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28 results on '"Otten, Hans-Martin"'

1. Improving sustainability of a patient decision aid for systemic treatment of metastatic colorectal cancer: A qualitative study

Author

Medisch Oncologische Disciplines, Onderzoek Medische Oncologie, Cancer, Global Health, MS Medische Oncologie, JC onderzoeksprogramma Kanker, van Nassau, Sietske C.M.W., Voogdt-Pruis, Helene R., de Jong, Vincent M.W., Otten, Hans Martin, Valkenburg-van Iersel, Liselot B., Swarte, Bas J., Buffart, Tineke E., Pruijt, Hans J., Mekenkamp, Leonie J., Koopman, Miriam, May, Anne M., Medisch Oncologische Disciplines, Onderzoek Medische Oncologie, Cancer, Global Health, MS Medische Oncologie, JC onderzoeksprogramma Kanker, van Nassau, Sietske C.M.W., Voogdt-Pruis, Helene R., de Jong, Vincent M.W., Otten, Hans Martin, Valkenburg-van Iersel, Liselot B., Swarte, Bas J., Buffart, Tineke E., Pruijt, Hans J., Mekenkamp, Leonie J., Koopman, Miriam, and May, Anne M.

Published
2024

2. Evaluating the Clinical Impact and Feasibility of Therapeutic Drug Monitoring of Pazopanib in a Real-World Soft-Tissue Sarcoma Cohort

Author

Apotheek O&O&O, Cancer, Medisch Oncologische Disciplines, MS Medische Oncologie, Meertens, Marinda, Giraud, Eline L., van der Kleij, Maud B.A., Westerdijk, Kim, Guchelaar, Niels A.D., Bleckman, Roos F., Rieborn, Amy, Imholz, Alex L.T., Otten, Hans Martin, Vulink, Annelie, Los, Maartje, Hamberg, Paul, van der Graaf, Winette T.A., Gelderblom, Hans, Moes, Dirk Jan A.R., Broekman, K. Esther, Touw, Daan J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Huitema, Alwin D.R., van Erp, Nielka P., Desar, Ingrid M.E., Steeghs, Neeltje, the Dutch Pharmacology Oncology Group (DPOG), Apotheek O&O&O, Cancer, Medisch Oncologische Disciplines, MS Medische Oncologie, Meertens, Marinda, Giraud, Eline L., van der Kleij, Maud B.A., Westerdijk, Kim, Guchelaar, Niels A.D., Bleckman, Roos F., Rieborn, Amy, Imholz, Alex L.T., Otten, Hans Martin, Vulink, Annelie, Los, Maartje, Hamberg, Paul, van der Graaf, Winette T.A., Gelderblom, Hans, Moes, Dirk Jan A.R., Broekman, K. Esther, Touw, Daan J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Huitema, Alwin D.R., van Erp, Nielka P., Desar, Ingrid M.E., Steeghs, Neeltje, and the Dutch Pharmacology Oncology Group (DPOG)

Published
2024

3. Evaluating the Clinical Impact and Feasibility of Therapeutic Drug Monitoring of Pazopanib in a Real-World Soft-Tissue Sarcoma Cohort

Author

Meertens, Marinda, Giraud, Eline L., van der Kleij, Maud B.A., Westerdijk, Kim, Guchelaar, Niels A.D., Bleckman, Roos F., Rieborn, Amy, Imholz, Alex L.T., Otten, Hans Martin, Vulink, Annelie, Los, Maartje, Hamberg, Paul, van der Graaf, Winette T.A., Gelderblom, Hans, Moes, Dirk Jan A.R., Broekman, K. Esther, Touw, Daan J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Huitema, Alwin D.R., van Erp, Nielka P., Desar, Ingrid M.E., Steeghs, Neeltje, Meertens, Marinda, Giraud, Eline L., van der Kleij, Maud B.A., Westerdijk, Kim, Guchelaar, Niels A.D., Bleckman, Roos F., Rieborn, Amy, Imholz, Alex L.T., Otten, Hans Martin, Vulink, Annelie, Los, Maartje, Hamberg, Paul, van der Graaf, Winette T.A., Gelderblom, Hans, Moes, Dirk Jan A.R., Broekman, K. Esther, Touw, Daan J., Koolen, Stijn L.W., Mathijssen, Ron H.J., Huitema, Alwin D.R., van Erp, Nielka P., Desar, Ingrid M.E., and Steeghs, Neeltje

