Publications by authors named "Philip Debruyne"

44 Publications

A phase II study of monalizumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: The I1 cohort of the EORTC-HNCG-1559 UPSTREAM trial.

Eur J Cancer 2021 Oct 9;158:17-26. Epub 2021 Oct 9.

Service d'Oncologie Médicale, Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, 1200 Brussels, Belgium. Electronic address:

Purpose: Monalizumab is a monoclonal antibody targeting the inhibitory natural killer group 2A (NKG2A) receptor localised on natural killer (NK) and T cells. Its ligand, the human leukocyte antigen E (HLA-E), is overexpressed in squamous cell carcinoma of the head and neck (SCCHN). By targeting the HLA-E-NKG2A pathway, monalizumab may enhance NK and T cell activity.

Experimental Design: The UPSTREAM trial is a biomarker-driven umbrella trial studying targeted therapies and immunotherapies in patients with recurrent/metastatic (R/M) SCCHN progressing after platinum therapy. The immunotherapy 1 (I1) cohort was a phase II, single-arm substudy evaluating monalizumab (10 mg/kg intravenously on day 1 of a 14-day cycle). The primary end-point was the objective response (OR) rate (Response Evaluation Criteria in Solid Tumours 1.1) over the first 16 weeks. A two-stage Simon design was used (H1 15%, H0 3%, α 8%, power 90%) with pre-planned interruption of accrual if no OR was observed after the first 25 patients.

Results: Twenty-six eligible patients were enrolled. Seventeen (65%) patients had received ≥2 previous lines of systemic treatment, and 15 (58%) patients were PD(-L)1 inhibitor pretreated. No OR was observed. Stable disease was observed in 6 patients (23%) with a median duration of 3.8 months (95% confidence interval [CI]: 2.7-NE). The median progression-free survival and overall survival were 1.7 months (95% CI: 1.5-1.8) and 6.7 months (95% CI: 3.0-9.6), respectively. The most frequent treatment-related adverse event was grade I/II fatigue (19%).

Conclusions: Monalizumab monotherapy has limited activity in R/M SCCHN. The I1 cohort did not meet its primary objective. Monalizumab combined with durvalumab is under investigation within UPSTREAM.
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http://dx.doi.org/10.1016/j.ejca.2021.09.003DOI Listing
October 2021

A randomised wait-list controlled trial to evaluate Emotional Freedom Techniques for self-reported cancer-related cognitive impairment in cancer survivors (EMOTICON).

EClinicalMedicine 2021 Sep 19;39:101081. Epub 2021 Aug 19.

Department of Medical Oncology, Kortrijk Cancer Centre, AZ Groeninge, Pres. Kennedylaan 4, Kortrijk B-8500, Belgium.

Background: Cancer-related cognitive impairment (CRCI) is a prevalent source of comprised quality of life in cancer survivors. This study evaluated the efficacy of Emotional Freedom Techniques (EFT) on self-reported CRCI (sr-CRCI).

Methods: In this prospective multicentre randomised wait-list controlled study (ClinicalTrials.gov Identifier: NCT02771028), eligible cancer survivors had completed curative treatment, were 18 years or older and screened positive for sr-CRCI with ≥ 43 on the Cognitive Failures Questionnaire (CFQ). Participants were randomised to the immediate treatment group (ITG) or wait-list control (WLC) group, based on age (< or ≥ 65 years), gender, treatment (chemotherapy or not), and centre. The ITG started to apply EFT after inclusion and performed this for 16 weeks. The WLC group could only start the application of EFT after 8 weeks of waiting. Evaluations took place at baseline (T0), 8 weeks (T1) and 16 weeks (T2). The primary outcome was the proportion of patients with sr-CRCI according to the CFQ score.

Findings: Between October 2016 and March 2020, 121 patients were recruited with CFQ ≥ 43 indicating sr-CRCI. At T1, the number of patients scoring positive on the CFQ was significantly reduced in the ITG compared to the WLC group (40.8% vs. 87.3% respectively; <0.01). For the WLC group, a reduction in CFQ scores was observed at T2, comparable to the effect of the ITG at T1. Linear mixed model analyses indicated a statistically significant reduction in the CFQ score, distress, depressive symptoms, fatigue and also an improvement in quality of life.

Interpretation: This study provides evidence for the application of EFT for sr-CRCI in cancer survivors and suggests that EFT may be useful for other symptoms in cancer survivors.
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http://dx.doi.org/10.1016/j.eclinm.2021.101081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385168PMC
September 2021

Multitumor Case Series of Germline , and -Mutated Patients Responding Favorably on Immune Checkpoint Inhibitors.

Curr Oncol 2021 08 24;28(5):3227-3239. Epub 2021 Aug 24.

Department of General Medical Oncology, Leuven Cancer Institute, University Hospitals Leuven, 3000 Leuven, Belgium.

In recent years, immune checkpoint inhibitors (ICPI) have become widely used for multiple solid malignancies. Reliable predictive biomarkers for selection of patients who would benefit most are lacking. Several tumor types with somatic or germline alterations in genes involved in the DNA damage response (DDR) pathway harbor a higher tumor mutational burden, possibly associated with an increased tumoral neoantigen load. These neoantigens are thought to lead to stronger immune activation and enhanced response to ICPIs. We present a series of seven patients with different malignancies with germline disease-associated variants in DDR genes (, , ) responding favorably to ICPIs.
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http://dx.doi.org/10.3390/curroncol28050280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8395488PMC
August 2021

Pain medication adherence in patients with cancer: a pragmatic review.

Pain Med 2021 Jan 27. Epub 2021 Jan 27.

Department of Medical Oncology, Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.

Objective: Adherence to pain medication in patients with cancer is crucial for successful pain therapy. This review aimed to investigate: the rate of adherence, which factors influence adherence, whether adherence differs in diverse patient populations, whether there are methods to improve adherence, and the relationship between adherence and pain relief.

Methods: This review was performed following the PRISMA guidelines. MEDLINE/Pubmed, Embase, Web Of Science, Cochrane and ClinicalTrials.gov were searched. All types of studies investigating adherence of patients with cancer, factors influencing adherence, and methods to improve adherence to pain medication were included. They were first screened on title and abstract and thereafter on full text. Selected articles were subjected to a quality assessment according to the PRISMA checklist. From included articles, study characteristics and outcomes were extracted.

Results: Out of 795 articles, 18 were included. Different methods were used to measure adherence, which led to adherence rates ranging from 8.9% to 82.0%. White Americans and men were found to be more adherent than African Americans and women. Due to various barriers, adherence is often suboptimal. Fear of addiction, physiological and harmful effects, tolerance, and disease progression are common concerns. Interventions, such as pain education booklets, pain consults, and specialised nurses, may be beneficial to increase the adherence. Lower adherence rates were associated with lower pain relief.

Conclusion: Adherence of cancer patients to pain medication is suboptimal. Health care workers should focus on barriers to increase the adherence in order to obtain a better pain relief.
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http://dx.doi.org/10.1093/pm/pnab010DOI Listing
January 2021

C-reactive protein and neutrophil-lymphocyte ratio are prognostic in metastatic clear-cell renal cell carcinoma patients treated with nivolumab.

Urol Oncol 2021 04 21;39(4):239.e17-239.e25. Epub 2021 Jan 21.

Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium. Electronic address:

Objective: To evaluate the impact of markers of systemic inflammation such as C-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR) on outcomes of metastatic clear-cell renal cell carcinoma (m-ccRCC) patients treated with nivolumab.

Patients And Methods: We retrospectively evaluated m-ccRCC patients treated with nivolumab and collected known prognostic factors and survival data. We used Kaplan-Meier survival analysis and cox proportional hazards regression analysis to study prognostic factors for overall survival (OS) and progression-free survival (PFS) since start of nivolumab. Harrell's C-index was used to evaluate the models.

Results: We included 113 patients. Median OS and PFS after initiation of nivolumab was 15 (interquartile range 7-28) and 4 months (interquartile range 3-11), respectively. Elevated baseline CRP was associated with worse OS (HR per 25 mg/l 1.35, 95% CI 1.16-1.52, P < 0.001) and PFS (HR per 25 mg/l 1.19, 95% CI 1.08-1.35, P = 0.001), independent from the international metastatic renal cell carcinoma database consortium (IMDC) prognostic criteria, increasing the model's C-index from 0.72 to 0.77 for OS and 0.59 to 0.62 for PFS. Elevated NLR was associated with worse OS (HR 1.10, 95% CI 1.04-1.17, P = 0.002) and PFS (HR 1.06, 95% CI 1.01-1.11, P = 0.03) independent from the other IMDC prognostic criteria. The model's C-index decreased from 0.72 to 0.70 for OS and increased from 0.59 to 0.60 for PFS.

Conclusions: Elevated baseline CRP and NLR predict worse OS and PFS on nivolumab in m-ccRCC patients. Including baseline CRP in the IMDC prognostic model improves its discriminatory power to predict OS and PFS since start of nivolumab.
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http://dx.doi.org/10.1016/j.urolonc.2020.12.020DOI Listing
April 2021

Unplanned hospitalizations in older patients with cancer: Occurrence and predictive factors.

J Geriatr Oncol 2021 04 19;12(3):368-374. Epub 2020 Nov 19.

Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address:

Background: This study aims to investigate the occurrence of unplanned hospitalizations in older patients with cancer and to determine predictive factors.

Methods: A prospective Belgian multicentre (n = 22), observational cohort study was performed. Patients ≥70 years with a malignant tumor were included. Patients underwent G8 screening followed by geriatric assessment (GA) if abnormal at baseline and were followed for unplanned hospitalizations at approximately three months. Uni- and multivariable regression models were performed to determine predictive factors associated with unplanned hospitalizations in older patients with an abnormal G8.

Results: In total, 7763 patients were included in the current analysis of which 2409 (31%) patients with a normal G8 score and 5354 (69%) with an abnormal G8 score. Patients with an abnormal G8 were hospitalized more frequently than patients with a normal G8 (22.9% versus 12.4%; p < 0.0001). Reasons for unplanned hospitalizations were most frequently cancer related (25.7%) or cancer therapy related (28%). In multivariable analysis, predictive factors for unplanned hospitalizations in older patients with cancer and an abnormal G8 were female gender, absence of surgery, chemotherapy, ADL dependency, malnutrition and presence of comorbidities.

Conclusion: Older patients with cancer and an abnormal G8 screening present a higher risk (23%) for unplanned hospitalizations. Predictive factors for these patients were identified and include not only patient and treatment related factors but also GA related factors.
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http://dx.doi.org/10.1016/j.jgo.2020.11.004DOI Listing
April 2021

Bone metastasis is associated with poor prognosis in metastatic papillary renal cell carcinoma patients treated with first agent angiogenesis inhibitors.

Urol Oncol 2020 08 17;38(8):686.e1-686.e9. Epub 2020 May 17.

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

Objective: Papillary renal cell carcinoma (papRCC) is a rare (10%-15%) subtype of renal cancer. Few prognostic biomarkers have been described in metastatic papRCC (m-papRCC) patients treated with vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs). We aimed to study the prognostic impact of bone metastases (BM) on response rate, progression-free and overall survival (PFS and OS) in patients with m-papRCC treated with first agent VEGFR-TKIs.

Patients And Methods: A multicentric, retrospective analysis of patient records was conducted. BM were detected by computed tomography and/or bone scintigraphy. The International Metastatic RCC Database Consortium (IMDC) score was calculated at start of first agent VEGFR-TKI treatment.

Results: Forty-nine patients were included. Best objective response was partial response in 20%, stable disease in 60% and early progressive disease in 20% of patients. Median PFS (mPFS) was 6.0 months and median OS (mOS) 14.0 months after start of first agent VEGFR-TKI. The IMDC score correlated with mOS: 77.5 months in good, 17.0 months in intermediate and 8.0 months in poor risk patients (P = 0.002). Patients with BM had a poorer outcome compared to patients without BM: mPFS was 4.0 vs. 7.0 months (P = 0.006) and mOS 7.5 vs. 19.0 months (P = 0.002). On bivariate analysis, the presence of BM was independently associated with PFS (P = 0.02) and OS (P = 0.049), independent of the IMDC risk groups.

Conclusion: In m-papRCC patients treated with first agent VEGFR-TKIs, the presence of BM is an unfavorable prognostic factor, associated with shorter PFS and OS.
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http://dx.doi.org/10.1016/j.urolonc.2020.04.031DOI Listing
August 2020

The prognostic value of patient-reported Health-Related Quality of Life and Geriatric Assessment in predicting early death in 6769 older (≥70 years) patients with different cancer tumors.

J Geriatr Oncol 2020 07 16;11(6):926-936. Epub 2020 Apr 16.

Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium; Department of Oncology, KU Leuven, Leuven, Belgium.

Objectives: We aimed to determine the prognostic value of baseline Health-Related Quality Of Life (HRQOL) and geriatric assessment (GA) to predict three-month mortality in older patients with cancer undergoing treatment.

Methods: Logistic regressions analysed HRQOL, as measured with the EORTC Global Health Status (GHS) scale, and geriatric information prognostic for early mortality controlling for oncology variables. The assessment was established with the odds ratio (OR), 95% confidence interval (CI) and level of significance set at p < 0.05. Discriminative power was evaluated with area under the curve (AUC).

Results: In total, 6769 patients were included in the study, of whom 1259 (18.60%) died at three months. Our model showed higher odds of early death for patients with lower HRQOL (GHS, OR 0.98, 95% CI 0.98-0.99; p < 0.001), a geriatric risk profile (G8 Screening Tool, 1.94, 1.14-3.29; p = 0.014), cognitive decline (Mini Mental State Examination, 1.41, 1.15-1.72; p = 0.001), being at risk for malnutrition (Mini Nutritional Assessment-Short Form, 1.54, 1.21-1.98; p = 0.001), fatigue (Visual Analogue Scale for Fatigue, 1.45, 1.16-1.82; p = 0.012) and comorbidities (Charlson Comorbidity index, 1.23, 1.02-1.49; p = 0.033). Additionally, older age, poor ECOG PS and being male increased the odds of early death, although the magnitude differed depending on tumor site and stage, and treatment (all p < 0.05). Predictive accuracy increased with 3.7% when including HRQOL and GA in the model.

Conclusion: The results suggest that, in addition to traditional clinical measures, HRQOL and GA provide additional prognostic information for early death, but the odds differ by patient and tumor characteristics.
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http://dx.doi.org/10.1016/j.jgo.2020.03.017DOI Listing
July 2020

PSMA expression on neovasculature of solid tumors.

Histol Histopathol 2020 Sep 13;35(9):919-927. Epub 2020 Apr 13.

Department of Nuclear Medicine, AZ Groeninge, Kortrijk, Belgium.

The use of prostate specific membrane antigen (PSMA) binding agents, labelled with diagnostic and therapeutic radio-isotopes is opening the potential for a new era of personalized management of prostate carcinoma. A wide variety of immunohistochemistry studies have shown PSMA also to be upregulated on the endothelial cells of the neovasculature of a wide variety of other solid tumors where it may facilitate endothelial cell sprouting and invasion through its regulation of lytic proteases that have the ability to cleave the extracellular matrix. Similar to the introduction of PSMA-targeting theranostics in prostate carcinoma, overexpression of PSMA on newly formed tumor vessels may serve as a target for imaging and subsequent treatment of cancer through the use of agents that are capable of blocking PSMA in its function or through PSMA-mediated delivery of chemotherapeutics or radiation agents. In this review, the available data on PSMA expression on tumor neovasculature in human solid tumors assessed by using immunohistochemistry are discussed.
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http://dx.doi.org/10.14670/HH-18-215DOI Listing
September 2020

Quality of blood samples collected at home does not affect clinical decision making for the administration of systemic cancer treatment.

Scand J Clin Lab Invest 2020 May;80(3):215-221

Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.

The aim of this exploratory clinical study was to evaluate whether the preanalytical quality of blood samples subjected to delayed centrifugation and transport - as a result of home-sampling - is affected in a way it alters the clinical decision-making for patients under systemic cancer therapy. This evaluation is part of a comprehensive investigation of the opportunities for oncological home-hospitalization. Forty-nine patients with cancer donated two additional blood samples during their ambulatory hospital visit. Fifteen blood analytes were compared between routine blood samples and samples that were subjected to transport and delayed centrifugation in order to mimic a locally implemented model for oncological home-hospitalisation. Deviations were analysed by means of Deming regression. For those analytes showing statistically significant intercepts and/or slopes, the mean deviations were compared to the desirable analytical bias; and the intra-individual differences were compared with the limits for clinical decision-making. Statistically significant intercepts and/or slopes were observed for haematocrit (HCT), mean cellular volume (MCV), platelets count (PLT) and C-reactive protein (CRP). Differences exceeding the allowable margins of desirable analytical bias were observed for HCT and MCV. Risk of different clinical decision-making couldn't be observed for any of the analytes showing statistically significant differences. These results demonstrate that home-collection of blood samples, transported at room temperature and centrifuged within a mean time of five hours after sampling, has no effect on clinical decision-making with regards to systemic cancer therapy. However, attention should be paid to the potential occurrence of haemolysis during the preanalytical phase, which can negatively influence haemolysis-dependent variables.
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http://dx.doi.org/10.1080/00365513.2020.1716267DOI Listing
May 2020

Effectiveness of Adjunctive Analgesics in Head and Neck Cancer Patients Receiving Curative (Chemo-) Radiotherapy: A Systematic Review.

Pain Med 2021 02;22(1):152-164

Department of Medical Oncology, Kortrijk Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.

Objective: Our aim was to give an overview of the effectiveness of adjunctive analgesics in head and neck cancer (HNC) patients receiving (chemo-) radiotherapy.

Design: Systematic review.

Interventions: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov were searched for studies concerning "head neck cancer," "adjunctive analgesics," "pain," and "radiotherapy."

Outcome Measures: Pain outcome, adverse events, and toxicity and other reported outcomes, for example, mucositis, quality of life, depression, etc.

Results: Nine studies were included in our synthesis. Most studies were of low quality and had a high risk of bias on several domains of the Cochrane Collaboration tool. Only two studies comprised high-quality randomized controlled trials in which pregabalin and a doxepin rinse showed their effectiveness for the treatment of neuropathic pain and pain from oral mucositis, respectively, in HNC patients receiving (chemo-) radiotherapy.

Conclusions: More high-quality trials are necessary to provide clear evidence on the effectiveness of adjunctive analgesics in the treatment of HNC (chemo-) radiation-induced pain.
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http://dx.doi.org/10.1093/pm/pnaa044DOI Listing
February 2021

Quantification of 18F-fluorodeoxyglucose uptake to detect residual nodal disease in locally advanced head and neck squamous cell carcinoma after chemoradiotherapy: results from the ECLYPS study.

Eur J Nucl Med Mol Imaging 2020 05 10;47(5):1075-1082. Epub 2020 Feb 10.

Department of Nuclear Medicine, Antwerp University Hospital, Edegem, Belgium.

Background: The Hopkins criteria were introduced for nodal response evaluation after therapy in head and neck cancer, but its superiority over quantification is not yet confirmed.

Methods: SUV thresholds and lesion-to-background ratios were explored in a prospective multicenter study of standardized FDG-PET/CT 12 weeks after CRT in newly diagnosed locally advanced head and neck squamous cell carcinoma (LAHNSCC) patients (ECLYPS). Reference standard was histology, negative FDG-PET/CT at 12 months after treatment or ≥ 2 years of negative follow-up. Area under the receiver operator characteristics curves (AUROC) were estimated and obtained thresholds were validated in an independent cohort of HNSCC patients (n = 127).

Results: In ECLYPS, 124 patients were available for quantification. With a median follow-up of 20.4 months, 23 (18.5%) nodal neck recurrences were observed. A SUV threshold of 2.2 (AUROC = 0.89; sensitivity = 79.7%; specificity = 80.8%) was identified as optimal metric to identify nodal recurrence within 1 year after therapy. For lesion-to-background ratios, an SUV/SUV threshold of 0.96 (AUROC = 0.89; sensitivity = 79.7%; specificity = 82.8%) had the best performance. Compared with Hopkins criteria (AUROC = 0.81), SUV and SUV/SUV provided a borderline significant (p = 0.040 and p = 0.094, respectively) improvement. Validation of thresholds yielded similar AUROC values (SUV = 0.93, SUV/SUV = 0.95), and were comparable to the Hopkins score (AUROC = 0.91; not statistically significant).

Conclusion: FDG quantification detects nodal relapse in LAHNSCC patients. When using EARL standardized PET acquisitions and reconstruction, absolute SUV metrics (SUV threshold 2.2) prove robust, yet ratios (SUV/SUV, threshold 0.96) may be more useful in routine clinical care. In this setting, the diagnostic value of quantification is comparable to the Hopkins criteria.

Trial Registration: US National Library for Medicine, NCT01179360. Registered 11 August 2010, https://clinicaltrials.gov/ct2/show/NCT01179360.
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http://dx.doi.org/10.1007/s00259-020-04710-4DOI Listing
May 2020

Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: A case-control study.

J Geriatr Oncol 2020 03 14;11(2):320-326. Epub 2019 Oct 14.

Department of Medical Oncology, Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium; Positive Ageing Research Institute (PARI), Anglia Ruskin University, Chelmsford, UK. Electronic address:

Objectives: We aimed to determine the proportion of "fit" versus "vulnerable" older patients with cancer included in phase II and III oncology registration trials, as compared to the proportions in a real life oncology setting.

Methods: Trial and patient characteristics of older (≥70years) patients treated at the OECI-designated clinical cancer centre in Kortrijk and included in a phase II or III oncology registration trial were collected retrospectively. These patients were matched individually with randomly-selected patients from the general oncology setting, based on gender, age, tumour type, tumour stage, and treatment intent. Patients' fitness, based on routine Geriatric-8 (G8) screening, was retrieved from prospectively constructed databases.

Results: Between November 2012 and October 2018, 218 older patients with cancer were included in a phase II or III oncology registration trial. Of those, 41 cases with a mean age of 76.0years were included in the analyses. A Fisher's Exact Test revealed a statistical significant difference between cases and matched controls, with a higher proportion of "fit" patients included in phase II or III oncology registration trials compared to the proportion in the matched control group (respectively 70.7% and 41.5%, p<.010).

Discussion: We provide evidence for the hypothesis that older patients included in phase II or III oncology trials are significantly fitter than the real life oncology population. Some form of geriatric evaluation should be integrated in future cancer clinical trials to enable stratification according to this parameter and allow subgroup analysis. This will broaden the application and interpretation of trial results.
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http://dx.doi.org/10.1016/j.jgo.2019.09.003DOI Listing
March 2020

An observational pilot study to evaluate the feasibility and quality of oncological home-hospitalization.

Eur J Oncol Nurs 2019 Jun 23;40:44-52. Epub 2019 Mar 23.

Cancer Centre, General Hospital Groeninge, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. Electronic address:

Purpose: The objective of this pilot study was to evaluate the feasibility of oncological home-hospitalization and to compare its quality with standard ambulatory hospital care in terms of patient-reported quality of life and related endpoints by means of a set of validated patient-reported outcome measures (PROMs).

Methods: An observational cohort study (clinicaltrials.gov identifier: NCT03073499) was conducted, allocating patients to (partial) home-hospitalization or standard ambulatory hospital care. PROMs were completed by both cohorts at start of treatment and eight weeks later. An additional study-specific questionnaire was presented to the intervention cohort at study-end assessing their satisfaction with and preferences for the provided homecare.

Results: Thirty patients received home-hospitalization, corresponding to 116 interventions. For twenty-eight patients, this comprised all assessments required prior to administration of treatment, which resulted in a significant reduction of waiting time for treatment administration at the hospital in comparison with the control cohort (n = 24) (average reduction of 1:12 h, p < 0.001). Two patients received actual subcutaneous therapy at home. None of the PROM's evaluated revealed significant differences between both cohorts (all p > 0.05). 29/30 patients of the intervention cohort were satisfied with the provided homecare and preferred to have it continued, 22/25 patients declared to feel at home at least as safe as in the hospital. No serious safety concerns were reported.

Conclusion: The results of this pilot study suggest that (partial) oncological home-hospitalization is feasible, safe and statistically not affecting patient-reported quality of life. Furthermore, this care model was acceptable and preferred by a substantial number of cancer patients.
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http://dx.doi.org/10.1016/j.ejon.2019.03.003DOI Listing
June 2019

Screening Methods for Age-Related Hearing Loss in Older Patients with Cancer: A Review of the Literature.

Geriatrics (Basel) 2018 Aug 2;3(3). Epub 2018 Aug 2.

Cancer Centre, Department of Medical Oncology, General Hospital Groeninge, B-8500 Kortrijk, Belgium.

As people grow older, they may experience loss in hearing sensitivity. Age-related hearing loss may negatively affect the patient's quality of life as it may lead to social isolation. In older patients with cancer, hearing loss can seriously interfere with the patient's ability to deal properly with all aspects of their disease, and may have a cumulative effect on their already decreased quality of life. Therefore, the proper screening of those conditions is essential in order to optimise the patient's comfort during and after treatment. This review article aims at providing a concise image of the nature of age-related hearing loss, and provides an overview of the screening methods that could be used in older patients with cancer.
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http://dx.doi.org/10.3390/geriatrics3030048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319208PMC
August 2018

Health related quality of life in older patients with solid tumors and prognostic factors for decline.

J Geriatr Oncol 2019 11 18;10(6):895-903. Epub 2019 Apr 18.

Department of General Medical Oncology, University Hospitals Leuven, Department of Oncology, KU Leuven, Leuven, Belgium.

Objectives: This study aims to investigate health-related quality of life (HRQOL) at baseline and at follow-up in older patients with cancer and to determine prognostic factors for HRQOL decline.

Methods: A prospective Belgian multicentre (n = 22) study was performed. Patients ≥70 years with a malignant tumor and abnormal G8 (≤14/17) screening tool were included. Patients underwent geriatric assessment (GA) and HRQOL evaluation with follow up at three months. Uni- and multivariate regression models were performed to determine factors associated (p < .05) with baseline HRQOL and HRQOL decline at follow-up.

Results: Results reflect data collected from 3673 patients. A multivariate analysis showed that younger patients, and those with poor Eastern Cooperative Oncology Group - Performance Status (ECOG-PS), specific tumor types (gastrointestinal, gynaecological and thorax) and higher stage had lower baseline HRQOL. In addition worse functional status and presence of pain, fatigue, depression and malnutrition were associated with lower baseline HRQOL. During treatment (n = 2972), improvement in HRQOL was observed in 1037 patients (35%) and a decline in 838 patients (28.2%). In multivariate analysis, stage and presence of baseline comorbidities, pain, fatigue or malnutrition were associated with HRQOL evolution.

Conclusion: Baseline HRQOL in older patients with cancer and an abnormal G8 depends on tumor and age related parameters. During follow-up, HRQOL improved in one third of patients, indicating that they may benefit from cancer treatment while one quarter demonstrated a HRQOL decline for which prognostic factors were identified.
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http://dx.doi.org/10.1016/j.jgo.2019.03.018DOI Listing
November 2019

Shifting specialized oncological care from hospital- to home-setting: is there support among patients, specialists and general practitioners?

Acta Clin Belg 2020 Aug 19;75(4):250-257. Epub 2019 Apr 19.

Cancer Centre, General Hospital Groeninge , Kortrijk, Belgium.

Objectives: Oncological home-hospitalization (OHH) might be a patient-centred approach to deal with the increasing burden of cancer on health-care facilities and finances. Before implementation into practice, its feasibility, costs and support among stakeholders should be evaluated. The purpose of this trial was to explore patients', specialists' and general practitioners' (GPs) perspectives towards the opportunities of implementing OHH within the Belgian health-care system.

Methods: A regional cross-sectional survey study was launched in order to investigate the stakeholders' views on OHH and the current cancer care focusing on integration of primary care and continuous care.

Results: Of the responders, 37 out of 163 patients (23%), 45 of 62 GPs (73%) and 10 of 15 specialists (67%) feel positive about the opportunities for OHH. Nevertheless, 11/15 specialists (73%) and 51/62 GPs (82%) feel primary care might currently be (too) little involved in order to ensure continuous care for cancer patients. Opportunities for improved continuous care are seen in better communication between primary care and hospital, and more patient contacts for primary care during the cancer treatment process.

Conclusion: The results of this local survey study demonstrated there is support among different stakeholder groups for the implementation of OHH within the Belgian health-care context. However, some barriers impeding transmural continuous care should be tackled before implementing such model into practice. Better communication between health-care professionals and more patients contacts are suggested, and an adjusted legal and financial framework is required.
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http://dx.doi.org/10.1080/17843286.2019.1605467DOI Listing
August 2020

Detection of alcohol abuse in older patients with cancer: The integration of alcohol screening questionnaires in the comprehensive geriatric assessment.

J Geriatr Oncol 2019 09 26;10(5):819-823. Epub 2019 Feb 26.

Department of Medical Oncology, Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium; Positive Ageing Research Institute, Anglia Ruskin University, Chelmsford, UK. Electronic address:

Objectives: We aimed to evaluate the feasibility of implementing an alcohol screening questionnaire as part of the comprehensive geriatric assessment (CGA) by reporting the prevalence of alcohol abuse in a group of older patients with cancer in a Belgian cancer centre.

Materials And Methods: Patients were recruited at the Geriatric Oncology Clinic of the Kortrijk Cancer Centre and were evaluated by use of a CGA. Two alcohol screening questionnaires were integrated into the CGA: the Cutdown-Annoyed-Guilty-Eye-opener (CAGE) questionnaire and the Alcohol Use Disorders Identification Test-screening version (AUDIT-C).

Results: 193 patients with a mean age of 77.7 years were included in the analyses. Abnormal scores on the CAGE were detected in 6.3% of males and 1.2% of women. Abnormal results on the AUDIT-C were noticed in 30.0% of men, and in 21.7% of women. A regression analysis could not find a significant effect of the CAGE questionnaire when entered as predictor for CGA domain scores. Regarding the AUDIT-C, significant results were detected for predicting the score of the Geriatric-8 questionnaire and polypharmacy in men, and the Independent Activities of Daily Living questionnaire in women. No association with one-year survival was detected for either alcohol screening questionnaire.

Discussion: It is feasible to implement an alcohol screening questionnaire as part of a CGA as results indicated a rather high level of alcohol abuse in this cohort.
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http://dx.doi.org/10.1016/j.jgo.2019.02.009DOI Listing
September 2019

Subjective, but not objective, cognitive complaints impact long-term quality of life in cancer patients.

J Psychosoc Oncol 2019 Jul-Aug;37(4):427-440. Epub 2019 Feb 23.

a Department of Medical Oncology , Cancer Centre, General Hospital Groeninge , Kortrijk , Belgium.

Objectives: Cognitive complaints, of objective or subjective nature, may negatively impact cancer patients' quality of life (QoL). Further, the early detection of cognitive alterations may lead to an improved QoL. However, the content of such screening is yet unclear. This paper presents long-term QoL data of cancer patients treated with curative intent and its relation with objective and subjective cognitive complaints, and patient-reported outcome measures (PROMs).

Methods: QoL data, measured by the EORTC QLQ C-30, were obtained at baseline, 6 (T1), 12 (T2), and 24 months (T3) after treatment start, and compared between patients with and without objective and subjective cognitive complaints. The predictive value of PROMs was also examined.

Results: QoL data at baseline was collected in 125 patients. Response rates at T1, T2, and T3 were 84.7%, 81.5%, and 83.1%, respectively. Eighty-nine patients returned their QoL questionnaires at all times. Baseline subjective cognitive complaints had a stronger association with worse scores on patients' overall QoL and QoL subscale scores than objective cognitive complaints. An exploratory analysis into the value of PROMs in predicting long-term QoL at T3 revealed a significant effect for the Hospital Anxiety and Depression Scale-Depression and FACIT Fatigue scale.

Conclusions: Self-perceived cognitive alterations are negatively associated with patients' overall QoL. As these troubles may already be present at baseline, oncology nurses should screen for the early signs of subjective cognitive complaints by use of PROMs, in order to refer the patient to proper intervention programs which may lead to an improved long-term QoL and faster reintegration into society.
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http://dx.doi.org/10.1080/07347332.2018.1504154DOI Listing
March 2020

The added value of an assessment of the patient's hand grip strength to the comprehensive geriatric assessment in G8-abnormal older patients with cancer in routine practice.

J Geriatr Oncol 2019 11 11;10(6):931-936. Epub 2019 Jan 11.

Department of Medical Oncology, Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium; Positive Ageing Research Institute, Faculty of Health, Social Care and Education, Anglia Ruskin University, Chelmsford, UK. Electronic address:

Objectives: A comprehensive geriatric assessment (CGA) is the key treatment approach to guide decisions in older patients with cancer. In this paper, the added value of an assessment of the patient's hand grip strength to predict survival in patients with an abnormal G8-questionnaire (G8) score is investigated.

Materials And Methods: Patients were screened by the G8, followed by a CGA in case of an abnormal screening (≤14.0). Hand grip strength was assessed by use of the JAMAR® hydraulic hand dynamometer. Cut-offs were applied according to the Fried frailty criteria. The survival rate was calculated twelve months after the CGA date.

Results: We retrospectively reviewed data of 2071 patients who were treated at the Kortrijk Geriatric Oncology Clinic (General Hospital Groeninge, Belgium) between November 2012 and December 2016. Of those, 944 patients with a mean age of 79.6 years were included in the analyses. 64.2% of patients presented an abnormal hand grip strength score. A log rank test revealed a statistical significant result between patients when accounting for the hand grip strength score (p < .01). When added to a Cox regression model, a significant result was found (p < .01). However, this added only 0.4% to the explained variance of the model.

Discussion: While a statistically significant result was detected, when adding the hand grip strength score to a regression model for survival, our data indicate that such assessment may clinically be less relevant when included in an already extensive test battery and may therefore provide only limited information in terms of patient survival.
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http://dx.doi.org/10.1016/j.jgo.2019.01.001DOI Listing
November 2019

Fibroblast Growth Factor Receptor-2 Polymorphism rs2981582 is Correlated With Progression-free Survival and Overall Survival in Patients With Metastatic Clear-cell Renal Cell Carcinoma Treated With Sunitinib.

Clin Genitourin Cancer 2019 04 16;17(2):e235-e246. Epub 2018 Nov 16.

Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, KU Leuven, Leuven, Belgium; Inserm UMR1162 Génomique Fonctionnelle des Tumeurs Solides, Université Paris-5 René Descartes, Paris, France. Electronic address:

Background: There are no validated markers that predict response or resistance in patients with metastatic clear-cell renal cell carcinoma (mccRCC) treated with vascular endothelial growth factor receptor tyrosine kinase inhibitors such as sunitinib and pazopanib. Recently, single nucleotide polymorphism (SNP) rs2981582 in Fibroblast Growth Factor Receptor 2 (FGFR2) was found to be associated with clinical outcome in patients with mccRCC treated with pazopanib and sunitinib. We aimed to validate these findings in patients treated with sunitinib.

Materials And Methods: Germline DNA was collected in patients with mccRCC starting first-line systemic therapy with sunitinib. SNP rs2981582 in FGFR2 C>T was genotyped. Association of the genotype with response rate, tumor shrinkage, median progression-free survival (mPFS), and median overall survival (mOS) was studied.

Results: We collected clinical data from 154 patients with available germline DNA. Baseline prognostic markers were well-balanced between both subgroups. Patients with the TT genotype had a poorer outcome compared with patients with the CT/CC genotype. The median shrinkage of selected tumor target lesions during treatment with sunitinib was -16% versus -31% (P = .002), mPFS was 8 versus 15 months (P = .0007), and mOS was 22 versus 33 months (P = .04), respectively. On multivariate analysis, rs2981582 remained an independent predictor of PFS (hazard ratio, 2.858; 95% confidence interval, 1.659-4.923; P < .0001) and OS (hazard ratio, 1.795; 95% confidence interval, 1.003-3.212; P = .049).

Conclusion: Polymorphism rs2981582 in FGFR2 is correlated to PFS and OS in patients with mccRCC treated with sunitinib. Prospective validation of the impact of this SNP is warranted.
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http://dx.doi.org/10.1016/j.clgc.2018.11.002DOI Listing
April 2019

ABCG2 Polymorphism rs2231142 and hypothyroidism in metastatic renal cell carcinoma patients treated with sunitinib.

Acta Clin Belg 2019 Jun 23;74(3):180-188. Epub 2018 May 23.

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

Background And Aim: Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) cause significant adverse events including thyroid dysfunction, mainly hypothyroidism, in a considerable proportion of patients. In a series of metastatic renal cell carcinoma (mRCC) patients treated with sunitinib, we aimed to study the correlation between hypothyroidism and single nucleotide polymorphisms (SNPs) in genes involved in sunitinib pharmacokinetics and pharmacodynamics.

Patients And Methods: We included 79 mRCC patients who started sunitinib between November 2005 and March 2016. Serum thyroid function markers were collected at start and during sunitinib therapy. Germ-line DNA genotyping for 16 SNPs in 8 candidate genes was performed. Endpoints were time to increase in thyroid stimulating hormone (TSH) and time to decrease in T4 or free T4 (FT4) on day 1 and day 28 of each sunitinib cycle.

Results: Patients with the ABCG2 rs2231142 CC-genotype had a significantly longer time-to-TSH-increase on day 1 (11 vs. 5 cycles; p = 0.0011), and time-to-T4/FT4-decrease on day 1 (not reached vs. 10 cycles; p = 0.013) and day 28 (28 vs. 7 cycles; p = 0.03) compared to CA-carriers. Patients with the CYP3A5 rs776746 GG-genotype had a significantly longer time-to-TSH-increase at day 1 compared to GA-patients: 11 vs. 5 cycles (p = 0.0071). Significant associations were also found between PDGFRA rs35597368 and rs1800812 and time-to-TSH-increase at day 28.

Conclusion: Polymorphism rs2231142 in the efflux pump ABCG2 is associated with hypothyroidism in mRCC patients treated with sunitinib.
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http://dx.doi.org/10.1080/17843286.2018.1477229DOI Listing
June 2019

Organization, quality and cost of oncological home-hospitalization: A systematic review.

Crit Rev Oncol Hematol 2018 Jun 10;126:145-153. Epub 2018 Apr 10.

