Roermond, Netherlands
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Dingemans A.-M.C.,Maastricht University | Bootsma G.,Atrium Medical | Pitz C.,Laurentius Hospital | Lunde R.,St. Jansgasthuis | And 2 more authors.
Radiotherapy and Oncology | Year: 2014

Background Non-small cell lung cancer (NSCLC) stage T4N0-1 or single nodal station IIIA-N2 are two stage III sub-groups for which the outcome of non-surgical therapy is not well known. We investigated the results of individualised isotoxic accelerated radiotherapy (INDAR) and chemotherapy in this setting. Methods Analysis of NSCLC patients included in 2 prospective trials (NCT00573040 and NCT00572325) stage T4N0-1 or IIIA-N2 with 1 pathologic nodal station, treated with chemo-radiotherapy (CRT) using INDAR with concurrent or sequential platinum-based chemotherapy. Overall survival (OS) was updated and calculated from date of diagnosis (Kaplan-Meier). Toxicity was scored following CTCAEv3.0. To allow comparison with other articles the subgroups were also analysed separately for toxicity, progression free and overall survival. Results 83 patients (42 T4N0-1 and 41 IIIA-N2) were identified: the median radiotherapy dose was 65 Gy. Thirty-seven percent of patients received sequential CRT and 63% received concurrent CRT. At a median follow-up of 48 months the median OS for T4N0-1 patients was 34 months with 55% 2-year survival and 25% 5-year survival. For stage IIIA-N2 at a median follow-up of 50 months the median OS was 26 months with 2- and 5-year survival rates of 53% and 24%, respectively. Conclusion Chemo-radiation using INDAR yields promising survival results in patients with single-station stage IIIA-N2 or T4N0-1 NSCLC. © 2013 Elsevier Ireland Ltd. All rights reserved.


Arits A.H.M.M.,Maastricht University | Mosterd K.,Maastricht University | Essers B.A.B.,Maastricht University | Spoorenberg E.,Maastricht University | And 12 more authors.
The Lancet Oncology | Year: 2013

Background: Superficial basal-cell carcinoma is most commonly treated with topical non-surgical treatments, such as photodynamic therapy or topical creams. Photodynamic therapy is considered the preferable treatment, although this has not been previously tested in a randomised control trial. We assessed the effectiveness of photodynamic therapy compared with imiquimod or fluorouracil in patients with superficial basal-cell carcinoma. Methods: In this single blind, non-inferiority, randomised controlled multicentre trial, we enrolled patients with a histologically proven superficial basal-cell carcinoma at seven hospitals in the Netherlands. Patients were randomly assigned to receive treatment with methylaminolevulinate photodynamic therapy (MAL-PDT; two sessions with an interval of 1 week), imiquimod cream (once daily, five times a week for 6 weeks), or fluorouracil cream (twice daily for 4 weeks). Follow-up was at 3 and 12 months post-treatment. Data were collected by one observer who was blinded to the assigned treatment. The primary outcome was the proportion of patients free of tumour at both 3 and 12 month follow up. A pre-specified non-inferiority margin of 10% was used and modified intention-to-treat analyses were done. This trial is registered as an International Standard Randomised controlled trial (ISRCTN 79701845). Findings: 601 patients were randomised: 202 to receive MAL-PDT, 198 to receive imiquimod, and 201 to receive fluorouracil. A year after treatment, 52 of 196 patients treated with MAL-PDT, 31 of 189 treated with imiquimod, and 39 of 198 treated with fluorouracil had tumour residue or recurrence. The proportion of patients tumour-free at both 3 and 12 month follow-up was 72·8% (95% CI 66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream, and 80·1% (74·7-85·9) for fluorouracil cream. The difference between imiquimod and MAL-PDT was 10·6% (95% CI 1·5-19·5; p=0·021) and 7·3% (-1·9 to 16·5; p=0·120) between fluorouracil and MAL-PDT, and between fluorouracil and imiquimod was -3·3% (-11·6 to 5·0; p=0·435. For patients treated with MAL-PDT, moderate to severe pain and burning sensation were reported most often during the actual MAL-PDT session. For other local adverse reactions, local skin redness was most often reported as moderate or severe in all treatment groups. Patients treated with creams more often reported moderate to severe local swelling, erosion, crust formation, and itching of the skin than patients treated with MAL-PDT. In the MAL-PDT group no serious adverse events were reported. One patient treated with imiquimod and two patients treated with fluorouracil developed a local wound infection and needed additional treatment in the outpatient setting. Interpretation: Topical fluorouracil was non-inferior and imiquimod was superior to MAL-PDT for treatment of superficial basal-cell carcinoma. On the basis of these findings, imiquimod can be considered the preferred treatment, but all aspects affecting treatment choice should be weighted to select the best treatment for patients. Funding: Grant of the Netherlands Organization for Scientific Research ZONMW (08-82310-98-08626). © 2013 Elsevier Ltd.


