months, 5-year event-free survival (EFS) was 50% and 53% for arm A and B (CLO arm). For patients #40 years, EFS was 58% vs 65% in arm A vs B, whereas in patients .40 years, EFS was 43% in both arms. Complete remission (CR) rate was 89% in both arms and similar in younger and older patients. Minimal residual disease (MRD) was assessed in 200 patients (60%). Fifty-four of 76 evaluable patients (71%) were MRD2 after consolidation 1 in arm A vs 75/81 (93%) in arm B (P 5 .001). Seventy (42%) patients proceeded to allogeneic hematopoietic stem cell transplantation in both arms. Five-year overall survival (OS) was similar in both arms: 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and nonrelapse mortality was 16% vs 17% after CR. CLO-treated patients experienced more serious adverse events, more infections, and more often went off protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity.

Published
2022

9. A randomized phase 3 study on the effect of thalidomide combined with adriamycin, dexamethasone, and high-dose melphalan, followed by thalidomide maintenance in patients with multiple myeloma

Author

Lokhorst, Henk M., van der Holt, Bronno, Zweegman, Sonja, Vellenga, Edo, Croockewit, Sandra, van Oers, Marinus H., von dem Borne, Peter, Wijermans, Pierre, Schaafsma, Ron, de Weerdt, Okke, Wittebol, Shulamiet, Delforge, Michel, Berenschot, Henriëtte, Bos, Gerard M., Jie, Kon-Siong G., Sinnige, Harm, van Marwijk-Kooy, Marinus, Joosten, Peter, Minnema, Monique C., van Ammerlaan, Rianne, and Sonneveld, Pieter

Published
2010
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10. High-dose imatinib versus high-dose imatinib in combination with intermediate-dose cytarabine in patients with first chronic phase myeloid leukemia: a randomized phase III trial of the Dutch-Belgian HOVON study group

Author

Thielen, Noortje, van der Holt, Bronno, Verhoef, Gregor E. G., Ammerlaan, Rianne A. H. M., Sonneveld, Pieter, Janssen, Jeroen J. W. M., Deenik, Wendy, Falkenburg, J. H. Frederik, Kersten, Marie José, Sinnige, Harm A. M., Schipperus, Martin, Schattenberg, Anton, van Marwijk Kooy, Rien, Smit, Willem M., Chu, Isabel W. T., Valk, Peter J. M., Ossenkoppele, Gert J., and Cornelissen, Jan J.

Published
2013
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11. Inferior Outcome of Addition of the Aminopeptidase Inhibitor Tosedostat to Standard Intensive Treatment for Elderly Patients with AML and High Risk MDS

Author

UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Janssen, Jeroen, Löwenberg, Bob, Manz, Markus, Bargetzi, Mario, Biemond, Bart, Borne, Peter von dem, Breems, Dimitri, Brouwer, Rolf, Chalandon, Yves, Deeren, Dries, Efthymiou, Anna, Gjertsen, Bjørn-Tore, Graux, Carlos, Gregor, Michael, Heim, Dominik, Hess, Urs, Hoogendoorn, Mels, Jaspers, Aurelie, Jie, Asiong, Jongen-Lavrencic, Mojca, Klein, Saskia, Klift, Marjolein van der, Kuball, Jürgen, Lammeren-Venema, Danielle van, Legdeur, Marie-Cecile, Loosdrecht, Arjan van de, Maertens, Johan, Kooy, Marinus van Marwijk, Moors, Ine, Nijziel, Marten, Obbergh, Florence van, Oosterveld, Margriet, Pabst, Thomas, Poel, Marjolein van der, Sinnige, Harm, Spertini, Olivier, Terpstra, Wim, Tick, Lidwine, Velden, Walter van der, Vekemans, Marie-Christiane, Vellenga, Edo, Weerdt, Okke de, Westerweel, Peter, Stüssi, Georg, Norden, Yvette van, Ossenkoppele, Gert, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Janssen, Jeroen, Löwenberg, Bob, Manz, Markus, Bargetzi, Mario, Biemond, Bart, Borne, Peter von dem, Breems, Dimitri, Brouwer, Rolf, Chalandon, Yves, Deeren, Dries, Efthymiou, Anna, Gjertsen, Bjørn-Tore, Graux, Carlos, Gregor, Michael, Heim, Dominik, Hess, Urs, Hoogendoorn, Mels, Jaspers, Aurelie, Jie, Asiong, Jongen-Lavrencic, Mojca, Klein, Saskia, Klift, Marjolein van der, Kuball, Jürgen, Lammeren-Venema, Danielle van, Legdeur, Marie-Cecile, Loosdrecht, Arjan van de, Maertens, Johan, Kooy, Marinus van Marwijk, Moors, Ine, Nijziel, Marten, Obbergh, Florence van, Oosterveld, Margriet, Pabst, Thomas, Poel, Marjolein van der, Sinnige, Harm, Spertini, Olivier, Terpstra, Wim, Tick, Lidwine, Velden, Walter van der, Vekemans, Marie-Christiane, Vellenga, Edo, Weerdt, Okke de, Westerweel, Peter, Stüssi, Georg, Norden, Yvette van, and Ossenkoppele, Gert

Abstract

Treatment results of AML in elderly patients are unsatisfactory. We hypothesized that addition of tosedostat, an aminopeptidase inhibitor, to intensive chemotherapy may improve outcome in this population. After establishing a safe dose in a run-in phase of the study in 22 patients, 231 eligible patients with AML above 65 years of age (median 70, range 66-81) were randomly assigned in this open label randomized Phase II study to receive standard chemotherapy (3+7) with or without tosedostat at the selected daily dose of 120 mg (n = 116), days 1-21. In the second cycle, patients received cytarabine 1000 mg/m2 twice daily on days 1-6 with or without tosedostat. CR/CRi rates in the 2 arms were not significantly different (69% (95% C.I. 60-77%) vs 64% (55-73%), respectively). At 24 months, event-free survival (EFS) was 20% for the standard arm versus 12% for the tosedostat arm (Cox-p = 0.01) and overall survival (OS) 33% vs 18% respectively (p = 0.006). Infectious complications accounted for an increased early death rate in the tosedostat arm. Atrial fibrillation was more common in the tosedostat arm as well. The results of the present study show that the addition of tosedostat to standard chemotherapy does negatively affect the therapeutic outcome of elderly AML patients.