Abstract

Introduction and Objective:Pazopanib is registered for metastatic renal cell carcinoma and soft-tissue sarcoma (STS). Its variable pharmacokinetic (PK) characteristics and narrow therapeutic range provide a strong rationale for therapeutic drug monitoring (TDM). Prior studies have defined target levels of drug exposure (≥ 20.5 mg/L) linked to prolonged progression-free survival (PFS), but the added value of using TDM remains unclear. This study investigates the effect of TDM of pazopanib in patients with STS on survival outcomes and dose-limiting toxicities (DLTs) and evaluates the feasibility of TDM-guided dosing. Methods: A TDM-guided cohort was compared to a non-TDM-guided cohort for PFS, overall survival (OS) and DLTs. PK samples were available from all patients, though not acted upon in the non-TDM-guided cohort. We evaluated the feasibility of TDM by comparing the proportion of underdosed patients in our TDM cohort with data from previous publications.Results: A total of 122 STS patients were included in the TDM-guided cohort (n = 95) and non-TDM-guided cohort (n = 27). The average exposure in the overall population was 30.5 mg/L and was similar in both groups. Median PFS and OS did not differ between the TDM-guided cohort and non-TDM-guided cohort (respectively 5.5 vs 4.4 months, p = 0.3, and 12.6 vs 10.1 months, p = 0.8). Slightly more patients in the non-TDM-guided cohort experienced DLTs (54%) compared to the TDM-guided cohort (44%). The proportion of underdosed patients (13.3%) was halved compared to historical data (26.7%). Conclusion: TDM reduced the proportion of patients with subtherapeutic exposure levels by ~ 50%. Nonetheless, the added value of TDM for achieving target trough levels of ≥ 20.5 mg/L for pazopanib on survival outcomes could not be confirmed in STS patients.

Published
2024

4. Reasons for non-feasibility of therapeutic drug monitoring of oral targeted therapies in oncology - an analysis of the closed cohorts of a multicentre prospective study

Author

van der Kleij, Maud B. A., Guchelaar, Niels A. D., Meertens, Marinda, Westerdijk, Kim, Giraud, Eline L., Bleckman, Roos F., Groenland, Stefanie L., van Eerden, Ruben A. G., Imholz, Alex L. T., Vulink, Annelie J. E., Otten, Hans-Martin, Fiebrich-Westra, Helle-Brit, Lubberman, Floor J. E., Desar, Ingrid M. E., Moes, Dirk-Jan A. R., Touw, Daan J., Koolen, Stijn L. W., Gelderblom, Hans, Reyners, An K. L., van Erp, Nielka P., Mathijssen, Ron H. J., Huitema, Alwin D. R., Steeghs, Neeltje, van der Kleij, Maud B. A., Guchelaar, Niels A. D., Meertens, Marinda, Westerdijk, Kim, Giraud, Eline L., Bleckman, Roos F., Groenland, Stefanie L., van Eerden, Ruben A. G., Imholz, Alex L. T., Vulink, Annelie J. E., Otten, Hans-Martin, Fiebrich-Westra, Helle-Brit, Lubberman, Floor J. E., Desar, Ingrid M. E., Moes, Dirk-Jan A. R., Touw, Daan J., Koolen, Stijn L. W., Gelderblom, Hans, Reyners, An K. L., van Erp, Nielka P., Mathijssen, Ron H. J., Huitema, Alwin D. R., and Steeghs, Neeltje

Abstract

BackgroundTherapeutic drug monitoring (TDM) - performing dose adjustments based on measured drug levels and established pharmacokinetic (PK) targets - could optimise treatment with drugs that show large interpatient variability in exposure. We evaluated the feasibility of TDM for multiple oral targeted therapies. Here we report on drugs for which routine TDM is not feasible.MethodsWe evaluated drug cohorts from the Dutch Pharmacology Oncology Group - TDM study. Based on PK levels taken at pre-specified time points, PK-guided interventions were performed. Feasibility of TDM was evaluated, and based on the success and practicability of TDM, cohorts could be closed.ResultsFor 10 out of 24 cohorts TDM was not feasible and inclusion was closed. A high incidence of adverse events resulted in closing the cabozantinib, dabrafenib/trametinib, everolimus, regorafenib and vismodegib cohort. The enzalutamide and erlotinib cohorts were closed because almost all PK levels were above target. Other, non-pharmacological reasons led to closing the palbociclib, olaparib and tamoxifen cohort.ConclusionsAlthough TDM could help personalising treatment for many drugs, the above-mentioned reasons can influence its feasibility, usefulness and clinical applicability. Therefore, routine TDM is not advised for cabozantinib, dabrafenib/trametinib, enzalutamide, erlotinib, everolimus, regorafenib and vismodegib. Nonetheless, TDM remains valuable for individual clinical decisions.

