Grard Nieuwenhuijzen - Academia.edu (original) (raw)
Papers by Grard Nieuwenhuijzen
Annals of surgical oncology, Jan 6, 2015
Severe morbidity after cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemo... more Severe morbidity after cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC) is, besides the obvious short-term consequences, associated with impaired long-term outcomes. The risk factors for severe morbidity in patients with peritoneal carcinomatosis (PC) of colorectal origin are poorly defined. This study aimed to identify risk factors for severe morbidity after CRS + HIPEC in patients with colorectal PC. Patients with colorectal PC who underwent CRS + HIPEC between 2007 and 2015 were categorized and compared between those with and those without severe morbidity. Risk factors were identified using logistic regression analysis. Morbidity was graded according to the Clavien-Dindo classification, with grade 3 or higher indicating severe morbidity. This study included 211 patients, of whom 53 patients (25.1 %) experienced morbidity of grade 3 or higher. The identified risk factors for severe morbidity were extensive prior surgery [odds ratio (OR) 4....
European Journal of Cancer, 2014
Neoadjuvant hormonal therapy (NHT) is playing an increasing role in the clinical management of br... more Neoadjuvant hormonal therapy (NHT) is playing an increasing role in the clinical management of breast cancer (BC) and may improve surgical outcomes for postmenopausal, oestrogen receptor (ER)-positive BC patients. However, there is currently no consensus on the optimal duration of NHT before surgery. Here, we present the outcomes of the TEAM IIA trial, a multicentre, phase II trial investigating the efficacy of six months of neoadjuvant exemestane in postmenopausal, strong ER-positive (ER+, ⩾50%) BC patients. 102 patients (stage T2-T4ac) were included in the study after exclusion of ineligible patients. Primary end-point was clinical response at 3 and 6 months as measured by palpation. Secondary end-point was radiological response as measured by magnetic resonance imaging (MRI), mammography and/or ultrasound. Linear mixed models (95% confidence interval (CI)) were used to compare changes in mean tumour size (in mm) between baseline, 3 and 6 months after the start of endocrine therapy. Conversion rates from mastectomy to breast conserving surgery (BCS) were evaluated. Median age of all patients was 72 years (range 53-88). Overall response rate by clinical palpation was 64.5% in all patients with a final palpation measurement. Four patients had clinically progressive disease. 63 patients had both 3-month and >3-month palpation measurements. Overall response was 58.7% at 3 months and 68.3% at final palpation (>3 months). Mean tumour size by clinical palpation at T=0 was 39.1mm (95% CI 34.8-43.4mm), and decreased to 23.0mm (95% CI 18.7-27.2mm) and 16.7 mm (95% CI 12.6-20.8) at T=3 and T>3 months, respectively (p=0.001). Final radiological response rates at the end of treatment for MRI (n=37), ultrasound (n=77) and mammography (n=56) were 70.3%, 41.6% and 48.2%, respectively. Feasibility of BCS improved from 61.8% to 70.6% (McNemar p=0.012). 6 months of neoadjuvant exemestane therapy helps reduce mean tumour size further in strongly ER-positive BC patients without significant side-effects compared to 3 months. Nevertheless, some patients still experience disease progression under exemestane. Feasibility of breast conservation rates improved by almost 10%.
Clinical nutrition (Edinburgh, Scotland), 2015
Early enteral feeding following surgery can be given orally, via a jejunostomy or via a nasojejun... more Early enteral feeding following surgery can be given orally, via a jejunostomy or via a nasojejunal tube. However, the best feeding route following esophagectomy is unclear. To determine the best route for enteral nutrition following esophagectomy regarding anastomotic leakage, pneumonia, percentage meeting the nutritional requirements, weight loss, complications of tube feeding, mortality, patient satisfaction and length of hospital stay. A systematic literature review following PRISMA and MOOSE guidelines. There were 17 eligible studies on early oral intake, jejunostomy or nasojejunal tube feeding. Only one nonrandomized study (N = 133) investigated early oral feeding specifically following esophagectomy. Early oral feeding was associated with a reduced length of stay with delayed oral feeding, without increased complication rates. Postoperative nasojejunal tube feeding was not significantly different from jejunostomy tube feeding regarding complications or catheter efficacy in th...
BMJ open, 2014
The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist th... more The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy. This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered. Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the st...
The Netherlands journal of medicine, 2013
The standardised mortality ratio (SMR) for rectal or anal cancer was above average in a large ter... more The standardised mortality ratio (SMR) for rectal or anal cancer was above average in a large tertiary referral centre for locally advanced rectal cancer in the Netherlands. The aim of this study was to investigate whether the increased SMR was indeed related to poor quality of care or whether it could be explained by inadequate adjustment for case-mix factors. Between 2006 and 2008, 381 patients were admitted for rectal or anal cancer. The SMR score of this diagnostic group was 230 (95% CI 140 to 355), corresponding with 20 in-hospital deaths. The hospital dataset was merged with data from the Eindhoven Cancer Registry to obtain more detailed information. Patients admitted for palliative care only accounted for 45% (9/20) of the in-hospital mortality. In contrast to the high SMR, postoperative mortality was low, i.e. 2.6%. The majority of the rectal or anal cancer patients were diagnosed in and referred from another hospital. Referred patients more often had an advanced tumour stag...
