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2. Fixed-duration venetoclax plus obinutuzumab improves quality of life and geriatric impairments in FCR-unfit patients with CLL

Author

Beckers, M. M. J., Bekker, A., Bellido, M., de Boer, F., Broers, R., Chamuleau, M., Croockewit, A. J., Dompeling, E. C., Eefting, M., van Gelder, M., Hoogendoorn, M., Houtenbos, I., Doorduijn, J. K., Droogendijk, J., van der Griend, R., de Heer, K., Henkens, C. M. A., Idink, C. A. M., Issa, D. E., van Kampen, R., Kater, A. P., Kersting, S., van der Klift, M., Laterveer, L., Levenga, H., Levin, M-D., Mous, R., Nijland, M., Nijziel, M., van Norden, Y., Posthuma, E. F. M., te Raa, G. D., Raymakers, R. A. P., Regelink, J. C., Sandberg, Y., Schaafsma, M. R., Silbermann, M. H., van der Spek, A. C., van der Straaten, H. M., Tanis, B., Terpstra, W. E., Tick, L. W., Tonino, S. H., Veelken, J. H., Velders, G. A., Vlasveld, L., Visser, H. P. J., Vos, J. M. I., Wittebol, S., van Zaanen, H. C. T., van der Straten, Lina, Stege, Claudia A. M., Kersting, Sabina, Nasserinejad, Kazem, Dubois, Julie, Dobber, Johan A., Mellink, Clemens H. M., van der Kevie-Kersemaekers, Anne-Marie F., Evers, Ludo M., de Boer, Fransien, Koene, Harry R., Schreurs, John, van der Klift, Marjolein, Velders, Gerjo A., van der Spek, Ellen, van der Straaten, Hanneke M., Hoogendoorn, Mels, van Gelder, Michel, Posthuma, Eduardus F. M., Visser, Hein P. J., Houtenbos, Ilse, Idink, Cecile A. M., Issa, Djamila E., Dompeling, Ellen C., van Zaanen, Henk C. T., Veelken, J. Hendrik, Levenga, Henriette, Tick, Lidwine W., Terpstra, Wim E., Tonino, Sanne H., Westerweel, Peter E., Langerak, Anton W., Kater, Arnon P., and Levin, Mark-David

Published
2023
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3. Genetic variants, thrombocytopenia, and clinical phenotype of type 2B von Willebrand disease:a median 16-year follow-up study

Author

van Kwawegen, C. B., Atiq, F., Endenburg, Dara, Fijnvandraat, K., van Galen, K. P.M., Cnossen, M. H., Schols, S. E.M., Kruip, Marieke J.H.A., van Heerde, Waander L., de Meris, J., van der Bom, Johanna G., Eikenboom, Jeroen, Meijer, Karina, Leebeek, Frank W.G., Coppens, M., Kors, A., Zweegman, S., Goverde, G. J., Jonkers, M. H., Dors, N., Nijziel, M. R., Nieuwenhuizen, L., Meijer, K., Tamminga, R. Y.J., van der Linden, P. W., Ypma, P. F., Eikenboom, H. C.J., van der Bom, J. G., Smiers, F. J.W., Granzen, B., Hamulyák, K., Brons, P., Laros-van Gorkom, B. A.P., Boender, J., Mauser-Bunschoten, E. P., van Kwawegen, C. B., Atiq, F., Endenburg, Dara, Fijnvandraat, K., van Galen, K. P.M., Cnossen, M. H., Schols, S. E.M., Kruip, Marieke J.H.A., van Heerde, Waander L., de Meris, J., van der Bom, Johanna G., Eikenboom, Jeroen, Meijer, Karina, Leebeek, Frank W.G., Coppens, M., Kors, A., Zweegman, S., Goverde, G. J., Jonkers, M. H., Dors, N., Nijziel, M. R., Nieuwenhuizen, L., Meijer, K., Tamminga, R. Y.J., van der Linden, P. W., Ypma, P. F., Eikenboom, H. C.J., van der Bom, J. G., Smiers, F. J.W., Granzen, B., Hamulyák, K., Brons, P., Laros-van Gorkom, B. A.P., Boender, J., and Mauser-Bunschoten, E. P.

Abstract

Background: Type 2B von Willebrand disease (VWD) is a bleeding disorder caused by gain-of-function variants in the VWF gene. The laboratory and clinical phenotype of type 2B VWD is heterogeneous. Objectives: We investigated associations between genotype and phenotype over a median of 16 years follow-up in a large cohort of well-characterized patients. Methods: We included 64 genetically confirmed type 2B VWD patients from the national multicenter “Willebrand in the Netherlands” study and retrospectively collected clinical and laboratory data from electronic patient records. We analyzed associations between genotype and thrombocytopenia, bleeding phenotype, and events leading to endothelial activation and von Willebrand factor (VWF) secretion, including surgery, desmopressin administration, pregnancy, and delivery. Results: Thrombocytopenia manifested in 67.2% of patients, with varying occurrences between genetic variants (p.Arg1306Trp: 75.0%, p.Arg1308Cys: 58.3%). The most important determinant of thrombocytopenia was the p.Arg1306Trp VWF variant (odds ratio, 25.1). Platelet counts strongly varied over time and were continuously <150 × 109/L in 37.5% of patients with p.Arg1306Trp vs 8.3% in p.Arg1308Cys. In our analysis, endothelial activation was not an independent determinant (odds ratio, 1.3) for thrombocytopenia occurrence. No association was found between thrombocytopenia and cumulative bleeding scores or annual bleeding rates. Four women showed declining platelet counts in all full-term pregnancies (n = 8) during the third trimester with a sharp decrease in the week before delivery. Postpartum hemorrhage, defined as >500 mL estimated blood loss at delivery, occurred in 5 of 8 deliveries, despite prophylactic treatment with VWF concentrates. Conclusion: This study reveals a strong association between VWF variant p.Arg1306Trp and thrombocytopenia in type 2B VWD patients.

Published
2024

4. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma

Author

MS Radiotherapie, Cancer, Verpleegkundig specialisten & PA's, Geurts, Y M, Neppelenbroek, S I M, Aleman, B M P, Janus, C P M, Krol, A D G, van Spronsen, D J, Plattel, W J, Roesink, J M, Verschueren, K M S, Zijlstra, J M, Koene, H R, Nijziel, M R, Schimmel, E C, de Jongh, E, Ong, F, Te Boome, L C J, van Rijn, R S, Böhmer, L H, Ta, B D P, Visser, H P J, Posthuma, E F M, Bilgin, Y M, Muller, K, van Kampen, D, So-Osman, C, Vermaat, J S P, de Weijer, R J, Kersten, M J, van Leeuwen, F E, Schaapveld, M, MS Radiotherapie, Cancer, Verpleegkundig specialisten & PA's, Geurts, Y M, Neppelenbroek, S I M, Aleman, B M P, Janus, C P M, Krol, A D G, van Spronsen, D J, Plattel, W J, Roesink, J M, Verschueren, K M S, Zijlstra, J M, Koene, H R, Nijziel, M R, Schimmel, E C, de Jongh, E, Ong, F, Te Boome, L C J, van Rijn, R S, Böhmer, L H, Ta, B D P, Visser, H P J, Posthuma, E F M, Bilgin, Y M, Muller, K, van Kampen, D, So-Osman, C, Vermaat, J S P, de Weijer, R J, Kersten, M J, van Leeuwen, F E, and Schaapveld, M

Published
2024

5. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma

Author

Geurts, Y. M., Neppelenbroek, S. I.M., Aleman, B. M.P., Janus, C. P.M., Krol, A. D.G., van Spronsen, D. J., Plattel, W. J., Roesink, J. M., Verschueren, K. M.S., Zijlstra, J. M., Koene, H. R., Nijziel, M. R., Schimmel, E. C., de Jongh, E., Ong, F., te Boome, L. C.J., van Rijn, R. S., Böhmer, L. H., Ta, B. D.P., Visser, H. P.J., Posthuma, E. F.M., Bilgin, Y. M., Muller, K., van Kampen, D., So-Osman, C., Vermaat, J. S.P., de Weijer, R. J., Kersten, M. J., van Leeuwen, F. E., Schaapveld, M., Geurts, Y. M., Neppelenbroek, S. I.M., Aleman, B. M.P., Janus, C. P.M., Krol, A. D.G., van Spronsen, D. J., Plattel, W. J., Roesink, J. M., Verschueren, K. M.S., Zijlstra, J. M., Koene, H. R., Nijziel, M. R., Schimmel, E. C., de Jongh, E., Ong, F., te Boome, L. C.J., van Rijn, R. S., Böhmer, L. H., Ta, B. D.P., Visser, H. P.J., Posthuma, E. F.M., Bilgin, Y. M., Muller, K., van Kampen, D., So-Osman, C., Vermaat, J. S.P., de Weijer, R. J., Kersten, M. J., van Leeuwen, F. E., and Schaapveld, M.