Kwee R.M.,Maastricht University | Truijman M.T.B.,Maastricht University | van Oostenbrugge R.J.,Maastricht University | Mess W.H.,Maastricht University | And 5 more authors.
PLoS ONE | Year: 2012

Purpose: To investigate the natural history of carotid atherosclerosis in patients who experienced a TIA or ischemic stroke. Patients and Methods: Ninety-two TIA/stroke patients (57 men, mean age 67.7±9.8 years) with ipsilateral <70% carotid stenosis underwent multisequence MRI of the plaque ipsilateral to the symptomatic side at baseline and after one year. For each plaque, several parameters were assessed at both time points. Results: Carotid lumen, wall and total vessel (= carotid lumen and wall) volume did not significantly change. Forty-four patients had a plaque with a lipid-rich necrotic core (LRNC) at baseline, of which 34 also had a LRNC after one year. In three patients a LRNC appeared after one year. Thirty patients had a plaque with a thin and/or ruptured fibrous cap (FC) at both time points. In seven patients, FC status changed from thin and/or ruptured into thick and intact. In three patients, FC status changed from thick and intact into thin and/or ruptured. Twenty patients had intraplaque hemorrhage (IPH) at both time points. In four patients, IPH disappeared, whereas in three patients, new IPH appeared at follow-up. Conclusion: In TIA/stroke patients, carotid plaque morphology does not significantly change over a one-year period. IPH and FC status change in a minority of patients. © 2012 Kwee et al.


Buijsen J.,Maastricht University | Lammering G.,Maastricht University | Jansen R.L.H.,Maastricht University | Beets G.L.,Maastricht University | And 7 more authors.
Radiotherapy and Oncology | Year: 2013

Purpose To investigate the toxicity of nelfinavir, administered during preoperative chemoradiotherapy (CRT) in patients with locally advanced rectal cancer. Material and methods Twelve patients were treated with chemoradiotherapy to 50.4 Gy combined with capecitabine 825 mg/m2 BID. Three dose levels (DL) of nelfinavir were tested: 750 mg BID (DL1), 1250 mg BID (DL2) and an intermediate level of 1000 mg BID (DL3). Surgery was performed between 8 and 10 weeks after completion of CRT. Primary endpoint was dose-limiting toxicity (DLT), defined as any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity. Results Eleven patients could be analyzed: 5 were treated in DL1, 3 in DL2 and 3 in DL3. The first 3 patients in DL1 did not develop a DLT. In DL2 one patient developed gr 3 diarrhea, 1 patient had gr 3 transaminase elevation and 1 patient had a gr 3 cholangitis with unknown cause. An intermediate dose level was tested in DL3. In this group 2 patients developed gr 3 diarrhea and 1 patient gr 3 transaminase elevation and gr 4 post-operative wound complication. Three patients achieved a pathological complete response (pCR). Conclusions Nelfinavir 750 mg BID was defined as the recommended phase II dose in combination with capecitabine and 50.4 Gy pre-operative radiotherapy in rectal cancer. First tumor response evaluations are promising, but a further phase II study is needed to get more information about efficacy of this treatment regimen. © 2013 Elsevier Ireland Ltd. All rights reserved.