The Annals of Thoracic Surgery, 2015
Supportive Care in Cancer, 2014
This study examined the individual and combined effect of having colorectal cancer (CRC) and diab... more This study examined the individual and combined effect of having colorectal cancer (CRC) and diabetes mellitus (DM) on health-related quality of life (HRQoL) and sexual functioning. Data from questionnaires collected in 2010 among CRC patients and a sample of the general Dutch population were used. All persons older than 60 years were included in this study. DM prevalence among the CRC sample as well as the sample of the general population was self-reported. HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire version 3.0 (QLQ-C30), and sexual functioning was assessed with four scales from the EORTC-QLQ-CR38. In total 624 persons without CRC and DM, 78 persons with DM only, 1,731 with CRC only, and 328 with both CRC and DM were included. Having both CRC and DM did not result in lower HRQoL and sexual functioning than the sum of the individual effects of both diseases. CRC, irrespective of having DM, was associated with lower scores on most EORTC-QLQ-C30 subscales, except global health, pain, and appetite loss. CRC was also independently associated with more erection problems among males. DM, irrespective of having CRC, was associated with lower physical functioning and more symptoms of dyspnea. Having both CRC and DM did not result in lower HRQoL and sexual functioning than the sum of the individual effects of both diseases. As CRC was found to be consistently associated with lower functioning and more symptoms, CRC and its treatment seem to contribute stronger to lower HRQoL and sexual functioning compared with DM.
Clinical Breast Cancer, 2014
Between 20% and 42% of patients with clinically node-positive breast cancer achieve a pathologic ... more Between 20% and 42% of patients with clinically node-positive breast cancer achieve a pathologic complete response (pCR) of axillary lymph nodes after neoadjuvant chemotherapy or immunotherapy, or both, (chemo[immuno]therapy). Hypothetically, axillary lymph node dissection (ALND) may be safely omitted in these patients. This study aimed to develop a model for predicting axillary pCR in these patients. We retrospectively identified patients with clinically node-positive breast cancer who were treated with neoadjuvant chemo(immuno)therapy and ALND between 2005 and 2012 in 5 hospitals. Patient and tumor characteristics, neoadjuvant chemo(immuno)therapy regimens, and pathology reports were extracted. Binary logistic regression analysis was used to predict axillary pCR with the following variables: age, tumor stage and type, hormone receptor and human epidermal growth factor receptor 2 (HER2) status, and administration of taxane and trastuzumab. The model was internally validated by bootstrap resampling. The overall performance of the model was assessed by the Brier score and the discriminative performance by receiver operating characteristic (ROC) curve analysis. A model was developed based on 291 patients and was internally validated with a scaled Brier score of 0.14. The area under the ROC curve of this model was 0.77 (95% confidence interval [CI], 0.71-0.82). At a cutoff value of predicted probability ≥ 0.50, the model demonstrated specificity of 88%, sensitivity of 43%, positive predictive value (PPV) of 65%, and negative predictive value (NPV) of 75%. This prediction model shows reasonable accuracy for predicting axillary pCR. However, omitting axillary treatment based solely on the nomogram score is not justified. Further research is warranted to noninvasively identify patients with axillary pCR.
The Lancet Oncology, 2014
Background If treatment of the axilla is indicated in patients with breast cancer who have a posi... more Background If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-eff ects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-eff ects.
Trials, Jan 27, 2015
BackgroundPostoperative ileus and anastomotic leakage are important complications following color... more BackgroundPostoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage.Methods/DesignThis multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to t...