Abstract

Background: The introduction of rituximab significantly improved the prognosis of diffuse large B-cell lymphoma (DLBCL), emphasizing the importance of evaluating the long-term consequences of exposure to radiotherapy, alkylating agents and anthracycline-containing (immuno)chemotherapy among DLBCL survivors. Methods: Long-term risk of subsequent malignant neoplasms (SMNs) was examined in a multicenter cohort comprising 2373 5-year DLBCL survivors treated at ages 15-61 years in 1989-2012. Observed SMN numbers were compared with expected cancer incidence to estimate standardized incidence ratios (SIRs) and absolute excess risks (AERs/10 000 person-years). Treatment-specific risks were assessed using multivariable Cox regression. Results: After a median follow-up of 13.8 years, 321 survivors developed one or more SMNs (SIR 1.5, 95% CI 1.3-1.8, AER 51.8). SIRs remained increased for at least 20 years after first-line treatment (SIR ≥20-year follow-up 1.5, 95% CI 1.0-2.2, AER 81.8) and were highest among patients ≤40 years at first DLBCL treatment (SIR 2.7, 95% CI 2.0-3.5). Lung (SIR 2.0, 95% CI 1.5-2.7, AER 13.4) and gastrointestinal cancers (SIR 1.5, 95% CI 1.2-2.0, AER 11.8) accounted for the largest excess risks. Treatment with >4500 mg/m2 cyclophosphamide/>300 mg/m2 doxorubicin versus ≤2250 mg/m2/≤150 mg/m2, respectively, was associated with increased solid SMN risk (hazard ratio 1.5, 95% CI 1.0-2.2). Survivors who received rituximab had a lower risk of subdiaphragmatic solid SMNs (hazard ratio 0.5, 95% CI 0.3-1.0) compared with survivors who did not receive rituximab. Conclusion: Five-year DLBCL survivors have an increased risk of SMNs. Risks were higher for survivors ≤40 years at first treatment and survivors treated with >4500 mg/m2 cyclophosphamide/>300 mg/m2 doxorubicin, and may be lower for survivors treated in the rituximab era, emphasizing the need for studies with longer follow

Published
2024

6. Risk of male breast cancer after Hodgkin lymphoma

Author

de Vries, Simone, Krul, Inge M., Schaapveld, Michael, Janus, Cecile P.M., Rademakers, Saskia E., Roesink, J. M., Nijziel, M. R., Bilgin, M. Y., van Leeuwen, F. E., Nijdam, A., Aleman, Berthe M.P., de Boer, J. P., Mutsaers, P. G.N.J., So-Osman, C., Zijlstra, J. M., Meijer, O. W.M., Rademakers, S. E., Krol, A. D.G., Kersten, M. J., Tonino, S. H., Jalink, M., Daniëls, L. A., van Spronsen, D. J., van der Maazen, R. W.M., Loonen, J., Oostvogels, R., de Weijer, R., Buter, D., de Boer, A., Aarsman, K. M., Oudbier, C. W., van den Berg, M., Verschueren, K., Schippers, M., Muller, K., Siemes, C., van der Spek, J. M., Jonkman, A., de Jongh, E., Sprangers, S., Paulissen, J., Posthuma, E. F.M., Brouwer, R. E., Soechit, S., Kuipers, S., te Boome, L., Gommers, S., de Vries, Simone, Krul, Inge M., Schaapveld, Michael, Janus, Cecile P.M., Rademakers, Saskia E., Roesink, J. M., Nijziel, M. R., Bilgin, M. Y., van Leeuwen, F. E., Nijdam, A., Aleman, Berthe M.P., de Boer, J. P., Mutsaers, P. G.N.J., So-Osman, C., Zijlstra, J. M., Meijer, O. W.M., Rademakers, S. E., Krol, A. D.G., Kersten, M. J., Tonino, S. H., Jalink, M., Daniëls, L. A., van Spronsen, D. J., van der Maazen, R. W.M., Loonen, J., Oostvogels, R., de Weijer, R., Buter, D., de Boer, A., Aarsman, K. M., Oudbier, C. W., van den Berg, M., Verschueren, K., Schippers, M., Muller, K., Siemes, C., van der Spek, J. M., Jonkman, A., de Jongh, E., Sprangers, S., Paulissen, J., Posthuma, E. F.M., Brouwer, R. E., Soechit, S., Kuipers, S., te Boome, L., and Gommers, S.

Abstract

Female survivors of Hodgkin lymphoma (HL) treated with chest radiotherapy have a strongly increased risk of breast cancer (BC), but the treatment-specific BC risk in male survivors of HL has not been evaluated. We assessed BC risk in a cohort of 3077 male survivors of 5-year HL treated at age ≤51 years in 20 Dutch hospitals between 1965 and 2013. We estimated standardized incidence ratios (SIRs), absolute excess risks per 10 000 person-years, and cumulative BC incidences. After a 20-year median follow-up, we observed 8 cases of male with BC. Male survivors of HL experienced a 23-fold (95% confidence interval [CI], 10.1-46.0) increased BC risk compared with the general population, representing 1.6 (95% CI, 0.7-3.3) excess BC incidences per 10 000 person-years. The 20- and 40-year cumulative BC incidences after HL treatment were 0.1% (95% CI, 0.02-0.3) and 0.7% (95% CI, 0.3-1.4), respectively. Treatment with chest radiotherapy without alkylating chemotherapy yielded a strongly increased SIR (20.7; 95% CI, 2.5-74.8), which was not significantly different for chest radiotherapy and alkylating chemotherapy (41.1; 95% CI, 13.4-96.0). Males treated with chest radiotherapy and anthracyclines had an SIR of 48.1 (95% CI, 13.1-123.1). Two patients died from BC (median follow-up, 4.7 years). To ensure early diagnosis and treatment, clinicians should be alert to BC symptoms in male survivors of HL.

Published
2023

7. Risk of male breast cancer after Hodgkin lymphoma

Author

van Leeuwen, F. E., Nijdam, A., Aleman, B. M. P., de Boer, J. P., Janus, C. P. M., Mutsaers, P. G. N. J., So-Osman, C., Zijlstra, J. M., Meijer, O. W. M., Rademakers, S. E., Krol, A. D. G., Kersten, M. J., Tonino, S. H., Jalink, M., Daniëls, L. A., van Spronsen, D. J., van der Maazen, R. W. M., Loonen, J., Roesink, J. M., Oostvogels, R., de Weijer, R., Buter, D., de Boer, A., Aarsman, K. M., Oudbier, C. W., Nijziel, M. R., van den Berg, M., Verschueren, K., Schippers, M., Boersma, R. S., Issa, D. E., Plattel, W. J., Stedema, F. G., Koene, H. R., Raymakers, E. R. P. M., Schimmel, E., van Hezewijk, M., Bouma, P., Muller, K., Siemes, C., van der Spek, J. M., Ong, F., Jonkman, A., de Jongh, E., Sprangers, S., Kortleve, J. P., Vermeiden, C. M., Ta, B., Vercoulen, L., Paulissen, J., Posthuma, E. F. M., Brouwer, R. E., Soechit, S., van der Wiel, M., Böhmer, L., Bilgin, M. Y., Kuipers, S., Houmes, M., te Boome, L., Gommers, S., de Vries, Simone, Krul, Inge M., Schaapveld, Michael, Janus, Cecile P. M., Rademakers, Saskia E., Roesink, Judith M., Nijziel, Marten R., Bilgin, Yavuz M., Aleman, Berthe M. P., and van Leeuwen, Flora E.