Published
2021

12. Improving the identification of frail elderly newly diagnosed multiple myeloma patients

Author

Stege, Claudia A.M., Nasserinejad, Kazem, Klein, Saskia K., Timmers, Gert Jan, Hoogendoorn, Mels, Ypma, Paula F., Nijhof, Inger S., Velders, Gerjo A., Strobbe, Leonie, Durdu-Rayman, Nazik, Westerman, Matthijs, Davidis-van Schoonhoven, Marjan A., van Kampen, Roel J.W., Beeker, Aart, Koster, Ad, Dijk, Amanda C., van de Donk, Niels W.C.J., van der Spek, Ellen, Leys, Rineke B.L., Silbermann, Matthijs H., Groen, Kaz, van der Burg-de Graauw, Nicole C.H.P., Sinnige, Harm A.M., van der Hem, Klaas G., Levenga, Henriette, Bilgin, Yavuz M., Sonneveld, Pieter, Levin, Mark David, Zweegman, Sonja, Stege, Claudia A.M., Nasserinejad, Kazem, Klein, Saskia K., Timmers, Gert Jan, Hoogendoorn, Mels, Ypma, Paula F., Nijhof, Inger S., Velders, Gerjo A., Strobbe, Leonie, Durdu-Rayman, Nazik, Westerman, Matthijs, Davidis-van Schoonhoven, Marjan A., van Kampen, Roel J.W., Beeker, Aart, Koster, Ad, Dijk, Amanda C., van de Donk, Niels W.C.J., van der Spek, Ellen, Leys, Rineke B.L., Silbermann, Matthijs H., Groen, Kaz, van der Burg-de Graauw, Nicole C.H.P., Sinnige, Harm A.M., van der Hem, Klaas G., Levenga, Henriette, Bilgin, Yavuz M., Sonneveld, Pieter, Levin, Mark David, and Zweegman, Sonja

Published
2021

13. Inferior Outcome of Addition of the Aminopeptidase Inhibitor Tosedostat to Standard Intensive Treatment for Elderly Patients with AML and High Risk MDS

Author

CTI Kuball, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Janssen, Jeroen, Löwenberg, Bob, Manz, Markus, Bargetzi, Mario, Biemond, Bart, Borne, Peter von dem, Breems, Dimitri, Brouwer, Rolf, Chalandon, Yves, Deeren, Dries, Efthymiou, Anna, Gjertsen, Bjørn-Tore, Graux, Carlos, Gregor, Michael, Heim, Dominik, Hess, Urs, Hoogendoorn, Mels, Jaspers, Aurelie, Jie, Asiong, Jongen-Lavrencic, Mojca, Klein, Saskia, Klift, Marjolein van der, Kuball, Jürgen, Lammeren-Venema, Danielle van, Legdeur, Marie-Cecile, Loosdrecht, Arjan van de, Maertens, Johan, Kooy, Marinus van Marwijk, Moors, Ine, Nijziel, Marten, Obbergh, Florence van, Oosterveld, Margriet, Pabst, Thomas, Poel, Marjolein van der, Sinnige, Harm, Spertini, Olivier, Terpstra, Wim, Tick, Lidwine, Velden, Walter van der, Vekemans, Marie-Christiane, Vellenga, Edo, Weerdt, Okke de, Westerweel, Peter, Stüssi, Georg, Norden, Yvette van, Ossenkoppele, Gert, CTI Kuball, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Janssen, Jeroen, Löwenberg, Bob, Manz, Markus, Bargetzi, Mario, Biemond, Bart, Borne, Peter von dem, Breems, Dimitri, Brouwer, Rolf, Chalandon, Yves, Deeren, Dries, Efthymiou, Anna, Gjertsen, Bjørn-Tore, Graux, Carlos, Gregor, Michael, Heim, Dominik, Hess, Urs, Hoogendoorn, Mels, Jaspers, Aurelie, Jie, Asiong, Jongen-Lavrencic, Mojca, Klein, Saskia, Klift, Marjolein van der, Kuball, Jürgen, Lammeren-Venema, Danielle van, Legdeur, Marie-Cecile, Loosdrecht, Arjan van de, Maertens, Johan, Kooy, Marinus van Marwijk, Moors, Ine, Nijziel, Marten, Obbergh, Florence van, Oosterveld, Margriet, Pabst, Thomas, Poel, Marjolein van der, Sinnige, Harm, Spertini, Olivier, Terpstra, Wim, Tick, Lidwine, Velden, Walter van der, Vekemans, Marie-Christiane, Vellenga, Edo, Weerdt, Okke de, Westerweel, Peter, Stüssi, Georg, Norden, Yvette van, and Ossenkoppele, Gert

Published
2021

16. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer

Author

Tol, Jolien, Koopman, Miriam, Cats, Annemieke, Rodenburg, Cees J., Creemers, Geert J.M., Schrama, Jolanda G., Erdkamp, Frans L.G., Vos, Allert H., van Groeningen, Cees J., Sinnige, Harm A.M., Richel, Dirk J., Voest, Emile E., Dijkstra, Jeroen R., Vink-Borger, Marianne E., Antonini, Ninja F., Mol, Linda, van Kriekan, Johan H.J.M., Dalesio, Otilia, and Punt, Cornelis J.A.

