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1. Determinants of lenalidomide response with or without erythropoiesis-stimulating agents in myelodysplastic syndromes: the HOVON89 trial

Author

van de Loosdrecht, A. A., Cremers, E. M. P., Alhan, C., Duetz, C., in ’t Hout, F. E. M., Visser-Wisselaar, H. A., Chitu, D. A., Verbrugge, A., Cunha, S. M., Ossenkoppele, G. J., Janssen, J. J. W. M., Klein, S. K., Vellenga, E., Huls, G. A., Muus, P., Langemeijer, S. M. C., de Greef, G. E., te Boekhorst, P. A. W., Raaijmakers, M. H. G., van Marwijk Kooy, M., Legdeur, M. C., Wegman, J. J., Deenik, W., de Weerdt, O., van Maanen-Lamme, T. M., Jobse, P., van Kampen, R. J. W., Beeker, A., Wijermans, P. W., Biemond, B. J., Tanis, B. C., van Esser, J. W. J., Schaar, C. G., Noordzij-Nooteboom, H. S., Jacobs, E. M. G., de Graaf, A. O., Jongen-Lavrencic, M., Stevens-Kroef, M. J. P. L., Westers, T. M., and Jansen, J. H.

Published
2024
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2. Determinants of lenalidomide response with or without erythropoiesis-stimulating agents in myelodysplastic syndromes:the HOVON89 trial

Author

van de Loosdrecht, A. A., Cremers, E. M.P., Alhan, C., Duetz, C., in ’t Hout, F. E.M., Visser-Wisselaar, H. A., Chitu, D. A., Verbrugge, A., Cunha, S. M., Ossenkoppele, G. J., Janssen, J. J.W.M., Klein, S. K., Vellenga, E., Huls, G. A., Muus, P., Langemeijer, S. M.C., de Greef, G. E., te Boekhorst, P. A.W., Raaijmakers, M. H.G., van Marwijk Kooy, M., Legdeur, M. C., Wegman, J. J., Deenik, W., de Weerdt, O., van Maanen-Lamme, T. M., Jobse, P., van Kampen, R. J.W., Beeker, A., Wijermans, P. W., Biemond, B. J., Tanis, B. C., van Esser, J. W.J., Schaar, C. G., Noordzij-Nooteboom, H. S., Jacobs, E. M.G., de Graaf, A. O., Jongen-Lavrencic, M., Stevens-Kroef, M. J.P.L., Westers, T. M., Jansen, J. H., van de Loosdrecht, A. A., Cremers, E. M.P., Alhan, C., Duetz, C., in ’t Hout, F. E.M., Visser-Wisselaar, H. A., Chitu, D. A., Verbrugge, A., Cunha, S. M., Ossenkoppele, G. J., Janssen, J. J.W.M., Klein, S. K., Vellenga, E., Huls, G. A., Muus, P., Langemeijer, S. M.C., de Greef, G. E., te Boekhorst, P. A.W., Raaijmakers, M. H.G., van Marwijk Kooy, M., Legdeur, M. C., Wegman, J. J., Deenik, W., de Weerdt, O., van Maanen-Lamme, T. M., Jobse, P., van Kampen, R. J.W., Beeker, A., Wijermans, P. W., Biemond, B. J., Tanis, B. C., van Esser, J. W.J., Schaar, C. G., Noordzij-Nooteboom, H. S., Jacobs, E. M.G., de Graaf, A. O., Jongen-Lavrencic, M., Stevens-Kroef, M. J.P.L., Westers, T. M., and Jansen, J. H.

Abstract

A randomized phase-II study was performed in low/int-1 risk MDS (IPSS) to study efficacy and safety of lenalidomide without (arm A) or with (arm B) ESA/G-CSF. In arm B, patients without erythroid response (HI-E) after 4 cycles received ESA; G-CSF was added if no HI-E was obtained by cycle 9. HI-E served as primary endpoint. Flow cytometry and next-generation sequencing were performed to identify predictors of response. The final evaluation comprised 184 patients; 84% non-del(5q), 16% isolated del(5q); median follow-up: 70.7 months. In arm A and B, 39 and 41% of patients achieved HI-E; median time-to-HI-E: 3.2 months for both arms, median duration of-HI-E: 9.8 months. HI-E was significantly lower in non-del(5q) vs. del(5q): 32% vs. 80%. The same accounted for transfusion independency-at-week 24 (16% vs. 67%), but similar in both arms. Apart from presence of del(5q), high percentages of bone marrow lymphocytes and progenitor B-cells, a low number of mutations, absence of ring sideroblasts, and SF3B1 mutations predicted HI-E. In conclusion, lenalidomide induced HI-E in patients with non-del(5q) and del(5q) MDS without additional effect of ESA/G-CSF. The identified predictors of response may guide application of lenalidomide in lower-risk MDS in the era of precision medicine. (EudraCT 2008-002195-10).

Published
2024

3. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., and Löwenberg, B.