Published
2023
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8. Fixed-duration venetoclax plus obinutuzumab improves quality of life and geriatric impairments in FCR-unfit patients with CLL

Author

van der Straten, Lina, Stege, Claudia A. M., Kersting, Sabina, Nasserinejad, Kazem, Dubois, Julie, Dobber, Johan A., Mellink, Clemens H. M., van der Kevie-Kersemaekers, Anne-Marie F., Evers, Ludo M., de Boer, Fransien, Koene, Harry R., Schreurs, John, van der Klift, Marjolein, Velders, Gerjo A., van der Spek, Ellen, van der Straaten, Hanneke M., Hoogendoorn, Mels, van Gelder, Michel, Posthuma, Eduardus F. M., Visser, Hein P. J., Houtenbos, Ilse, Idink, Cecile A. M., Issa, Djamila E., Dompeling, Ellen C., van Zaanen, Henk C. T., Veelken, J. Hendrik, Levenga, Henriette, Tick, Lidwine W., Terpstra, Wim E., Tonino, Sanne H., Westerweel, Peter E., Langerak, Anton W., Kater, Arnon P., Levin, Mark-David, Beckers, M. M. J., Bekker, A., Bellido, M., de Boer, F., Broers, R., Chamuleau, M., Croockewit, A. J., Dompeling, E. C., Eefting, M., van Gelder, M., Hoogendoorn, M., Houtenbos, I., Doorduijn, J. K., Droogendijk, J., van der Griend, R., de Heer, K., Henkens, C. M. A., Idink, C. A. M., Issa, D. E., van Kampen, R., Kater, A. P., Kersting, S., van der Klift, M., Laterveer, L., Levenga, H., Levin, M-D., Mous, R., Nijland, M., Nijziel, M., van Norden, Y., Posthuma, E. F. M., te Raa, G. D., Raymakers, R. A. P., Regelink, J. C., Sandberg, Y., Schaafsma, M. R., Silbermann, M. H., van der Spek, A. C., van der Straaten, H. M., Tanis, B., Terpstra, W. E., Tick, L. W., Tonino, S. H., Veelken, J. H., Velders, G. A., Vlasveld, L., Visser, H. P. J., Vos, J. M. I., Wittebol, S., and van Zaanen, H. C. T.

Abstract

•Geriatric assessments can aid in identifying patients with less physical resilience who are at increased risk of grade ≥3 adverse events.•Fixed-duration Ven-O improves HRQoL in patients with CLL with and without geriatric impairments.

Published
2023
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9. BMI is an important determinant of VWF and FVIII levels and bleeding phenotype in patients with von Willebrand disease

Author

Atiq, Ferdows, Fijnvandraat, Karin, van Galen, Karin P. M., Laros-van Gorkom, Britta A. P., Meijer, Karina, de Meris, Joke, Coppens, Michiel, Mauser-Bunschoten, Eveline P., Cnossen, Marjon H., van der Bom, Johanna G., Eikenboom, Jeroen, Leebeek, Frank W. G., Coppens, M., Kors, A., Zweegman, S., de Meris, J., Goverde, G. J., Jonkers, M. H., Dors, N., Nijziel, M. R., Nieuwenhuizen, L., Meijer, K., Tamminga, R. Y. J., van der LindenHagaZiekenhuis, P. W., Ypma, P. F., Eikenboom, H. C. J., van der Bom, J. G., Smiers, F. J. W., Granzen, B., Hamulyák, K., Brons, P., Laros‐van Gorkom, B. A. P., Leebeek, F. W. G., Cnossen, M. H., Atiq, F., Mauser-Bunschoten, E. P., van Galen, K. P. M., Hematology, Pediatrics, Paediatric Haematology, ACS - Pulmonary hypertension & thrombosis, Vascular Medicine, ARD - Amsterdam Reproduction and Development, VU University medical center, Kindergeneeskunde, MUMC+: MA Medische Staf Kindergeneeskunde (9), RS: FHML non-thematic output, and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
Male, medicine.medical_specialty, Letter, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], E–Only Articles, Hemorrhage, von Willebrand Disease, Type 2, von Willebrand Disease, Type 1, Body Mass Index, Text mining, Internal medicine, von Willebrand Factor, Correspondence, Von Willebrand disease, Medicine, Humans, In patient, Hematology, Factor VIII, business.industry, Middle Aged, Blood coagulation factors, medicine.disease, Phenotype, Immunology, Female, business, Body mass index
Abstract

Contains fulltext : 208376.pdf (Publisher’s version ) (Open Access)

Published
2019
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10. Inhibitor development and mortality in non-severe hemophilia A

Author

Eckhardt, C. L., Loomans, J. I., van Velzen, A. S., Peters, M., Mauser-Bunschoten, E. P., Schwaab, R., Mazzucconi, M. G., Tagliaferri, A., Siegmund, B., Reitter-Pfoertner, S. E., van der Bom, J. G., Fijnvandraat, K., Kamphuisen, P. W., Peerlinck, K., Oldenburg, J., Santagostino, E., Astermark, J., Eckhardt, C. L, van Velzen, A. S, Streefkerk, N., Loomans, J. L., van Eijkelenburg, A., Jansen, A. J., Kruijt, C. C., van Tienoven, B., van Baar, A. C. G., Corten, I. W., Meijer, K., Nijziel, M. R., Dors, N., Hamulyak, K., Beckers, E., Brons, P. P., Laros-van Gorkom, B. A. P., van Heerde, W. L., Leebeek, F., Kruip, M., Cnossen, M. H., Mauser-Bunschoten, E., Fischer, K., Smiers, F. J., Hermans, C., Klamroth, R., Escuriola-Ettingshausen, C., Königs, C., Petrini, P., Holmström, M., Mäkipernaa, A., Male, C., Pabinger, I., Keenan, R. D., Liesner, R., Khair, K., Yee, T. T., Hart, D. P., Rangarajan, S., Mitchell, M., Thompson, G., Haya, S., Moret, A., Cid, A. R., Jimenez-Yuste, V., Mancuso, M. E., Mazzuconni, M. G., Santoro, C., Morfini, M., Castaman, G., Schinco, P., Rivolta, G. F., Platokouki, H., and McRae, S.

Published
2015
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12. CLEC4M and STXBP5 gene variations contribute to von Willebrand factor level variation in von Willebrand disease

Author

Sanders, Y. V., van der Bom, J. G., Isaacs, A., Cnossen, M. H., de Maat, M. P. M., Laros-van Gorkom, B. A. P., Fijnvandraat, K., Meijer, K., van Duijn, C. M., Mauser-Bunschoten, E. P., Eikenboom, J., Leebeek, F. W. G., Coppens, M., Kors, A., de Meris, J., Nijziel, M. R., Tamminga, R. Y. J., Ypma, P. F., Smiers, F. J. W., Granzen, B., Hamulyák, K., and Brons, P.

Published
2015
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14. Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial

Author

Oerlemans, S., Arts, L.P.J., Kieffer, J.M., Prins, J.B., Hoogendoorn, M., Poel, M., Koster, A., Lensen, C., Stevens, W.B.C., Issa, D., Pruijt, J.F., Oosterveld, M., Griend, R. van der, Nijziel, M., Tick, L., Posthuma, E.F., Poll-Franse, L.V. van de, Oerlemans, S., Arts, L.P.J., Kieffer, J.M., Prins, J.B., Hoogendoorn, M., Poel, M., Koster, A., Lensen, C., Stevens, W.B.C., Issa, D., Pruijt, J.F., Oosterveld, M., Griend, R. van der, Nijziel, M., Tick, L., Posthuma, E.F., and Poll-Franse, L.V. van de

Abstract

Contains fulltext : 244124.pdf (Publisher’s version ) (Open Access), BACKGROUND: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results. OBJECTIVE: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting. METHODS: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98). RESULTS: Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3%), and an effect could therefore not be determined. CONCLUSIONS: Return of individual PRO results seems to meet patients' wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed

Published
2021

15. Inferior outcome of addition of the aminopeptidase inhibitor tosedostat to standard intensive treatment for elderly patients with aml and high risk mds

Author

Janssen, J, Löwenberg, Bob, Manz, M, Bargetzi, M, Biemond, B, van den Borne, P, Breems, D, Brouwer, R, Chalandon, Y, Deeren, D, Efthymiou, A, Gjertsen, BT, Graux, C, Gregor, M, Heim, D, Hess, U, Hoogendoorn, M, Jaspers, A, Jie, A, Jongen - Lavrencic, Mojca, Klein, S, van der Klift, Maarten, Kuball, J, van Lammeren-Venema, D, Legdeur, MC, van de Loosdrecht, A, Maertens, J, Kooy, MM, Moors, I, Nijziel, M, van Obbergh, F, Oosterveld, M, Pabst, T, Poel, M, Sinnige, H, Spertini, O, Terpstra, W, Tick, L, van der Velden, W, Vekemans, MC, Vellenga, E, de Weerdt, O, Westerweel, P, Stüssi, G, van Norden, Yvette, Ossenkoppele, G, Janssen, J, Löwenberg, Bob, Manz, M, Bargetzi, M, Biemond, B, van den Borne, P, Breems, D, Brouwer, R, Chalandon, Y, Deeren, D, Efthymiou, A, Gjertsen, BT, Graux, C, Gregor, M, Heim, D, Hess, U, Hoogendoorn, M, Jaspers, A, Jie, A, Jongen - Lavrencic, Mojca, Klein, S, van der Klift, Maarten, Kuball, J, van Lammeren-Venema, D, Legdeur, MC, van de Loosdrecht, A, Maertens, J, Kooy, MM, Moors, I, Nijziel, M, van Obbergh, F, Oosterveld, M, Pabst, T, Poel, M, Sinnige, H, Spertini, O, Terpstra, W, Tick, L, van der Velden, W, Vekemans, MC, Vellenga, E, de Weerdt, O, Westerweel, P, Stüssi, G, van Norden, Yvette, and Ossenkoppele, G

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

20. Frontline treatment with the combination obinutuzumab±chlorambucil for chronic lymphocytic leukemia outside clinical trials: results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Herishanu Y, Shaulov A, Fineman R, BasiC-Kinda S, Aviv A, Wasik-Szczepanek E, Jaksic O, Zdrenghea M, Greenbaum U, Mandac I, Simkovic M, Morawska M, Benjamini O, Spacek M, Nemets A, Bairey O, Trentin L, Ruchlemer R, Laurenti L, Ciocan O, Doubek M, Shvidel L, Dali N, Miras F, De Meuter A, Dimou M, Mauro F, Coscia M, Bumbea H, Szasz R, Tadmor T, Gutwein O, Gentile M, Scarfo L, Tedeschi A, Sportoletti P, Vazquez E, Marquet J, Assouline S, Papaioannou M, Braester A, Levato L, Gregor M, Rigolin G, Loscertales J, Perez A, Nijziel M, Popov V, Collado R, Slavutsky I, Itchaki G, Ringelstein S, Goldschmidt N, Perry C, Levi S, Polliack A, and Ghia P

Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O±Clb in unfit patients with CLL, in a "real-world" setting. Patients with documented del(17p13.1)/TP53mutation were excluded. A total of 437 patients (median age, 75.9years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min)were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95%CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del(11q22.3) and/or IGHV-unmutated], lymph nodes of diameter >5cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a "real-world" setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del(11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease. This article is protected by copyright. All rights reserved.

Published
2020

21. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., and Tedeschi A.

Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.

Published
2020

22. von Willebrand factor propeptide and the phenotypic classification of von Willebrand disease

Author

Sanders, Yvonne V., Groeneveld, Dafna, Meijer, Karina, Fijnvandraat, Karin, Cnossen, M. H., Van Der Bom, J. G., Coppens, M., De Meris, Joke, Laros-Van Gorkom, B. A.P., Mauser-Bunschoten, Eveline P., Leebeek, F. W.G., Eikenboom, Jeroen, Fijnvandraat, K., Kors, A., Zweegman, S., De Meris, J., Goverde, G. J., Jonkers, M. H., Dors, N., Nijziel, M. R., Meijer, K., Tamminga, R. Y.J., Van Der Linden, P. W., Ypma, P. F., Eikenboom, J., Smiers, F. J.W., Granzen, B., Hamulyák, K., Brons, P., Sanders, Y. V., RS: GROW - Developmental Biology, RS: GROW - R4 - Reproductive and Perinatal Medicine, Hematology, Pediatrics, CCA - Disease profiling, CCA - Innovative therapy, CCA - Quality of life, Anatomy and neurosciences, NCA - Neuroinflamation, Vascular Ageing Programme (VAP), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), ACS - Amsterdam Cardiovascular Sciences, AII - Amsterdam institute for Infection and Immunity, Paediatric Infectious Diseases / Rheumatology / Immunology, Vascular Medicine, and Other departments

Subjects
Male, VONWILLEBRAND-FACTOR, CLEARANCE, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Biochemistry, hemic and lymphatic diseases, Missense mutation, ASSAY, ADULT PATIENTS, Child, Netherlands, Aged, 80 and over, biology, FACTOR-VIII, Hematology, Middle Aged, Prognosis, QUANTITATIVE-ANALYSIS, Null allele, Pathophysiology, von Willebrand Diseases, Phenotype, Child, Preschool, cardiovascular system, VWF PROPEPTIDE, Female, circulatory and respiratory physiology, Adult, medicine.medical_specialty, congenital, hereditary, and neonatal diseases and abnormalities, Adolescent, Immunology, Hemorrhage, Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9], DIAGNOSIS, Young Adult, Von Willebrand factor, Antigen, Internal medicine, von Willebrand Factor, Von Willebrand disease, medicine, Humans, Clinical significance, Protein Precursors, Protein precursor, Aged, MULTIMERIZATION, business.industry, Infant, Cell Biology, medicine.disease, Cross-Sectional Studies, Endocrinology, Mutation, biology.protein, business, FACTOR SURVIVAL, Follow-Up Studies
Abstract

Item does not contain fulltext The ratios between von Willebrand factor propeptide (VWFpp) or factor VIII activity ( FVIII: C) and VWF antigen (VWF:Ag) reflect synthesis, secretion, and clearance of VWF. We aimed to define the pathophysiology of 658 patients with type 1, 2, or 3 von Willebrand disease (VWD) with VWF levels

Published
2015
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23. RBIN: zeldzame bloedingsstoornissen in Nederland

Author

Saes, J., Schols, S. E. M., Smit, Y., Peters, M., Meijer, K., Meer, F., Cnossen, M., Schutgens, R., Nieuwenhuizen, L., Ilmar Kruis, Heerde, W., and Nijziel, M.

Subjects
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
Abstract

Item does not contain fulltext

Published
2017

24. Factor VIII gene (F8) mutation and risk of inhibitor development in nonsevere hemophilia A

Author

Eckhardt, C.L., Velzen, A.S. van, Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Gorkom, B.A.P., Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., INSIGHT Study Grp, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre de malformations vasculaires congénitales, Cardiovascular Centre (CVC), Vascular Ageing Programme (VAP), RS: CARIM School for Cardiovascular Diseases, Biochemie, Interne Geneeskunde, Pediatrics, Hematology, Epidemiology, Other departments, Paediatric Infectious Diseases / Rheumatology / Immunology, ACS - Amsterdam Cardiovascular Sciences, and AII - Amsterdam institute for Infection and Immunity

Subjects
Invasive mycoses and compromised host Translational research [N4i 2], Adult, medicine.medical_specialty, Age-related aspects of cancer [ONCOL 2], Time Factors, Adolescent, Genotype, Immunology, Mutation, Missense, Kaplan-Meier Estimate, Hemophilia A, DIAGNOSIS, Biochemistry, Gastroenterology, Young Adult, Interquartile range, Risk Factors, Internal medicine, medicine, Missense mutation, Humans, Cumulative incidence, Desmopressin, Genotyping, POLYMORPHISMS, Retrospective Studies, Hematology, Factor VIII, Cardiovascular diseases [NCEBP 14], business.industry, Incidence (epidemiology), DESMOPRESSIN, Cell Biology, Middle Aged, MILD, Antibodies, Neutralizing, Confidence interval, Treatment Outcome, business, medicine.drug, Follow-Up Studies
Abstract

Neutralizing antibodies (inhibitors) toward factor VIII form a severe complication in nonsevere hemophilia A, profoundly aggravating the bleeding pattern. Identification of high-risk patients is hampered by lack of data that take exposure days to therapeutic factor VIII concentrates into account. In the INSIGHT study, we analyzed the association between F8 mutation and inhibitor development in patients with nonsevere hemophilia A (factor VIII 2-40 IU/dL). This analysis included 1112 non-severe hemophilia A patients from 14 centers in Europe and Australia that had genotyped at least 70% of their patients. Inhibitor risk was calculated as Kaplan-Meier incidence with cumulative number of exposure days as the time variable. During 44 800 exposure days (median, 24 exposure days per patient; interquartile range [IQR], 7-90), 59 of the 1112 patients developed an inhibitor; cumulative incidence of 5.3% (95% confidence interval [CI], 4.0-6.6) after a median of 28 exposure days (IQR, 12-71). The inhibitor risk at 50 exposure days was 6.7% (95% CI, 4.5-8.9) and at 100 exposure days the risk further increased to 13.3% (95% CI, 9.6-17.0). Among a total of 214 different F8 missense mutations 19 were associated with inhibitor development. These results emphasize the importance of F8 genotyping in nonsevere hemophilia A. ( Blood . 2013; 122(11):1954-1962) © 2013 by The American Society of Hematology.

Published
2013
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25. Dutch guidelines for the diagnosis and treatment of chronic lymphocytic leukaemial

Author

Kersting, S., Levin, M-D., Chamuleau, M., Daenen, S. M. G. J., Dompeling, E. C., Doorduijn, J. K., van Gelder, M., Hoogendoorn, M., Kerst, J. M., Nijland, M., Nijziel, M. R., Posthuma, E. F. M., Raymakers, R. A. P., Schaafsma, M. R., Silbermann, M. H., van der Straaten, H. M., Veelken, J. H., Vos, J. M. I., Wittebol, S., van Oers, M. H. J., Kater, A. P., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Hematologie (9), Interne Geneeskunde, Hematology, CCA - Clinical Therapy Development, and Molecular cell biology and Immunology

Subjects
Chronic lymphocytic leukaemia, guidelines, HOVON, CLL
Abstract

In recent years, considerable progress has been made in the treatment of patients with chronic lymphocytic leukaemia (CLL). Therefore, the CLL working group of the Dutch/Belgium Haemato-Oncology Foundation for Adults in the Netherlands (HOVON) framework revised the Dutch guidelines based on new studies and expert opinion of members of the working group.

Published
2016

26. Prediction of DDAVP response in 850 non-severe hemophilia A patients

Author

Loomans, J.I., Velzen, A.S. van, Eckhardt, C.L., Peters, M., Astermark, J., Brons, P.P., Carcao, M.D., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jackson, S.C., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Konigs, C., Kruip, M.J.H.A., Laros-Van Gorkom, B.A.P., Leebeek, F.W.G., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nance, D., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Rise Study Grp

Published
2014

27. Von Willebrand Factor antigen and age explain variation in baseline FVIII:C among nonsevere hemophilia A patients with the same F8 genotype (Arg593Cys and Asn618Ser)

Author

Loomans, J.I., Velzen, A.S. van, Eckhardt, C.L., Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstroom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Konigs, C., Kruip, M.J.H.A., Laros-Van Gorkom, B.A.P., Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Insight Rise Study Grp

Published
2014

28. Clinical presentation of inhibitor development in non-severe hemophilia A: half of patients have high titer inhibitors and present with bleeding complications

Author

Eckhardt, C.L., Loomans, J.I., Velzen, A.S. van, Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Laros-Gorkom, B.A.P. van, Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Insight Study Grp

Published
2014

29. Inhibitors increase the burden of disease in nonsevere haemophilia A patients - treatment strategies to obtain hemostasis

Author

Velzen, A.S. van, Eckhardt, C.L., Streefkerk, N., Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Gorkom, B.A.P.L. van, Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., McRae, S., Meijer, K., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and INSIGHT Study Grp

Published
2014

31. Risk of male breast cancer after Hodgkin lymphoma

Author

de Vries, Simone, Krul, Inge M., Schaapveld, Michael, Janus, Cecile P. M., Rademakers, Saskia E., Roesink, Judith M., Nijziel, Marten R., Bilgin, Yavuz M., van Leeuwen, F. E., Nijdam, A., Aleman, B. M. P., de Boer, J. P., Janus, C. P. M., Mutsaers, P. G. N. J., So-Osman, C., Zijlstra, J. M., Meijer, O. W. M., Rademakers, S. E., Krol, A. D. G., Kersten, M. J., Tonino, S. H., Jalink, M., Daniëls, L. A., van Spronsen, D. J., van der Maazen, R. W. M., Loonen, J., Roesink, J. M., Oostvogels, R., de Weijer, R., Buter, D., de Boer, A., Aarsman, K. M., Oudbier, C. W., Nijziel, M. R., van den Berg, M., Verschueren, K., Schippers, M., Boersma, R. S., Issa, D. E., Plattel, W. J., Stedema, F. G., Koene, H. R., Raymakers, E. R. P. M., Schimmel, E., van Hezewijk, M., Bouma, P., Muller, K., Siemes, C., van der Spek, J. M., Ong, F., Jonkman, A., de Jongh, E., Sprangers, S., Kortleve, J. P., Vermeiden, C. M., Ta, B., Vercoulen, L., Paulissen, J., Posthuma, E. F. M., Brouwer, R. E., Soechit, S., van der Wiel, M., Böhmer, L., Bilgin, M. Y., Kuipers, S., Houmes, M., te Boome, L., Gommers, S., Aleman, Berthe M. P., and van Leeuwen, Flora E.

Abstract

•Male survivors of HL treated with chest radiotherapy have an increased risk of developing BC compared with the general population.•Although the occurrence of male BC is an uncommon event, clinicians should be alert to BC symptoms in male survivors of HL.

Published
2024
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33. Factor VIII gene (F8) mutation and risk of inhibitor development in nonsevere hemophilia A

Author

Eckhardt, CL, van Velzen, AS, Peters, M, Astermark, J, Brons, PP, Castaman, G, Cnossen, Marjon, Dors, N, Escuriola-Ettingshausen, C, Hamulyak, K, Hart, DP, Hay, CRM, Haya, S, van Heerde, WL, Hermans, C, Holmstrom, M, Jimenez-Yuste, V, Keenan, RD, Klamroth, R, Laros-Van Gorkom, BAP, Leebeek, Frank, Liesner, R, Makipernaa, A, Male, C, Mauser-Bunschoten, E, Mazzucconi, MG, Mcrae, S, Meyer, K, Mitchell, M, Morfini, M, Nijziel, M, Oldenburg, J, Peerlinck, K, Petrini, P, Platokouki, H, Reitter-Pfoertner, SE, Santagostino, E, Schinco, P, Smiers, FJ, Siegmund, B, Tagliaferri, A, Yee, TT, Kamphuisen, PW, van der Bom, JG (Anske), Fijnvandraat, K, Eckhardt, CL, van Velzen, AS, Peters, M, Astermark, J, Brons, PP, Castaman, G, Cnossen, Marjon, Dors, N, Escuriola-Ettingshausen, C, Hamulyak, K, Hart, DP, Hay, CRM, Haya, S, van Heerde, WL, Hermans, C, Holmstrom, M, Jimenez-Yuste, V, Keenan, RD, Klamroth, R, Laros-Van Gorkom, BAP, Leebeek, Frank, Liesner, R, Makipernaa, A, Male, C, Mauser-Bunschoten, E, Mazzucconi, MG, Mcrae, S, Meyer, K, Mitchell, M, Morfini, M, Nijziel, M, Oldenburg, J, Peerlinck, K, Petrini, P, Platokouki, H, Reitter-Pfoertner, SE, Santagostino, E, Schinco, P, Smiers, FJ, Siegmund, B, Tagliaferri, A, Yee, TT, Kamphuisen, PW, van der Bom, JG (Anske), and Fijnvandraat, K

Published
2013

34. Tissue factor activity in human monocytes is regulated by plasma: implications for the high and low responder phenomenon

Author

Nijziel, M., van Oerle, R., van 't Veer, C., van Pampus, E., Lindhout, T., Hamulyák, K., and Other departments

Abstract

The 'high and low responder phenomenon' of monocyte tissue factor (MTF) activity has been attributed to effects on monocytes by granulocytes, platelets and lipopolysaccharide (LPS). To study the possible contribution of plasma to the high and low responder phenomenon, we measured the MTF activity in isolated cryopreserved human monocytes from two donors (monocytes A and monocytes B) after incubation in a plasma environment depleted of granulocytes, platelets and LPS. In buffer only, MTF activity was 643 and 679 fM (fM = final concentration of tissue factor), in normal pooled plasma, it was 1478 and 1615 fM (P = 0.001), respectively, in monocytes A and in monocytes B. Incubation with individual plasma samples from healthy controls (n = 43) gave a median MTF of 1355 fM (range 1044-1976 fM) and 1329 fM (range 858-1951 fM) respectively. A plasma consistently induced a higher or lower level of MTF activity in both monocytes: r = 0.82 (P

Published
2001

39. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Rosa Ruchlemer, Angeles Medina Perez, Ariel Aviv, Alessandra Tedeschi, Sandra Bašić-Kinda, Sarit Assouline, Marta Morawska, Mihnea Zdrenghea, Maria Papaioannou, Gilad Itchaki, Viola Maria Popov, Odit Gutwein, Rosa Collado, Michael Gregor, Horia Bumbea, Inga Mandac, Livio Trentin, Neta Goldschmidt, Paolo Sportoletti, Adir Shaulov, Marta Coscia, Gian Matteo Rigolin, Anatoly Nemets, Francesca Romana Mauro, Róbert Szász, Nagib Dali, Fatima Miras, Massimo Gentile, Shimrit Ringelstein, Martin Simkovic, Martin Spacek, Uri Greenbaum, Aaron Polliack, Lydia Scarfò, Michael Doubek, Riva Fineman, Andrei Braester, Lev Shvidel, M.R. Nijziel, Irma Slavutsky, Tamar Tadmor, Eva Gimeno Vázquez, Yair Herishanu, Juan Marquet, Ozren Jakšić, Shai Levi, Ohad Benjamini, Javier Loscertales, Oana Stanca Ciocan, Paolo Ghia, Luciano Levato, Chava Perry, Maria Dimou, Anne De Meûter, Ewa Wasik-Szczepanek, Luca Laurenti, Osnat Bairey, Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, L., Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, M., Scarfo', L., Tedeschi, A., Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., and Ghia, P.

Subjects
obinutuzumab, Oncology, Male, chemistry.chemical_compound, 0302 clinical medicine, Obinutuzumab, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Chronic, Humanized, chronic lymphocytic leukemia, obinutuzumab, chlorambucil, Aged, 80 and over, Leukemia, Hematology, Lymphocytic, 3. Good health, Survival Rate, 030220 oncology & carcinogenesis, Ibrutinib, Female, Aged, Antibodies, Monoclonal, Humanized, Chlorambucil, Chromosomes, Human, Pair 17, Disease-Free Survival, Humans, Retrospective Studies, Tumor Suppressor Protein p53, Chromosome Deletion, Leukemia, Lymphocytic, Chronic, B-Cell, IGHV@, medicine.drug, Human, medicine.medical_specialty, chronic lymphocytic leukemia, chlorambucil, Antibodies, Chromosomes, NO, 03 medical and health sciences, Internal medicine, medicine, Progression-free survival, Survival rate, Venetoclax, business.industry, Pair 17, B-Cell, Clinical trial, Settore MED/15 - MALATTIE DEL SANGUE, chemistry, business, 030215 immunology
Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.

Published
2020

40. Thromboprophylaxis in patients with locally advanced cervical cancer treated with chemoradiation and brachytherapy.

Author

Leijtens L, Piek J, Verrijssen AS, Rijkaart D, Wortman B, Oele-Egelmeer A, Daniëls-Gooszen A, Thijs A, Nijziel M, Kolfschoten S, Bekkers R, and Cnossen J

Subjects
Humans, Female, Middle Aged, Prospective Studies, Aged, Adult, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Pulmonary Embolism prevention & control, Pulmonary Embolism etiology, Pulmonary Embolism epidemiology, Incidence, Venous Thrombosis prevention & control, Venous Thrombosis etiology, Venous Thrombosis epidemiology, Uterine Cervical Neoplasms radiotherapy, Uterine Cervical Neoplasms therapy, Uterine Cervical Neoplasms pathology, Brachytherapy adverse effects, Chemoradiotherapy adverse effects, Venous Thromboembolism prevention & control, Venous Thromboembolism etiology, Venous Thromboembolism epidemiology
Abstract

Objective: To determine the incidence of clinical and subclinical venous thromboembolic events (VTE) in patients with locally advanced cervical cancer (LACC) treated with high-dose thromboprophylaxis during definitive chemoradiation and brachytherapy., Methods: A prospective observational study was undertaken from August 2021 to December 2023 in patients with primary LACC treated with definitive chemoradiation in two Dutch tertiary hospitals. Patients received high-dose thromboprophylaxis during chemoradiation and brachytherapy. In week 4 or 5 of the overall treatment time, plasma D-dimer levels were determined, and all patients underwent venous ultrasound imaging of the legs to screen for deep vein thrombosis (DVT). If indicated, patients received a CT-angiography to screen for pulmonary embolism (PE)., Results: Among 89 included patients, cumulative incidence of clinical and subclinical (V)TE was 7.9 % (n = 7). DVT was found in two patients, PE in three patients, DVT and PE in one patient and one patient had an arterial thromboembolic event (ATE). Of these patients, three (3.4 %) had subclinical VTE, diagnosed during the screening before brachytherapy, and four (4.5 %) had clinical VTE of whom two developed VTE during chemoradiation, one during hospitalization for brachytherapy and one after completing treatment. Of the seven patients with VTE, two (28.6 %) were treated with hyperthermia. Adverse bleeding events after brachytherapy occurred in eight patients., Conclusion: Routine thromboprophylaxis in patients with LACC leads to a relative low incidence of thromboembolic events during chemoradiation and brachytherapy. Further research should focus on identifying high risk factors leading to targeted screening and prevention of VTE in high risk patients., Competing Interests: Declaration of competing interest There is no conflict of interest in all authors., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Published
2025
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41. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma.

Author

Geurts YM, Neppelenbroek SIM, Aleman BMP, Janus CPM, Krol ADG, van Spronsen DJ, Plattel WJ, Roesink JM, Verschueren KMS, Zijlstra JM, Koene HR, Nijziel MR, Schimmel EC, de Jongh E, Ong F, Te Boome LCJ, van Rijn RS, Böhmer LH, Ta BDP, Visser HPJ, Posthuma EFM, Bilgin YM, Muller K, van Kampen D, So-Osman C, Vermaat JSP, de Weijer RJ, Kersten MJ, van Leeuwen FE, and Schaapveld M

Subjects
Humans, Rituximab adverse effects, Survivors, Cyclophosphamide, Doxorubicin, Neoplasms, Second Primary epidemiology, Neoplasms, Second Primary etiology, Lymphoma, Large B-Cell, Diffuse epidemiology
Abstract

Background: The introduction of rituximab significantly improved the prognosis of diffuse large B-cell lymphoma (DLBCL), emphasizing the importance of evaluating the long-term consequences of exposure to radiotherapy, alkylating agents and anthracycline-containing (immuno)chemotherapy among DLBCL survivors., Methods: Long-term risk of subsequent malignant neoplasms (SMNs) was examined in a multicenter cohort comprising 2373 5-year DLBCL survivors treated at ages 15-61 years in 1989-2012. Observed SMN numbers were compared with expected cancer incidence to estimate standardized incidence ratios (SIRs) and absolute excess risks (AERs/10 000 person-years). Treatment-specific risks were assessed using multivariable Cox regression., Results: After a median follow-up of 13.8 years, 321 survivors developed one or more SMNs (SIR 1.5, 95% CI 1.3-1.8, AER 51.8). SIRs remained increased for at least 20 years after first-line treatment (SIR ≥20-year follow-up 1.5, 95% CI 1.0-2.2, AER 81.8) and were highest among patients ≤40 years at first DLBCL treatment (SIR 2.7, 95% CI 2.0-3.5). Lung (SIR 2.0, 95% CI 1.5-2.7, AER 13.4) and gastrointestinal cancers (SIR 1.5, 95% CI 1.2-2.0, AER 11.8) accounted for the largest excess risks. Treatment with >4500 mg/m 2 cyclophosphamide/>300 mg/m 2 doxorubicin versus ≤2250 mg/m 2 /≤150 mg/m 2 , respectively, was associated with increased solid SMN risk (hazard ratio 1.5, 95% CI 1.0-2.2). Survivors who received rituximab had a lower risk of subdiaphragmatic solid SMNs (hazard ratio 0.5, 95% CI 0.3-1.0) compared with survivors who did not receive rituximab., Conclusion: Five-year DLBCL survivors have an increased risk of SMNs. Risks were higher for survivors ≤40 years at first treatment and survivors treated with >4500 mg/m 2 cyclophosphamide/>300 mg/m 2 doxorubicin, and may be lower for survivors treated in the rituximab era, emphasizing the need for studies with longer follow-up for rituximab-treated patients., Competing Interests: Disclosure MJK has received research support from Kite/Gilead and financial compensation for attending advisory boards and/or presentations from Roche, Kite/Gilead, Novartis, BMS/Celgene, Miltenyi Biotec, Takeda and Adicet Bio. All other authors have declared no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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42. Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial.

Author

Oerlemans S, Arts LPJ, Kieffer JM, Prins J, Hoogendoorn M, van der Poel M, Koster A, Lensen C, Stevens WBC, Issa D, Pruijt JFM, Oosterveld M, van der Griend R, Nijziel M, Tick L, Posthuma EFM, and van de Poll-Franse LV

Subjects
Humans, Internet, Netherlands, Patient Reported Outcome Measures, Lymphoma therapy, Research Design
Abstract

Background: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results., Objective: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting., Methods: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98)., Results: Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3%), and an effect could therefore not be determined., Conclusions: Return of individual PRO results seems to meet patients' wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice., Trial Registration: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790., International Registered Report Identifier (irrid): RR2-10.1186/s13063-017-1943-2., (©Simone Oerlemans, Lindy Paulina Johanna Arts, Jacobien M Kieffer, Judith Prins, Mels Hoogendoorn, Marjolein van der Poel, Ad Koster, Chantal Lensen, Wendy Bernadina Catharina Stevens, Djamila Issa, Johannes F M Pruijt, Margriet Oosterveld, René van der Griend, Marten Nijziel, Lidwine Tick, Eduardus F M Posthuma, Lonneke V van de Poll-Franse. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 14.12.2021.)

Published
2021
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43. Inferior Outcome of Addition of the Aminopeptidase Inhibitor Tosedostat to Standard Intensive Treatment for Elderly Patients with AML and High Risk MDS.

Author

Janssen J, Löwenberg B, Manz M, Bargetzi M, Biemond B, Borne PVD, Breems D, Brouwer R, Chalandon Y, Deeren D, Efthymiou A, Gjertsen BT, Graux C, Gregor M, Heim D, Hess U, Hoogendoorn M, Jaspers A, Jie A, Jongen-Lavrencic M, Klein S, Klift MV, Kuball J, Lammeren-Venema DV, Legdeur MC, Loosdrecht AV, Maertens J, Kooy MVM, Moors I, Nijziel M, Obbergh FV, Oosterveld M, Pabst T, Poel MV, Sinnige H, Spertini O, Terpstra W, Tick L, Velden WV, Vekemans MC, Vellenga E, Weerdt O, Westerweel P, Stüssi G, Norden YV, and Ossenkoppele G

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/m 2 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
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44. Hemorrhagic disorders of fibrinolysis: a clinical review.

Author

Saes JL, Schols SEM, van Heerde WL, and Nijziel MR

Abstract

Hyperfibrinolytic bleeding can be caused by a deficiency of one of the inhibitors of fibrinolysis (plasminogen activator inhibitor type 1 [PAI-1] or α2-antiplasmin [α2-AP]), or an excess of one of the activators of fibrinolysis: tissue-type plasminogen activator or urokinase-type plasminogen activator. This review focuses on the clinical implications of these disorders. The bleeding phenotype of fibrinolytic disorders is characterized by delayed bleeding after trauma, surgery and dental procedures. Bleeding in areas of high fibrinolytic activity is also common, such as menorrhagia and epistaxis. Patients with α2-AP deficiency present with the most severe bleeding episodes. Recently, it was discovered that hyperfibrinolytic disorders are associated with a high rate of obstetric complications such as miscarriage and preterm birth, especially in PAI-1 deficient patients. Hyperfibrinolytic disorders are probably underdiagnosed because of lack of knowledge and lack of accurate diagnostic tests. A substantial part of the large group of patients diagnosed as 'bleeding of unknown origin' could actually have a hyperfibrinolytic disorder. In the case of a high index of suspicion (i.e. because of a positive family history, recurrent bleeding or uncommon type of bleeding such as an intramedullary hematoma), further testing should not be withheld because of normal results of standard hemostatic screening assays. Timely diagnosis is important because these disorders can generally be treated well with antifibrinolytic agents., (© 2018 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.)

Published
2018
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45. Acquired von Willebrand Disease Associated with Mantle Cell Lymphoma.

Author

Maas D, Laros-van Gorkom B, Gianotten S, Cruijsen M, van Heerde W, and Nijziel M

Abstract

We present a rare case of acquired von Willebrand syndrome (AVWS) caused by a mantle cell lymphoma. A 61-year-old male suffered from recurrent bleeding symptoms since a few months. Initially, physical examination was normal. von Willebrand factor antigen (VWF:Ag) level and factor VIII activity (FVIII:C) were low (0.31 IU/ml and 0.43 IU/ml, resp.). Ristocetin cofactor activity (VWF:RCo) was 0.09 IU/ml, and collagen binding activity (VWF:CB) was 0.10 IU/ml. VWF:RCo/VWF:Ag ratio was 0.29, and RIPA value was normal. Highest molecular weight VWF multimers were absent. A diagnosis of von Willebrand Disease (VWD) type 2A was made. However, no genetic mutation was found. No inhibitory antibodies against VWF or factor VIII were detected. A few months later, cervical, axillary, and inguinal lymphadenopathy was found on physical examination. A CT scan confirmed multiple enlarged lymph nodes, and a clonal B-cell population matching a mantle cell lymphoma was detected in the bone marrow. Chemoimmunotherapy resulted in a very good partial remission and concomitantly in a rapid decrease of bleeding problems and complete normalization of FVIII:C and VWF:Ag. The diagnosis of AVWS cannot be rejected by negative mixing studies due to difficulties in the detection of autoantibodies and because of a highly heterogeneous pathogenesis of AVWS. When the suspicion of AVWS is high, an extensive investigation should be performed to find the underlying cause.

Published
2018
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46. Mortality caused by intracranial bleeding in non-severe hemophilia A patients.

Author

Loomans JI, Eckhardt CL, Reitter-Pfoertner SE, Holmström M, van Gorkom BL, Leebeek FWG, Santoro C, Haya S, Meijer K, Nijziel MR, van der Bom JG, and Fijnvandraat K

Subjects
Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Australia, Child, Child, Preschool, Cohort Studies, Comorbidity, Europe, Factor VIII therapeutic use, Hemophilia A complications, Hemophilia A drug therapy, Hemorrhage drug therapy, Humans, Infant, Infant, Newborn, International Cooperation, Intracranial Hemorrhages complications, Male, Middle Aged, Phenotype, Recombinant Proteins therapeutic use, Risk Factors, Young Adult, Hemophilia A mortality, Intracranial Hemorrhages mortality
Abstract

Essentials Data on bleeding-related causes of death in non-severe hemophilia A (HA) patients are scarce. Such data may provide new insights into areas of care that can be improved. Non-severe HA patients have an increased risk of dying from intracranial bleeding. This demonstrates the need for specialized care for non-severe HA patients., Summary: Background Non-severe hemophilia (factor VIII concentration [FVIII:C] of 2-40 IU dL -1 ) is characterized by a milder bleeding phenotype than severe hemophilia A. However, some patients with non-severe hemophilia A suffer from severe bleeding complications that may result in death. Data on bleeding-related causes of death, such as fatal intracranial bleeding, in non-severe patients are scarce. Such data may provide new insights into areas of care that can be improved. Aims To describe mortality rates, risk factors and comorbidities associated with fatal intracranial bleeding in non-severe hemophilia A patients. Methods We analyzed data from the INSIGHT study, an international cohort study of all non-severe hemophilia A patients treated with FVIII concentrates during the observation period between 1980 and 2010 in 34 participating centers across Europe and Australia. Clinical data and vital status were collected from 2709 patients. We report the standardized mortality rate for patients who suffered from fatal intracranial bleeding, using a general European male population as a control population. Results Twelve per cent of the 148 deceased patients in our cohort of 2709 patients died from intracranial bleeding. The mortality rate between 1996 and 2010 for all ages was 3.5-fold higher than that in the general population (95% confidence interval [CI] 2.0-5.8). Patients who died from intracranial bleeding mostly presented with mild hemophilia without clear comorbidities. Conclusion Non-severe hemophilia A patients have an increased risk of dying from intracranial bleeding in comparison with the general population. This demonstrates the need for specialized care for non-severe hemophilia A patients., (© 2017 International Society on Thrombosis and Haemostasis.)

Published
2017
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47. The incidence and treatment of bleeding episodes in non-severe haemophilia A patients with inhibitors.

Author

van Velzen AS, Eckhardt CL, Streefkerk N, Peters M, Hart DP, Hamulyak K, Klamroth R, Meijer K, Nijziel M, Schinco P, Yee TT, van der Bom JG, and Fijnvandraat K

Subjects
Adolescent, Adult, Antibodies chemistry, Cohort Studies, Factor VIII analysis, Factor VIII antagonists & inhibitors, Female, Humans, Incidence, Middle Aged, Phenotype, Young Adult, Hemophilia A drug therapy, Hemophilia A epidemiology, Hemorrhage drug therapy
Abstract

The development of an inhibitory antibody in non-severe haemophilia A patients may aggravate the bleeding phenotype considerably. Effective treatment of bleeding episodes may be challenging, with ensuing severe complications. At present, evidence is scarce for optimal treatment of bleeding episodes in this patient group. The aim of this study was to describe the incidence and the treatment of bleeding episodes in inhibitor patients in a population-based unselected cohort of non-severe haemophilia A patients with clinically relevant inhibitors. Data were available for 100 of the 107 non-severe haemophilia A patients (factor VIII (FVIII) baseline, 2-40 IU/dl) from 29 centres in Europe and one centre in Australia who had developed a clinically relevant inhibitor between 1980 and 2011. The majority (89 %) of the patients were treated during the inhibitor period for bleeding episodes or a surgical intervention: 66 % needed treatment for bleeding episodes, at a median annual bleeding rate (ABR) of 1.1 (interquartile range (IQR) 0.1-2.5) and a median total of 2 (IQR 1-6) bleeding episodes. Compared to the median ABR before inhibitor development of 0.095 bleeds per year (IQR 0.02-0.42), the increase in ABR is more than a 10-fold. More than 90 % of the bleeding episodes were treated with only one type of product, most frequently (51 %) FVIII concentrates. This study provides the incidence of bleeding episodes and treatment choices in non-severe haemophilia A patients with inhibitors. The 10-fold increase to a median ABR of 1.1 episodes per year emphasizes the impact of inhibitor development for non-severe haemophilia A patients.

Published
2016
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48. Incidentally detected diffuse signal alterations of bone marrow on MRI: is bone marrow biopsy indicated?

Author

Spierings J, van der Linden AN, Kuijper PH, Tick LW, and Nijziel MR

Subjects
Adult, Aged, Female, Hematologic Diseases diagnosis, Humans, Male, Middle Aged, Retrospective Studies, Young Adult, Biopsy, Bone Marrow pathology, Hematologic Diseases pathology, Incidental Findings, Magnetic Resonance Imaging
Abstract

Background: Advanced imaging techniques as magnetic resonance imaging (MRI) are increasingly performed in the diagnostic workup of patients. Incidentally, diffuse signal alterations of the bone marrow are detected because MRI visualises various components of the bone marrow. The clinical significance of these signal alterations is unknown., Objective: The main goal of this study was to determine the diagnostic value of a bone marrow biopsy in patients with incidentally found diffuse signal alterations of the bone marrow., Methods: We retrospectively examined all bone marrow biopsies performed from 1 January 2007 to 31 December 2013 (n = 1947). Patients were included when the biopsy was obtained following an MRI with a diffuse abnormal bone marrow signal. Patients who underwent MRI for suspected malignancy were excluded. Histological and cytological results of the bone marrow examinations were analysed., Results: 15 of the 1947 bone marrow biopsies (0.77%) were performed because of diffuse signal alterations on MRI. In seven of these 15 bone marrow biopsies (47%) a clinically important haematological disorder was found. Eight patients had a normal bone marrow evaluation., Conclusion: Based on this retrospective study, a bone marrow examination in patients with incidentally detected diffuse signal alterations should be considered to exclude haematological pathology. Prospective studies have to be performed to further investigate the best diagnostic strategy.

Published
2014

49. Serum antibody response to influenza virus vaccination during chemotherapy treatment in adult patients with solid tumours.

Author

Wumkes ML, van der Velden AM, Los M, Leys MB, Beeker A, Nijziel MR, van der Velden AW, Westerman M, Meerveld-Eggink A, Rimmelzwaan GF, Rijkers GT, and Biesma DH

Subjects
Adult, Aged, Breast Neoplasms immunology, Colorectal Neoplasms immunology, Female, Humans, Influenza Vaccines administration & dosage, Influenza, Human immunology, Male, Middle Aged, Netherlands, Serum immunology, Antibodies, Viral blood, Antineoplastic Agents therapeutic use, Breast Neoplasms drug therapy, Colorectal Neoplasms drug therapy, Influenza Vaccines immunology, Influenza, Human prevention & control, Vaccination methods
Abstract

Background: Higher rates of hospitalization and mortality are described in oncology patients with influenza virus infection compared to the general population. Yearly influenza vaccination is recommended for patients treated with chemotherapy. The optimal moment to administer the vaccine during a treatment cycle has not been studied extensively., Patients and Methods: During the influenza season 2011-2012 we conducted a multicenter randomized controlled trial (OFLUVAC, NTR2858, no sponsoring) in the Netherlands. Patients receiving adjuvant chemotherapy for breast or colorectal cancer were randomized between early (day 5 after chemotherapy) and late (day 16 after chemotherapy) vaccination with the influenza virus vaccine (Influvac(®) 2011/2012-Vaxigrip(®) 2011/2012). Influenza virus-specific antibody titres were determined before, 3 and 12 weeks after vaccination by haemagglutination inhibition., Results: Thirty-eight breast cancer patients (early=21; late=17) and 18 colorectal cancer patients (early=8; late=10) were analyzed. In breast cancer patients overall serologic responses were adequate. A statistically significant higher response in patients who received early compared to late vaccination in the chemotherapy cycle was observed. Geometric mean titres post vaccination on day 5 versus day 16 were 69.3 versus 27.4 (H3N2), 76.4 versus 17.5 (H1N1) and 34.4 versus 26.0 (B/Brisbane), respectively. In colorectal cancer patients overall serologic responses were adequate, no significant difference was found between early and late vaccination. Geometric mean titres post vaccination on day 5 versus day 16 were 170.1 versus 192.4 (H3N2), 233.0 versus 280.8 (H1N1) and 62.6 versus 75.9 (B/Brisbane), respectively., Conclusion: Overall antibody response to the influenza virus vaccine in patients treated with chemotherapy for breast or colorectal cancer patients is adequate. Breast cancer patients seem to mount the best antibody response when vaccinated early after a chemotherapy cycle (≤day 5). No difference was found between early and late vaccination in colorectal cancer patients., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Published
2013
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50. Influenza vaccination coverage in patients treated with chemotherapy: current clinical practice.

Author

Wumkes ML, van der Velden AM, van der Velden AW, Stouthard JM, Nijziel MR, Westerman M, Beeker A, Meerveld-Eggink A, Rijkers GT, and Biesma DH

Subjects
Aged, Antineoplastic Agents adverse effects, Antineoplastic Agents therapeutic use, Breast Neoplasms drug therapy, Colorectal Neoplasms drug therapy, Female, General Practitioners psychology, General Practitioners statistics & numerical data, Health Knowledge, Attitudes, Practice, Humans, Influenza Vaccines immunology, Influenza, Human immunology, Male, Middle Aged, Netherlands, Surveys and Questionnaires, Breast Neoplasms immunology, Colorectal Neoplasms immunology, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Practice Patterns, Physicians' statistics & numerical data
Abstract

Background: Influenza virus vaccination is recommended for patients treated with chemotherapy. Little is known about vaccination coverage in these patients., Methods: Vaccination coverage in the Netherlands was analysed by questionnaires completed by general practitioners, within a catchment area of 1.3 million people, in the period 2010-2011., Results: Of 433 eligible adult patients treated with chemotherapy for breast or colorectal cancer, 144 patients gave permission for us to approach their general practitioner with a questionnaire. General practitioners were asked about vaccination coverage, awareness of recommendations and their opinion about the responsibility for vaccination. We received 114 (79%) completed questionnaires. Sixty-seven out of 114 patients (59%) were vaccinated against influenza. Forty-four (66%) of these patients also had an indication for vaccination based on age (age ≥60 years). According to 48% of the general practitioners, the responsibility for vaccination belongs to the competence of the treating medical oncologist., Conclusion: Influenza vaccination coverage is limited to 59% of patients treated with chemotherapy. Guidelines for responsibility (general practitioner or medical oncologist) may increase the vaccination rate of cancer patients.

Published
2013

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