Subjects
Colorectal cancer -- Care and treatment, Chemotherapy -- Usage, Chemotherapy -- Health aspects, Cancer -- Chemotherapy, Cancer -- Usage, Cancer -- Health aspects
Abstract

A study was conducted to evaluate the effect of addition of cetuximab to bevacizumab and chemotherapy in the treatment of metastatic colorectal cancer. Results indicated that the addition of cetuximab to the prescribed treatment resulted in a poorer quality of life and increased the risk of adverse effects among patients with colorectal cancer.

Published
2009

17. Inferior Outcome of Addition of the Aminopeptidase Inhibitor Tosedostat to Standard Intensive Treatment for Elderly Patients with AML and High Risk MDS

Author

Janssen, Jeroen, primary, Löwenberg, Bob, additional, Manz, Markus, additional, Bargetzi, Mario, additional, Biemond, Bart, additional, Borne, Peter von dem, additional, Breems, Dimitri, additional, Brouwer, Rolf, additional, Chalandon, Yves, additional, Deeren, Dries, additional, Efthymiou, Anna, additional, Gjertsen, Bjørn-Tore, additional, Graux, Carlos, additional, Gregor, Michael, additional, Heim, Dominik, additional, Hess, Urs, additional, Hoogendoorn, Mels, additional, Jaspers, Aurelie, additional, Jie, Asiong, additional, Jongen-Lavrencic, Mojca, additional, Klein, Saskia, additional, Klift, Marjolein van der, additional, Kuball, Jürgen, additional, Lammeren-Venema, Danielle van, additional, Legdeur, Marie-Cecile, additional, Loosdrecht, Arjan van de, additional, Maertens, Johan, additional, Kooy, Marinus van Marwijk, additional, Moors, Ine, additional, Nijziel, Marten, additional, Obbergh, Florence van, additional, Oosterveld, Margriet, additional, Pabst, Thomas, additional, Poel, Marjolein van der, additional, Sinnige, Harm, additional, Spertini, Olivier, additional, Terpstra, Wim, additional, Tick, Lidwine, additional, Velden, Walter van der, additional, Vekemans, Marie-Christiane, additional, Vellenga, Edo, additional, Weerdt, Okke de, additional, Westerweel, Peter, additional, Stüssi, Georg, additional, Norden, Yvette van, additional, and Ossenkoppele, Gert, additional

Published
2021
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18. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial

Author

Koopman, Miriam, Antonini, Ninja F, Douma, Joep, Wals, Jaap, Honkoop, Aafke H, Erdkamp, Frans LG, de Jong, Robert S, Rodenburg, Cees J, Vreugdenhil, Gerard, Loosveld, Olaf JL, van Bochove, Aart, Sinnige, Harm AM, Creemers, Geert-Jan M, Tesselaar, Margot ET, Slee, Peter H Th J, Werter, Marjon JBP, Mol, Linda, Dalesio, Otilia, and Punt, Cornelis JA

Published
2007
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20. Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients

Author

Huls, Gerwin, Chitu, Dana A, Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A, Biemond, Bart J, Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J, Vellenga, Edo, Löwenberg, Bob, Huls, Gerwin, Chitu, Dana A, Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A, Biemond, Bart J, Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J, Vellenga, Edo, and Löwenberg, Bob

Published
2019

21. Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients

Author

UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, Huls, Gerwin, Chitu, Dana A., Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A., Biemond, Bart J., Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J., Vellenga, Edo, Löwenberg, Bob, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, Huls, Gerwin, Chitu, Dana A., Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A., Biemond, Bart J., Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J., Vellenga, Edo, and Löwenberg, Bob

Abstract

The prevention of relapse is the major therapeutic challenge in older patients with acute myeloid leukemia (AML) who have obtained a complete remission (CR) on intensive chemotherapy. In this randomized phase 3 study (HOVON97) in older patients (≥60 years) with AML or myelodysplastic syndrome with refractory anemia with excess of blasts, in CR/CR with incomplete hematologic recovery (CRi) after at least 2 cycles of intensive chemotherapy, we assessed the value of azacitidine as postremission therapy with respect to disease-free survival (DFS; primary end point) and overall survival (OS; secondary end point). In total, 116 eligible patients were randomly (1:1) assigned to either observation (N = 60) or azacitidine maintenance (N = 56; 50 mg/m2, subcutaneously, days 1-5, every 4 weeks) until relapse, for a maximum of 12 cycles. Fifty-five patients received at least 1 cycle of azacitidine, 46 at least 4 cycles, and 35 at least 12 cycles. The maintenance treatment with azacitidine was feasible. DFS was significantly better for the azacitidine treatment group (logrank; P = .04), as well as after adjustment for poor-risk cytogenetic abnormalities at diagnosis and platelet count at randomization (as surrogate for CR vs CRi; Cox regression; hazard ratio, 0.62; 95% confidence interval, 0.41-0.95; P = .026). The 12-month DFS was estimated at 64% for the azacitidine group and 42% for the control group. OS did not differ between treatment groups, with and without censoring for allogeneic hematopoietic cell transplantation. Rescue treatment was used more often in the observation group (n = 32) than in the azacitidine maintenance group (n = 9). We conclude that azacitidine maintenance after CR/CRi after intensive chemotherapy is feasible and significantly improves DFS. The study is registered with The Netherlands Trial Registry (NTR1810) and EudraCT (2008-001290-15).

Published
2019

22. Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients

Author

MS Hematologie, Cancer, Regenerative Medicine and Stem Cells, Infection & Immunity, CTI Kuball, Huls, Gerwin, Chitu, Dana A, Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A, Biemond, Bart J, Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J, Vellenga, Edo, Löwenberg, Bob, MS Hematologie, Cancer, Regenerative Medicine and Stem Cells, Infection & Immunity, CTI Kuball, Huls, Gerwin, Chitu, Dana A, Havelange, Violaine, Jongen-Lavrencic, Mojca, van de Loosdrecht, Arjan A, Biemond, Bart J, Sinnige, Harm, Hodossy, Beata, Graux, Carlos, van Marwijk Kooy, Rien, de Weerdt, Okke, Breems, Dimitri, Klein, Saskia, Kuball, Jürgen, Deeren, Dries, Terpstra, Wim, Vekemans, Marie-Christiane, Ossenkoppele, Gert J, Vellenga, Edo, and Löwenberg, Bob

Published
2019

23. Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study

Author

Nielsen, Lene Kongsgaard, primary, Stege, Claudia, additional, Lissenberg-Witte, Birgit, additional, van der Holt, Bronno, additional, Mellqvist, Ulf-Henrik, additional, Salomo, Morten, additional, Bos, Gerard, additional, Levin, Mark-David, additional, Visser-Wisselaar, Heleen, additional, Hansson, Markus, additional, van der Velden, Annette, additional, Deenik, Wendy, additional, Coenen, Juleon, additional, Hinge, Maja, additional, Klein, Saskia, additional, Tanis, Bea, additional, Szatkowski, Damian, additional, Brouwer, Rolf, additional, Westerman, Matthijs, additional, Leys, Rineke, additional, Sinnige, Harm, additional, Haukås, Einar, additional, van der Hem, Klaas, additional, Durian, Marc, additional, Gimsing, Peter, additional, van de Donk, Niels, additional, Sonneveld, Pieter, additional, Waage, Anders, additional, Abildgaard, Niels, additional, and Zweegman, Sonja, additional

Published
2019
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24. Health-Related Quality of Life in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Either Thalidomide or Lenalidomide-Based Regimen Until Progression (HOVON-87/NMSG18 Study): A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Study

Author

Nielsen, Lene Kongsgaard, primary, Stege, Claudia, additional, Lissenberg-Witte, Birgit, additional, van der Holt, Bronno, additional, Mellqvist, Ulf-Henrik, additional, Salomo, Morten, additional, Bos, Gerard M., additional, Levin, Mark-David, additional, Visser-Wisselaar, Heleen, additional, Hansson, Markus, additional, van der Velden, Annette, additional, Deenik, Wendy, additional, Coenen, Juleon, additional, Hinge, Maja, additional, Klein, Saskia K., additional, Szatkowski, Damian, additional, Westerman, Matthijs, additional, Leys, Rineke, additional, Sinnige, Harm, additional, Haukas, Einar, additional, van der Hem, Klaas, additional, Gimsing, Peter, additional, van de Donk, Niels, additional, Sonneveld, Pieter, additional, Waage, Anders, additional, Abildgaard, Niels, additional, and Zweegman, Sonja, additional

Published
2019
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25. Case report : Coxiella burnetii vascular infection and lymphoma in the Netherlands

Author

van Roeden, Sonja E., Melenotte, Cléa, Hermans, Mirjam H.A., Sinnige, Harm A M, Nooijen, Peet T. G. A., Audoly, Gilles, Hoepelman, Andy I.M., Oosterheert, Jan Jelrik, Raoult, Didier, Wever, Peter C., van Roeden, Sonja E., Melenotte, Cléa, Hermans, Mirjam H.A., Sinnige, Harm A M, Nooijen, Peet T. G. A., Audoly, Gilles, Hoepelman, Andy I.M., Oosterheert, Jan Jelrik, Raoult, Didier, and Wever, Peter C.

Published
2018

26. Case report: Coxiella burnetii vascular infection and lymphoma in the Netherlands

Author

UMC Utrecht, MS Infectieziekten, Circulatory Health, Infection & Immunity, MS Interne Geneeskunde, van Roeden, Sonja E., Melenotte, Cléa, Hermans, Mirjam H.A., Sinnige, Harm A M, Nooijen, Peet T. G. A., Audoly, Gilles, Hoepelman, Andy I.M., Oosterheert, Jan Jelrik, Raoult, Didier, Wever, Peter C., UMC Utrecht, MS Infectieziekten, Circulatory Health, Infection & Immunity, MS Interne Geneeskunde, van Roeden, Sonja E., Melenotte, Cléa, Hermans, Mirjam H.A., Sinnige, Harm A M, Nooijen, Peet T. G. A., Audoly, Gilles, Hoepelman, Andy I.M., Oosterheert, Jan Jelrik, Raoult, Didier, and Wever, Peter C.

Published
2018

27. Thalidomide before and after autologous stem cell transplantation in recently diagnosed multiple myeloma (HOVON-50): long-term results from the phase 3, randomised controlled trial

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, van de Donk, Niels WCJ, van der Holt, Bronno, Minnema, Monique C., Vellenga, Edo, Croockewit, Sandra, Kersten, Marie José, von dem Borne, Peter A., Ypma, Paula, Schaafsma, Ron, de Weerdt, Okke, Klein, Saskia K., Delforge, Michel, Levin, Mark David, Bos, Gerard M., Jie, Kon Siong G., Sinnige, Harm, Coenen, Jules LLM, de Waal, Esther G., Zweegman, Sonja, Sonneveld, Pieter, Lokhorst, Henk M., MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, van de Donk, Niels WCJ, van der Holt, Bronno, Minnema, Monique C., Vellenga, Edo, Croockewit, Sandra, Kersten, Marie José, von dem Borne, Peter A., Ypma, Paula, Schaafsma, Ron, de Weerdt, Okke, Klein, Saskia K., Delforge, Michel, Levin, Mark David, Bos, Gerard M., Jie, Kon Siong G., Sinnige, Harm, Coenen, Jules LLM, de Waal, Esther G., Zweegman, Sonja, Sonneveld, Pieter, and Lokhorst, Henk M.