De Ruysscher D.,Maastricht University | De Ruysscher D.,University Hospital Leuvan Leuven | Wanders R.,Maastricht University | Van Baardwijk A.,Maastricht University | And 9 more authors.
Journal of Thoracic Oncology | Year: 2012

Background: Stage IV non-small-cell lung cancer (NSCLC) patients with oligometastases (< 5 metastatic lesions) may experience long-term survival when all macroscopic tumor sites are treated radically, but no prospective data on NSCLCs with synchronous oligometastases are available. Methods: A prospective single-arm phase II trial was conducted. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). The study is listed in clinicaltrials.gov, number NCT01282450. Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44-81). Twenty-nine (74%) had local stage III; 17 (44%) brain, seven (18%) bone, and four (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval 7.6-19.4); 1-, 2-, and 3-year OS was 56.4%, 23.3%, and 17.5%, respectively. Median progression-free survival (PFS) was 12.1 months (95% confidence interval 9.6-14.3); 1-year PFS was 51.3%, and both 2- and 3-year PFS was 13.6%. Only two patients (5%) had a local recurrence. No patient or tumor parameter, including volume and 18F-deoxyglucose uptake was significantly correlated with OS or PFS. The treatment was well tolerated. Conclusion: In this phase II study, long-term PFS was found in a subgroup of NSCLC patients with synchronous oligometastases when treated radically. Identification of this favorable subgroup before therapy is needed. Copyright © 2012 by the International Association for the Study of Lung Cancer.


Teunissen J.,VieCuri Medical Center | Hochs A.H.J.,VieCuri Medical Center | Vaessen-Verberne A.,Amphia Hospital | Boehmer A.L.M.,Maasstad Hospital | And 12 more authors.
European Respiratory Journal | Year: 2014

Bronchiolitis is a common disorder in young children that often results in hospitalisation. Except for a possible effect of nebulised hypertonic saline (sodium chloride), no evidence-based therapy is available. This study investigated the efficacy of nebulised 3% and 6% hypertonic saline compared with 0.9% hypertonic saline in children hospitalised with viral bronchiolitis. In this multicentre, double-blind, randomised, controlled trial, children hospitalised with acute viral bronchiolitis were randomised to receive either nebulised 3%, 6% hypertonic saline or 0.9% normal saline during their entire hospital stay. Salbutamol was added to counteract possible bronchial constriction. The primary endpoint was the length of hospital stay. Secondary outcomes were need for supplemental oxygen and tube feeding. From the 292 children included in the study (median age 3.4 months), 247 completed the study. The median length of hospital stay did not differ between the groups: 69 h (interquartile range 57), 70 h (IQR 69) and 53 h (IQR 52), for 3% (n=84) and 6% (n=83) hypertonic saline and 0.9% (n=80) normal saline, respectively, (p=0.29). The need for supplemental oxygen or tube feeding did not differ significantly. Adverse effects were similar in the three groups. Nebulisation with hypertonic saline (3% or 6% sodium chloride) although safe, did not reduce the length of stay in hospital, duration of supplemental oxygen or tube feeding in children hospitalised with moderateto- severe viral bronchiolitis. Copyright © 2014 ERS.


Toebosch S.,Laurentius Hospital | Tudyka V.,Laurentius Hospital | Masclee A.,Maastricht University | Koek G.,Maastricht University
World Journal of Gastroenterology | Year: 2012

The exact aetiology of sigmoid volvulus in Parkinson's disease (PDD) remains unclear. A multiplicity of factors may give rise to decreased gastrointestinal function in PDD patients. Early recognition and treatment of constipation in PDD patients may alter complications like sigmoid volvulus. Treatment of sigmoid volvulus in PDD patients does not differ from other patients and involves endoscopic detorsion. If feasible, secondary sigmoidal resection should be performed. However, if the expected surgical morbidity and mortality is unacceptably high or if the patient refuses surgery, percutaneous endoscopic colostomy (PEC) should be considered. We describe an elderly PDD patient who presented with sigmoid volvulus. She was treated conservatively with endoscopic detorsion. Surgery was consistently refused by the patient. After recurrence of the sigmoid volvulus a PEC was placed. © 2012 Baishideng. All rights reserved.


