Publications by authors named "Mariëtte J Agterof"

8 Publications

  • Page 1 of 1

Extravasation of an antibody-drug conjugate: A case report of epidermal necrosis after trastuzumab-emtansine extravasation.

J Clin Pharm Ther 2020 Aug 15;45(4):832-835. Epub 2020 May 15.

Department of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands.

What Is Known And Objective: Trastuzumab-emtansine is an antibody-drug conjugate developed to decrease off-target toxicity. According to the product label, reactions secondary to extravasation are mild or moderate.

Case Summary: We report on a 51-year-old woman who developed epidermal necrosis after extravasation of trastuzumab-emtansine, which required surgical intervention. Six weeks later, the lesions were healed with residual hyperpigmentation.

What Is New And Conclusion: We describe the course of a case of severe toxicity following trastuzumab-emtansine extravasation. We provide treatment recommendations and recommend amending the information on the product label on extravasation.
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http://dx.doi.org/10.1111/jcpt.13148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383643PMC
August 2020

Real-World Effectiveness of Palbociclib Versus Clinical Trial Results in Patients With Advanced/Metastatic Breast Cancer That Progressed on Previous Endocrine Therapy.

Breast Cancer (Auckl) 2019 10;13:1178223418823238. Epub 2019 Jan 10.

Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands.

Objective: The aim of this study was to assess the real-world effectiveness and tolerability of palbociclib combined with endocrine therapy for the treatment of hormone receptor positive (HR-positive), human epidermal growth factor receptor 2 negative (HER2-negative), advanced/metastatic breast cancer that progressed on previous endocrine therapy, and to compare these results with the outcomes of the PALOMA-3 clinical trial.

Methods: This study was a retrospective observational cohort study including all patients who started with palbociclib in the St. Antonius Hospital between September 1, 2016 and April 1, 2018 for the treatment of HR-positive, HER2-negative advanced/metastatic breast cancer that progressed on previous endocrine therapy. Individual patient data were collected from electronic medical records. Primary study outcomes were progression-free survival (PFS) and the number of permanent treatment discontinuations before disease progression due to adverse events (AEs). Secondary outcomes were the frequency of all (serious) AEs and the frequency of and reasons for dose reductions, -interruptions and cycle delays.

Results: A total of 46 patients were studied with a median follow-up of 13.0 months. Overall, the median PFS in real-world clinical practice was 10.0 months (95% confidence interval (CI) 4.9-15.1), compared with 9.5 months in PALOMA-3 (95% CI 9.2-11.0). Two patients discontinued treatment because of AEs. Neutropenia was the most frequent grade 3-4 AE, but with no febrile neutropenia events. Most AEs were managed with palbociclib dose modifications. Regarding these modifications, more cycle delays, less dose reductions, and less dose interruptions occurred in clinical practice compared with PALOMA-3 (59 vs 36%, 22 vs 34%, and 9 vs 54%, respectively). Patients who did not meet the PALOMA-3 study eligibility criteria (n = 16) showed a lower median PFS of 5.5 months (95% CI 4.7-6.4).

Conclusions: The effectiveness and tolerability of palbociclib in real-world clinical practice corresponded well with the results obtained in the PALOMA-3 clinical trial. Despite the differences in dose modifications, this study suggests that there is no efficacy-effectiveness gap in this patient population.
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http://dx.doi.org/10.1177/1178223418823238DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6330732PMC
January 2019

A prognostic model for short term adverse events in normotensive patients with pulmonary embolism.

Am J Hematol 2011 Aug 31;86(8):646-9. Epub 2011 May 31.

Department of Internal Medicine, Julius Center for Health Sciences and Primary Care University Medical Centre Utrecht, The Netherlands.

Risk stratification of patients with PE has gained interest in terms of the identification of patients in whom treatment on an outpatient base can be considered. Previous studies are of limited value due to their focus on adverse clinical events within several months after diagnosis of PE. We developed a prognostic model, based on easily accessible, clinical, and laboratory parameters, to predict adverse events during the first 10 days after the diagnosis of acute PE. We have analyzed the data of 210 outpatients with confirmed PE. Collected data included medical history, pulse rate, blood pressure, NT-proBNP, and D-dimer concentrations. The primary outcome was the occurrence of adverse clinical events in a 10 day follow-up period. Our final prognostic model to predict short-term adverse events consists of NT-proBNP levels, D-dimer concentrations, pulse rate, and the occurrence of active malignancy; the total score ranges from 0 to 37 points. Patients with a low score (no active malignancy, pulse rate <90 bpm, NT-proBNP <500 pg/ml, and D-dimer <3,000 μg/l FEU) have a 10-day adverse event risk <1.5%. This risk increases to over 30% in patients with a maximum score, based on high pulse rate, D-dimer concentrations, and NT-proBNP levels. Our prognostic model, once prospectively validated in an independent sample of patients, can be used in the early risk stratification of PE to estimate the risk of adverse events and to differentiate between candidates for in- or out- hospital treatment.
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http://dx.doi.org/10.1002/ajh.22066DOI Listing
August 2011

Out of hospital anticoagulant therapy in patients with acute pulmonary embolism is frequently practised but not perfect.

