Cornelis J H van de Velde

Publications (195)1156.39 Total impact

• Article: Intraoperative Near-Infrared Fluorescence Imaging of Parathyroid Adenomas using Low-Dose Methylene Blue.

  Joost R van der Vorst, Boudewijn E Schaafsma, Floris P R Verbeek, Rutger-Jan Swijnenburg, Quirijn Tummers, Merlijn Hutteman, Jaap F Hamming, J Kievit, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer
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  ABSTRACT: Background: Intraoperative identification of parathyroid adenomas can be challenging. We hypothesized that low-doses methylene blue (MB) and near-infrared fluorescence (NIRF) imaging could be used to identify parathyroid adenomas intraoperatively. Methods: MB was injected intravenously after exploration at a dose of 0.5 mg/kg into 12 patients who underwent parathyroid surgery. NIRF imaging was performed using the Mini-FLARE™ imaging system. Results: In 10 of 12 patients, histology confirmed a parathyroid adenoma. In 9 of these patients, NIRF could clearly identify the parathyroid adenoma during surgery. Seven of these 9 patients had a positive preoperative (99m) Tc-sestamibi SPECT scan. Importantly, in two patients, parathyroid adenomas could be identified only using NIRF. Conclusion: This is the first study to show that low-dose MB can be used as NIRF tracer for identification of parathyroid adenomas, and suggests a correlation with preoperative (99m) Tc-sestamibi SPECT scanning. © 2013 Wiley Periodicals, Inc. Head Neck, 2013.
  Head & Neck 05/2013; · 2.40 Impact Factor
• Article: Specific Adverse Events Predict Survival Benefit in Patients Treated With Tamoxifen or Aromatase Inhibitors: An International Tamoxifen Exemestane Adjuvant Multinational Trial Analysis.

  Duveken B Y Fontein, Caroline Seynaeve, Peyman Hadji, Elysée T M Hille, Willemien van de Water, Hein Putter, Elma Meershoek-Klein Kranenbarg, Annette Hasenburg, Robert J Paridaens, Jean-Michel Vannetzel, Christos Markopoulos, Yasuo Hozumi, John M S Bartlett, Stephen E Jones, Daniel William Rea, Johan W R Nortier, Cornelis J H van de Velde
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  ABSTRACT: PURPOSESpecific adverse events (AEs) associated with endocrine therapy and related to depletion or blocking of circulating estrogens may be related to treatment efficacy. We investigated the relationship between survival outcomes and specific AEs including vasomotor symptoms (VMSs), musculoskeletal adverse events (MSAEs), and vulvovaginal symptoms (VVSs) in postmenopausal patients with breast cancer participating in the international Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. PATIENTS AND METHODS Primary efficacy end points were disease-free survival (DFS), overall survival (OS), and distant metastases (DM). VMSs, MSAEs, and VVSs arising in the first year of endocrine treatment were considered. Patients who did not start or who discontinued their allocated therapy and/or had an event (recurrence/death) within 1 year after randomization were excluded. Landmark analyses and time-dependent multivariate Cox proportional hazards models assessed survival differences up to 5 years from the start of treatment. RESULTS: VMSs, 0.731 [95% CI, 0.618 to 0.866]; MSAEs, 0.826 [95% CI, 0.694 to 0.982]; VVSs, 0.769 [95% CI, 0.585 to 1.01]; multivariate HR for OS: VMSs, 0.583 [95% CI, 0.424 to 0.803]; MSAEs, 0.811 [95% CI, 0.654 to 1.005]; VVSs, 0.570 [95% CI, 0.391 to 0.831]) and fewer DM (VMSs, 0.813 [95% CI, 0.664 to 0.996]; MSAEs, 0.749 [95% CI, 0.601 to 0.934]; VVSs, 0.687 [95% CI, 0.436 to 1.085]) than patients not reporting these symptoms. Increasing numbers of specific AEs were also associated with better survival outcomes. Outcomes were unrelated to treatment allocation. CONCLUSION Certain specific AEs are associated with superior survival outcomes and may therefore be useful in predicting treatment responses in patients with breast cancer treated with endocrine therapy.
  Journal of Clinical Oncology 04/2013; · 18.37 Impact Factor
• Article: Timing of the sentinel lymph node biopsy in breast cancer patients receiving neoadjuvant therapy - Recommendations for clinical guidance.