The Breast, 2012
Background: After introduction of sentinel node biopsy (SNB) in patients with breast cancer a hig... more Background: After introduction of sentinel node biopsy (SNB) in patients with breast cancer a higher proportion of micrometastases and isolated tumor cells are being detected. Prognostic impact and clinical relevance of this minimal nodal involvement is under debate and substantial variation in the use of axillary surgery and/or systemic adjuvant treatment could be expected. Methods: Data from the population-based Eindhoven Cancer Registry were used on all (n ¼ 9038) women who underwent SNB for invasive breast cancer from 1996 to 2008 and medical files were studied to determine the role of minimal nodal involvement in the decision to use adjuvant systemic treatment. Results: Forty-five percent of 172 patients with isolated tumor cells and 76% of 605 patients with micrometastases received adjuvant systemic treatment. Thirty-five of 59 patients with isolated tumor cells and 153 of 193 patients with micrometastases received systemic therapy based on primary tumor characteristics. The remainder probably received adjuvant therapy based on presence of minimal nodal involvement. Thirty-seven percent of the patients with isolated tumor cells underwent an axillary lymph node dissection compared to 75% when micrometastases were present. Multivariate analyses showed a significantly higher chance of receiving systemic treatment when isolated tumor cells (OR 1.5 (95% CI, 1.05e2.15)) or micrometastases (OR 10.7 (95% CI, 8.56e13.27)) were present, compared to a negative lymph node status. Conclusion: The debate on necessity of performing completion ALND and administration of systemic therapy in patients with minimal nodal involvement is reflected by the treatment patterns observed in our population-based study. Synopsis: Describing time-trends and predictors of axillary and systemic treatment of patients with breast cancer and micrometastases or isolated tumor cells in their sentinel lymph node(s). The Breast xxx (2012) 1e5 Please cite this article in press as: Maaskant-Braat AJ, et al., Axillary and systemic treatment of patients with breast cancer and micrometastatic disease or isolated tumor cells in the sentinel lymph node, The Breast (2012),
Trials, 2012
Background: Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients c... more Background: Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design: The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion: The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients.
European Journal of Surgical Oncology (EJSO), 2003
Aims: The use of axillary lymph node dissection (ALND) in women with breast cancer is associated ... more Aims: The use of axillary lymph node dissection (ALND) in women with breast cancer is associated with considerable morbidity. Sentinel node biopsy (SNB) removes the lymph node in the axillary basin indicative for receiving first lymphatic drainage from the breast. This study compares the nature and severity of physical morbidity among breast cancer patients who underwent primary surgery for breast cancer combined with either ALND or SNB. Also, it assesses influence of subsequent radiotherapy on morbidity. Method: Two hundred and thirteen ALND patients were compared with 180 SNB patients retrospectively. Morbidity was measured using a disease-specific quality-of-life questionnaire. Results: Patients' demographic characteristics were alike. The axillary procedure is the strongest and most consistent factor in explaining differences in a variety of self-reported complaints. Patients having had SNB have a 3.2-fold lower risk of experiencing pain, a 5-fold lower risk of lymph oedema, a 7.7-fold lower risk of numbness, a 3.7-fold lower risk of tingling sensations, a 7.1-fold lower risk of loss of strength in arm/hand, a 3.6-fold lower risk of loss of active motion range of the arm and a 2.9-fold lower risk of impaired use of the arm. Axillary radiation therapy adds to complaints next to the axillary surgical procedure by increasing the risk of lymph oedema 2.4-fold and enhancing the risk of impaired use of the arm by 2.6-fold. Axillary radiation therapy does not explain lymph oedema by itself. Conclusion: SNB is associated with less morbidity compared to ALND in patients with primary breast cancer.
European Journal of Cancer, 2013
Abstract Introduction: Multifocal breast cancer is associated with a higher risk of nodal involve... more Abstract Introduction: Multifocal breast cancer is associated with a higher risk of nodal involvement compared to unifocal breast cancer and the drainage pattern from multifocal localisations may be different. For this reason, the value of the sentinel node biopsy (SNB) procedure for this indication is debated. The aim of the current analysis was to evaluate the sentinel node identification rate and nodal involvement in patients with a multifocal tumour in the EORTC 10981-22023 AMAROS trial.
European Journal of Cancer, 2007
Heath-related quality of life Risk perception Disease impact Well-being A B S T R A C T We compar... more Heath-related quality of life Risk perception Disease impact Well-being A B S T R A C T We compared the health-related quality of life, impact of the disease, risk perception of recurrence and dying of breast cancer, and understanding of diagnosis of patients with ductal carcinoma in situ (DCIS) and invasive breast cancer 2-3 years after treatment. We included all women (N = 211) diagnosed with DCIS or invasive breast cancer TNM stage I (T1, N0, and M0) in three community hospitals in the southern part of The Netherlands in the period 2002-2003. After verifying the medical files, 180 disease free patients proved eligible for study entry, 47 of whom had DCIS and 133 stage I invasive breast cancer.