Published
2020
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5. Comparative therapeutic value of post-remission approaches in patients with acute myeloid leukemia aged 40–60 years

Author

Cornelissen, J J, Versluis, J, Passweg, J R, van Putten, W L J, Manz, M G, Maertens, J, Beverloo, H B, Valk, P J M, van Marwijk Kooy, M, Wijermans, P W, Schaafsma, M R, Biemond, B J, Vekemans, M-C, Breems, D A, Verdonck, L F, Fey, M F, Jongen-Lavrencic, M, Janssen, J J W M, Huls, G, Kuball, J, Pabst, T, Graux, C, Schouten, H C, Gratwohl, A, Vellenga, E, Ossenkoppele, G, and Löwenberg, B

Published
2015
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8. Effect of thalidomide with melphalan and prednisone on health-related quality of life (HRQoL) in elderly patients with newly diagnosed multiple myeloma: a prospective analysis in a randomized trial

Author

Verelst, Silvia G. R., Termorshuizen, F., Uyl-de Groot, C. A., Schaafsma, M. R., Ammerlaan, A. H. M., Wittebol, S., Sinnige, H. A. M., Zweegman, S., van Marwijk Kooy, M., van der Griend, R., Lokhorst, H. M., Sonneveld, P., Wijermans, P. W., and Dutch-Belgium Hemato-Oncology Cooperative Group (HOVON)

Published
2011
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9. Autologous haematopoietic stem-cell transplantation versus bortezomib–melphalan–prednisone, with or without bortezomib–lenalidomide–dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study

Author

Cavo, M. Gay, F. Beksac, M. Pantani, L. Petrucci, M.T. Dimopoulos, M.A. Dozza, L. van der Holt, B. Zweegman, S. Oliva, S. van der Velden, V.H.J. Zamagni, E. Palumbo, G.A. Patriarca, F. Montefusco, V. Galli, M. Maisnar, V. Gamberi, B. Hansson, M. Belotti, A. Pour, L. Ypma, P. Grasso, M. Croockewit, A. Ballanti, S. Offidani, M. Vincelli, I.D. Zambello, R. Liberati, A.M. Andersen, N.F. Broijl, A. Troia, R. Pascarella, A. Benevolo, G. Levin, M.-D. Bos, G. Ludwig, H. Aquino, S. Morelli, A.M. Wu, K.L. Boersma, R. Hajek, R. Durian, M. von dem Borne, P.A. Caravita di Toritto, T. Zander, T. Specchia, G. Waage, A. Gimsing, P. Mellqvist, U.-H. van Marwijk Kooy, M. Minnema, M. Mandigers, C. Cafro, A.M. Palmas, A. Carvalho, S. Spencer, A. Boccadoro, M. Sonneveld, P.

Abstract

Background: The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib–melphalan–prednisone (VMP) as intensification therapy, and bortezomib–lenalidomide–dexamethasone (VRD) consolidation therapy with no consolidation. Methods: In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18–65 years, had symptomatic multiple myeloma stage 1–3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0–2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m2 administered orally on days 1–4) and prednisone (60 mg/m2 administered orally on days 1–4) or autologous HSCT after high-dose melphalan (200 mg/m2), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1–21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1–21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment. Findings: Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2–67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3–64·5] vs 41·9 months [37·5–46·9]; hazard ratio [HR] 0·73, 0·62–0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3–49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0–not estimable] vs 45·5 months [39·5–58·4]; HR 0·77, 0·63–0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]). Interpretation: This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. Funding: Janssen and Celgene. © 2020 Elsevier Ltd

Published
2020

10. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, Carlos, Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, Marie-Christiane, van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Havelange, Violaine, Sonet, Anne, UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, Carlos, Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, Marie-Christiane, van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Havelange, Violaine, and Sonet, Anne

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

13. Bortezomib before and after high-dose chemotherapy improves the survival in patients with newly diagnosed multiple myeloma and renal insufficiency - a subgroup analysis of the prospective randomised GMMG HD4/HOVON 65 study: V817

Author

Scheid, C., Sonneveld, P., Schmidt-Wolf, I., van der Holt, B., Hielscher, T., el Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Hänel, M., Vellenga, E., Schubert, J., Blau, I. W., Jie, A., van de Velde, H., Peter, N., Schaafsma, M., Lindemann, W., Kersten, M. J., Duehrsen, U., Delforge, M., Weisel, K., Croockewit, S., Martin, H., Wittebol, S., Schouten, H., van Marwijk-Kooy, M., Wijermans, P., Lokhorst, H. M., and Goldschmidt, H.

Published
2011

14. Bortezomib during induction and maintenance before and after autologous transplantation improves overall survival in patients with renal impairment: subgroup analysis from the HOVON-65/GMMG-HD4 randomized trial for newly diagnosed multiple myeloma: O270

Author

Scheid, C., Sonneveld, P., Schmidt-Wolf, I., van der Holt, B., Hielscher, T., el Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Hänel, M., Vellenga, E., Schubert, J., Blau, I. W., Jie, A., van de Velde, H., Peter, N., Schaafsma, M., Lindemann, W., Kersten, M., Duehrsen, U., Delforge, M., Weisel, K., Croockewit, S., Martin, H., Wittebol, S., Schouten, H., van Marwijk-Kooy, M., Wijermans, P., Lokhorst, H., and Goldschmidt, H.

Published
2011

15. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, GE, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Meyer, G, Segers, A, Shi, M, Wang, TF, Yeo, E, Zhang, G, Zwicker, JI, Weitz, JI, Büller, HR, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, PW, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, JW, Crowther, M, Roberts, RS, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, JC, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, MI, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, HM, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, CM, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Graduate School, CCA - Cancer Treatment and Quality of Life, Vascular Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, Other Research, Other departments, Neurology, APH - Societal Participation & Health, APH - Quality of Care, Coronel Institute of Occupational Health, ARD - Amsterdam Reproduction and Development, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, and ACS - Microcirculation

Subjects
Adult, Dalteparin, Male, Randomization, Pyridines, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Edoxaban, Neoplasms, medicine, Humans, Aged, Intention-to-treat analysis, Heparin, business.industry, Standard treatment, Low-Molecular-Weight, Anticoagulants, Cancer, Follow-Up Studies, Heparin, Low-Molecular-Weight, Intention to Treat Analysis, Middle Aged, Thiazoles, Venous Thromboembolism, General Medicine, medicine.disease, Thrombosis, chemistry, 030220 oncology & carcinogenesis, Anesthesia, Venous Thromboembolism, cancer, thrombosis, business, medicine.drug
Abstract

BACKGROUND Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials. gov number, NCT02073682.)

