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Simkens L.H.J.,University of Amsterdam | Van Tinteren H.,Netherlands Cancer Institute | May A.,University Utrecht | Ten Tije A.J.,Amphia Hospital | And 20 more authors.
The Lancet | Year: 2015

Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36-57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56-0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 [23%] patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis. © 2015 Elsevier Ltd.


Van Den Broek M.,Leiden University | Dirven L.,Leiden University | De Vries-Bouwstra J.K.,Leiden University | Dehpoor A.J.,Leiden University | And 6 more authors.
Annals of the Rheumatic Diseases | Year: 2012

Objective: Several prediction models for rapid radiological progression (RRP) in the first year of rheumatoid arthritis have been designed to aid rheumatologists in their choice of initial treatment. The association was assessed between RRP and disability and joint damage progression in 8 years. Methods: Patients from the BeSt cohort were used. RRP was defined as an increase of ≥5 points in the Sharp/van der Heijde score (SHS) in year 1. Functional ability over 8 years, measured with the health assessment questionnaire (HAQ), was compared for patients with and without RRP using linear mixed models. Joint damage progression from years 1 to 8 was compared using logistic regression analyses. Results: RRP was observed in 102/465 patients. Over 8 years, patients with RRP had worse functional ability: difference in HAQ score 0.21 (0.14 after adjustment for disease activity score (over time)). RRP was associated with joint damage progression ≥25 points in SHS in years 1-8: OR 4.6. Conclusion: RRP in year 1 is a predictor of worse functional ability over 8 years, independent of baseline joint damage and disease activity. Patients with RRP have more joint damage progression in subsequent years. RRP is thus a relevant outcome on which to base the initial treatment decision.


De Jong P.H.,Erasmus Medical Center | Hazes J.M.,Erasmus Medical Center | Han H.K.,Maasstad Hospital | Huisman M.,Sint Francicus Gasthuis Hospital | And 9 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis. Methods In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression. Results 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM. Conclusions Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.


De Jong P.H.P.,Rotterdam University | Hazes J.M.,Rotterdam University | Barendregt P.J.,Maasstad Hospital | Huisman M.,Sint Francicus Gasthuis Hospital | And 9 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: To determine the most effective induction disease-modifying antirheumatic drug (DMARD) strategy in early rheumatoid arthritis (RA), second to compare one single dose of intramuscular glucocorticoids (GCs) with daily oral GCs during the induction phase. Methods: The 3-month data of a single-blinded clinical trial in patients with recent-onset arthritis (tREACH) were used. Patients were included who had a high probability (>70%) of progressing to persistent arthritis, based on the prediction model of Visser. Patients were randomised into three induction therapy strategies: (A) combination therapy (methotrexate (MTX) + sulfasalazine + hydroxychloroquine) with GCs intramuscularly; (B) combination therapy with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. A total of 281 patients were randomly assigned to strategy (A) (n=91), (B) (n=93) or (C) (n=97). Results: The Disease Activity Score (DAS) after 3 months was lower in patients receiving initial combination therapy than in those receiving MTX monotherapy (0.39 (0.67 to 0.11, 95% CI)). DAS did not differ between the different GC bridging treatments. After 3 months 50% fewer biological agents were prescribed in the combination therapy groups. Although the proportion of patients with medication adjustments differed significantly between the treatment arms, no differences were seen in these adjustments due to adverse events after stratification for drug. Conclusion: Triple DMARD induction therapy is better than MTX monotherapy in early RA. Furthermore, no differences were seen in medication adjustments due to adverse events after stratification for drug. Intramuscular and oral GCs are equally effective as bridging treatments and both can be used.