Endocrine Related Cancer, 2013
The incidence of thyroid cancer (TC) is increasing worldwide, partly due to increased detection. ... more The incidence of thyroid cancer (TC) is increasing worldwide, partly due to increased detection. We therefore assessed combined trends in incidence, survival and mortality of the various types of TC in The Netherlands between 1989 and 2009. We included all patients R15 years with TC, diagnosed in the period 1989-2009 and recorded in The Netherlands Cancer Registry (nZ8021). Information on age, gender, date of diagnosis, histological type of tumour and tumour-node-metastasis classification was recorded. Mortality data (up to 1st January 2010) were derived from Statistics Netherlands. Annual percentages of change in incidence, mortality and relative survival were calculated. Since 1989 the incidence of TC increased significantly in The Netherlands (estimated annual percentage change (EAPC)ZC1.7%). The incidence rates increased for all age groups (except for females O60 years), papillary tumours (EAPCZC3.5%), T1 and T3 TC (EAPCZC7.9 and C5.8% respectively). Incidence rates decreased for T4 TC (K2.3%) and remained stable for follicular, medullary anaplastic and T2 TC. Five-year relative survival rates remained stable for papillary (88%) and follicular (77%) TC, all age groups and T1-T3 TC (96, 94 and 80% respectively) and somewhat lower for T4 (53%), medullary (65%) and anaplastic TC (5%) in the 2004-2009 period compared with earlier periods. Mortality due to TC decreased (EAPCZK1.9%). TC detection and incidence has been rising in The Netherlands, while mortality rates are decreasing and survival rates remained stable or slightly decreasing.
Cancer Causes & Control, 2008
Much progress has been made in the early diagnosis and treatment of breast cancer. We have assess... more Much progress has been made in the early diagnosis and treatment of breast cancer. We have assessed the changing burden of this disease, by means of a comprehensive description of trends in incidence, survival, and mortality. Data on breast cancer patients diagnosed between 1975 and 2004 (n = 26,464) registered in the population-based Eindhoven Cancer Registry were investigated. Incidence for patients aged below 40 and 40-49 has increased by 2.1% and 2.4% annually, since 1995 (p = 0.08 and p = 0.001, respectively). Mortality decreased in all age groups, but most markedly among women aged 50-69 (-1.5% yearly since 1985, p = 0.14). The proportion of stage I tumors increased from 25% to 39%, that of advanced stages (III & IV) decreased from 30% (1975-1984) to 13% in 1995-2004, and the proportion of in situ tumors increased from 1.5% to 10%. Adjuvant systemic treatment was administered to 15% of patients in 1975-1984 vs. 49% in 1995-2004. Relative 10-year survival rates for women aged 50-69 (period analysis) increased from 53% to 75% between 1975 and 2004. The best prognosis was observed for women aged 45-54. Women younger than 35 had a particularly poor prognosis. The observed improvement in survival of breast cancer patients during the last three decades is impressive. The peak in breast cancer incidence is not yet in sight considering the recent trends in exposure to known risk factors and improved diagnosis. The combination of increasing incidence and improved survival rates implies that the number of prevalent cases will continue to increase considerably in the next 10 years.
Cancer, 2007
BACKGROUND. The objectives of this study were to study the probability of local control after bre... more BACKGROUND. The objectives of this study were to study the probability of local control after breast-conserving therapy (BCT) in a large population of patients with early-stage breast cancer aged 40 years and to determine which factors had prognostic value. METHODS. All patients (n ¼ 758) aged 40 years with clinical stage I or II breast cancer who underwent BCT in general hospitals in the southern part of the Netherlands between 1988 and 2002 were selected for the current analysis. BCT included local excision of the tumor followed by irradiation of the breast. Of 758 patients, 329 patients (43%) received adjuvant systemic treatment, and 36 patients (5%) underwent a microscopically incomplete excision. The median follow-up was 8.5 years.
Breast Cancer Research and Treatment, 2011
Sentinel node biopsy (SNB) for axillary staging in breast cancer allows the application of more e... more Sentinel node biopsy (SNB) for axillary staging in breast cancer allows the application of more extensive pathologic examination techniques. Micrometastases are being detected more often, however, coinciding with stage migration. Besides assessing the prognostic relevance of micrometastases and the need for administering adjuvant systemic and regional therapies, there still seems to be room for improvement. In a population-based analysis, we compared survival of patients with sentinel node micrometastases with those with node-negative and node-positive disease in the era after introduction of SNB. Data from the population-based Eindhoven Cancer Registry were used on all (n = 6803) women who underwent SNB for invasive breast cancer in the Southeast Region of The Netherlands in the period 1996-2006. In 451 patients (6.6%) a sentinel node micrometastasis (pN1mi) was detected and in 126 patients (1.9%) isolated tumor cells (pN0(i?)). Micrometastases or isolated tumor cells in the SNB did not convey any significant survival difference compared with nodenegative disease. After adjustment for age, pT, and grade, still no survival difference emerged pN1mi: [HR 0.9 (95% CI, 0.6-1.3)] and pN0(i?): [HR 0.4 (95% CI, 0.14-1.3)] and neither was the case after additional adjustment for adjuvant systemic therapy. Our practice-based study showed that the presence of sentinel node micrometastases in breast cancer patients has hardly any impact on breast cancer overall survival during the first years after diagnosis.
BMC Medical Physics, 2008
Background: Surgical resection is the preferred treatment of potentially curable esophageal cance... more Background: Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer.