Published
2018

21. Bortezomib before and after high-dose therapy in myeloma : long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, Sonneveld, P, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, and Sonneveld, P

Published
2018

22. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, Sonneveld, P, Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, and Sonneveld, P

Published
2018

23. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, GE, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Wang, TF, Zwicker, JI, Weitz, JI, Büller, HR, Kamphuizen, PW, Eikelboom, JW, Roberts, RS, Wautrecht, JC, Tassoni, MI, Otten, HM, Rojas Hernandez, CM, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, GE, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Wang, TF, Zwicker, JI, Weitz, JI, Büller, HR, Kamphuizen, PW, Eikelboom, JW, Roberts, RS, Wautrecht, JC, Tassoni, MI, Otten, HM, and Rojas Hernandez, CM

Abstract

BACKGROUND: Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS: In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS: Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk,-3.4 percentage points; 95% CI,-7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS: Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin.

Published
2018

24. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Goldschmidt, H, primary, Lokhorst, H M, additional, Mai, E K, additional, van der Holt, B, additional, Blau, I W, additional, Zweegman, S, additional, Weisel, K C, additional, Vellenga, E, additional, Pfreundschuh, M, additional, Kersten, M J, additional, Scheid, C, additional, Croockewit, S, additional, Raymakers, R, additional, Hose, D, additional, Potamianou, A, additional, Jauch, A, additional, Hillengass, J, additional, Stevens-Kroef, M, additional, Raab, M S, additional, Broijl, A, additional, Lindemann, H W, additional, Bos, G M J, additional, Brossart, P, additional, van Marwijk Kooy, M, additional, Ypma, P, additional, Duehrsen, U, additional, Schaafsma, R M, additional, Bertsch, U, additional, Hielscher, T, additional, Jarari, Le, additional, Salwender, H J, additional, and Sonneveld, P, additional

Published
2017
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25. Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., and Löwenberg, B.

Abstract

More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n?=?222) to receive standard chemotherapy (“3?+?7”) with or without lenalidomide at a dose of 20?mg/day 1–21. In the second cycle, patients received cytarabine 1000?mg/m2twice daily on days 1–6 with or without lenalidomide (20?mg/day 1–21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).

Published
2020
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26. Comparative therapeutic value of post-remission approaches in patients with acute myeloid leukemia aged 40-60 years

Author

Cornelissen, J. J., Versluis, J., Passweg, J. R., Van Putten, W. L J, Manz, M. G., Maertens, J., Beverloo, H. B., Valk, P. J M, Van Marwijk Kooy, M., Wijermans, P. W., Schaafsma, M. R., Biemond, B. J., Vekemans, M. C., Breems, D. A., Verdonck, L. F., Fey, M. F., Jongen-Lavrencic, M., Janssen, J. J W M, Huls, G., Kuball, J., Pabst, T., Graux, C., Schouten, H. C., Gratwohl, A., Vellenga, E., Ossenkoppele, G., Löwenberg, B., Cornelissen, J. J., Versluis, J., Passweg, J. R., Van Putten, W. L J, Manz, M. G., Maertens, J., Beverloo, H. B., Valk, P. J M, Van Marwijk Kooy, M., Wijermans, P. W., Schaafsma, M. R., Biemond, B. J., Vekemans, M. C., Breems, D. A., Verdonck, L. F., Fey, M. F., Jongen-Lavrencic, M., Janssen, J. J W M, Huls, G., Kuball, J., Pabst, T., Graux, C., Schouten, H. C., Gratwohl, A., Vellenga, E., Ossenkoppele, G., and Löwenberg, B.

Published
2015

27. Comparative therapeutic value of post-remission approaches in patients with acute myeloid leukemia aged 40-60 years

Author

UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, Cornelissen, J J, Versluis, J, Passweg, J R, van Putten, W L J, Manz, M G, Maertens, J, Beverloo, H B, Valk, P J M, van Marwijk Kooy, M, Wijermans, P W, Schaafsma, M R, Biemond, B J, Vekemans, Marie-Christiane, Breems, D A, Verdonck, L F, Fey, M F, Jongen-Lavrencic, M, Janssen, J J W M, Huls, G, Kuball, J, Pabst, T, Graux, Carlos, Schouten, H C, Gratwohl, A, Vellenga, E, Ossenkoppele, G, Löwenberg, B, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, Cornelissen, J J, Versluis, J, Passweg, J R, van Putten, W L J, Manz, M G, Maertens, J, Beverloo, H B, Valk, P J M, van Marwijk Kooy, M, Wijermans, P W, Schaafsma, M R, Biemond, B J, Vekemans, Marie-Christiane, Breems, D A, Verdonck, L F, Fey, M F, Jongen-Lavrencic, M, Janssen, J J W M, Huls, G, Kuball, J, Pabst, T, Graux, Carlos, Schouten, H C, Gratwohl, A, Vellenga, E, Ossenkoppele, G, and Löwenberg, B

Abstract

The preferred type of post-remission therapy (PRT) in patients with acute myeloid leukemia (AML) in first complete remission (CR1) is a subject of continued debate, especially in patients at higher risk of nonrelapse mortality (NRM), including patients >40 years of age. We report results of a time-dependent multivariable analysis of allogenic hematopoietic stem cell transplantation (alloHSCT) (n=337) versus chemotherapy (n=271) or autologous HSCT (autoHSCT) (n=152) in 760 patients aged 40-60 years with AML in CR1. Patients receiving alloHSCT showed improved overall survival (OS) as compared with chemotherapy (respectively, 57±3% vs 40±3% at 5 years, P<0.001). Comparable OS was observed following alloHSCT and autoHSCT in patients with intermediate-risk AML (60±4 vs 54±5%). However, alloHSCT was associated with less relapse (hazard ratio (HR) 0.51, P<0.001) and better relapse-free survival (RFS) (HR 0.74, P=0.029) as compared with autoHSCT in intermediate-risk AMLs. AlloHSCT was applied following myeloablative conditioning (n=157) or reduced intensity conditioning (n=180), resulting in less NRM, but comparable outcome with respect to OS, RFS and relapse. Collectively, these results show that alloHSCT is to be preferred over chemotherapy as PRT in patients with intermediate- and poor-risk AML aged 40-60 years, whereas autoHSCT remains a treatment option to be considered in patients with intermediate-risk AML.Leukemia advance online publication, 23 December 2014; doi:10.1038/leu.2014.332.