Bruijn J.,Vlietland Hospital | Bruijn J.,Sophia Childrens Hospital | Locher H.,Sophia Childrens Hospital | Passchier J.,Erasmus Medical Center | And 3 more authors.
Pediatrics | Year: 2010

BACKGROUND: In past decades, numerous population- and hospital-based studies have revealed a relationship between migraine or headache and psychopathology in children. OBJECTIVE: To describe and assess all clinical studies on the prevalence and manifestations of psychological functioning and psychiatric comorbidity in children with migraine and to provide recommendations for its diagnosis and treatment. METHODS: A literature search was performed in Medline, Embase, PsycINFO, and the Cochrane Database to identify clinical studies that assessed psychological functioning and/or psychiatric comorbidity in children with migraine. Trial quality was assessed according to a standardized and validated set of criteria. RESULTS: Seven studies met our inclusion criteria. Evidence assessment was performed by using the best-evidence synthesis method of Slavin. On the basis of this method, we found strong evidence that children with migraine in a clinical setting do not exhibit more withdrawn behavior, do not have more thought problems, do not have more social problems, and do not exhibit more delinquent or aggressive behavior than healthy children. Furthermore, there is strong evidence that children with migraine have more somatic complaints and exhibit internalizing behavior which is, given the construct of the outcome measure used, a consequence of the nature of their disease rather than a sign of psychological dysfunctioning. Finally, compared with healthy children, there is limited evidence that children with migraine in a clinical setting are more frequently diagnosed with oppositional defiant disorder, and they are not more frequently diagnosed with attention-deficit/ hyperactivity disorder, conduct disorder, dysthymia, or depression. CONCLUSIONS: On the basis of this review, we conclude that children with migraine at referral to a specialist do not exhibit more psychological dysfunctioning and (to a lesser extent) do not exhibit more psychiatric comorbidity compared with healthy controls. Copyright © 2010 by the American Academy of Pediatrics.


Kusadasi N.,Erasmus Medical Center | Kusadasi N.,Vlietland Hospital | Groeneveld A.B.J.,Erasmus Medical Center
Shock | Year: 2013

Although a variety of disease-modifying agents have been studied as potential sepsis treatments, no beneficial effects on the course of sepsis, in terms of survival, have been observed until now. Because of their plasticity, mesenchymal stromal cells (MSCs) have been implicated as an effective novel therapy modality for various diseases and are widely used for cellular therapies and tissue engineering. The existing knowledge supports the idea that MSCs might be beneficial in sepsis treatment. Our objective was to selectively address the evidence, based on multistep processes, supporting the potential of MSC-based therapies in clinical sepsis trials. In this study, we performed a stepwise approach to defend the evaluation of MSC treatments for sepsis from the bench to the bedside. Altogether, the reviewed data postulate that the signals produced by inflamed tissues might determine the functional effects of MSCs. These effects include bacterial clearance, suppression of inflammation, antiapoptosis, or stimulation of regenerative responses. We conclude that the clinical application of MSCs is a feasible and well-tolerated approach and therefore may have benefits for patients with sepsis. Copyright © 2013 by the Shock Society.


Kasius K.M.,Canisius Wilhelmina Hospital | Claes F.,Vlietland Hospital | Verhagen W.I.M.,Canisius Wilhelmina Hospital | Meulstee J.,Canisius Wilhelmina Hospital
Clinical Neurophysiology | Year: 2012

Objective: To test our hypothesis that comparing the sensory nerve conduction velocity of the median nerve across the wrist with that of the forearm is more sensitive than comparing it with that of the palm in the electrodiagnostic confirmation of carpal tunnel syndrome (CTS). Methods: One hundred and fifty seven consecutive patients with clinically defined CTS were prospectively included and electrophysiologically examined. Antidromic nerve conduction velocities were measured in 3 segments of the median nerve: forearm, wrist, and palm. Differences and ratios in nerve conduction velocities were computed between the forearm and wrist and between the palm and wrist segments. Results: Comparing the median nerve conduction velocities of the forearm with the wrist segment provides a greater sensitivity (79.6% and 82.8% for the second and third digit, respectively) than comparing the palm with the wrist segment (65.6% and 65.0%). Applying the ratio leads to slightly higher sensitivities for both comparisons. Conclusions: The modified segmental palmar test is a sensitive, robust and easily applicable method in diagnosing CTS. Significance: We recommend to use the median nerve sensory conduction velocity in the forearm as a reference in the segmental palmar test instead of that in the palm. © 2012 International Federation of Clinical Neurophysiology.