Annals of surgical oncology, Jan 6, 2015
Severe morbidity after cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemo... more Severe morbidity after cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC) is, besides the obvious short-term consequences, associated with impaired long-term outcomes. The risk factors for severe morbidity in patients with peritoneal carcinomatosis (PC) of colorectal origin are poorly defined. This study aimed to identify risk factors for severe morbidity after CRS + HIPEC in patients with colorectal PC. Patients with colorectal PC who underwent CRS + HIPEC between 2007 and 2015 were categorized and compared between those with and those without severe morbidity. Risk factors were identified using logistic regression analysis. Morbidity was graded according to the Clavien-Dindo classification, with grade 3 or higher indicating severe morbidity. This study included 211 patients, of whom 53 patients (25.1 %) experienced morbidity of grade 3 or higher. The identified risk factors for severe morbidity were extensive prior surgery [odds ratio (OR) 4....
European Journal of Cancer, 2014
Neoadjuvant hormonal therapy (NHT) is playing an increasing role in the clinical management of br... more Neoadjuvant hormonal therapy (NHT) is playing an increasing role in the clinical management of breast cancer (BC) and may improve surgical outcomes for postmenopausal, oestrogen receptor (ER)-positive BC patients. However, there is currently no consensus on the optimal duration of NHT before surgery. Here, we present the outcomes of the TEAM IIA trial, a multicentre, phase II trial investigating the efficacy of six months of neoadjuvant exemestane in postmenopausal, strong ER-positive (ER+, ⩾50%) BC patients. 102 patients (stage T2-T4ac) were included in the study after exclusion of ineligible patients. Primary end-point was clinical response at 3 and 6 months as measured by palpation. Secondary end-point was radiological response as measured by magnetic resonance imaging (MRI), mammography and/or ultrasound. Linear mixed models (95% confidence interval (CI)) were used to compare changes in mean tumour size (in mm) between baseline, 3 and 6 months after the start of endocrine therapy. Conversion rates from mastectomy to breast conserving surgery (BCS) were evaluated. Median age of all patients was 72 years (range 53-88). Overall response rate by clinical palpation was 64.5% in all patients with a final palpation measurement. Four patients had clinically progressive disease. 63 patients had both 3-month and >3-month palpation measurements. Overall response was 58.7% at 3 months and 68.3% at final palpation (>3 months). Mean tumour size by clinical palpation at T=0 was 39.1mm (95% CI 34.8-43.4mm), and decreased to 23.0mm (95% CI 18.7-27.2mm) and 16.7 mm (95% CI 12.6-20.8) at T=3 and T>3 months, respectively (p=0.001). Final radiological response rates at the end of treatment for MRI (n=37), ultrasound (n=77) and mammography (n=56) were 70.3%, 41.6% and 48.2%, respectively. Feasibility of BCS improved from 61.8% to 70.6% (McNemar p=0.012). 6 months of neoadjuvant exemestane therapy helps reduce mean tumour size further in strongly ER-positive BC patients without significant side-effects compared to 3 months. Nevertheless, some patients still experience disease progression under exemestane. Feasibility of breast conservation rates improved by almost 10%.
Clinical nutrition (Edinburgh, Scotland), 2015
Early enteral feeding following surgery can be given orally, via a jejunostomy or via a nasojejun... more Early enteral feeding following surgery can be given orally, via a jejunostomy or via a nasojejunal tube. However, the best feeding route following esophagectomy is unclear. To determine the best route for enteral nutrition following esophagectomy regarding anastomotic leakage, pneumonia, percentage meeting the nutritional requirements, weight loss, complications of tube feeding, mortality, patient satisfaction and length of hospital stay. A systematic literature review following PRISMA and MOOSE guidelines. There were 17 eligible studies on early oral intake, jejunostomy or nasojejunal tube feeding. Only one nonrandomized study (N = 133) investigated early oral feeding specifically following esophagectomy. Early oral feeding was associated with a reduced length of stay with delayed oral feeding, without increased complication rates. Postoperative nasojejunal tube feeding was not significantly different from jejunostomy tube feeding regarding complications or catheter efficacy in th...
BMJ open, 2014
The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist th... more The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy. This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered. Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the st...
The Netherlands journal of medicine, 2013
The standardised mortality ratio (SMR) for rectal or anal cancer was above average in a large ter... more The standardised mortality ratio (SMR) for rectal or anal cancer was above average in a large tertiary referral centre for locally advanced rectal cancer in the Netherlands. The aim of this study was to investigate whether the increased SMR was indeed related to poor quality of care or whether it could be explained by inadequate adjustment for case-mix factors. Between 2006 and 2008, 381 patients were admitted for rectal or anal cancer. The SMR score of this diagnostic group was 230 (95% CI 140 to 355), corresponding with 20 in-hospital deaths. The hospital dataset was merged with data from the Eindhoven Cancer Registry to obtain more detailed information. Patients admitted for palliative care only accounted for 45% (9/20) of the in-hospital mortality. In contrast to the high SMR, postoperative mortality was low, i.e. 2.6%. The majority of the rectal or anal cancer patients were diagnosed in and referred from another hospital. Referred patients more often had an advanced tumour stag...