Published
2015

28. Comparative therapeutic value of post-remission approaches in patients with acute myeloid leukemia aged 40-60 years

Author

HAG Diabetes, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, MS Hematologie, Infection & Immunity, Cancer, Cornelissen, J. J., Versluis, J., Passweg, J. R., Van Putten, W. L J, Manz, M. G., Maertens, J., Beverloo, H. B., Valk, P. J M, Van Marwijk Kooy, M., Wijermans, P. W., Schaafsma, M. R., Biemond, B. J., Vekemans, M. C., Breems, D. A., Verdonck, L. F., Fey, M. F., Jongen-Lavrencic, M., Janssen, J. J W M, Huls, G., Kuball, J., Pabst, T., Graux, C., Schouten, H. C., Gratwohl, A., Vellenga, E., Ossenkoppele, G., Löwenberg, B., HAG Diabetes, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, MS Hematologie, Infection & Immunity, Cancer, Cornelissen, J. J., Versluis, J., Passweg, J. R., Van Putten, W. L J, Manz, M. G., Maertens, J., Beverloo, H. B., Valk, P. J M, Van Marwijk Kooy, M., Wijermans, P. W., Schaafsma, M. R., Biemond, B. J., Vekemans, M. C., Breems, D. A., Verdonck, L. F., Fey, M. F., Jongen-Lavrencic, M., Janssen, J. J W M, Huls, G., Kuball, J., Pabst, T., Graux, C., Schouten, H. C., Gratwohl, A., Vellenga, E., Ossenkoppele, G., and Löwenberg, B.