Mannesse C.K.,Vlietland Hospital | Vondeling A.M.,Robert Bosch GmbH | van Marum R.J.,Robert Bosch GmbH | van Solinge W.W.,University Utrecht | And 3 more authors.
Ageing Research Reviews | Year: 2013

Aim of the study was to analyze temporal trends in prevalence of hyponatremia over four decades in different settings. A systematic review of the literature from 1966 to 2009 yielded prevalences of hyponatremia, with standard errors (SE) and pooled estimated means (PEM), calculated by year and setting (geriatric, ICU, other hospital wards, psychiatric hospitals, nursing homes, outpatients). 53 studies were included. Prevalence of hyponatremia was stable from 1976 to 2006, and higher on geriatric wards accept for ICU: e.g. PEM prevalence of mild hyponatremia (serum sodium <135. mM) was 22.2% (95%CI 20.2-24.3) on geriatric wards, 6.0% (95%CI 5.9-6.1) on other hospital wards and 17.2% (SE 7.0) in one ICU-study; for severe hyponatremia (serum sodium < 125. mM) these figures were 4.5% (95%CI 3.0-6.1), 0.8% (95%CI 0.7-0.8) and 10.3% (SE 5.6). In nursing homes PEM prevalence of mild hyponatremia was 18.8% (95%CI 15.6-22.2). The higher prevalence on geriatric wards could partly be explained by age-related changes in the regulation of serum sodium. Other underlying factors can be the presence of multiple diagnoses and the use of polypharmacy. © 2012 Elsevier B.V..


Van Rensch P.J.H.,Postoperative Joint Infection Unit | Van de Pol G.J.,Postoperative Joint Infection Unit | Goosen J.H.M.,Postoperative Joint Infection Unit | Wymenga A.B.,Postoperative Joint Infection Unit | De Man F.H.R.,Vlietland Hospital
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2014

Purpose: Primary stability in arthrodesis of the knee can be achieved by external fixation, intramedullary nailing or plate fixation. Each method has different features and results. We present a practical algorithm for arthrodesis of the knee following a failed (infected) arthroplasty, based on our own results and a literature review. Methods: Between 2004 and 2010, patients were included with an indication for arthrodesis after failed (revision) arthroplasty of the knee. Patients were analyzed with respect to indication, fusion method and bone contact. End-point was solid fusion. Results: Twenty-six arthrodeses were performed. Eighteen patients were treated because of an infected arthroplasty. In total, ten external fixators, ten intramedullary nails and six plate fixations were applied; solid fusion was achieved in 3/10, 8/10 and 3/6, respectively. Conclusions: There is no definite answer as to which method is superior in performing an arthrodesis of the knee. Intramedullary nailing achieved the best fusion rates, but was used most in cases without-or cured-infection. Our data and the contemporary literature suggest that external fixation can be abandoned as standard fusion method, but can be of use following persisting infection. The Ilizarov circular external fixator, however, seems to render high fusion rates. Good patient selection and appropriate individual treatment are the key to a successful arthrodesis. Based upon these findings, a practical algorithm was developed. Level of evidence: Retrospective case series, Level IV. © 2013 Springer-Verlag Berlin Heidelberg.


Kasius K.M.,Canisius Wilhelmina Hospital | Claes F.,Vlietland Hospital | Verhagen W.I.,Canisius Wilhelmina Hospital | Meulstee J.,Canisius Wilhelmina Hospital
Muscle and Nerve | Year: 2012

Introduction: In up to 30% of patients with carpal tunnel syndrome (CTS), the cross-sectional area (CSA) of the median nerve may not be enlarged. We hypothesize that this could be the result of secondary atrophy of the nerve in severe CTS. The aim of this study was to measure the ultrasonographic CSA of the median nerve at the wrist in patients with severe CTS. Methods: In 14 consecutive patients with clinically and electrophysiologically defined severe CTS, the CSA of the median nerve was measured and compared with that of control subjects. Results: CSA of the median nerve exceeded the upper limit of normal in the majority of patients with severe CTS. Conclusions: Atrophy of the median nerve in severe CTS does not explain negative ultrasonographic test results. Instead, the CSA of the median nerve is enlarged in most patients with severe CTS. © 2011 Wiley Periodicals, Inc.

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