The Annals of Thoracic Surgery, 2015
Supportive Care in Cancer, 2014
This study examined the individual and combined effect of having colorectal cancer (CRC) and diab... more This study examined the individual and combined effect of having colorectal cancer (CRC) and diabetes mellitus (DM) on health-related quality of life (HRQoL) and sexual functioning. Data from questionnaires collected in 2010 among CRC patients and a sample of the general Dutch population were used. All persons older than 60 years were included in this study. DM prevalence among the CRC sample as well as the sample of the general population was self-reported. HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire version 3.0 (QLQ-C30), and sexual functioning was assessed with four scales from the EORTC-QLQ-CR38. In total 624 persons without CRC and DM, 78 persons with DM only, 1,731 with CRC only, and 328 with both CRC and DM were included. Having both CRC and DM did not result in lower HRQoL and sexual functioning than the sum of the individual effects of both diseases. CRC, irrespective of having DM, was associated with lower scores on most EORTC-QLQ-C30 subscales, except global health, pain, and appetite loss. CRC was also independently associated with more erection problems among males. DM, irrespective of having CRC, was associated with lower physical functioning and more symptoms of dyspnea. Having both CRC and DM did not result in lower HRQoL and sexual functioning than the sum of the individual effects of both diseases. As CRC was found to be consistently associated with lower functioning and more symptoms, CRC and its treatment seem to contribute stronger to lower HRQoL and sexual functioning compared with DM.
Clinical Breast Cancer, 2014
Between 20% and 42% of patients with clinically node-positive breast cancer achieve a pathologic ... more Between 20% and 42% of patients with clinically node-positive breast cancer achieve a pathologic complete response (pCR) of axillary lymph nodes after neoadjuvant chemotherapy or immunotherapy, or both, (chemo[immuno]therapy). Hypothetically, axillary lymph node dissection (ALND) may be safely omitted in these patients. This study aimed to develop a model for predicting axillary pCR in these patients. We retrospectively identified patients with clinically node-positive breast cancer who were treated with neoadjuvant chemo(immuno)therapy and ALND between 2005 and 2012 in 5 hospitals. Patient and tumor characteristics, neoadjuvant chemo(immuno)therapy regimens, and pathology reports were extracted. Binary logistic regression analysis was used to predict axillary pCR with the following variables: age, tumor stage and type, hormone receptor and human epidermal growth factor receptor 2 (HER2) status, and administration of taxane and trastuzumab. The model was internally validated by bootstrap resampling. The overall performance of the model was assessed by the Brier score and the discriminative performance by receiver operating characteristic (ROC) curve analysis. A model was developed based on 291 patients and was internally validated with a scaled Brier score of 0.14. The area under the ROC curve of this model was 0.77 (95% confidence interval [CI], 0.71-0.82). At a cutoff value of predicted probability ≥ 0.50, the model demonstrated specificity of 88%, sensitivity of 43%, positive predictive value (PPV) of 65%, and negative predictive value (NPV) of 75%. This prediction model shows reasonable accuracy for predicting axillary pCR. However, omitting axillary treatment based solely on the nomogram score is not justified. Further research is warranted to noninvasively identify patients with axillary pCR.
The Lancet Oncology, 2014
Background If treatment of the axilla is indicated in patients with breast cancer who have a posi... more Background If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-eff ects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-eff ects.
Trials, Jan 27, 2015
BackgroundPostoperative ileus and anastomotic leakage are important complications following color... more BackgroundPostoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage.Methods/DesignThis multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to t...