Published
2015

29. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial

Author

Büller, Hr, Gallus, As, Prins, Mh, Raskob, G, Decousus, H, Charbonnier, B, Leizorovicz, A, Laporte, S, Quenet, S, Brandjes, Dp, Middeldorp, S, Blüguermann, J, Amuchastegui, L, Ahuad Guerrero, R, Oberti, P, Alvarez, C, Cassettari, A, Santos, D, Macin, S, Santini, F, Ward, C, Coughlin, P, Salem, H, Gan, E, Leyden, M, Prosser, I, Crispin, P, Carroll, P, Gallus, A, Mcrae, S, Waites, J, Pilger, E, Koppensteiner, R, Kyrle, P, Schinko, H, Mrochek, A, Mitkovskaya, N, Prystrom, A, Motte, S, Ninane, V, Delcroix, M, Hainaut, P, Schneider, E, Saraiva, J, Maia, L, Barreto, S, Fernandes Manenti, E, Araujo, G, Dutra, O, Fiss, E, Moreira, R, Yankov, K, Nenkova, S, Ivanov, Y, Kostov, V, Bhargava, R, Chan, Y, Miron, Mj, Cusson, J, Ugarte, S, Morales, A, Andresen, M, Lanas, F, Arriagada, G, Mendoza, Jj, Zuñiga, C, Sepulveda, P, Wang, C, Liu, Z, Yuan, Y, Ma, Z, Fang, B, Liu, J, Bai, C, Wu, H, Yang, L, Ying, K, Kang, J, Li, Q, Cheng, Z, Zhang, J, Wang, H, Xie, C, Xia, G, Du, Y, Wu, Q, Zhou, X, Chen, L, Yi, Q, Wu, C, Hao, Q, Liu, S, Xiong, S, Jiang, S, Zhao, L, Xiao, Q, Qin, Z, Zhou, J, Dennis, R, Miserque, N, Igueredo, M, Londoño, D, Hildebrando, J, Granados, M, Buitrago, R, Solano, Mh, Pacheco Alvis PM, Botero, R, Saenz, O, Bergovec, M, Padovan, M, Vucic, N, Samarzija, M, Chlumsky, J, Spacek, R, Klimsa, Z, Gregor, P, Povolny, J, Podpera, I, Holm, F, Lang, P, Matoska, P, Sabl, P, Spinar, J, Spac, J, Husted, S, Avnstrom, S, Rasmussen, S, Christensen, A, Guindy, R, Hassanein, M, Paumets, M, Meriste, S, Ferrari, E, Achkar, A, Azarian, R, Meneveau, N, Lorut, C, Mouallem, J, Crestani, B, Proton, A, Salmeron, S, Lerousseau, L, Mottier, D, Wahl, D, Siafakas, N, Papadimitriou, D, Katis, K, Katsaris, G, Gaga, A, Damianos, A, Tipparaju, S, Kalkunte, S, Vidhut, J, Kalashetti, S, Mehta, P, Talwar, D, Ramanathan, R, Mishra, R, Zeltzer, D, Lahav, M, Brenner, B, Caraco, Y, Elias, M, Piovella, F, Barone, M, Poggio, R, Palla, A, Ghirarduzzi, A, Pini, M, Lodigiani, C, Prandoni, Paolo, Agnelli, G, Imberti, D, Scannapieco, G, Salvi, A, Bautista, E, Diaz, J, Mercado, R, Ranero, A, Rodriguez, D, Jerjes, C, Villeda Espinoza, E, Van Der Meer, J, Ijfering, W, Van Marwijk Kooy, M, Boersma, W, Van Leendert, R, Kroon, C, Dullemond Westland, A, Viergever, P, Kuipers, A, Grootenboers, M, Creemers, J, Pieters, W, De Munck, D, Timmer, H, Jackson, S, Sandset, P, Meyer, P, Kristiansen, T, Portugal, J, Paz, E, Salazar, D, Chavez, W, Castillo, L, De Guia, T, Lenora, F, Tomkowski, W, Kloczko, J, Rybak, Z, Gaciong, Z, Sobkowicz, B, Pruszczyk, P, Nizankowski, R, Mirek Bryniarska, E, Kukla, P, Reis, A, França, A, Cortez, M, Sa, J, Santos, F, Marques, Ma, Gordeev, I, Gendlin, G, Yablonsky, P, Sokurenko, G, Soroka, V, Lusov, V, Markov, V, Shvats, Y, Katerlnitskiy, I, Lapin, O, Lyamina, N, Subbotin, Y, Kim, I, Zilber, E, Kchaisheva, L, Poliacik, P, Macek, V, Pretorius, Jp, Abdullah, I, Basson, M, Bollinger, C, Breedt, J, Gani, M, Jansen, J, Le Roux, G, Nortje, H, Van Der Linder, M, Van Zyl, L, Viljoen, J, Bruning, A, Pujol Farriols, R, Raguer, E, Nuffal, D, Sanchez Rodriguez, A, Eriksson, H, Almgren, T, Carlsson, A, Elf, J, Olsson, Cg, Aagesen, J, Savas, I, Sahin, A, Erdogan, Y, Ozhan, M, Ongen, G, Celikel, T, Turker, H, Arseven, O, Tuncay, E, Ozacar, R, Gudz, I, Nykonenko, O, Skupyy, O, Kovalskyy, I, Prasol, V, Cohen, A, Rodriguez Cintron, W, Gurka, D, Bradley, J, Oliver, G, Spyropoulos, A, Lerner, R, Fulmer, J, Lu, Np, Wright, P, Han, D, Servi, R, Nadar, V, Quaranta, A, Gehring, J, Ginsberg, R, Jacobson, A, Colan, D, Vanway, C, Gurza, E, Braslow, B, Shorr, A, Rehm, J, Martin, J, Sellers, M, Concha, M, Gordon, I, Pullman, J, Moran, J, Welker, J, Panzarella, P, Mullins, M, Willms, D, Mcgrew, F, Turki, M, Menajovsky, L., Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Amsterdam Cardiovascular Sciences, Vascular Medicine, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), SA Pathology at Flinders Medical Center (ASG), Flinders University, Department of Epidemiology (MHP), Maastricht University [Maastricht], College of Public Health (CPH), University of Oklahoma (OU), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, MESH: Pulmonary Embolism, Oligosaccharides, MESH: Factor X, 030204 cardiovascular system & hematology, MESH: Intention to Treat Analysis, MESH: Aged, 80 and over, 0302 clinical medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, Aged, 80 and over, MESH: Aged, education.field_of_study, Idrabiotaparinux, MESH: Middle Aged, General Medicine, Heparin, Middle Aged, Intention to Treat Analysis, 3. Good health, Pulmonary embolism, Acute Disease, MESH: Acute Disease, Drug Therapy, Combination, Female, medicine.drug, Adult, medicine.medical_specialty, MESH: Enoxaparin, Adolescent, Population, Biotin, MESH: Anticoagulants, Double blind, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Biotin, medicine, Humans, Enoxaparin, education, Aged, MESH: Adolescent, MESH: Humans, Intention-to-treat analysis, business.industry, Warfarin, Anticoagulants, MESH: Adult, Odds ratio, medicine.disease, MESH: Male, Surgery, MESH: Drug Therapy, Combination, Factor X, Pulmonary Embolism, business, MESH: Female, MESH: Oligosaccharides, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; BACKGROUND: Treatment of pulmonary embolism with low-molecular-weight heparin and vitamin K antagonists, such as warfarin, is not ideal. We aimed to assess non-inferiority of idrabiotaparinux, a reversible longlasting indirect inhibitor of activated factor X, to warfarin in patients with acute symptomatic pulmonary embolism. METHODS: In our randomised, double-blind, double-dummy, non-inferiority trial, we enrolled adults with objectively documented acute symptomatic pulmonary embolism attending 291 centres in 37 countries. We excluded patients who were pregnant, had active bleeding, kidney failure, or malignant hypertension, or were at high risk of death, bleeding, or adverse reactions to study drugs. We randomly allocated patients to receive 5-10 days' enoxaparin 1*0 mg/kg twice daily followed by subcutaneous idrabiotaparinux (starting dose 3*0 mg) or adjusted-dose warfarin (target international normalised ratio 2*0-3*0); regimens lasted 3 months or 6 months dependent on clinical presentation. Block randomisation was done with a central interactive computerised system, stratified by study centre and intended treatment duration. The primary efficacy outcome was recurrent venous thromboembolism at 99 days after randomisation. We estimated the odds ratio and 95% CI with a Mantel-Haenzsel χ(2) analysis (non-inferiority margin 2*0) in the intention-to-treat population. The main safety outcome was clinically relevant bleeding (major or non-major) in all patients at day 99. This study is registered with ClinicalTrials.gov, number NCT00345618. FINDINGS: Between Aug 1, 2006, and Jan 31, 2010, we enrolled 3202 patients aged 18-96 years. 34 (2%) of 1599 patients randomly allocated to receive enoxaparin-idrabiotaparinux and 43 (3%) of 1603 patients randomly allocated to receive enoxaparin-warfarin had recurrent venous thromboembolism (odds ratio 0*79, 95% CI 0*50-1*25; p(non-inferiority)=0*0001). 72 (5%) of 1599 patients in the enoxaparin-idrabiotaparinux group and 106 (7%) of 1603 patients in the enoxaparin-warfarin group had clinically relevant bleeding (0*67, 0*49-0*91; p(superiority)=0*0098). We noted similar differences in outcomes in those patients treated to 6 months. INTERPRETATION: Idrabiotaparinux could provide an attractive alternative to warfarin for the long-term treatment of pulmonary embolism, and seems to be associated with reduced bleeding. FUNDING: Sanofi-Aventis (Paris, France).