Published
2018

28. 5-fluorouracil/leucovorin/interferon alpha-2a in patients with advanced colorectal cancer; effects of maintenance therapy on remission duration

Author

Buter, Jan, Sinnige, Harm A.M., Sleijfer, Dirk Th., Vries, Elisabeth G.E. de, Willemse, Pax H.B., Graaf, Winette T.A. van der, Verschueren, Rene C.J., and Mulder, Nanno H.

Subjects
Colorectal cancer, Interferon alpha -- Health aspects, Fluorouracil -- Health aspects, Leucovorin -- Health aspects, Health
Abstract

Background. A Phase II study of combination treatment with 5-fluorouracil (5-FU), leucovorin (LV), and interferon alpha-2a (IFN) in patients with previously untreated metastatic colorectal cancer was previously reported by the authors. Therapy was on an outpatient basis and consisted of LV 60 mg orally every 8 hours days 1-3, IFN 18 X [10.sup.6] IU subcutaneously days 1-3, and bolus 5-FU 750 mg/[m.sup.2] intravenously days 2-3. Treatment was repeated every 14 days, until a maximum of 8 courses was administered. A response rate of 54% [95% confidence interval (CI), 34-72%] was observed. However, remission duration after cessation of therapy was short, with a median duration of 5 months (range, 2 to 13+ months). Methods. Subsequent to the above study, patients on this induction treatment who achieved remission received maintenance therapy: the above described 3-day regimen every 6 weeks until progression, for a maximum of 2 years. Results. Fifty-three patients were enrolled in the induction regimen and 18 out of 29 patients who achieved remission received maintenance treatment. In 50 assessable patients 3 complete recoveries and 26 partial recoveries were observed for a response rate of 58% (CI, 43-72%). Median remission duration of patients receiving maintenance therapy was 9.4 months (CI, 8.4-10.3 months) compared with 4.7 months (CI, 3.2-6.2 months) for patients without maintenance therapy. Median overall survival of all patients was 16.6 months. Toxicity of maintenance therapy was confined to WHO grade 2. Conclusions. The high response rate of this 5-FU/LV/IFN regimen holds true in a larger group of patients. The group that received maintenance treatment had a remission duration of just over 9 months, the maintenance regimen added little toxicity. Cancer 1995;75:1072-6. Key words: interferon, 5-fluorouracil, leucovorin, colorectal cancer, clinical trial, remission duration.

Published
1995

29. Quality of life with melphalan/prednisone plus either thalidomide (MPT-T) or lenalidomide (MPR-R) in non-transplant eligible newly diagnosed multiple myeloma:results of the HOVON87/NMSG18 study

Author

Stege, Claudia A.M., Kongsgaard Nielsen, Lene, Witte, Birgit, van der Holt, Bronno, Mellqvist, Ulf-Henrik, Salomo, Morten, Bos, Gerard, Levin, Mark-David, Visser-Wisselaar, Heleen, Hansson, Markus, van der Velden, Annette, Deenik, Wendy, Gruber, Astrid, Coenen, Juleon, Plesner, Torben, Klein, Saskia, Tanis, Bea, Szatkowski, Damian L., Brouwer, Rolf, Westerman, Matthijs, Leys, Rineke, Sinnige, Harm, Haukås, Einar, van der Hem, Klaas, Durian, Marc, Mattijssen, Vera, Gimsing, Peter, van de Donk, Niels, Stevens-Kroef, Marian, Sonneveld, Pieter, Waage, Anders, Zweegman, Sonja, and Abildgaard , Niels

Published
2017

30. Improved Survival with Thalidomide Before and after Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma: Long-Term Results from the HOVON-50 Study

Author

van de Donk, Niels, primary, van der Holt, Bronno, additional, Minnema, Monique C., additional, Vellenga, Edo, additional, Croockewit, Sandra, additional, Kersten, Marie José, additional, von dem Borne, Peter A., additional, Ypma, Paula, additional, Schaafsma, Ron, additional, de Weerdt, Okke, additional, Klein, Saskia K., additional, Delforge, Michel, additional, Levin, Mark-David, additional, Bos, Gerard M., additional, Jie, Kon-Siong G., additional, Sinnige, Harm, additional, Coenen, Jules L.L.M., additional, de Waal, Esther G., additional, Zweegman, Sonja, additional, Sonneveld, Pieter, additional, and Lokhorst, Henk M., additional

Published
2018
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31. Hoge dosis imatinib versus hoge dosis imatinib in combinatie met intermediaire dosis cytarabine bij patienten met nieuw gediagnosticeerde chronische myeloïde leukemie

Author

Thielen, N., van der Holt, B., Verhoef, G. E. G., Ammerlaan, Rianne A. H. M., Sonneveld, P., Janssen, J. J. W. M., Deenik, W., Falkenburg, J. H. F., Kersten, M. J., Sinnige, Harm A. M., Schipperus, M., Schattenberg, A., van Marwijk Kooy, R., Smit, W. M., Chu, Isabel W. T., Valk, Peter J. M., Ossenkoppele, G. J., Cornelissen, J. J., Amsterdam institute for Infection and Immunity, Cancer Center Amsterdam, and Clinical Haematology

Published
2014

33. Case report: <italic>Coxiella burnetii</italic> vascular infection and lymphoma in the Netherlands.

Author

van Roeden, Sonja E., Melenotte, Cléa, Hermans, Mirjam H. A., Sinnige, Harm A. M., Nooijen, Peet T. G. A., Audoly, Gilles, Hoepelman, Andy I. M., Oosterheert, Jan Jelrik, Raoult, Didier, and Wever, Peter C.

Subjects
LYMPHOMA diagnosis, BACTERIAL diseases, BLOOD vessels, FLUORESCENT antibody technique, Q fever, RNA, STAINS & staining (Microscopy), FLUORESCENCE in situ hybridization, RETROPERITONEUM, GRAM-negative aerobic bacteria, TUMORS
Abstract

Objectives and design: Non-Hodgkin lymphoma has been linked to infection with Coxiella burnetii, potentially through overproduction of IL-10 during infection with C. burnetii.Materials and methods: Description of a case report.Results: We describe a patient with retroperitoneal non-Hodgkin lymphoma and vascular infection with C. burnetii. Immunofluorescence staining and fluorescence in situ hybridization targeting specific C. burnetii 16S rRNA were performed on the retroperitoneal lymphoma tissue sample obtained at diagnosis of NHL. Both were strongly positive for the presence of C. burnetii.Conclusions: This case provokes questions regarding a potential association between C. burnetii and NHL, and underlines the importance of further exploration of this association. [ABSTRACT FROM AUTHOR]

Published
2018
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34. Clofarabin Added to Standard Treatment in Adult Patients with Newly Diagnosed ALL: First Results of the Randomized Phase III HOVON-100 Study

Author

Rijneveld, A.W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen, Petersen, Eefke, Bellido, Mar, Schouten, Harry C., van der Velden, Walter J F M, Selleslag, Dominik, Schipperus, Martin R., Halkes, Constantijn J.M., Klein, Saskia, Havelange, Violaine, van Marwijk Kooij, Marinus, Legdeur, Marie-Cecile, Refos, Jeannine, van der Velden, Vincent, Cornelissen, Jan J, Homburg, Crista, de Haas, Valerie, Deeren, Dries, Gaddiseur, Alain, Sinnige, Harm, and Breems, Dimitri

Published
2017
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35. Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group

Author

Labar, Boris, Suciu, Stefan, Willemze, Roel, Muus, Petra, Marie, Jean-Pierre, Fillet, Georges, Berneman, Zwi, Jakšić, Branimir, Fereman, Walter, Bron, Dominique, Sinnige, Harm, Mistrik, Martin, Vreugdenhil, Gerard, de Bock, Robrecht, Nemet, Damir, Gilotay, Caroline, Amadori, Sergio, and De Witte, Theo

Abstract

Background Corticosteroids are the standard component for the treatment of ALL and LL patients. Our aim was to assess whether dexamethasone (DXM) result in a better outcome than Prednisolone (PDN). Design and Metdhods Adult ALL and LL patients were randomized to receive in induction on days 1-8, 15-22, either DXM 8 mg/m(2) or PDN 60 mg/m(2). Those who reached complete remission (CR), two courses of consolidation (HAM and MA) were administered. Subsequently patient younger than 50 years, with a donor, had to receive AlloSCT, whereas the others, either autoSCT or high dose maintenance chemotherapy with prophylactic CNS irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival (EFS). Analysis were done by intention to treat. RESULTS: Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either DXM (163 patients) or PDN (162 patients). After induction and first consolidation course, 131 (80,4%) patients in DXM group and 124(76,5%) in PDN group achieved CR. No significant difference was observed between the 2 treatment groups regarding EFS: P=0.82, hazard ratio 0.97, 95% confidence interval 0.75-1.25, the 6-year EFS rates (+/-SE) were 25.9%(3.6%) vs. 28.7% (3.5%). Disease-Free survival (DFS) from CR was similar in DXM and PDN group: hazard ratio1.03, 95% confindence interval 0.76-1.40. The 6-year DFS rate was 32.3% (DXM) vs. 37,5% (PDN) group, the 6-year cummulative incidence of relapse was 32.3 (DXM) vs. 37.5% (PDN) group, the 6-year cumulative incidence of relapse was 49.8% vs. 53.5% (Gray test: P=0.30) and of death was 18% vs. 9% (Gray test: P=0.07). Conclusions In the ALL-4 trial in adult patients, DXM did not show any advantage compared to PDN. This study is registered with Clinical Trials gov. number NCT00002700.

Published
2010

36. Randomized Phase III Trial in Non-Transplant Eligible Patients with Newly Diagnosed Symptomatic Multiple Myeloma Comparing Melphalan-Prednisone-Thalidomide Followed By Thalidomide Maintenance (MPT-T) Versus Melphalan-Prednisone-Lenalidomide Followed By Maintenance with Lenalidomide (MPR-R); A Joint Study of the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and the Nordic Myeloma Study Group (NMSG)

Author

Zweegman, Sonja, primary, Holt, Bronno van der, additional, Mellqvist, Ulf-Henrik, additional, Salomo, Morten, additional, Bos, Gerard M.J., additional, Levin, Mark-David, additional, Visser-Wisselaar, Heleen A, additional, Hansson, Markus, additional, van der Velden, Annette WG, additional, Deenik, Wendy, additional, Gruber, Astrid, additional, Coenen, Juleon LLM, additional, Plesner, Torben, additional, Klein, Saskia K, additional, Tanis, Bea, additional, Szatkowski, Damian L, additional, Brouwer, Rolf, additional, Westerman, Matthijs, additional, Leys, M (Rineke) BL, additional, van de Donk, Niels W.C.J., additional, Haukås, Einar, additional, van der Hem, Klaas, additional, Durian, MF, additional, Mattijssen, E (Vera) JM, additional, Sinnige, Harm AM, additional, Stevens-Kroef, Marian JPL, additional, Sonneveld, Pieter, additional, and Waage, Anders, additional