The Breast, 2012
Background: After introduction of sentinel node biopsy (SNB) in patients with breast cancer a hig... more Background: After introduction of sentinel node biopsy (SNB) in patients with breast cancer a higher proportion of micrometastases and isolated tumor cells are being detected. Prognostic impact and clinical relevance of this minimal nodal involvement is under debate and substantial variation in the use of axillary surgery and/or systemic adjuvant treatment could be expected. Methods: Data from the population-based Eindhoven Cancer Registry were used on all (n ¼ 9038) women who underwent SNB for invasive breast cancer from 1996 to 2008 and medical files were studied to determine the role of minimal nodal involvement in the decision to use adjuvant systemic treatment. Results: Forty-five percent of 172 patients with isolated tumor cells and 76% of 605 patients with micrometastases received adjuvant systemic treatment. Thirty-five of 59 patients with isolated tumor cells and 153 of 193 patients with micrometastases received systemic therapy based on primary tumor characteristics. The remainder probably received adjuvant therapy based on presence of minimal nodal involvement. Thirty-seven percent of the patients with isolated tumor cells underwent an axillary lymph node dissection compared to 75% when micrometastases were present. Multivariate analyses showed a significantly higher chance of receiving systemic treatment when isolated tumor cells (OR 1.5 (95% CI, 1.05e2.15)) or micrometastases (OR 10.7 (95% CI, 8.56e13.27)) were present, compared to a negative lymph node status. Conclusion: The debate on necessity of performing completion ALND and administration of systemic therapy in patients with minimal nodal involvement is reflected by the treatment patterns observed in our population-based study. Synopsis: Describing time-trends and predictors of axillary and systemic treatment of patients with breast cancer and micrometastases or isolated tumor cells in their sentinel lymph node(s). The Breast xxx (2012) 1e5 Please cite this article in press as: Maaskant-Braat AJ, et al., Axillary and systemic treatment of patients with breast cancer and micrometastatic disease or isolated tumor cells in the sentinel lymph node, The Breast (2012),
Trials, 2012
Background: Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients c... more Background: Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design: The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion: The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients.
European Journal of Surgical Oncology (EJSO), 2003
Aims: The use of axillary lymph node dissection (ALND) in women with breast cancer is associated ... more Aims: The use of axillary lymph node dissection (ALND) in women with breast cancer is associated with considerable morbidity. Sentinel node biopsy (SNB) removes the lymph node in the axillary basin indicative for receiving first lymphatic drainage from the breast. This study compares the nature and severity of physical morbidity among breast cancer patients who underwent primary surgery for breast cancer combined with either ALND or SNB. Also, it assesses influence of subsequent radiotherapy on morbidity. Method: Two hundred and thirteen ALND patients were compared with 180 SNB patients retrospectively. Morbidity was measured using a disease-specific quality-of-life questionnaire. Results: Patients' demographic characteristics were alike. The axillary procedure is the strongest and most consistent factor in explaining differences in a variety of self-reported complaints. Patients having had SNB have a 3.2-fold lower risk of experiencing pain, a 5-fold lower risk of lymph oedema, a 7.7-fold lower risk of numbness, a 3.7-fold lower risk of tingling sensations, a 7.1-fold lower risk of loss of strength in arm/hand, a 3.6-fold lower risk of loss of active motion range of the arm and a 2.9-fold lower risk of impaired use of the arm. Axillary radiation therapy adds to complaints next to the axillary surgical procedure by increasing the risk of lymph oedema 2.4-fold and enhancing the risk of impaired use of the arm by 2.6-fold. Axillary radiation therapy does not explain lymph oedema by itself. Conclusion: SNB is associated with less morbidity compared to ALND in patients with primary breast cancer.
European Journal of Cancer, 2013
Abstract Introduction: Multifocal breast cancer is associated with a higher risk of nodal involve... more Abstract Introduction: Multifocal breast cancer is associated with a higher risk of nodal involvement compared to unifocal breast cancer and the drainage pattern from multifocal localisations may be different. For this reason, the value of the sentinel node biopsy (SNB) procedure for this indication is debated. The aim of the current analysis was to evaluate the sentinel node identification rate and nodal involvement in patients with a multifocal tumour in the EORTC 10981-22023 AMAROS trial.
European Journal of Cancer, 2007
Heath-related quality of life Risk perception Disease impact Well-being A B S T R A C T We compar... more Heath-related quality of life Risk perception Disease impact Well-being A B S T R A C T We compared the health-related quality of life, impact of the disease, risk perception of recurrence and dying of breast cancer, and understanding of diagnosis of patients with ductal carcinoma in situ (DCIS) and invasive breast cancer 2-3 years after treatment. We included all women (N = 211) diagnosed with DCIS or invasive breast cancer TNM stage I (T1, N0, and M0) in three community hospitals in the southern part of The Netherlands in the period 2002-2003. After verifying the medical files, 180 disease free patients proved eligible for study entry, 47 of whom had DCIS and 133 stage I invasive breast cancer.