Thromb Res 2010 Dec;126(6):481-5

Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands.

Introduction: Traditionally, patients with pulmonary embolism (PE) are treated in-hospital until they reach an adequate international normalized ratio (INR). Analogous to patients with a deep venous thrombosis, therapy with low-molecular-weight heparin facilitates out of hospital treatment of PE. We retrospectively analysed the current practice of early anticoagulant therapy in 86 acute PE patients with emphasis on the occurrence and safety of outpatient treatment.

Methods: Data were collected from two large regional teaching hospitals and from a specialized anticoagulation clinical, where patients were followed in the period after hospital discharge. The course of hospitalization and LMWH transitioning therapy and the quality of treatment in the first three months after diagnosis were compared between patients discharged before and patients discharged after reaching adequate INR.

Results: Forty-four patients (51.2%) were discharged early, before reaching an adequate INR, and 42 patients (48.8%) were discharged after reaching adequate INR. Early discharged patients needed more time to reach adequate INR compared to other patients (13 versus 6 days). In 28 patients (32.6%), the LMWH transitioning therapy was stopped prematurely; 21 patients were from the early discharged group. During the first 3 months, the mean individual times below, in and above the INR range were equal between the two groups.

Conclusion: Enhanced compliance to existing guidelines and tools, and further development of guidelines, with focus on intensification of monitoring of INR values in an outpatient setting and preventing premature discontinuation of transitioning therapy, are warranted for a safe and early discharge of stable patients with PE.
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http://dx.doi.org/10.1016/j.thromres.2010.08.019DOI Listing
December 2010

Risk stratification of patients with pulmonary embolism based on pulse rate and D-dimer concentration.

Thromb Haemost 2009 Oct;102(4):683-7

Department of Internal Medicine, University Medical Centre Utrecht, P.O. Box 85500, 3508 AB Utrecht, the Netherlands.

To enable outpatient treatment of a selected group of patients with pulmonary embolism (PE), insight in the determinants of adverse clinical outcome is warranted. We have identified risk factors for serious adverse events (SAE) within the first 10 days of acute PE. We have retrospectively analysed data of 440 consecutive patients with acute PE. Collected data included age, gender, medical history, blood pressure, pulse rate and D-dimer concentration. The variables associated with SAE in the first 10 days in univariate analysis (p<0.15) have been included in a multivariate logistic regression model (backward conditional, p out >0.10). In 440 patients with acute PE, 20 SAEs occurred in a 10-day follow-up period. Pulse rate > or = 100 beats per minute (bpm) (OR, 6.85; 95%CI 1.43-32.81) and D-dimer concentration > or = 3,000 microg/ml (OR, 5.51; 95%CI 0.68-44.64) were significantly related to the SAEs. All SAEs were predicted by a pulse rate > or = 100 bpm and/or a D-dimer concentration > or = 3,000 microg/ml. Older age, gender, history of venous thromboembolism (VTE), heart failure, chronic obstructive pulmonary disease, cancer or a systolic blood pressure < 90 mm Hg had no significant influence on short term SAEs. Pulse rate and D-dimer concentration can be used to identify patients with acute PE, who are at risk for adverse clinical outcome during the first 10 days of hospitalisation. Outpatient treatment of PE-patients with a pulse rate > or = 100 bpm and/or a D-dimer concentration > or = 3,000 microg/ml has to be discouraged.
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http://dx.doi.org/10.1160/TH09-04-0229DOI Listing
October 2009

The role of fibrin monomers in optimizing the diagnostic work-up of deep vein thrombosis.

Thromb Haemost 2007 May;97(5):807-13

Department of Haematology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.

Despite the use of a clinical score and D-dimers to exclude deep vein thrombosis (DVT), the majority of patients still need repeated ultrasound (US). The aim of the study was to investigate whether fibrin monomers (FMs), as markers of thrombin generation, have additional value in the diagnosis of DVT. This is a posthoc analysis of 464 outpatients, participants in a management study using D-dimers (Tina-Quant and a clinical score in the exclusion of DVT. Two new FM assays (Auto LIA-FM and IATRO SF, Japan) were performed. Overall sensitivity, negative predictive value (NPV) and specificity of the D-dimer test were 98%, 98% and 42%. The optimal cut-off point for the Auto LIA-FM test was
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May 2007

Images in clinical Medicine. Bortezomib-induced skin lesions.

N Engl J Med 2005 Jun;352(24):2534

St. Antonius Ziekenhuis, 3435 CM Nieuwegein, The Netherlands.

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http://dx.doi.org/10.1056/NEJMicm041166DOI Listing
June 2005