  Duveken B Y Fontein, Willemien van de Water, J Sven D Mieog, Gerrit-Jan Liefers, Cornelis J H van de Velde
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  ABSTRACT: Neoadjuvant chemotherapy (NAC) is an increasingly important component in the treatment of both locally advanced and early-stage breast cancer. With this, a debate on the timing of the sentinel lymph node biopsy (SLNB) has emerged. At the end of the last century, the SLNB was introduced as an axillary staging modality, and this paper aims to further elucidate this issue in the context of NAC. We compiled available data on the SLNB after NAC and provide clinical guidance for timing the SLNB in this context. On the basis of our findings, we recommend that the SLNB can be performed after NAC in all cases. In patients with a clinically node-negative (cN0) status prior to NAC, the SLNB should be performed after NAC, and in case of a histologically confirmed negative SLNB, a completion axillary lymph node dissection (ALND) has no added value and can be omitted. In patients with clinically positive nodal involvement (cN+) prior to NAC, all axillary surgery can also be performed after NAC.
  European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 03/2013; · 2.56 Impact Factor
• Article: Intraoperative Near-Infrared Fluorescence-Guided Identification of the Ureters using Low-Dose Methylene Blue: A First-in-Human Experience.

  Floris P R Verbeek, Joost R van der Vorst, Boudewijn E Schaafsma, Rutger-Jan Swijnenburg, Katja N Gaarenstroom, Henk W Elzevier, Cornelis J H van de Velde, John V Frangioni, Alexander L Vahrmeijer
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  ABSTRACT: PURPOSE: Near-infrared (NIR) fluorescence imaging is a promising technique that offers, real-time, visual information during surgery. The current study reports the first clinical results of ureter imaging using NIR fluorescence after a simple peripheral infusion of methylene blue (MB). Furthermore, optimal timing and dose of MB were assessed. MATERIALS AND METHODS: A total of 12 patients that underwent lower abdominal surgery were included in this prospective feasibility study. NIR fluorescence imaging was performed using the Mini-FLARE™ imaging system. To determine optimal timing and dose, MB was injected intravenously at doses of 0.25, 0.5 or 1 mg/kg, after exposure of the ureters. Subsequently imaging was performed for up to 60 min following injection. RESULTS: In all patients both ureters could be clearly visualized within 10 minutes after infusion of MB. Signal lasted at least up to 60 minutes after injection. The mean signal-to-background ratio (SBR) of the ureter was 2.27 ± 1.22 (N = 4), 2.61 ± 1.88 (N = 4) and 3.58 ± 3.36 (N = 4) for the 0.25, 0.5 and 1 mg/kg groups, respectively. A mixed model analysis was used to compare SBRs between dose groups and time points and to assess the relation between dose and time. A significant difference between time points (P < 0.001) was found. However no difference between dose groups was observed (P = 0.811). CONCLUSIONS: This study demonstrates the first successful use of NIR fluorescence using low-dose MB for the identification of the ureters during lower abdominal surgery.
  The Journal of urology 03/2013; · 4.02 Impact Factor
• Article: Ex vivo sentinel node mapping in colon cancer combining blue dye staining and fluorescence imaging.

  Boudewijn E Schaafsma, Floris P R Verbeek, Joost R van der Vorst, Merlijn Hutteman, Peter J K Kuppen, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer
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  ABSTRACT: BACKGROUND: The sentinel lymph node procedure has been proposed to improve nodal staging in colon cancer patients. The aim of this study was to assess the added value of near-infrared (NIR) fluorescence imaging to conventional blue dye staining for ex vivo sentinel lymph node mapping. MATERIALS AND METHODS: We included 22 consecutive patients undergoing surgery for colon cancer. After tumor resection, we submucosally injected a premixed cocktail of the near-infrared lymphatic tracer HSA800 and blue dye around the tumor for detection of sentinel lymph nodes. We used the Mini-FLARE imaging system for fluorescence imaging. RESULTS: In 95% of patients, we identified at least one sentinel lymph node. Overall, a total of 77 sentinel lymph nodes were identified, 77 of which were fluorescent (100%) and 70 of which were blue (91%). Sentinel lymph nodes that were located deeper in the mesenteric fat could easily be located by NIR fluorescence. In four of five patients with lymph node metastases, tumor cells were present in at least one of the sentinel lymph nodes. CONCLUSIONS: This study shows the successful use and added value of the NIR fluorescence tracer HSA800 to conventional blue dye for the ex vivo sentinel lymph node procedure in colon cancer.
  Journal of Surgical Research 01/2013; · 2.25 Impact Factor
• Article: Elderly Postmenopausal Patients With Breast Cancer Are at Increased Risk for Distant Recurrence: A Tamoxifen Exemestane Adjuvant Multinational Study Analysis.

  Willemien van de Water, Caroline Seynaeve, Esther Bastiaannet, Christos Markopoulos, Steve E Jones, Daniel Rea, Annette Hasenburg, Hein Putter, Elysee T M Hille, Robert Paridaens, Anton J M de Craen, Rudi G J Westendorp, Cornelis J H van de Velde, Gerrit-Jan Liefers
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  ABSTRACT: Introduction. For postmenopausal patients with hormone-sensitive breast cancer, outcome is worse with increasing age at diagnosis. The aim of this study was to assess the incidence of breast cancer recurrence (locoregional and distant), and contralateral breast cancer by age at diagnosis.Methods. Patients enrolled in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial were included. Primary endpoints were locoregional recurrence, distant recurrence, and contralateral breast cancer. Age at diagnosis was categorized as younger than 65 years, 65-74 years, and 75 years or older.Results. Overall, 9,766 patients were included, of which 5,349 were younger than 65 years (reference group), 3,060 were 65-74 years, and 1,357 were 75 years or older. With increasing age, a decreased administration of radiotherapy after breast conserving surgery (94%, 92%, and 88%, respectively) and adjuvant chemotherapy (51%, 23%, and 5%, respectively) was observed. Risk of distant recurrence increased with age at diagnosis; multivariable hazard ratio for patients aged 65-74 years was 1.20 (95% confidence interval [CI]: 1.00-1.44), hazard ratio for patients aged 75 years or older was 1.39 (95% CI: 1.08-1.79). Risks of locoregional recurrence and contralateral breast cancer were not significantly different across age groups.Conclusion. Elderly patients with breast cancer were at increased risk for distant recurrence. Other studies have shown that the risk of distant recurrence is mainly affected by adjuvant systemic therapy. All TEAM patients received adjuvant endocrine treatment; however, chemotherapy was administered less often in elderly patients. These findings are suggestive for consideration of chemotherapy in relatively fit elderly breast cancer patients with hormone-sensitive disease.
  The Oncologist 12/2012; · 3.91 Impact Factor
• Article: Aspirin Use After Diagnosis Improves Survival in Older Adults with Colon Cancer: A Retrospective Cohort Study.

  Marlies S Reimers, Esther Bastiaannet, Myrthe P P van Herk-Sukel, Valery E P Lemmens, Colette B M van den Broek, Cornelis J H van de Velde, Anton J M de Craen, Gerrit Jan Liefers
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  ABSTRACT: OBJECTIVES: To assess survival in relation to aspirin use after diagnosis in older adults with colon cancer. DESIGN: Subgroup analysis of a previously published cohort and retrospective study. SETTING: Individuals registered in the Eindhoven Cancer Registry (ECR) between 1998 and 2007, linked to prescriptions of low-dose aspirin (80 mg) registered in a community pharmacy database. PARTICIPANTS: Five hundred thirty-six individuals aged 70 and older diagnosed with colon cancer with or without aspirin use after diagnosis. MEASUREMENTS: Survival was analyzed with user status as a time-dependent covariate. Multivariate Poisson regression survival models were used to study the effect of aspirin on overall survival. RESULTS: One hundred seven participants (20.0%) started aspirin after being diagnosed with colon cancer; 429 (80.0%) were not prescribed aspirin. Three hundred thirty-nine participants (63.2%) had died by the end of follow-up. Aspirin use after diagnosis was associated with longer overall survival (rate ratio (RR) = 0.51, 95% confidence interval (CI) = 0.38-0.70, P < .001). Multivariate proportional hazards regression analysis revealed that aspirin use was associated with longer overall survival (adjusted RR = 0.59, 95% CI = 0.44-0.81, P = .001). CONCLUSION: Aspirin use after the diagnosis of colon cancer in older adults was associated with longer survival. Low-dose aspirin could be used as an effective adjuvant therapy in older adults with colon cancer.
  Journal of the American Geriatrics Society 11/2012; · 3.74 Impact Factor
• Article: Time trends in chemotherapy (administration and costs) and relative survival in stage III colon cancer patients - a large population-based study from 1990 to 2008.

  Colette B M van den Broek, Esther Bastiaannet, Jan Willem T Dekker, Johanneke E A Portielje, Anton J M de Craen, Marloes A G Elferink, Cornelis J H van de Velde, Gerrit-Jan Liefers, Ellen Kapiteijn
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  ABSTRACT: Background. Use of adjuvant chemotherapy for stage III colon cancer has increased since several trials have shown the beneficial effect on survival. In this population-based study we show time trends in the administration and costs of chemotherapy and relative survival of patients with stage III colon cancer. Methods. All patients surgically treated for adenocarcinoma of the colon stage III between 1990 and 2008 in The Netherlands were included. Relative survival (using period analyses) and Relative Excess Risks of death (RER) were calculated. The costs of chemotherapy were estimated. Results. A total of 24 111 colon cancer patients with stage III were included in the cohort. The administration (from 9.5% in 1990 to 61.8% in 2008; p < 0.001) and costs of chemotherapy (from €38 467 in 1990 to €3 876 150 in 2008) increased during the study period. Multivariable relative survival improved for patients receiving adjuvant chemotherapy (RER 0.93; 95% CI 0.92-0.94; p < 0.001). In contrast, relative survival remained stable for patients, younger than 80 years, who did not receive chemotherapy (RER 1.00; 95% CI 1.00-1.01; p = 0.3). Patients aged 80 years and older without chemotherapy, relative survival increased during the study period (RER 0.98; 95% CI 0.97-0.99; p < 0.001). Conclusions. The administration, the costs of chemotherapy and the survival of patients with stage III colon cancer increased over time. Whereas the costs and administration of chemotherapy increased extensively, relative survival increased to a lesser extent. For patients treated with adjuvant chemotherapy relative survival increased equally in all age groups.
  Acta oncologica (Stockholm, Sweden) 11/2012; · 2.27 Impact Factor
• Article: Conditional Probability of Survival Nomogram for 1-, 2-, and 3-Year Survivors After an R0 Resection for Gastric Cancer.