Endocrine Related Cancer, 2013
The incidence of thyroid cancer (TC) is increasing worldwide, partly due to increased detection. ... more The incidence of thyroid cancer (TC) is increasing worldwide, partly due to increased detection. We therefore assessed combined trends in incidence, survival and mortality of the various types of TC in The Netherlands between 1989 and 2009. We included all patients R15 years with TC, diagnosed in the period 1989-2009 and recorded in The Netherlands Cancer Registry (nZ8021). Information on age, gender, date of diagnosis, histological type of tumour and tumour-node-metastasis classification was recorded. Mortality data (up to 1st January 2010) were derived from Statistics Netherlands. Annual percentages of change in incidence, mortality and relative survival were calculated. Since 1989 the incidence of TC increased significantly in The Netherlands (estimated annual percentage change (EAPC)ZC1.7%). The incidence rates increased for all age groups (except for females O60 years), papillary tumours (EAPCZC3.5%), T1 and T3 TC (EAPCZC7.9 and C5.8% respectively). Incidence rates decreased for T4 TC (K2.3%) and remained stable for follicular, medullary anaplastic and T2 TC. Five-year relative survival rates remained stable for papillary (88%) and follicular (77%) TC, all age groups and T1-T3 TC (96, 94 and 80% respectively) and somewhat lower for T4 (53%), medullary (65%) and anaplastic TC (5%) in the 2004-2009 period compared with earlier periods. Mortality due to TC decreased (EAPCZK1.9%). TC detection and incidence has been rising in The Netherlands, while mortality rates are decreasing and survival rates remained stable or slightly decreasing.
Cancer Causes & Control, 2008
Much progress has been made in the early diagnosis and treatment of breast cancer. We have assess... more Much progress has been made in the early diagnosis and treatment of breast cancer. We have assessed the changing burden of this disease, by means of a comprehensive description of trends in incidence, survival, and mortality. Data on breast cancer patients diagnosed between 1975 and 2004 (n = 26,464) registered in the population-based Eindhoven Cancer Registry were investigated. Incidence for patients aged below 40 and 40-49 has increased by 2.1% and 2.4% annually, since 1995 (p = 0.08 and p = 0.001, respectively). Mortality decreased in all age groups, but most markedly among women aged 50-69 (-1.5% yearly since 1985, p = 0.14). The proportion of stage I tumors increased from 25% to 39%, that of advanced stages (III & IV) decreased from 30% (1975-1984) to 13% in 1995-2004, and the proportion of in situ tumors increased from 1.5% to 10%. Adjuvant systemic treatment was administered to 15% of patients in 1975-1984 vs. 49% in 1995-2004. Relative 10-year survival rates for women aged 50-69 (period analysis) increased from 53% to 75% between 1975 and 2004. The best prognosis was observed for women aged 45-54. Women younger than 35 had a particularly poor prognosis. The observed improvement in survival of breast cancer patients during the last three decades is impressive. The peak in breast cancer incidence is not yet in sight considering the recent trends in exposure to known risk factors and improved diagnosis. The combination of increasing incidence and improved survival rates implies that the number of prevalent cases will continue to increase considerably in the next 10 years.
Cancer, 2007
BACKGROUND. The objectives of this study were to study the probability of local control after bre... more BACKGROUND. The objectives of this study were to study the probability of local control after breast-conserving therapy (BCT) in a large population of patients with early-stage breast cancer aged 40 years and to determine which factors had prognostic value. METHODS. All patients (n ¼ 758) aged 40 years with clinical stage I or II breast cancer who underwent BCT in general hospitals in the southern part of the Netherlands between 1988 and 2002 were selected for the current analysis. BCT included local excision of the tumor followed by irradiation of the breast. Of 758 patients, 329 patients (43%) received adjuvant systemic treatment, and 36 patients (5%) underwent a microscopically incomplete excision. The median follow-up was 8.5 years.
Breast Cancer Research and Treatment, 2011
Sentinel node biopsy (SNB) for axillary staging in breast cancer allows the application of more e... more Sentinel node biopsy (SNB) for axillary staging in breast cancer allows the application of more extensive pathologic examination techniques. Micrometastases are being detected more often, however, coinciding with stage migration. Besides assessing the prognostic relevance of micrometastases and the need for administering adjuvant systemic and regional therapies, there still seems to be room for improvement. In a population-based analysis, we compared survival of patients with sentinel node micrometastases with those with node-negative and node-positive disease in the era after introduction of SNB. Data from the population-based Eindhoven Cancer Registry were used on all (n = 6803) women who underwent SNB for invasive breast cancer in the Southeast Region of The Netherlands in the period 1996-2006. In 451 patients (6.6%) a sentinel node micrometastasis (pN1mi) was detected and in 126 patients (1.9%) isolated tumor cells (pN0(i?)). Micrometastases or isolated tumor cells in the SNB did not convey any significant survival difference compared with nodenegative disease. After adjustment for age, pT, and grade, still no survival difference emerged pN1mi: [HR 0.9 (95% CI, 0.6-1.3)] and pN0(i?): [HR 0.4 (95% CI, 0.14-1.3)] and neither was the case after additional adjustment for adjuvant systemic therapy. Our practice-based study showed that the presence of sentinel node micrometastases in breast cancer patients has hardly any impact on breast cancer overall survival during the first years after diagnosis.
BMC Medical Physics, 2008
Background: Surgical resection is the preferred treatment of potentially curable esophageal cance... more Background: Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer.