Publications by authors named "Christof Vulsteke"

15 Publications

  • Page 1 of 1

Immunoglobin G/total antibody testing for SARS-CoV-2: A prospective cohort study of ambulatory patients and health care workers in two Belgian oncology units comparing three commercial tests.

Eur J Cancer 2021 Feb 27;148:328-339. Epub 2021 Feb 27.

Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Wilrijkstraat 10, Edegem, B-2650, Belgium; Center for Oncological Research (CORE), Integrated Personalised and Precision Oncology Network (IPPON), University of Antwerp, Universiteitsplein 1, Wilrijk, B-2610, Belgium.

Background: Coronavirus disease (COVID-19) is interfering heavily with the screening, diagnosis and treatment of cancer patients. Better knowledge of the seroprevalence and immune response after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in this population is important to manage them safely during the pandemic.

Methods: 922 cancer patients, 100 non-cancer patients and 94 health care workers (HCW) attending the Multidisciplinary Oncology Unit of Antwerp University Hospital from 24th of March 2020 till 31st of May 2020, and the Oncology Unit of AZ Maria Middelares Hospital, Ghent, from 13th of April 2020 till 31st of May 2020 participated in the study. The Alinity® (A; Abbott) and Liaison® (D; DiaSorin) commercially available assays were used to measure SARS-CoV-2 IgG, while total SARS-CoV-2 Ig was measured by Elecsys® (R; Roche).

Results: In the overall study population IgG/total SARS-CoV-2 antibodies were found in respectively 32/998 (3.2%), 68/1020 (6.7%), 37/1010 (3.7%) and of individuals using the A, D or R test. Forty-six out of 618 (7.4%) persons had a positive SARS-CoV-2 polymerase chain reaction (RT-PCR) test. Seroprevalence in cancer patients (A:2.2%, D:6.2%, R:3.0%), did not significantly differ from that in non-cancer patients (A:1.1%, D:5.6%, R:0.0%), but was lower than the HCW (A:13%, D:12%, R:12%; respectively Fisher's exact test p = 0.00001, p = 0.046, p = 0.0004). A positive SARS-CoV-2 RT-PCR was found in 6.8% of the cancer patients, 2.3% of the non-cancer patients and 28.1% of the HCW (Fisher's exact test p = 0.0004). Correlation between absolute values of the different Ig tests was poor in the cancer population. Dichotomising a positive versus negative test result, the A and R test correlated well (kappa 0.82 p McNemar test = 0.344), while A and D and R and D did not (respectively kappa 0.49 and 0.57; result significantly different p McNemar test = <0.0001 for both). The rate of seroconversion (>75%) and median absolute antibody levels (A: 7.0 versus 4.7; D 74.0 versus 26.6, R: 16.34 versus 7.32; all >P Mann Whitney U test = 0.28) in cancer patients and HCW with a positive RT-PCR at least 7 days earlier did not show any differences. However, none (N = 0/4) of the patients with hematological tumours had seroconversion and absolute antibody levels remained much lower compared to patients with solid tumours (R: 0.1 versus 37.6, p 0.003; D 4.1 versus 158, p 0.008) or HCW (all p < 0.0001).

Conclusion: HCW were at high risk of being infected by SARS-CoV-2 during the first wave of the pandemic. Seroprevalence in cancer patients was low in the study period. Although Ig immune response in cancer patients with solid tumours does not differ from healthy volunteers, patients with hematological tumours have a very poor humoral immune response. This has to be taken into account in future vaccination programmes in this population. SARS-CoV-2 antibody tests have divergent results and seem to have little added value in the management of cancer patients.
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http://dx.doi.org/10.1016/j.ejca.2021.02.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914028PMC
February 2021

Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma.

N Engl J Med 2021 03 12;384(12):1125-1135. Epub 2021 Feb 12.

From Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).

Background: Patients with advanced urothelial carcinoma have poor overall survival after platinum-containing chemotherapy and programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor treatment.

Methods: We conducted a global, open-label, phase 3 trial of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-containing chemotherapy and had had disease progression during or after treatment with a PD-1 or PD-L1 inhibitor. Patients were randomly assigned in a 1:1 ratio to receive enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight on days 1, 8, and 15 of a 28-day cycle) or investigator-chosen chemotherapy (standard docetaxel, paclitaxel, or vinflunine), administered on day 1 of a 21-day cycle. The primary end point was overall survival.

Results: A total of 608 patients underwent randomization; 301 were assigned to receive enfortumab vedotin and 307 to receive chemotherapy. As of July 15, 2020, a total of 301 deaths had occurred (134 in the enfortumab vedotin group and 167 in the chemotherapy group). At the prespecified interim analysis, the median follow-up was 11.1 months. Overall survival was longer in the enfortumab vedotin group than in the chemotherapy group (median overall survival, 12.88 vs. 8.97 months; hazard ratio for death, 0.70; 95% confidence interval [CI], 0.56 to 0.89; P = 0.001). Progression-free survival was also longer in the enfortumab vedotin group than in the chemotherapy group (median progression-free survival, 5.55 vs. 3.71 months; hazard ratio for progression or death, 0.62; 95% CI, 0.51 to 0.75; P<0.001). The incidence of treatment-related adverse events was similar in the two groups (93.9% in the enfortumab vedotin group and 91.8% in the chemotherapy group); the incidence of events of grade 3 or higher was also similar in the two groups (51.4% and 49.8%, respectively).

Conclusions: Enfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based treatment and a PD-1 or PD-L1 inhibitor. (Funded by Astellas Pharma US and Seagen; EV-301 ClinicalTrials.gov number, NCT03474107.).
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http://dx.doi.org/10.1056/NEJMoa2035807DOI Listing
March 2021

Small cell carcinoma of the prostate after low-dose-rate brachytherapy: a case report.

J Med Case Rep 2020 Oct 28;14(1):203. Epub 2020 Oct 28.

Department of Urology, AZ Maria Middelares, Buitenring-Sint-Denijs 30, 9000, Ghent, Belgium.

Background: Small cell carcinoma of the prostate is a rare condition with important differences from prostatic adenocarcinoma in terms of clinical and prognostic characteristics. A low prostate-specific antigen and a symptomatic patient, including paraneoplastic symptoms, characterize small cell carcinoma of the prostate. Diagnosis is made on the basis of prostate biopsy, and fluorodeoxyglucose positron emission tomography/computed tomography is often used for staging because up to 60% of patients present with de novo metastatic disease. Patients with metastatic disease are usually treated with platinum-based cytotoxic chemotherapy regimens similar to those used for small cell carcinoma of the lung. However, prognosis remains poor, with a median overall survival of 9 to 17 months despite therapy.

Case Presentation: This report describes a case of an 80-year-old Caucasian patient with lymph node and bone metastatic small cell carcinoma of the prostate following low-dose-rate brachytherapy for a low-risk prostate carcinoma and treated with chemotherapy and immunotherapy.

Conclusion: Low-dose-rate brachytherapy might be an etiology of small cell prostate cancer.
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http://dx.doi.org/10.1186/s13256-020-02523-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592557PMC
October 2020

SARS-CoV-2 and cancer: Are they really partners in crime?

Cancer Treat Rev 2020 Sep 11;89:102068. Epub 2020 Jul 11.

Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Wilrijkstraat 10, Edegem B-2650, Belgium; Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), University of Antwerp, Universiteitsplein 1, Wilrijk B-2610, Belgium.

The outbreak of the SARS-CoV-2 pandemic has overwhelmed health care systems in many countries. The clinical presentation of the SARS-CoV-2 varies between a subclinical or flu-like syndrome to that of severe pneumonia with multi-organ failure and death. Initial reports have suggested that cancer patients may have a higher susceptibility to get infected by the SARS-CoV-2 virus but current evidence remains poor as it is biased by important confounders. Patients with ongoing or recent cancer treatment for advanced active disease, metastatic solid tumors and hematological malignancies are at higher risk of developing severe COVID-19 respiratory disease that requires hospitalization and have a poorer disease outcome compared to individuals without cancer. However it is not clear whether these are independent risk factors, or mainly driven by male gender, age, obesity, performance status, uncontrolled diabetes, cardiovascular disease and various other medical conditions. These often have a greater influence on the probability to die due to SARS-CoV-2 then cancer. Delayed diagnosis and suboptimal cancer management due to the pandemic results in disease upstaging and has considerable impact cancer on specific death rates. Surgery during the peak of the pandemic seems to increase mortality, but there is no convincing evidence that adjuvant systemic cancer therapy and radiotherapy are contraindicated, implicating that cancer treatment can be provided safely after individual risk/benefit assessment and some adaptive measures. Underlying immunosuppression, elevated cytokine levels, altered expression of the angiotensin converting enzyme (ACE-2) and TMPRSS2, and a prothrombotic status may fuel the effects of a SARS-CoV-2 in some cancer patients, but have the potential to be used as biomarkers for severe disease and therapeutic targets. The rapidly expanding literature on COVID-19 should be interpreted with care as it is often hampered by methodological and statistical flaws.
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http://dx.doi.org/10.1016/j.ctrv.2020.102068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351667PMC
September 2020

Prescreening for COVID-19 in patients receiving cancer treatment using a patient-reported outcome platform.

ESMO Open 2020 06;5(3):e000817

Department of Medical Oncology, MOCA, University Hospital Antwerp (UZA), Antwerp, Belgium; Department of Molecular Imaging, Pathology, Radiotherapy & Oncology (MIPRO), Center for Oncological Research (CORE), Antwerp University, Antwerp, Belgium.

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http://dx.doi.org/10.1136/esmoopen-2020-000817DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307523PMC
June 2020

Metastasis-directed therapy for oligometastatic urological tumours: still no second-hand news.

Ecancermedicalscience 2020 7;14:1036. Epub 2020 May 7.

Department of Radiation Oncology, Leuven University Hospital, Leuven, Belgium.

For patients presenting with limited metastatic disease burden, known as the oligometastatic state of disease, a more aggressive treatment approach targeting the new or progressive metastatic lesions might improve patient outcome, with no or only limited toxicity to be expected from the treatment. This review provides an overview of the existing evidence and on-going trials on oligometastatic disease and metastasis-directed therapy in the field of renal, bladder and prostate cancer.
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http://dx.doi.org/10.3332/ecancer.2020.1036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289610PMC
May 2020

AMTRA: a multicentered experience of a web-based monitoring and tailored toxicity management system for cancer patients.

Support Care Cancer 2021 Feb 9;29(2):859-867. Epub 2020 Jun 9.

Department of Oncology, Multidisciplinary Oncological Center Antwerp, MOCA, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.

Background: Technology-based interventions are increasingly being introduced in routine clinical cancer care. There is a need for reliable systems to monitor treatment-related toxicity in a standardized manner. Such electronic tools bridge the gap in providing quality home-based monitoring.

Methods: From July 2017 to December 2017, we performed a multicentered, non-randomized prospective cohort analysis with patients who were receiving routine chemotherapy for various solid tumors, using a web-based patient-reported toxicity registration, management, and intervention system called AMTRA (ambulatory Monitoring of cancer Therapy using an interactive Application) linked to the homecare nursing organization Remedus®. Twelve common toxicities plus pain and two biometrics could be registered daily or more frequently as required. These were processed centrally to generate tailored advice for lesser symptoms or a phone call from a dedicated nurse in case of severe or prolonged toxicity. A compliance tool to monitor oral therapies was incorporated in the system.

Results: One hundred sixty-eight patients (92%) were enrolled, with 31,514 registrations analyzed. One hundred eight patients reported severe toxicity (> 1461 registrations), resulting in 102 clinical interventions ranging from self-management advice, supplemental consultations to hospitalizations. Compliance to oral chemotherapy was high using AMTRA with a median of 98.7% (95 confidence interval (CI) [93.5-100.0%]). Seventy-nine percent of patients stated that the availability of AMTRA self-reports was useful in communication with the care provider, while 75% felt more in control while managing their treatment.

Conclusions: The application of an interactive PRO-system in routine symptom management of cancer patients allowed standardized documentation of toxicities and recorded a high compliance with oral treatment. It allows for rapid interaction for toxicities and cancer-related symptoms experienced at home.
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http://dx.doi.org/10.1007/s00520-020-05550-6DOI Listing
February 2021

Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer.

Breast Cancer Res Treat 2020 May 2;181(1):97-105. Epub 2020 Apr 2.

Roche nv/sa, Dantestraat 75, 1070, Brussels, Belgium.

Purpose: The subcutaneous (SC) administration of trastuzumab is highly preferred by patients. At home, administration of trastuzumab SC might further improve patient benefit. The aims of the BELIS study are to evaluate the safety and tolerability of trastuzumab SC when administered at home by a healthcare professional (HCP) and to evaluate patient-reported outcomes for treatment experience of at home cancer therapy.

Methods: This open-label phase IIIb study enrolled HER2-positive early breast cancer patients in Belgium and Israel who completed the first six cycles of trastuzumab IV (neo)adjuvant therapy. The study consisted of three consecutive treatment periods: three cycles of trastuzumab IV and SC each at the hospital and six cycles of trastuzumab SC at home.

Results: Between November 2013 and December 2014, 23 centres enrolled 102 patients in the intent-to-treat population of which 101 patients entered the safety population. No new safety signals were detected with as expected, more mild administration site events with trastuzumab SC when compared to IV treatment. All patients agreed that they had benefit from at home administration to a large (18/81; 22%) or very large (63/81; 78%) extent. All HCPs (21/21) agreed that SC is the quickest method from start of preparation to finish of administration and that less resource use is needed.

Conclusion: The results of the BELIS study support that trastuzumab SC can be safely administered at home by a HCP and all patients considered this setting as beneficial. HCPs consider the SC formulation as the quickest method to administer trastuzumab.

Trial Registration: EudraCT Identifier: 2013-000123-13. ClinicalTrials.gov Identifier: NCT01926886.
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http://dx.doi.org/10.1007/s10549-020-05604-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7182624PMC
May 2020

Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.

N Engl J Med 2019 12 28;381(25):2391-2402. Epub 2019 Sep 28.

From Grupo Español de Investigación en Cáncer de Ovario (GEICO) and the Medical Oncology Department, Clínica Universidad de Navarra (A.G.-M.) and GEICO and Hospital Universitario La Paz-IdiPAZ (A.R.), Madrid, GEICO and Medical Oncology, Catalan Institute of Oncology, Girona Biomedical Research Institute, and the Department of Medical Sciences, Medical School University of Girona, Girona (P.B.-G.), and GEICO and Hospital Universitario Reina Sofía, Cordoba (M.J.R.-P.) - all in Spain; the Gynecologic Oncology Group (GOG) and the Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health (B.P.), and GOG and the Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College (R.E.O.), New York, and US Oncology Research (USOR) and the Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester (R.G.M.) - all in New York; Belgium and Luxembourg Gynecologic Oncology Group (BGOG) and the Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven (I.V.), BGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent (C.V.), and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp (C.V.) - all in Belgium; the Nordic Society of Gynecologic Oncology (NSGO) and the Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense (R.D.C.), NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen (M.R.M.), and NSGO and the Department of Oncology, Aalborg University, Aalborg (B.L.) - all in Denmark; GOG and Gynecologic Oncology, Medical University of South Carolina, Charleston (W.G.); GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR (C.M.); Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Fondazione IRCCS National Cancer Institute of Milan (D.L.), and MITO and the Department of Obstetrics and Gynecology, San Raffaele Scientific Institute (G.M.) - both in Milan; USOR and the Department of Medical Oncology, BC Cancer, Vancouver, BC (P.H.), and GOG and the Department of Obstetrics and Gynecology, McGill University, and the Department of Oncology, McGill University Health Centre, Division of Gynecologic Oncology, Montreal (K.J.) - all in Canada; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Lyon, France (G.F.); Arbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany (K.B.); the Division of Gynecologic Oncology, Ohio State University, Columbus (F.B.); GOG and the Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia (A.F.H.), and GOG and Hanjani Institute for Gynecologic Oncology, Asplundh Cancer Pavilion, Abington Jefferson Hospital, Sidney Kimmel Medical College of Thomas Jefferson University, Willow Grove (M.S.S.) - all in Pennsylvania; GOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (W.H.B.); Israeli Society of Gynecologic Oncology and Department of Gynecology and Gynecologic Oncology, Hillel Yaffe Medical Center, Technion Israel Institute of Technology, Haifa, Israel (I.B.); GlaxoSmithKline/Tesaro, Waltham, MA (K.S., I.A.M., Y.L., D.G.); and Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).

Background: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.

Methods: In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival.

Results: Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.

Conclusions: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.).
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http://dx.doi.org/10.1056/NEJMoa1910962DOI Listing
December 2019

Effect of lipegfilgrastim administration as prophylaxis of chemotherapy-induced neutropenia on dose modification and incidence of neutropenic events: real-world evidence from a non-interventional study in Belgium and Luxembourg.

Acta Clin Belg 2021 Feb 9;76(1):10-15. Epub 2019 Aug 9.

Department of Medical Oncology, AZ Maria Middelares , Ghent, Belgium.

: This study evaluated the effect of lipegfilgrastim, a glycopegylated granulocyte-colony stimulating factor, used as primary (PP) or secondary prophylaxis (SP) on chemotherapy (CT) treatment modifications, as well as the incidence of CT-induced neutropenic events in adult patients receiving cytotoxic CT with or without biological therapy (BT) for solid and hematological tumors, in routine clinical practice. Other objectives were to characterize the population of lipegfilgrastim-treated cancer patients and safety assessment. : This phase 4, prospective, observational study was conducted at 15 centers from Belgium and Luxembourg, between 2015 and 2017. : Of 139 patients, 82.7% had breast cancer and 54.7% were treated with dose-dense regimens. Most received lipegfilgrastim as PP (82.0%) and were at high-risk of febrile neutropenia (FN) (68.3%). FN and grade III/IV neutropenia were reported for 7.9% and 22.3% patients. Among 123 evaluated patients, CT/BT dose modifications were recorded for 33.3% (PP) and 52.4% (SP) of patients receiving lipegfilgrastim; dose reductions, followed by dose delays, were more frequent than omissions. Among 45 patients with dose modifications, FN was reported for 8.8% and 9.1% patients and grade IV neutropenia for 17.6% and 18.2% of patients when lipegfilgrastim was applied for PP and SP, respectively. Adverse events related to lipegfilgrastim occurred for 55 (39.6%) patients; bone pain and back pain were more frequent. Lipegfilgrastim-related serious adverse events were reported for 9 (6.5%) patients. : Use of lipegfilgrastim in real-world settings resulted in limited CT dose modifications and low incidences of neutropenic events, with no new safety concerns arising.
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http://dx.doi.org/10.1080/17843286.2019.1646539DOI Listing
February 2021

Quality of care in oncology: quality indicators in testicular cancer: a hospital-based approach.

Acta Clin Belg 2018 Feb 6;73(1):29-33. Epub 2017 Jun 6.

a Department of Urology , AZ Maria Middelares , Gent , Belgium.

Introduction: The Belgian Health Care Knowledge Centre (KCE) conducted a literature search leading to twelve quality indicators for testicular cancer. Data obtained from three nationwide databases, showed only five fully measurable quality indicators, one was partially measurable, and two could be determined using a proxy indicator. The four remaining indicators could not be assessed. In this study, we aimed to investigate if these quality indicators were registered and measurable in a medium-volume center.

Methods: In our medium-volume cancer center new testicular cancer diagnoses were registered since 2003. 48 patients were diagnosed with testicular cancer between 2004 and 2014. Through medical file review we measured and evaluated the predefined set of indicators. The results were pooled in a database and compared to the KCE report (KCE Reports 149A. D2010/10.273/96).

Results: All 12 indicators could be measured in the entire patient cohort of 48 patients. Mean age was 34.9 years (range 16-85). In comparison with the KCE report, we documented higher rates of tumor marker assessment (98% vs. 73%), staging imaging (100% vs. 95%), multidisciplinary board discussion (100% vs. 58%), orchidectomy (98% vs. 84%), follow-up imaging (100% vs. 54%), and active surveillance (77% vs. 21%). In contrast, we found a lower rate of radiotherapy (6% vs. 20.3%) and chemotherapy (41.6% vs. 53%). Two patients were lost to follow-up, the remaining 46 patients are still alive. Four patients relapsed, all were seminomas.

Conclusion: Implementation of quality indicators for testicular cancer is feasible for a medium-volume peripheral cancer center.
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http://dx.doi.org/10.1080/17843286.2017.1331814DOI Listing
February 2018

First evidence of treatment efficacy in metastatic carcinoma of the parotid gland with BRD4/NUT translocation.

J Chemother 2016 Jun;28(3):242-6

b Department of General Medical Oncology , UZ Leuven , Belgium.

Background: Nuclear protein in testis (NUT) midline carcinomas (NMC) are characterized by rearrangements of the gene NUT. In the majority of NMCs, a translocation t(15;19), resulting in a BRD4/NUT fusion gene, is present. Nuclear protein in testis midline carcinomas is a rare, but probably underdiagnosed entity due to misdiagnosis. Most cases have been reported in the mediastinum and upper aero-digestive tract. The clinical course of a NMC is extremely aggressive, in spite of intensive chemotherapy and radiotherapy, with an average survival < 1 year.

Methods And Results: A 32-year-old man presented with a pre-auricular swelling on the left side. After partial parotidectomy, the diagnosis of a NMC was made based on the presence of t(15;19)(q14;p13.1) and BRD4/NUT fusion gene demonstrated by fluorescence in situ hybridization (FISH). During postoperative radiotherapy, the patient developed bone metastases for which chemotherapy consisting of cisplatine, doxorubicine and ifosfamide (PAI) was initiated with remarkable clinical and radiological improvement. Nevertheless, the response was not durable.

Conclusion: This case illustrates that responses to chemotherapy in the palliative treatment of a t(15;19)-translocated salivary gland carcinoma are possible but not durable.
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http://dx.doi.org/10.1179/1973947815Y.0000000046DOI Listing
June 2016

Clinical and genetic risk factors for epirubicin-induced cardiac toxicity in early breast cancer patients.

Breast Cancer Res Treat 2015 Jul 28;152(1):67-76. Epub 2015 May 28.

Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven and Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Herestraat 49, 3000, Louvain, Belgium.

Anthracycline-induced cardiotoxicity (ACT) is a well-known serious adverse drug reaction leading to substantial morbidity. The purpose of this study was to assess ACT occurrence and clinical and genetic risk factors in early breast cancer patients. In 6 genes of interest (ABCC1, ABCC2, CYBA, NCF4, RAC2, SLC28A3), 10 single nucleotide polymorphisms (SNPs) involved in ACT were selected based on a literature search. Eight hundred and seventy-seven patients treated between 2000 and 2010 with 3-6 cycles of (neo) adjuvant 5-fluorouracil, epirubicin and cyclophosphamide (FEC) were genotyped for these SNPs using Sequenom MassARRAY. Main outcome measures were asymptomatic decrease of left ventricular ejection fraction (LVEF) > 10 % and cardiac failure grade 3-5 (CTCAE 4.0). To evaluate the impact of these 10 SNPs as well as clinical factors (age, relative dose intensity of epirubicin, left-sided radiotherapy, occurrence of febrile neutropenia, and planned and received cycles of epirubicin) on decrease of LVEF and cardiac failure, we performed uni- and multivariable logistic regression analysis. Additionally, exploratory analyses including 11 additional SNPs related to the metabolism of anthracyclines were performed. After a median follow-up of 3.62 years (range 0.40-9.60), a LVEF decline of > 10 % occurred in 153 patients (17.5 %) and cardiac failure in 16 patients (1.8 %). In multivariable analysis, six cycles of FEC compared to three cycles received and heterozygous carriers of the rs246221 T-allele in ABCC1 relative to homozygous carriers of the T-allele were significantly associated with LVEF decline of > 10 % (OR 1.3, 95 % CI 1.1-1.4, p < 0.001 and OR 1.6, 95 % CI 1.1-2.3, p = 0.02). Radiotherapy for left-sided breast cancer was associated with cardiac failure (OR 3.7, 95 % CI 1.2-11.5, p 0.026). The other 9 SNPs and clinical factors tested were not significantly associated. In our exploratory analysis, no other SNPs related to anthracycline metabolism were retained in the multivariate model for prediction of LVEF decline. ACT in breast cancer patients is related to number of received cycles of epirubicin and left-sided radiotherapy. Additional studies should be performed to independently confirm the potential association between rs246221 in ABCC1 and LVEF.
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http://dx.doi.org/10.1007/s10549-015-3437-9DOI Listing
July 2015

Multivariable regression analysis of febrile neutropenia occurrence in early breast cancer patients receiving chemotherapy assessing patient-related, chemotherapy-related and genetic risk factors.

BMC Cancer 2014 Mar 19;14:201. Epub 2014 Mar 19.

Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.

Background: Febrile neutropenia (FN) is common in breast cancer patients undergoing chemotherapy. Risk factors for FN have been reported, but risk models that include genetic variability have yet to be described. This study aimed to evaluate the predictive value of patient-related, chemotherapy-related, and genetic risk factors.

Methods: Data from consecutive breast cancer patients receiving chemotherapy with 4-6 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) or three cycles of FEC and docetaxel were retrospectively recorded. Multivariable logistic regression was carried out to assess risk of FN during FEC chemotherapy cycles.

Results: Overall, 166 (16.7%) out of 994 patients developed FN. Significant risk factors for FN in any cycle and the first cycle were lower platelet count (OR = 0.78 [0.65; 0.93]) and haemoglobin (OR = 0.81 [0.67; 0.98]) and homozygous carriers of the rs4148350 variant T-allele (OR = 6.7 [1.04; 43.17]) in MRP1. Other significant factors for FN in any cycle were higher alanine aminotransferase (OR = 1.02 [1.01; 1.03]), carriers of the rs246221 variant C-allele (OR = 2.0 [1.03; 3.86]) in MRP1 and the rs351855 variant C-allele (OR = 2.48 [1.13; 5.44]) in FGFR4. Lower height (OR = 0.62 [0.41; 0.92]) increased risk of FN in the first cycle.

Conclusions: Both established clinical risk factors and genetic factors predicted FN in breast cancer patients. Prediction was improved by adding genetic information but overall remained limited. Internal validity was satisfactory. Further independent validation is required to confirm these findings.
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http://dx.doi.org/10.1186/1471-2407-14-201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994907PMC
March 2014