  Johan L Dikken, Raymond E Baser, Mithat Gonen, Michael W Kattan, Manish A Shah, Marcel Verheij, Cornelis J H van de Velde, Murray F Brennan, Daniel G Coit
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  ABSTRACT: BACKGROUND: Survival estimates after curative surgery for gastric cancer are based on AJCC staging, or on more accurate multivariable nomograms. However, the risk of dying of gastric cancer is not constant over time, with most deaths occurring in the first 2 years after resection. Therefore, the prognosis for a patient who survives this critical period improves. This improvement over time is termed conditional probability of survival (CPS). Objectives of this study were to develop a CPS nomogram predicting 5-year disease-specific survival (DSS) from the day of surgery for patients surviving a specified period of time after a curative gastrectomy and to explore whether variables available with follow-up improve the nomogram in the follow-up setting. METHODS: A CPS nomogram was developed from a combined US-Dutch dataset, containing 1,642 patients who underwent an R0 resection with or without chemotherapy/radiotherapy for gastric cancer. Weight loss, performance status, hemoglobin, and albumin 1 year after resection were added to the baseline variables of this nomogram. RESULTS: The CPS nomogram was highly discriminating (concordance index: 0.772). Surviving 1, 2, or 3 years gives a median improvement of 5-year DSS from surgery of 7.2, 19.1, and 31.6 %, compared with the baseline prediction directly after surgery. Introduction of variables available at 1-year follow-up did not improve the nomogram. CONCLUSIONS: A robust gastric cancer nomogram was developed to predict survival for patients alive at time points after surgery. Introduction of additional variables available after 1 year of follow-up did not further improve this nomogram.
  Annals of Surgical Oncology 11/2012; · 4.17 Impact Factor
• Article: Costs of different follow-up strategies in early breast cancer: A review of the literature.

  Marjan van Hezewijk, M Elske van den Akker, Cornelis J H van de Velde, Astrid N Scholten, Elysée T M Hille
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  ABSTRACT: We reviewed the literature between January 1985 and June 2011 on the costs of different follow-up strategies for patients treated for early breast cancer. A total of 186 abstracts were retrieved of which eleven publications were considered relevant; 6 randomised clinical trials, 4 retrospective cohort studies and 1 'minisymposium'. The follow-up strategies, outcome measures and methods of analysis used in these studies vary widely, so no general conclusions can be drawn. However, from the results we infer that patient-led follow-up by a nurse practitioner, follow-up by a general practitioner, or telephone follow-up is feasible and cost-effective, without routine additional tests, except annual mammograms. In this era of increasing health care costs, cost-effectiveness, evaluated in a standardised way, should be taken into account in future clinical trials.
  Breast (Edinburgh, Scotland) 10/2012; · 2.09 Impact Factor
• Article: Quality of Care Indicators for the Surgical Treatment of Gastric Cancer: A Systematic Review.

  Johan L Dikken, Jurriën Stiekema, Cornelis J H van de Velde, Marcel Verheij, Annemieke Cats, Michel W J M Wouters, Johanna W van Sandick
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  ABSTRACT: BACKGROUND: Quality assurance is increasingly acknowledged as a crucial factor for the (surgical) treatment of gastric cancer. The purpose of the current study was to define a minimum set of evidence-based quality of care indicators for the surgical treatment of locally advanced gastric cancer. METHODS: A systematic review of the literature published between January 1990 and May 2011 was performed, using search terms on gastric cancer, treatment, and quality of care. Studies were selected based on predefined selection criteria. Potential quality of care indicators were assessed based on their level of evidence and were grouped into structure, process, and outcome indicators. RESULTS: A total of 173 articles were included in the current study. For structural measures, evidence was found for the inverse relationship between hospital volume and postoperative mortality as well as overall survival. Regarding process measures, the most common indicators concerned surgical technique, perioperative care, and multimodality treatment. The only outcome indicator with supporting evidence was a microscopically radical resection. CONCLUSIONS: Although specific literature on quality of care indicators for the surgical treatment of locally advanced gastric cancer is limited, several quality of care indicators could be identified. These indicators can be used in clinical audits and other quality assurance programs.
  Annals of Surgical Oncology 10/2012; · 4.17 Impact Factor
• Article: Mammostrat as an Immunohistochemical Multigene Assay for Prediction of Early Relapse Risk in the Tamoxifen Versus Exemestane Adjuvant Multicenter Trial Pathology Study.

  John M S Bartlett, Kenneth J Bloom, Tammy Piper, Thomas J Lawton, Cornelis J H van de Velde, Douglas T Ross, Brian Z Ring, Robert S Seitz, Rodney A Beck, Annette Hasenburg, Dirk Kieback, Hein Putter, Christos Markopoulos, Luc Dirix, Caroline Seynaeve, Daniel Rea
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  ABSTRACT: PURPOSESome postmenopausal patients with hormone-sensitive early breast cancer remain at high risk of relapse despite endocrine therapy and, in addition, might benefit from adjuvant chemotherapy. The challenge is to prospectively identify such patients. The Mammostrat test uses five immunohistochemical markers to stratify patients regarding recurrence risk and may inform treatment decisions. We tested the efficacy of this panel in the Tamoxifen versus Exemestane Adjuvant Multicenter (TEAM) trial. PATIENTS AND METHODS Pathology blocks from 4,598 TEAM patients were collected, and tissue microarrays (TMAs) were constructed. The cohort was 47% node-positive, and 36% of patients in the cohort were treated with adjuvant chemotherapy. Triplicate 0.6-mm(2) TMA cores were stained, and positivity for p53, HTF9C, CEACAM5, NDRG1, and SLC7A5 was assessed. Cases were assigned a Mammostrat risk score, and distant relapse-free survival (DRFS) and disease-free survival (DFS) were analyzed.ResultsIn multivariate regression analyses, which were corrected for conventional clinicopathologic markers, Mammostrat provided significant additional information on DRFS after endocrine therapy in estrogen receptor (ER) -positive node-negative patients (n = 1,226) who did not receive chemotherapy (P = .004). Additional analyses in all patients not exposed to chemotherapy, irrespective of nodal status (n = 2,559) and in the entire cohort (n = 3,837) showed Mammostrat scores provided additional information on DRFS in these groups (P = .001 and P < .001, respectively; multivariate analyses). No differences were seen between the two endocrine treatment regimens. CONCLUSION The Mammostrat score predicts DRFS for patients treated with exemestane and patients treated with tamoxifen followed by exemestane irrespective of nodal status and chemotherapy. The ability of this test to provide additional outcome data after treatment provides additional evidence of its use in risk stratification of ER-positive postmenopausal patients with breast cancer.
  Journal of Clinical Oncology 10/2012; · 18.37 Impact Factor
• Article: Addition of interferon-alpha to the p53-SLP(®) vaccine results in increased production of interferon-gamma in vaccinated colorectal cancer patients: A phase I/II clinical trial.

  Eliane C M Zeestraten, Frank M Speetjens, Marij J P Welters, Sepideh Saadatmand, Linda F M Stynenbosch, Rogier Jongen, Ellen Kapiteijn, Hans Gelderblom, Hans W Nijman, A Rob P M Valentijn, Jaap Oostendorp, Lorraine M Fathers, Jan W Drijfhout, Cornelis J H van de Velde, Peter J K Kuppen, Sjoerd H van der Burg, Cornelis J M Melief
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  ABSTRACT: We previously established safety and immunogenicity of a p53 synthetic long peptides (p53-SLP®) vaccine. In the current trial we investigated whether combination of Interferon-alpha (IFN-α) with p53-SLP® is both safe and able to improve the induced p53-specific IFN-γ response. Eleven colorectal cancer patients successfully treated for metastatic disease were enrolled in this study. Of these, nine patients completed follow up after two injections with p53-SLP®together with IFN-α. Safety and p53-specific immune responses were determined before and after vaccination. Furthermore, cryopreserved PBMCs were compared head-to-head to cryopreserved PBMCs obtained in our previous trial with p53-SLP® only. Toxicity of p53-SLP® vaccination in combination with IFN-α was limited to grade 1 or 2, with predominantly small ongoing swellings at the vaccination site. All patients harbored p53-specific T cells after vaccination and most patients showed p53-specific antibodies. Compared to the previous trial, addition of IFN-α significantly improved the frequency of p53-specific T cells in IFN-γ ELISPOT. Moreover, in this trial, p53-specific T cells were detectable in blood samples of all patients in a direct ex vivo multiparameter flowcytometric assay, opposed to only 2 out of 10 patients vaccinated with p53-SLP® only. Finally, patients in this trial displayed a broader p53-specific immunoglobulin-G response, indicating an overall better p53-specific T-helper response. Our study shows that p53-SLP(®) vaccination combined with IFN-α injection is safe and capable of inducing p53-specific immunity. When compared to a similar trial with p53-SLP® vaccination alone the combination was found to induce significantly more IFN-γ producing p53-specific T-cells. © 2012 Wiley Periodicals, Inc.
  International Journal of Cancer 09/2012; · 5.44 Impact Factor
• Article: Influence of semi-quantitative oestrogen receptor expression on adjuvant endocrine therapy efficacy in ductal and lobular breast cancer - A TEAM study analysis.

  Willemien van de Water, Duveken B Y Fontein, Johanna G H van Nes, John M S Bartlett, Elysée T M Hille, Hein Putter, Tammy Robson, Gerrit-Jan Liefers, Rudi M H Roumen, Caroline Seynaeve, Luc Y Dirix, Robert Paridaens, Elma Meershoek-Klein Kranenbarg, Johan W R Nortier, Cornelis J H van de Velde
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  ABSTRACT: BACKGROUND: Multiple studies suggest better efficacy of chemotherapy in invasive ductal breast carcinomas (IDC) than invasive lobular breast carcinomas (ILC). However, data on efficacy of adjuvant endocrine therapy regimens and histological subtypes are sparse. This study assessed endocrine therapy efficacy in IDC and ILC. The influence of semi-quantitative oestrogen receptor (ER) expression by Allred score was also investigated. METHODS: Dutch and Belgian patients enrolled in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial were randomized to exemestane (25mg daily) alone or following tamoxifen (20mg daily) for 5years. Inclusion was restricted to IDC and ILC patients. Histological subtype was assessed locally; ER expression was centrally reviewed according to Allred score (ER-poor (<7; n=235); ER-rich (⩾7; n=1789)). Primary end-point was relapse-free survival (RFS), which was the time from randomization to disease relapse. FINDINGS: Overall, 2140 (82%) IDC and 463 (18%) ILC patients were included. RFS was similar for both endocrine treatment regimens in IDC (hazard ratio (HR) for exemestane was 0.83 (95%confidence interval (CI) 0.67-1.03)), and ILC (HR 0.69 (95%CI 0.45-1.06)). Irrespective of histological subtype, patients with ER-rich Allred scores allocated to exemestane alone had an improved RFS (multivariable HR 0.71 (95%CI 0.56-0.89)). In contrast, patients with ER-poor Allred scores allocated to exemestane had a worse RFS (multivariable HR 2.33 (95%CI 1.32-4.11)). Significant effect modification by ER-Allred score was confirmed (multivariable p=0.003). INTERPRETATION: Efficacy of endocrine therapy regimens was similar for IDC and ILC. However, ER-rich patients showed superior efficacy to upfront exemestane, while ER-poor patients had better outcomes with sequential therapy, irrespective of histological subtype, emphasising the relevance of quantification of ER expression. FUNDING: The Dutch/Belgian TEAM trial is supported by an unrestricted research grant from Pfizer. The sponsors have in no way influenced the design and conduct of the study, collection, management, analysis and interpretation of the data and preparation, review or approval of the manuscript.
  European journal of cancer (Oxford, England: 1990) 09/2012; · 4.12 Impact Factor
• Article: Near-infrared fluorescence sentinel lymph node mapping of the oral cavity in head and neck cancer patients.

  Joost R van der Vorst, Boudewijn E Schaafsma, Floris P R Verbeek, Stijn Keereweer, Jeroen C Jansen, Lilly-Ann van der Velden, Antonius P M Langeveld, Merlijn Hutteman, Clemens W G M Löwik, Cornelis J H van de Velde, John V Frangioni, Alexander L Vahrmeijer
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  ABSTRACT: OBJECTIVES: Elective neck dissection is frequently performed during surgery in head and neck cancer patients. The sentinel lymph node (SLN) procedure can prevent the morbidity of a neck dissection and improve lymph node staging by fine pathology. Near-infrared (NIR) fluorescence imaging is a promising technique to identify the sentinel lymph node (SLN) intraoperatively. This feasibility study explored the use of indocyanine green adsorbed to human serum albumin (ICG:HSA) for SLN mapping in head and neck cancer patients. MATERIALS AND METHODS: A total of 10 consecutive patients with oral cavity or oropharyngeal cancer and a clinical N0 neck were included. After exposure of the neck, 1.6mL of ICG:HSA (500μM) was injected at four quadrants around the tumor. During the neck dissection, levels I-IV were measured for fluorescence using the Mini-FLARE imaging system. RESULTS: In all 10 patients, NIR fluorescence imaging enabled visualization of one or more SLNs. A total of 17 SLNs were identified. The mean contrast between the fluorescent signal of the lymph nodes and of the surrounding tissue was 8.7±6.4. In 3 patients, of which 1 was false-negative, lymph node metastases were found. After administration of ICG:HSA, the average number of fluorescent lymph nodes significantly increased over time (P<0.001). CONCLUSION: This study demonstrated feasibility to detect draining lymph nodes in head and neck cancer patients using NIR fluorescence imaging. However, the fluorescent tracer quickly migrated beyond the SLN to higher tier nodes.
  Oral Oncology 08/2012; · 2.86 Impact Factor
• Article: Image-guided hepatopancreatobiliary surgery using near-infrared fluorescent light.