Published
2024

5. Reasons for non-feasibility of therapeutic drug monitoring of oral targeted therapies in oncology - an analysis of the closed cohorts of a multicentre prospective study

Author

Apotheek O&O&O, Cancer, MS Medische Oncologie, van der Kleij, Maud B A, Guchelaar, Niels A D, Meertens, Marinda, Westerdijk, Kim, Giraud, Eline L, Bleckman, Roos F, Groenland, Stefanie L, van Eerden, Ruben A G, Imholz, Alex L T, Vulink, Annelie J E, Otten, Hans-Martin, Fiebrich-Westra, Helle-Brit, Lubberman, Floor J E, Desar, Ingrid M E, Moes, Dirk-Jan A R, Touw, Daan J, Koolen, Stijn L W, Gelderblom, Hans, Reyners, An K L, van Erp, Nielka P, Mathijssen, Ron H J, Huitema, Alwin D R, Steeghs, Neeltje, Dutch Pharmacology Oncology Group (DPOG), Apotheek O&O&O, Cancer, MS Medische Oncologie, van der Kleij, Maud B A, Guchelaar, Niels A D, Meertens, Marinda, Westerdijk, Kim, Giraud, Eline L, Bleckman, Roos F, Groenland, Stefanie L, van Eerden, Ruben A G, Imholz, Alex L T, Vulink, Annelie J E, Otten, Hans-Martin, Fiebrich-Westra, Helle-Brit, Lubberman, Floor J E, Desar, Ingrid M E, Moes, Dirk-Jan A R, Touw, Daan J, Koolen, Stijn L W, Gelderblom, Hans, Reyners, An K L, van Erp, Nielka P, Mathijssen, Ron H J, Huitema, Alwin D R, Steeghs, Neeltje, and Dutch Pharmacology Oncology Group (DPOG)

Published
2024

7. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, Huitema, Alwin D R, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, and Huitema, Alwin D R

Abstract

BACKGROUND: Older patients with metastatic castration-resistant prostate cancer (mCRPC) may be more prone to chemotherapy-induced hematological toxicity, but tailored docetaxel dosing guidelines in older patients are lacking because of conflicting data.OBJECTIVE: This study aims to evaluate the impact of older age on the incidence of hematological toxicity in patients with mCRPC treated with docetaxel in daily clinical practice.METHODS: This study included patients with mCRPC treated with docetaxel between January 2006 and January 2016 at the Netherlands Cancer Institute and Medical Center Slotervaart for whom dosing and hematological toxicity data were available from electronic patient records. We evaluated the impact of age on the incidence of grade 3 and 4 hematological toxicity.RESULTS: In total, 175 patients treated with docetaxel were included in the analysis, with a median age of 67 years (range 47-86). Baseline hematological laboratory values were not age related. After the first treatment cycle, hematological toxicity occurred significantly more frequently in the oldest age quartile (25%, p = 0.02) than in the younger age quartiles (9%, 11%, and 7%, respectively, for age quartiles 1, 2, and 3).CONCLUSION: The risk of hematological toxicity was significantly higher in the oldest age quartile than in younger patients with mCRPC treated with docetaxel in daily clinical practice.

Published
2019

8. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort

Author

de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Abstract

The incidence of neutropenia in metastatic castration-resistant prostate cancer (mCRPC) patients treated with docetaxel has been reported to be lower compared to patients with other solid tumors treated with a similar dose. It is suggested that this is due to increased clearance of docetaxel in mCRPC patients, resulting in decreased exposure. The aims of this study were to (1) determine if exposure in mCRPC patients is lower vs patients with other solid tumors by conducting a meta-analysis, (2) evaluate the incidence of neutropenia in patients with mCRPC vs other solid tumors in a clinical cohort, and (3) discuss potential clinical consequences. A meta-analysis was conducted of studies which reported areas under the plasma concentration-time curves (AUCs) of docetaxel and variability. In addition, grade 3/4 neutropenia was evaluated using logistic regression in a cohort of patients treated with docetaxel. The meta-analysis included 36 cohorts from 26 trials (n = 1150 patients), and showed that patients with mCRPC had a significantly lower mean AUC vs patients with other solid tumors (fold change [95% confidence interval (CI)]: 1.8 [1.5-2.2]), with corresponding AUCs of 1.82 and 3.30 mg∙h/L, respectively. Logistic regression, including 812 patient, demonstrated that patients with mCRPC had a 2.2-fold lower odds of developing grade 3/4 neutropenia compared to patients with other solid tumors (odds ratio [95%CI]: 0.46 [0.31-0.90]). These findings indicate that mCRPC patients have a lower risk of experiencing severe neutropenia, possibly attributable to lower systemic exposure to docetaxel.

Published
2019

9. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients : A meta-analysis and evaluation of a clinical cohort

Author

de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

10. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., Huitema, Alwin D.R., Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., and Huitema, Alwin D.R.

Published
2019

11. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients : A meta-analysis and evaluation of a clinical cohort

Author

de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

12. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., Huitema, Alwin D.R., Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., and Huitema, Alwin D.R.

Published
2019

13. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

14. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, Huitema, Alwin D R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, and Huitema, Alwin D R

Published
2019

15. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients : A meta-analysis and evaluation of a clinical cohort

Author

de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

16. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., Huitema, Alwin D.R., Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., and Huitema, Alwin D.R.

Published
2019

17. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

18. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, Huitema, Alwin D R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, and Huitema, Alwin D R

Published
2019

19. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort

Author

Cancer, Apotheek Onderzoek, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, Cancer, Apotheek Onderzoek, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

20. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

UMC Utrecht, Apotheek Onderzoek, Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., Huitema, Alwin D.R., UMC Utrecht, Apotheek Onderzoek, Crombag, Marie Rose B.S., de Vries Schultink, Aurelia H.M., van Doremalen, Jacobine G.C., Otten, Hans Martin, Bergman, Andries M., Schellens, Jan H.M., Beijnen, Jos H., and Huitema, Alwin D.R.

Published
2019

21. Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, Beijnen, Jos H, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Vries Schultink, Aurelia H M, Crombag, Marie-Rose B S, van Werkhoven, Erik, Otten, Hans-Martin, Bergman, Andre M, Schellens, Jan H M, Huitema, Alwin D R, and Beijnen, Jos H

Published
2019

22. Age-Associated Hematological Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Docetaxel in Clinical Practice

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, Huitema, Alwin D R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Crombag, Marie-Rose B S, de Vries Schultink, Aurelia H M, van Doremalen, Jacobine G C, Otten, Hans-Martin, Bergman, Andries M, Schellens, Jan H M, Beijnen, Jos H, and Huitema, Alwin D R

Published
2019

23. Relationship between type of unprovoked venous thromboembolism and cancer location: An individual patient data meta-analysis

Author

Jara Palomares, Luis, van Es, Nick, Praena-Fernández, Juan Manuel, Le Gal, Grégoire, Otten, Hans-Martin, Robin, Philippe, Piccioli, Andrea, Lécumberri, Ramon, Religa, Piotr, Rieu, Viriginie, Rondina, Matthew T., Beckers, P. M., Prandoni, Paolo, Salaun, Pierre-Yves, Di Nisio, Marcello, Bossuyt, Patrick M., Kraaijpoelc, K., Büller, Harry R., Carrier, Marc, Jara Palomares, Luis, van Es, Nick, Praena-Fernández, Juan Manuel, Le Gal, Grégoire, Otten, Hans-Martin, Robin, Philippe, Piccioli, Andrea, Lécumberri, Ramon, Religa, Piotr, Rieu, Viriginie, Rondina, Matthew T., Beckers, P. M., Prandoni, Paolo, Salaun, Pierre-Yves, Di Nisio, Marcello, Bossuyt, Patrick M., Kraaijpoelc, K., Büller, Harry R., and Carrier, Marc

Abstract

[Background] Unprovoked venous thromboembolism (VTE) may be the first manifestation of an underlying cancer. We aimed to assess the period prevalence of occult cancer detection stratified by VTE location (deep vein thrombosis [DVT], pulmonary embolism [PE] or both) and the anatomical relationship between occult cancer and VTE., [Methods] Post-hoc analysis of a systematic review and individual patient data meta-analysis of adults with unprovoked VTE with at least 12 months of follow-up. Cancer types were grouped according to thoracic, abdomino-pelvic, or other locations., [Results] A total of 2300 patients were eligible including 1218 with DVT only (53%), 719 with PE only (31%), and 363 with both PE and DVT (16%). The pooled 12-month period prevalence of cancer in DVT only, PE only, and DVT + PE was 5.6% (95% CI, 4.4 to 7.2), 4.3% (95% CI, 2.7 to 6.9), and 5.6% (95% CI, 1.7 to 15.5), respectively. Most occult cancers were located in the abdomen (68.4%). The proportion of patients with an abdomino-pelvic cancer was not different in patients with DVT + PE (81%; 95% CI, 54 to 96) than in those with DVT (68%; 95% CI, 57 to 78) or PE alone (65%; 95% CI, 48 to 79)., [Conclusion] The 12-month prevalence of occult cancer was similar in patients with DVT only, PE only, or both. Most cancers were located in the abdomen, and there was no relationship between VTE type and cancer location.

Published
2019

24. Individualised versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome (IDEAL DVT): a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial

Author

ten Cate-Hoek, Arina J., ten Cate-Hoek, Arina J., Amin, Elham E., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine W., Middeldorp, Saskia, Mostard, Guy J. M., ten Wolde, Marije, van den Heiligenberg, Simone M., van Wissen, Sanne, van de Poel, Marlene H. W., Villalta, Sabina, Serne, Erik H., Otten, Hans-Martin, Klappe, Edith H., Bistervels, Ingrid M., Lauw, Mandy N., Piersma-Wichers, Margriet, Prandoni, Paolo, Joore, Manuela A., Prins, Martin H., ten Cate, Hugo, IDEAL DVT Investigators, ten Cate-Hoek, Arina J., ten Cate-Hoek, Arina J., Amin, Elham E., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine W., Middeldorp, Saskia, Mostard, Guy J. M., ten Wolde, Marije, van den Heiligenberg, Simone M., van Wissen, Sanne, van de Poel, Marlene H. W., Villalta, Sabina, Serne, Erik H., Otten, Hans-Martin, Klappe, Edith H., Bistervels, Ingrid M., Lauw, Mandy N., Piersma-Wichers, Margriet, Prandoni, Paolo, Joore, Manuela A., Prins, Martin H., ten Cate, Hugo, and IDEAL DVT Investigators

Abstract

Background Therapy with elastic compression stockings has been the cornerstone for prevention of post-thrombotic syndrome for decades in patients after acute deep venous thrombosis. It is uncertain who benefits most from therapy, and what the optimum duration of therapy should be. We therefore aimed to assess the safety and efficacy of individualised duration of compression therapy versus the standard duration of 24 months following an initial treatment period of 6 months. Methods We did a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial at 12 hospitals in the Netherlands and two in Italy. We randomly assigned patients (1:1) with acute proximal deep vein thrombosis of the leg and without pre-existent venous insufficiency (Clinical Etiological Anatomical and Pathophysiological score

Published
2018

25. Individually shortened duration versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome: a cost-effectiveness analysis

Author

Amin, Elham E., Amin, Elham E., ten Cate-Hoek, Arina J., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine, Middeldorp, Saskia, Mostard, Guy, ten Wolde, Marije, van den Heiligenberg, Simone, van Wissen, Sanne, van de Poet, Marlene, Villalta, Sabina, Serne, Erik, Otten, Hans Martin, Klappe, Edith, Prandoni, Paolo, Prins, Martin H., ten Cate, Hugo, Joore, Manuela A., Amin, Elham E., Amin, Elham E., ten Cate-Hoek, Arina J., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine, Middeldorp, Saskia, Mostard, Guy, ten Wolde, Marije, van den Heiligenberg, Simone, van Wissen, Sanne, van de Poet, Marlene, Villalta, Sabina, Serne, Erik, Otten, Hans Martin, Klappe, Edith, Prandoni, Paolo, Prins, Martin H., ten Cate, Hugo, and Joore, Manuela A.

Abstract

Background The IDEAL DVT study showed that it was safe to shorten the duration of elastic compression therapy on an individualised basis after deep vein thrombosis for prevention of post-thrombotic syndrome. In this study, we assessed the cost-effectiveness of this strategy.Methods IDEAL DVT was a multicentre, randomised, non-inferiority trial that included patients with acute proximal deep vein thrombosis of the leg. After 6 months of elastic compression therapy, patients were randomly assigned (1: 1) to the standard 2 years of elastic stocking compression therapy or shortened duration of compression therapy based on the patient's Villalta score. For our cost-effectiveness analysis, we assessed quality-adjusted life-years (QALYs), measured with the three-level version of EQ-5D (EQ-5D-3L; Dutch and UK tariff) and the 36-item Short Form Health Survey (SF-36), and costs in (SIC) (health-care and societal perspective) according to the intention-to-treat approach. Data were collected at 3, 6, 12, and 24 months after diagnosis of thrombosis. We calculated incremental net monetary benefit using a QALY threshold of (SIC) 30 000, and obtained bootstrapped means and 95% CIs. IDEAL DVT is registered with ClinicalTrials.gov, number NCT01429714.Findings Between March 22, 2011, and July 1, 2015, 865 patients were enrolled in IDEAL DVT. 437 were assigned to individualised duration of elastic compression therapy and 428 to standard duration of elastic compression therapy. Nine patients were eventually excluded because of recurrent venous thromboembolism within 6 months after the first event. From a societal perspective, for every QALY lost measured with the EQ-5D Dutch tariff, cost savings were (SIC) 305 center dot 992 (incremental net monetary benefit (SIC) 3205, 95% CI 502-5741), and for every QALY lost based on the Short-Form Six-Dimension (SF-6D) utility score (derived from SF-36), cost savings were (SIC) 6030.941 ((SIC) 3540, 95% CI 1174-5953). Using the UK t

Published
2018

26. Individually shortened duration versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome: a cost-effectiveness analysis

Author

Amin, Elham E., ten Cate-Hoek, Arina J., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine, Middeldorp, Saskia, Mostard, Guy, ten Wolde, Marije, van den Heiligenberg, Simone, van Wissen, Sanne, van de Poet, Marlene, Villalta, Sabina, Serne, Erik, Otten, Hans Martin, Klappe, Edith, Prandoni, Paolo, Prins, Martin H., ten Cate, Hugo, Joore, Manuela A., Amin, Elham E., ten Cate-Hoek, Arina J., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine, Middeldorp, Saskia, Mostard, Guy, ten Wolde, Marije, van den Heiligenberg, Simone, van Wissen, Sanne, van de Poet, Marlene, Villalta, Sabina, Serne, Erik, Otten, Hans Martin, Klappe, Edith, Prandoni, Paolo, Prins, Martin H., ten Cate, Hugo, and Joore, Manuela A.

Abstract

Background The IDEAL DVT study showed that it was safe to shorten the duration of elastic compression therapy on an individualised basis after deep vein thrombosis for prevention of post-thrombotic syndrome. In this study, we assessed the cost-effectiveness of this strategy.Methods IDEAL DVT was a multicentre, randomised, non-inferiority trial that included patients with acute proximal deep vein thrombosis of the leg. After 6 months of elastic compression therapy, patients were randomly assigned (1: 1) to the standard 2 years of elastic stocking compression therapy or shortened duration of compression therapy based on the patient's Villalta score. For our cost-effectiveness analysis, we assessed quality-adjusted life-years (QALYs), measured with the three-level version of EQ-5D (EQ-5D-3L; Dutch and UK tariff) and the 36-item Short Form Health Survey (SF-36), and costs in (SIC) (health-care and societal perspective) according to the intention-to-treat approach. Data were collected at 3, 6, 12, and 24 months after diagnosis of thrombosis. We calculated incremental net monetary benefit using a QALY threshold of (SIC) 30 000, and obtained bootstrapped means and 95% CIs. IDEAL DVT is registered with ClinicalTrials.gov, number NCT01429714.Findings Between March 22, 2011, and July 1, 2015, 865 patients were enrolled in IDEAL DVT. 437 were assigned to individualised duration of elastic compression therapy and 428 to standard duration of elastic compression therapy. Nine patients were eventually excluded because of recurrent venous thromboembolism within 6 months after the first event. From a societal perspective, for every QALY lost measured with the EQ-5D Dutch tariff, cost savings were (SIC) 305 center dot 992 (incremental net monetary benefit (SIC) 3205, 95% CI 502-5741), and for every QALY lost based on the Short-Form Six-Dimension (SF-6D) utility score (derived from SF-36), cost savings were (SIC) 6030.941 ((SIC) 3540, 95% CI 1174-5953). Using the UK t

Published
2018

27. Individualised versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome (IDEAL DVT): a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial

Author

ten Cate-Hoek, Arina J., Amin, Elham E., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine W., Middeldorp, Saskia, Mostard, Guy J. M., ten Wolde, Marije, van den Heiligenberg, Simone M., van Wissen, Sanne, van de Poel, Marlene H. W., Villalta, Sabina, Serne, Erik H., Otten, Hans-Martin, Klappe, Edith H., Bistervels, Ingrid M., Lauw, Mandy N., Piersma-Wichers, Margriet, Prandoni, Paolo, Joore, Manuela A., Prins, Martin H., ten Cate, Hugo, IDEAL DVT Investigators, ten Cate-Hoek, Arina J., Amin, Elham E., Bouman, Annemieke C., Meijer, Karina, Tick, Lidwine W., Middeldorp, Saskia, Mostard, Guy J. M., ten Wolde, Marije, van den Heiligenberg, Simone M., van Wissen, Sanne, van de Poel, Marlene H. W., Villalta, Sabina, Serne, Erik H., Otten, Hans-Martin, Klappe, Edith H., Bistervels, Ingrid M., Lauw, Mandy N., Piersma-Wichers, Margriet, Prandoni, Paolo, Joore, Manuela A., Prins, Martin H., ten Cate, Hugo, and IDEAL DVT Investigators

Abstract

Background Therapy with elastic compression stockings has been the cornerstone for prevention of post-thrombotic syndrome for decades in patients after acute deep venous thrombosis. It is uncertain who benefits most from therapy, and what the optimum duration of therapy should be. We therefore aimed to assess the safety and efficacy of individualised duration of compression therapy versus the standard duration of 24 months following an initial treatment period of 6 months. Methods We did a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial at 12 hospitals in the Netherlands and two in Italy. We randomly assigned patients (1:1) with acute proximal deep vein thrombosis of the leg and without pre-existent venous insufficiency (Clinical Etiological Anatomical and Pathophysiological score

Published
2018

28. Screening for cancer in patients with unprovoked venous thromboembolism: protocol for a systematic review and individual patient data meta-analysis

Author

van Es, Nick, Le Gal, Grégoire, Otten, Hans-Martin, Robin, Philippe, Piccioli, Andrea, Lécumberri, Ramon, Jara Palomares, Luis, Religa, Piotr, Rieu, Viriginie, Rondina, Matthew T., Beckers, Mariëlle M., Prandoni, Paolo, Salaun, Pierre-Yves, Di Nisio, Marcello, Bossuyt, Patrick M., Büller, Harry R., Carrier, Marc, van Es, Nick, Le Gal, Grégoire, Otten, Hans-Martin, Robin, Philippe, Piccioli, Andrea, Lécumberri, Ramon, Jara Palomares, Luis, Religa, Piotr, Rieu, Viriginie, Rondina, Matthew T., Beckers, Mariëlle M., Prandoni, Paolo, Salaun, Pierre-Yves, Di Nisio, Marcello, Bossuyt, Patrick M., Büller, Harry R., and Carrier, Marc

Abstract

[Introduction] Occult cancer is present in 4%–9% of patients with unprovoked venous thromboembolism (VTE). Screening for cancer may be considered in these patients, with the aim to diagnose cancers in an early, potentially curable stage. Information is needed about the risk of occult cancer, overall and in specific subgroups, additional risk factors and on the performance of different screening strategies., [Methods and analysis] MEDLINE, Embase and CENTRAL databases were searched from November 2007 to January 2016 for prospective studies that had evaluated protocol-mandated screening for cancer in patients with unprovoked VTE and with at least 12 months’ follow-up. Two reviewers independently assessed articles for eligibility. Ten eligible studies were identified and individual patient data were obtained from each of them. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool . Generalised linear mixed-effects models was used to calculate estimates in a one-stage meta-analytic approach, overall and in a number of subgroups, including patients undergoing limited screening only, elderly patients, patients with previous VTE, smokers and patients using oestrogens., [Ethics and dissemination] Ethical approval is not required for this systematic review and individual patient data meta-analysis. Findings have been submitted for publication in peer-reviewed journals and presentations at national and international conferences to provide clinicians and other decision-makers with valid and precise risk estimates of occult cancer, overall and in specific clinical subgroups, with risk factors for occult cancer, with estimates of the diagnostic performance of limited screening and with an exploration of the benefit of extensive screening strategies.

Published
2017

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