Hofstra J.M.,Radboud University Nijmegen | Branten A.J.W.,Radboud University Nijmegen | Wirtz J.J.J.M.,Laurentius Hospital | Noordzij T.C.,Franciscus Hospital | And 2 more authors.
Nephrology Dialysis Transplantation | Year: 2010

Background. Immunosuppressive therapy in idiopathic membranous nephropathy (iMN) is debated. Accurate identification of patients at high risk for end-stage renal disease (ESRD) allows early start of therapy in these patients. It is unknown if early start of therapy is more effective andor less toxic than late start (i.e. when GFR deteriorates).Methods. We conducted a randomized open-label study in patients with iMN, a normal renal function and a high risk for ESRD (urinary β2m >0.5 μgmin, UIgG >125 mg day). Patients started with immunosuppressive therapy (cyclophosphamide for 12 months, and steroids) either immediately after randomization or when renal function deteriorated (ΔsCr ≥+25 and sCr >135 μmoll or ΔsCr ≥+50). End points were remission rates, duration of the nephrotic syndrome (NS), renal function and complications.Results. The study included 26 patients (24 M2 F), age 48 ± 12 years; sCr 96 μmoll (range 68-126) and median proteinuria 10.0 g10 mmol Cr. Early treatment resulted in a more rapid onset of remission (P = 0.003) and a shorter duration of the NS (P = 0.009). However, at the end of the follow-up (72 ± 22 m), there were no differences in overall remission rate, sCr (93 versus 105 μmoll), proteinuria, relapse rate and adverse events.Conclusions. In high-risk patients with iMN, immunosuppressive treatment is effective in inducing a remission. Early treatment shortens the duration of the nephrotic phase, but does not result in better preservation of renal function. Our study indicates that treatment decisions must be based on risk and benefit assessment in the individual patient.


Vermeulen J.,Maasstad Hospital | Leijtens J.W.A.,Laurentius Hospital | Mannaerts G.H.H.,Sint Franciscus Hospital
Digestive Surgery | Year: 2010

Aims: Reversal of Hartmann's procedure (HP) is a complex operation and only performed in 50-60% of the patients. Stomal incision reversal (SIR), a new minimally invasive procedure for HP reversal, was assessed and compared to the standard surgical approach. Methods: 16 patients who had undergone HP for perforated diverticulitis underwent HP reversal by SIR. The only incision in SIR is the one to release the end colostomy. Intra-abdominal adhesiolysis is done manually. A stapled end-to-end colorectal anastomosis is created. The 16 patients who underwent SIR were compared with 32 control patients who were matched according to gender, age, American Society of Anesthesiologists (ASA) classification and Hinchey stage. Results: The operation time was shorter after SIR than after reversal by laparotomy [75 min (58-208) vs. 141 min (85-276); p < 0.001]. Patients after SIR had a shorter hospital stay than patients after laparotomy [4 days (2-22) vs. 9 days (4-64); p < 0.001]. The numbers of total postoperative surgical complications (early and late) were not different (p = 0.13). The anastomotic leakage rate was similar in both groups (6%). The conversion rate in the SIR group was 19% (n = 3). Conclusion: SIR compared favorably with HP reversal by laparotomy in terms of operation time and hospital stay, without increasing the number of postoperative complications. Copyright © 2010 S. Karger AG, Basel.


Ten Tusscher M.P.M.,University of Antwerp | Ten Tusscher M.P.M.,Laurentius Hospital | Van Rijn R.J.,VU University Amsterdam
Strabismus | Year: 2010

Dissociated vertical divergence (DVD) is commonly encountered in the infantile strabismus syndrome. The movement is said to be dissociated since alignment differs between right and left eye fixation. It has been hypothesized that DVD is caused by a primitive reflex present in fish. Visual pathways in the fish brain indeed are dissociated with complete crossing at the optic chiasm and projection to the superior colliculus instead of a visual cortex. Neuroanatomical data and clinical characteristics of DVD, however, contradict this hypothesis. From these data a new hypothesis arises: corticotectal lateralization. The absence of binocular development in the cerebral cortex in infantile strabismus gives rise to dissociated activation of subcortical pathways through individual less tightly linked colliculi. © 2010 Informa Healthcare USA, Inc.

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