  Floris P R Verbeek, Joost R van der Vorst, Boudewijn E Schaafsma, Merlijn Hutteman, Bert A Bonsing, Fijs W B van Leeuwen, John V Frangioni, Cornelis J H van de Velde, Rutger-Jan Swijnenburg, Alexander L Vahrmeijer
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  ABSTRACT: BACKGROUND: Improved imaging methods and surgical techniques have created a new era in hepatopancreatobiliary (HPB) surgery. Despite these developments, visual inspection, palpation, and intraoperative ultrasound remain the most utilized tools during surgery today. This is problematic, though, especially in laparoscopic HPB surgery, where palpation is not possible. Optical imaging using near-infrared (NIR) fluorescence can be used for the real-time assessment of both anatomy (e.g., sensitive detection and demarcation of tumours and vital structures) and function (e.g., assessment of luminal flow and tissue perfusion) during both open and minimally invasive surgeries. METHODS: This article reviews the published literature related to preclinical development and clinical applications of NIR fluorescence imaging during HPB surgery. RESULTS: NIR fluorescence imaging combines the use of otherwise invisible NIR fluorescent contrast agents and specially designed camera systems, which are capable of detecting these contrast agents during surgery. Unlike visible light, NIR fluorescent light can penetrate several millimetres through blood and living tissue, thus providing improved detectability. Applications of this technique during HPB surgery include tumour imaging in liver and pancreas, and real-time imaging of the biliary tree. CONCLUSIONS: NIR fluorescence imaging is a promising new technique that may someday improve surgical accuracy and lower complications.
  Journal of hepato-biliary-pancreatic sciences. 07/2012;
• Article: Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer.

  Boudewijn E Schaafsma, Joost R van der Vorst, Katja N Gaarenstroom, Alexander A W Peters, Floris P R Verbeek, Cornelis D de Kroon, J Baptist M Z Trimbos, Mariette I E van Poelgeest, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer
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  ABSTRACT: Near-infrared fluorescence imaging using indocyanine green (ICG) has recently been introduced as a novel technique for sentinel lymph node (SLN) mapping in early-stage cervical cancer. Although preclinical research has shown that ICG adsorbed to human serum albumin (ICG:HSA) improves its performance, the need for HSA has not yet been confirmed in cervical cancer patients. The current randomized study aims to determine whether ICG:HSA offers advantages over using ICG alone. Eighteen consecutive early-stage cervical cancer patients scheduled to undergo pelvic lymphadenectomy were included. Prior to surgery, 1.6 mL of 500 μM ICG:HSA or 500 μM ICG alone was injected transvaginally in 4 quadrants around the tumor. The Mini-FLARE imaging system was used for intraoperative NIR fluorescence detection and quantitation. SLNs were identified intraoperatively in 78% of the patients. Patient and tumor characteristics were equally distributed over both treatment groups. No significant difference in signal-to-background ratio (9.3 vs. 10.1, P=.72) or average number of detected SLNs (2.9 vs 2.7, P=.84) was found between the ICG:HSA group and the ICG alone group, respectively. In conclusion, this double-blind, randomized trial showed no advantage of ICG:HSA over ICG alone for the SLN procedure in early-stage cervical cancer. Further optimization is required to improve the intraoperative detection rate.
  Gynecologic Oncology 07/2012; 127(1):126-30. · 3.89 Impact Factor
• Article: Randomized Comparison of Near-infrared Fluorescence Imaging Using Indocyanine Green and 99(m) Technetium With or Without Patent Blue for the Sentinel Lymph Node Procedure in Breast Cancer Patients.