Published
2014
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38. Thalidomide Combined With High Dose Melphalan Improves Event Free and Overall Survival In Patients With Newly Diagnosed Multiple Myeloma: Extended Follow-Up Of The HOVON-50 Trial

Author

Lokhorst, Henk, primary, Holt, Bronno van der, additional, Zweegman, Sonja, additional, Vellenga, Edo, additional, Croockewit, Sandra, additional, Van Oers, Marinus H.J., additional, dem Borne, Peter von, additional, Wijermans, Pierre W., additional, Schaafsma, M. R, additional, de Weerdt, Okke, additional, Wittebol, Shulamiet, additional, Delforge, Michel, additional, Bos, Gerard M.J., additional, Sinnige, Harm, additional, MarwijkKooy, Marinus, additional, Joosten, Peter, additional, Minnema, Monique C., additional, Ammerlaan, Rianne, additional, and Sonneveld, Pieter, additional

Published
2013
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39. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group.

Author

Labar, Boris, Suciu, Stefan, Willemze, Roel, Muus, Petra, Marie, Jean Pierre, Fillet, Georges, Berneman, Zwi, Jaksic, Branimir, Feremans, Walter, Bron, Dominique, Sinnige, Harm, Mistrik, Martin, Vreugdenhil, Gerard, De Bock, Robrecht, Nemet, Damir, Gilotay, C., Amadori, Sergio, De Witte, Theo, EORTC Leukemia Group, Labar, Boris, Suciu, Stefan, Willemze, Roel, Muus, Petra, Marie, Jean Pierre, Fillet, Georges, Berneman, Zwi, Jaksic, Branimir, Feremans, Walter, Bron, Dominique, Sinnige, Harm, Mistrik, Martin, Vreugdenhil, Gerard, De Bock, Robrecht, Nemet, Damir, Gilotay, C., Amadori, Sergio, De Witte, Theo, and EORTC Leukemia Group

Abstract

Corticosteroids are a standard component of the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Our aim was to determine whether dexamethasone results in a better outcome than prednisolone., Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2010

40. Preliminary Results From a Phase III Trial of Imatinib Versus Imatinib in Combination with Cytarabine in Patients with First Chronic Phase Myeloid Leukemia

Author

Thielen, Noortje, primary, van der Holt, Bronno, additional, Cornelissen, Jan J, additional, Ammerlaan, Rianne, additional, Sonneveld, Pieter, additional, Kersten, Marie José, additional, Falkenburg, J.H. Frederik, additional, Sinnige, Harm, additional, Schipperus, Martin, additional, Schattenberg, Anton, additional, van Marwijk Kooy, Marinus, additional, Smit, Willem, additional, Verhoef, Gregor, additional, Chu, Isabel, additional, Valk, Peter, additional, Janssen, Jeroen JWM, additional, and Ossenkoppele, Gert, additional

Published
2011
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41. Phase III Study of the Value of Thalidomide Added to Melphalan Plus Prednisone in Elderly Patients With Newly Diagnosed Multiple Myeloma: The HOVON 49 Study

Author

Wijermans, Pierre, primary, Schaafsma, Martijn, additional, Termorshuizen, Fabian, additional, Ammerlaan, Rianne, additional, Wittebol, Shulamiet, additional, Sinnige, Harm, additional, Zweegman, Sonja, additional, van Marwijk Kooy, Marinus, additional, van der Griend, René, additional, Lokhorst, Henk, additional, and Sonneveld, Pieter, additional

Published
2010
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42. Final Analysis of HOVON-50 Randomized Phase III Study on the Effect of Thalidomide Combined with Adriamycine, Dexamethasone (AD) and High Dose Melphalan (HDM) in Patients with Multiple Myeloma (MM)

Author

Lokhorst, Henk, primary, van der Holt, Bronno, primary, Zweegman, Sonja, primary, Von Dem Borne, Peter A., primary, Bos, Gerard M.J., primary, Croockewit, Sandra, primary, Cornelissen, Jan J., primary, van Oers, Marinus, primary, Schaafsma, Martyn Ronald, primary, Sinnige, Harm, primary, Delforge, Michel, primary, de Weerdt, Okke, primary, Wijermans, Pierre W, primary, Wittebol, Shulamiet, primary, Vellenga, Edo, primary, Jie, Asiong, primary, Berenschot, Henriette, primary, Marwijk-kooy, Marinus, primary, and Sonneveld, Pieter, primary

Published
2008
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46. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Abstract

Clofarabine (CLO) is a nucleoside analogue with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase III study aimed to evaluate whether CLO added to induction and consolidation would improve outcome in adults with newly diagnosed ALL.Treatment for younger (18-40 years) patients consisted of a pediatric inspired protocol and for older patients (41-70 years) of a semi-intensive protocol was used. 340 patients were randomized. After a median follow up of 70 months,5-year EFS was 50% and 53% for arm A and B (CLO arm). For patients ≤40 years, EFS was 58% vs 65% in arm A vs B, while in patients >40 years EFS was 43% in both arms. CR rate was 89% in both arms and similar in younger and older patients.Minimal residual disease (MRD) was assessedin 200 patients (60%).Fifty-fourof 76evaluable patients(71%) were MRD negative after consolidation 1 in arm A vs 75/81 (93%) in arm B (p=0.001). Seventy (42%) patients proceeded to allogeneic hematopoietic stemcell transplantation in both arms. Five years OS was similar in both arms, 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and non-relapse mortality was 16% vs 17% after CR. CLO treated patients experienced more serious adverse events, moreinfections, and more often went off-protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD-negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity.The trial is registered at www.trialregister.nl as NTR2004.