Published
2012

30. Bortezomib during induction and maintenance before and after autologous transplantation improves overall survival in patients with renal impairment : subgroup analysis from the HOVON-65/GMMG-HD4 randomized trial for newly diagnosed multiple myeloma

Author

Scheid, C., Sonneveld, P., Schmidt-Wolf, I., van der Holt, B., Hielscher, T., el Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Hanel, M., Vellenga, E., Schubert, J., Blau, I. W., Jie, A., van de Velde, H., Peter, N., Schaafsma, M., Lindemann, W., Kersten, M., Dührsen, Ulrich, Delforge, M., Weisel, K., Croockewit, S., Martin, H., Wittebol, S., Schouten, H., van Marwijk-Kooy, M., Wijermans, P., Lokhorst, H., Goldschmidt, H., GMMG, and HOVON

Subjects
Medizin
Published
2011

31. First interim safety analysis of a phase III randomized trial in a newly diagnosed systemic peripheral T-cell lymphoma trated with CHOP chemotherapy with or without alemtuzumab and consolidated by autologous hematopoietic stem cell transplant

Author

D'Amore, Francesco Annibale, Gomes da Silva, M, Leppa, S, Relander, T, Pezzutto, A, Lauritzsen, GF, Weidmann, E, Van Gelder, M, Merup, M, Hagberg, H, Fagerli, UM, Brown, Peter De Nully, Boye Hansen, P, Mariz, JM, Jankovska, M, Walewski, J, Doorduijn, J, van Hoof, A, Christiansen, Ilse, Jyrkkiö, S, Kluin-Nelemans, JC, van Marwijk Kooy, M, Fijnheer, R, Stevens, W, Zijlstra, J, Böhmer, L, Lugtenburg, PJ, Grube, M, Prochazka, V, Salek, D, Greil, R, Trümper, L, Wulf, G, Altmann, B, Ziepert, M, Loeffler, M, Jantunen, E, Hopfinger, G, Van den Neste, E, and Toldbod, H

Published
2011

32. Bortezomib before and after high-dose chemotherapy improves the survival in patients with newly diagnosed multiple myeloma and renal insufficiency - a subgroup analysis of the prospective randomised GMMG HD4/HOVON 65 study

Author

Scheid, C., Sonneveld, P., Schmidt-Wolf, I., van der Holt, B., Hielscher, T., el Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Hanel, M., Vellenga, E., Schubert, J., Blau, I. W., Jie, A., van de Velde, H., Peter, N., Schaafsma, M., Lindemann, W., Kersten, M. J., Dührsen, Ulrich, Delforge, M., Weisel, K., Croockewit, S., Martin, H., Wittebol, S., Schouten, H., van Marwijk-Kooy, M., Wijermans, P., Lokhorst, H. M., Goldschmidt, H., and GMMG HOVON

Subjects
Medizin
Published
2011

33. A randomized clinical trial on the effectiveness of an intervention to treat psychological distress and improve quality of life after autologous stem cell transplantation

Author

Braamse, Annemarie M. J., primary, van Meijel, B., additional, Visser, O. J., additional, Boenink, A. D., additional, Cuijpers, P., additional, Eeltink, C. E., additional, Hoogendoorn, A. W., additional, van Marwijk Kooy, M., additional, van Oppen, P., additional, Huijgens, P. C., additional, Beekman, A. T. F., additional, and Dekker, J., additional

Published
2015
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36. Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial

Author

Sonneveld, P., Schmidt-Wolf, I.G., van der Holt, B., El Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Vellenga, E., Broyl, A., Blau, I.W., Weisel, K.C., Wittebol, S., Bos, G.M., Stevens-Kroef, M.J., Scheid, C., Pfreundschuh, M., Hose, D., Jauch, A., van der Velde, H., Raymakers, R., Schaafsma, M.R., Kersten, M.J., van Marwijk-Kooy, M., Duehrsen, U., Lindemann, W., Wijermans, P.W., Lokhorst, H.M., Goldschmidt, H.M., Sonneveld, P., Schmidt-Wolf, I.G., van der Holt, B., El Jarari, L., Bertsch, U., Salwender, H., Zweegman, S., Vellenga, E., Broyl, A., Blau, I.W., Weisel, K.C., Wittebol, S., Bos, G.M., Stevens-Kroef, M.J., Scheid, C., Pfreundschuh, M., Hose, D., Jauch, A., van der Velde, H., Raymakers, R., Schaafsma, M.R., Kersten, M.J., van Marwijk-Kooy, M., Duehrsen, U., Lindemann, W., Wijermans, P.W., Lokhorst, H.M., and Goldschmidt, H.M.