  Joost R van der Vorst, Boudewijn E Schaafsma, Floris P R Verbeek, Merlijn Hutteman, J Sven D Mieog, Clemens W G M Lowik, Gerrit-Jan Liefers, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer
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  ABSTRACT: BACKGROUND: Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve sentinel lymph node (SLN) mapping of breast cancer. We performed a randomized clinical trial to assess the value of blue dyes when used in combination with NIR fluorescence. We also preliminarily examined the possibility of performing SLN mapping without radiotracers. METHODS: Clinical trial subjects were 24 consecutive breast cancer patients scheduled to undergo SLN biopsy. All patients received standard of care using 99(m) technetium-nanocolloid and received 1.6 mL of 500 μM ICG injected periareolarly. Patients were randomly assigned to undergo SLN biopsy with or without patent blue. To assess the need for radiocolloids to localize the SLN or SLNs, the surgeon did not use the handheld gamma probe during the first 15 min after the axillary skin incision. RESULTS: SLN mapping was successful in 23 of the 24 patients. No significant difference was found in signal-to-background ratio between the groups with and without patent blue (8.3 ± 3.8 vs. 10.3 ± 5.7, respectively, P = 0.32). In both groups, 100 % of SLNs were radioactive and fluorescent, and in the patent blue group, only 84 % of SLNs were stained blue. In 25 % of patients, the use of the gamma probe was necessary to localize the SLN within the first 15 min. CONCLUSIONS: This study shows that there is no benefit of using patent blue for SLN mapping in breast cancer patients when using NIR fluorescence and 99(m) technetium-nanocolloid. NIR fluorescence imaging outperformed patent blue in all patients.
  Annals of Surgical Oncology 07/2012; · 4.17 Impact Factor
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  Available from: PubMed Central

  Article: The New American Joint Committee on Cancer/International Union Against Cancer staging system for adenocarcinoma of the stomach: increased complexity without clear improvement in predictive accuracy.

  Johan L Dikken, Cornelis J H van de Velde, Mithat Gönen, Marcel Verheij, Murray F Brennan, Daniel G Coit
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  ABSTRACT: To evaluate the changes in the 7th edition American Joint Committee on Cancer (AJCC) staging system for stomach cancer compared to the 6th edition; to compare the predictive accuracy of the two staging systems. In a combined database containing 2,196 patients who underwent an R0 resection for gastric adenocarcinoma, differences between the two staging systems were evaluated and stage-specific survival estimates compared. Concordance probability and Brier scores were estimated for both systems to examine the predictive accuracy. Nodal status cutoff values were changed, leading to a more even distribution for the redefined N1, N2, and N3 group. AJCC 6th edition stage II reflected a highly heterogeneous population, which is now adequately subdivided in the AJCC 7th edition into stages IIA, IIB, and IIIA. The predictive accuracy of N classification improved significantly as measured by concordance. Despite increased complexity, the predictive accuracy of AJCC 7th stage grouping was significantly worse than that of the AJCC 6th edition. The increased complexity of the 7th edition staging system is accompanied by improvements in the predictive value of nodal staging as compared to the 6th edition, but it was no better in overall stage-specific predictive accuracy. Future refinements of the tumor, node, metastasis staging system should consider whether increased complexity is balanced by improved prognostic accuracy.
  Annals of Surgical Oncology 05/2012; 19(8):2443-51. · 4.17 Impact Factor
• Article: The relationship between volume or surgeon specialty and outcome in the surgical treatment of lung cancer: a systematic review and meta-analysis.

  Erik M von Meyenfeldt, Gea A Gooiker, Willem van Gijn, Piet N Post, Cornelis J H van de Velde, Rob A E M Tollenaar, Houke M Klomp, Michel W J M Wouters
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  ABSTRACT: Whether improvement of quality of surgical cancer care can be achieved by centralizing care in high-volume specialized centers is a subject of ongoing debate. We have conducted a meta-analysis of the literature on the effect of procedural volume or surgeon specialty on outcome of lung resections for cancer. A systematic search of articles published between January 1, 1990 and January 20, 2011 on the effects of surgeon specialty and hospital or surgeon volume of lung resections on mortality and survival was conducted. After strict inclusion, meta-analysis assuming a random-effects model was performed. Meta-regression was used to identify volume cutoff values. Heterogeneity and the risk of publication bias were evaluated. Nineteen relevant studies were found. Studies were heterogeneous, especially in defining volume categories. The pooled estimated effect size was significant in favor of high-volume hospitals regarding postoperative mortality (odds ratio [OR] 0.71; confidence interval 0.62-0.81), but not for survival (OR 0.93; confidence interval 0.84-1.03). Surgeon volume showed no significant effect on outcome. General surgeons had significantly higher mortality risks than general thoracic (OR 0.78; 0.70-0.88) or cardiothoracic surgeons (OR 0.82; 0.69-0.96). A minimal annual volume of resections for lung cancer could not be identified. Hospital volume and surgeon specialty are important determinants of outcome in lung cancer resections, but evidence-based minimal-volume standards are lacking. Evaluation of individual institutions in a national audit program might help elucidate the influence of individual quality-of-care parameters, including hospital volume, on outcome.
  Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer 05/2012; 7(7):1170-8. · 4.55 Impact Factor