Published
2021
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47. Frailty Predicts Survival and Toxicity in Newly Diagnosed Multiple Myeloma Patients Ineligible for Autologous Stem Cell Transplantation; Report of the HOVON-87/Nmsg-18 Study Group

Author

Stege, Claudia A.M., van der Holt, Bronno, Mellqvist, Ulf-Henrik, Levin, Mark-David, Salomo, Morten, Abildgaard, Niels, Bos, Gerard, Visser-Wisselaar, Heleen, Hansson, Markus, van der Velden, Annette, Deenik, Wendy, Gruber, Astrid, Coenen, Jules L.L.M., Plesner, Torben, Klein, Saskia, Tanis, Bea, Szatkowski, Damian L., Brouwer, Rolf, Westerman, Matthijs, Leijs, Maria Berhardina, Sinnige, Harm, Haukaas, Einar, van der Hem, Klaas, Durian, Marc, Mattijssen, Vera, Gimsing, Peter, Van De Donk, Niels WCJ, Stevens-Kroef, Marian, Sonneveld, Pieter, Waage, Anders, and Zweegman, Sonja

Abstract

Introduction

Published
2017
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49. Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study.

Author

Nielsen LK, Stege C, Lissenberg-Witte B, van der Holt B, Mellqvist UH, Salomo M, Bos G, Levin MD, Visser-Wisselaar H, Hansson M, van der Velden A, Deenik W, Coenen J, Hinge M, Klein S, Tanis B, Szatkowski D, Brouwer R, Westerman M, Leys R, Sinnige H, Haukås E, van der Hem K, Durian M, Gimsing P, van de Donk N, Sonneveld P, Waage A, Abildgaard N, and Zweegman S

Subjects
Antineoplastic Combined Chemotherapy Protocols therapeutic use, Humans, Melphalan therapeutic use, Prednisone therapeutic use, Prospective Studies, Lenalidomide therapeutic use, Multiple Myeloma diagnosis, Multiple Myeloma drug therapy, Quality of Life, Thalidomide therapeutic use
Abstract

Data on the impact of long term treatment with immunomodulatory drugs (IMiD) on health-related quality of life (HRQoL) is limited. The HOVON-87/NMSG18 study was a randomized, phase 3 study in newly diagnosed transplant ineligible patients with multiple myeloma, comparing melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R). The EORTC QLQ-C30 and MY20 questionnaires were completed at baseline, after three and nine induction cycles and six and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in HRQoL reporting. Patients reported clinically relevant improvement in global quality of life (QoL), future perspective and role and emotional functioning, and less fatigue and pain in both arms. The latter being of large effect size. In general, improvement occurred after 6-12 months of maintenance only and was independent of the World Health Organisation performance at baseline. Patients treated with MPR-R reported clinically relevant worsening of diarrhea, and patients treated with MPT-T reported a higher incidence of neuropathy. Patients who remained on lenalidomide maintenance therapy for at least three months reported clinically meaningful improvement in global QoL and role functioning at six months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, HRQoL improves both during induction and maintenance therapy with immunomodulatory drugs. The side effect profile of treatment did not negatively affect global QoL, but it was, however, clinically relevant for the patients. ( Clinicaltrials.gov identifier: NTR1630 )., (Copyright© 2020 Ferrata Storti Foundation.)

Published
2020
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50. Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients.

Author

Huls G, Chitu DA, Havelange V, Jongen-Lavrencic M, van de Loosdrecht AA, Biemond BJ, Sinnige H, Hodossy B, Graux C, Kooy RVM, de Weerdt O, Breems D, Klein S, Kuball J, Deeren D, Terpstra W, Vekemans MC, Ossenkoppele GJ, Vellenga E, and Löwenberg B

Subjects
Age Factors, Aged, Aged, 80 and over, Disease-Free Survival, Female, Humans, Leukemia, Myeloid, Acute epidemiology, Maintenance Chemotherapy, Male, Middle Aged, Remission Induction, Antimetabolites, Antineoplastic therapeutic use, Azacitidine therapeutic use, Leukemia, Myeloid, Acute drug therapy
Abstract

The prevention of relapse is the major therapeutic challenge in older patients with acute myeloid leukemia (AML) who have obtained a complete remission (CR) on intensive chemotherapy. In this randomized phase 3 study (HOVON97) in older patients (≥60 years) with AML or myelodysplastic syndrome with refractory anemia with excess of blasts, in CR/CR with incomplete hematologic recovery (CRi) after at least 2 cycles of intensive chemotherapy, we assessed the value of azacitidine as postremission therapy with respect to disease-free survival (DFS; primary end point) and overall survival (OS; secondary end point). In total, 116 eligible patients were randomly (1:1) assigned to either observation (N = 60) or azacitidine maintenance (N = 56; 50 mg/m 2 , subcutaneously, days 1-5, every 4 weeks) until relapse, for a maximum of 12 cycles. Fifty-five patients received at least 1 cycle of azacitidine, 46 at least 4 cycles, and 35 at least 12 cycles. The maintenance treatment with azacitidine was feasible. DFS was significantly better for the azacitidine treatment group (logrank; P = .04), as well as after adjustment for poor-risk cytogenetic abnormalities at diagnosis and platelet count at randomization (as surrogate for CR vs CRi; Cox regression; hazard ratio, 0.62; 95% confidence interval, 0.41-0.95; P = .026). The 12-month DFS was estimated at 64% for the azacitidine group and 42% for the control group. OS did not differ between treatment groups, with and without censoring for allogeneic hematopoietic cell transplantation. Rescue treatment was used more often in the observation group (n = 32) than in the azacitidine maintenance group (n = 9). We conclude that azacitidine maintenance after CR/CRi after intensive chemotherapy is feasible and significantly improves DFS. The study is registered with The Netherlands Trial Registry (NTR1810) and EudraCT (2008-001290-15)., (© 2019 by The American Society of Hematology.)

Published
2019
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