Abstract

Item does not contain fulltext, PURPOSE: We investigated whether bortezomib during induction and maintenance improves survival in newly diagnosed multiple myeloma (MM). PATIENTS AND METHODS: In all, 827 eligible patients with newly diagnosed symptomatic MM were randomly assigned to receive induction therapy with vincristine, doxorubicin, and dexamethasone (VAD) or bortezomib, doxorubicin, and dexamethasone (PAD) followed by high-dose melphalan and autologous stem-cell transplantation. Maintenance consisted of thalidomide 50 mg (VAD) once per day or bortezomib 1.3 mg/m(2) (PAD) once every 2 weeks for 2 years. The primary analysis was progression-free survival (PFS) adjusted for International Staging System (ISS) stage. RESULTS: Complete response (CR), including near CR, was superior after PAD induction (15% v 31%; P < .001) and bortezomib maintenance (34% v 49%; P < .001). After a median follow-up of 41 months, PFS was superior in the PAD arm (median of 28 months v 35 months; hazard ratio [HR], 0.75; 95% CI, 0.62 to 0.90; P = .002). In multivariate analysis, overall survival (OS) was better in the PAD arm (HR, 0.77; 95% CI, 0.60 to 1.00; P = .049). In high-risk patients presenting with increased creatinine more than 2 mg/dL, bortezomib significantly improved PFS from a median of 13 months to 30 months (HR, 0.45; 95% CI, 0.26 to 0.78; P = .004) and OS from a median of 21 months to 54 months (HR, 0.33; 95% CI, 0.16 to 0.65; P < .001). A benefit was also observed in patients with deletion 17p13 (median PFS, 12 v 22 months; HR, 0.47; 95% CI, 0.26 to 0.86; P = .01; median OS, 24 months v not reached at 54 months; HR, 0.36; 95% CI, 0.18 to 0.74; P = .003). CONCLUSION: Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.

Published
2012

37. Bortezomib Induction and Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma: Results of the Randomized Phase III HOVON-65/GMMG-HD4 Trial

Author

Sonneveld, Pieter, Schmidt-Wolf, IGH, van der Holt, Ronnie, Jarari, L (Laila), Bertsch, U, Salwender, H, Zweegman, S, Vellenga, E, Broijl, A., Blau, IW, Weisel, KC, Wittebol, S, Bos, G (Gerard), Stevens-Kroef, M, Scheid, C, Pfreundschuh, M, Hose, D, Jauch, A, te Velde, H, Raymakers, R, Schaafsma, MR, Kersten, MJ, van Marwijk-Kooy, M, Duehrsen, U, Lindemann, W, Wijermans, PW, Lokhorst, HM, Goldschmidt, HM, Sonneveld, Pieter, Schmidt-Wolf, IGH, van der Holt, Ronnie, Jarari, L (Laila), Bertsch, U, Salwender, H, Zweegman, S, Vellenga, E, Broijl, A., Blau, IW, Weisel, KC, Wittebol, S, Bos, G (Gerard), Stevens-Kroef, M, Scheid, C, Pfreundschuh, M, Hose, D, Jauch, A, te Velde, H, Raymakers, R, Schaafsma, MR, Kersten, MJ, van Marwijk-Kooy, M, Duehrsen, U, Lindemann, W, Wijermans, PW, Lokhorst, HM, and Goldschmidt, HM

Abstract

Purpose We investigated whether bortezomib during induction and maintenance improves survival in newly diagnosed multiple myeloma (MM). Patients and Methods In all, 827 eligible patients with newly diagnosed symptomatic MM were randomly assigned to receive induction therapy with vincristine, doxorubicin, and dexamethasone (VAD) or bortezomib, doxorubicin, and dexamethasone (PAD) followed by high-dose melphalan and autologous stem-cell transplantation. Maintenance consisted of thalidomide 50 mg (VAD) once per day or bortezomib 1.3 mg/m(2) (PAD) once every 2 weeks for 2 years. The primary analysis was progression-free survival (PFS) adjusted for Inter Results Complete response (CR), including near CR, was superior after PAD induction (15% v 31%; P < .001) and bortezomib maintenance (34% v 49%; P < .001). After a median follow-up of 41 months, PFS was superior in the PAD arm (median of 28 months v 35 months; hazard ratio [ HR], 0.75; 95% CI, 0.62 to 0.90; P = .002). In multivariate analysis, overall survival (OS) was better in the PAD arm (HR, 0.77; 95% CI, 0.60 to 1.00; P = .049). In high-risk patients presenting with increased creatinine more than 2 Conclusion Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.

Published
2012

38. Abrupt versus gradual withdrawal of vitamin K antagonist treatment in patients with venous thromboembolic disease: assessment of hypercoagulability and clinical outcome

Author

de Groot, M. R., Njo, T. L., van Marwijk Kooy, M., Büller, H. R., and Other departments

Abstract

It is yet unclear whether vitamin K antagonist treatment should be stopped abruptly or gradually after an episode of venous thromboembolism. The mode of withdrawal might influence a potential development of a hypercoagulable state, which could influence the risk for recurrent disease. We prospectively studied 37 consecutive patients in whom acenocoumarol was discontinued either abrupt (18) or gradually (19) (2/3 and 1/3 of the initial dose for one week). Blood sampling was performed at various time points up to 18 days after complete withdrawal and was analysed for INR, prothrombin fragment F1 + 2 and D-dimer. All patients were clinically followed-up for the assessment of the association between hypercoagulability and occurrence of disease such as recurrent venous thromboembolism or malignancy. An approximately fourfold increase was observed (median increase from 0.3 to 1.3 nmol/l) in the F1 + 2 levels after both abrupt and gradual withdrawal and in the D-dimer concentrations in the abrupt withdrawal group (0.10 to 0.44 mg/l), while those in whom acenocoumarol was discontinued gradually showed a less pronounced increase of the D-dimer levels (0.11 to 0.29 mg/L) (not significant). During follow-up one recurrent venous thromboembolic event occurred in each group, and a diagnosis of cancer was made four times. All these patients had the highest D-dimer concentrations measured in the entire study group. This study indicates the potential for a hypercoagulable state after acenocoumarol discontinuation, which was not prevented by tapering the acenocoumarol dose. D-dimer, measured 2 to 3 weeks after acenocoumarol withdrawal, might be an important tool to identify patients at risk for recurrent venous thromboembolism and/or for the presence of an underlying malignancy

Published
2000

39. Identification Of Chromosomal Abnormalities By Microarray-Based Genomic Profiling As Compared To Karyotyping In Patients With Low and Intermediate-1 Risk Myelodysplastic Syndromes Within a Prospective Clinical Trial: A Study On Behalf Of The HOVON89 Study Group

Author

Stevens-Kroef, Marian J.P.L., primary, Simons, Annet, additional, El Idrissi-Zaynoun, Najat, additional, van der Reijden, Bert A., additional, Cremers, Eline M.P., additional, Alhan, Canan, additional, Westers, Theresia M., additional, Visser-Wisselaar, Heleen A., additional, Chitu, Dana, additional, Vellenga, Edo, additional, Klein, S. K., additional, Wijermans, Pierre W., additional, De Greef, Georgine E., additional, Schaafsma, Martyn R., additional, van Marwijk Kooy, M., additional, Muus, Petra, additional, Ossenkoppele, Gert J., additional, van de Loosdrecht, Arjan A., additional, and Jansen, Joop H., additional

Published
2013
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40. Bortezomib before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in newly diagnosed multiple myeloma: a subgroup analysis from the HOVON-65/GMMG-HD4 trial

Author

Scheid, C., primary, Sonneveld, P., additional, Schmidt-Wolf, I. G. H., additional, van der Holt, B., additional, Jarari, L. e., additional, Bertsch, U., additional, Salwender, H., additional, Zweegman, S., additional, Blau, I. W., additional, Vellenga, E., additional, Weisel, K., additional, Pfreundschuh, M., additional, Jie, K.-S., additional, Neben, K., additional, van de Velde, H., additional, Duehrsen, U., additional, Schaafsma, M. R., additional, Lindemann, W., additional, Kersten, M. J., additional, Peter, N., additional, Hanel, M., additional, Croockewit, S., additional, Martin, H., additional, Wittebol, S., additional, Bos, G. M., additional, van Marwijk-Kooy, M., additional, Wijermans, P., additional, Goldschmidt, H., additional, and Lokhorst, H. M., additional

Published
2013
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41. Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study

Author

Segeren, CM, Sonneveld, Pieter, van der Holt, Ronnie, Vellenga, E, Croockewit, AJ, Verhoef, GEG, Cornelissen, Jan, Schaafsma, MR, van Oers, MHJ, Wijermans, PW, Fibbe, WE, Wittebol, S, Schouten, HC (Harry), van Marwijk Kooy, M, Biesma, DH, Baars, JW, Slater, RM, Steijaert, MMC, Buijt, Ivonne, Lokhorst, HM, Segeren, CM, Sonneveld, Pieter, van der Holt, Ronnie, Vellenga, E, Croockewit, AJ, Verhoef, GEG, Cornelissen, Jan, Schaafsma, MR, van Oers, MHJ, Wijermans, PW, Fibbe, WE, Wittebol, S, Schouten, HC (Harry), van Marwijk Kooy, M, Biesma, DH, Baars, JW, Slater, RM, Steijaert, MMC, Buijt, Ivonne, and Lokhorst, HM

Published
2003

42. Efficacy of escalated imatinib combined with cytarabine in newly diagnosed patients with chronic myeloid leukemia

Author

Deenik, W., primary, Janssen, J. J. W. M., additional, van der Holt, B., additional, Verhoef, G. E. G., additional, Smit, W. M., additional, Kersten, M. J., additional, Daenen, S. M. G. J., additional, Verdonck, L. F., additional, Ferrant, A., additional, Schattenberg, A. V. M. B., additional, Sonneveld, P., additional, van Marwijk Kooy, M., additional, Wittebol, S., additional, Willemze, R., additional, Wijermans, P. W., additional, Beverloo, H. B., additional, Lowenberg, B., additional, Valk, P. J. M., additional, Ossenkoppele, G. J., additional, and Cornelissen, J. J., additional

Published
2009
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43. Treatment of Older Patients, 40 to 70 Years of Age, with Acute Lymphoblastic Leukemia According to a Chemotherapy Regimen That Includes a Novel Pre-Phase for Rapid Tumor Load Reduction. Results of the Dutch-Belgian HOVON-71 Study.

Author

Daenen, Simon M. G. J., primary, van der Holt, Bronno, additional, Dekker, Adriaan W., additional, Willemze, Roelof, additional, Rijneveld, Anita, additional, Biemond, Bart J., additional, Muus, Petra, additional, van de Loosdrecht, Arjan A, additional, Schouten, Harry, additional, van Marwijk Kooy, M., additional, Breems, Dimitri, additional, Maertens, Johan, additional, Demuynck, Hilde, additional, Wijermans, Pierre W, additional, Wittebol, Shulamiet, additional, de Klerk, Ellen W., additional, and Cornelissen, Jan J., additional

Published
2009
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45. Vincristine, doxorubicin and dexamethasone (VAD) administered as rapid intravenous infusion for first-line treatment in untreated multiple myeloma

Author

Segeren, C, Sonneveld, Pieter, van der Holt, Ronnie, Baars, JW, Biesma, DH, Cornelissen, Jan, Croockewit, AJ, Fibbe, WE, Löwenberg, Bob, van Marwijk Kooy, M, van Oers, MHJ, Richel, DJ, Schouten, HC (Harry), Vellenga, E, Verhoef, GEG, Wijermans, P, Wittebol, S, Lokhorst, HM, Segeren, C, Sonneveld, Pieter, van der Holt, Ronnie, Baars, JW, Biesma, DH, Cornelissen, Jan, Croockewit, AJ, Fibbe, WE, Löwenberg, Bob, van Marwijk Kooy, M, van Oers, MHJ, Richel, DJ, Schouten, HC (Harry), Vellenga, E, Verhoef, GEG, Wijermans, P, Wittebol, S, and Lokhorst, HM

Published
1999

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