Cancer Centre, General Hospital Groeninge, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium. Electronic address:

Background: Home-hospitalization might be a patient-centred approach facing the increasing burden of cancer on societies. This systematic review assessed how oncological home-hospitalization has been organized and to what extent its quality and costs were evaluated.

Results: Twenty-four papers describing parenteral cancer drug administration to adult patients in their homes were included. Most papers concluded oncological home-hospitalization had no significant effect on patient-reported quality of life (7/8 = 88%), but large majority of patients were satisfied (12/13, 92%) and preferred home treatment (7/8, 88%). No safety risks were associated with home-hospitalization (10/10, 100%). The cost of home-hospitalization was found beneficial in five trials (5/9, 56%); others reported no financial impact (2/9, 22%) or additional costs (2/9, 22%).

Conclusion: Despite heterogeneity, majority of reported models for oncological home-hospitalization demonstrated that this is a safe, equivalent and acceptable alternative to ambulatory hospital care. More well-designed trials are needed to evaluate its economic impact.
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http://dx.doi.org/10.1016/j.critrevonc.2018.03.011DOI Listing
June 2018

The use of uHear™ to screen for hearing loss in older patients with cancer as part of a comprehensive geriatric assessment.

Acta Clin Belg 2018 Apr 24;73(2):132-138. Epub 2017 Oct 24.

b Department of Radiotherapy and Experimental Cancer Research , Ghent University , Ghent , Belgium.

Objective: We previously validated uHear™ to screen for hearing loss in older patients with cancer without a known hearing loss, as part of a comprehensive geriatric assessment (CGA). In view of low specificity, we tested a new modified uHear™ scoring system as described by Handzel.

Methods: Patients, aged ≥70 years, were evaluated by uHear™ and conventional audiometry, which is considered the gold standard, as part of a CGA. The pass or fail screening cut-off for uHear™ was defined as having ≥2 consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 to 2.0 kHz (modified Handzel-uHear™ scoring system). To accept the modified Handzel-uHear™ as screening tool, it was predefined that the combined sensitivity (S) and specificity (Sp) of the test (S + Sp/2) was at least 80% and that an actual combined (S + Sp)/2 of 90% would be found.

Results: Ninety ears (45 subjects) were tested. Of those ears, 24.4% were identified as impaired by conventional audiometry. Modified Handzel-uHear™ identified 26.7% of tested ears as impaired. The combined (S + Sp)/2 of the modified Handzel-uHear™ was calculated as 77.5%, while in previous cohort, this was retrospectively calculated as 94.6%. A new uHear™ scoring system was proposed and tested in current and previous cohort. A (S + Sp)/2 of 80.2 and 78.8%, respectively, were obtained.

Conclusion: uHear™ is a feasible tool for use within the CGA and shows promising results. However, further research is warranted to optimize the cut-off method before it could be routinely implemented within geriatric oncology.
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http://dx.doi.org/10.1080/17843286.2017.1392070DOI Listing
April 2018

Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography After Concurrent Chemoradiotherapy in Locally Advanced Head-and-Neck Squamous Cell Cancer: The ECLYPS Study.

J Clin Oncol 2017 Oct 30;35(30):3458-3464. Epub 2017 Aug 30.

Tim Van den Wyngaert, Nils Helsen, Laurens Carp, Carl G. Van Laer, Jan B. Vermorken, and Sigrid Stroobants, Antwerp University Hospital, Edegem; Tim Van den Wyngaert, Laurens Carp, and Sigrid Stroobants, University of Antwerp, Wilrijk; Michel J. Martens, Algemeen Ziekenhuis (AZ) Turnhout, Turnhout; Isabel Hutsebaut and Sabine A.E. Meersschout, AZ Sint-Jan, Brugge; Philip R. Debruyne, AZ Groeninge, Kortrijk; Annelies L.M. Maes, Jessa Ziekenhuis, Hasselt; Joost van Dinther, Sint-Augustinus Hospital; Olivier Lenssen and Danielle Van den Weyngaert, Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium; Sara Hakim, Otto S. Hoekstra, and Remco De Bree, Vrije Universiteit Medical Center, Amsterdam; Remco De Bree, University Medical Center Utrecht, Utrecht, the Netherlands; and Philip R. Debruyne, Anglia Ruskin University, Chelmsford, United Kingdom.

Purpose To assess the standardized implementation and reporting of surveillance [F]fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scan of the neck in locoregionally advanced head-and-neck squamous cell carcinoma (LAHNSCC) after concurrent chemoradiotherapy (CCRT). Patients and Methods We performed a prospective multicenter study of FDG-PET/CT scanning 12 weeks after CCRT in newly diagnosed patients with LAHNSCC (stage IVa/b) that used standardized reconstruction and Hopkins reporting criteria. The reference standard was histology or > 12 months of clinical follow-up. The primary outcome measure was the negative predictive value (NPV) of FDG-PET/CT scans and other supporting diagnostic test characteristics, including time dependency with increasing follow-up time. Results Of 152 patients, 125 had adequate primary tumor control after CCRT and entered follow-up (median, 20.4 months). Twenty-three (18.4%) had residual neck disease. Overall, NPV was 92.1% (95% CI, 86.9% to 95.3%; null hypothesis: NPV = 85%; P = .012) with sensitivity of 65.2% (95% CI, 44.9% to 81.2%), specificity of 91.2% (95% CI, 84.1% to 95.3%), positive predictive value of 62.5% (95% CI, 45.5% to 76.9%), and accuracy of 86.4% (95% CI, 79.3% to 91.3%). Sensitivity was time dependent and high for residual disease manifesting up to 9 months after imaging but lower (59.7%) for disease detected up to 12 months after imaging. Standardized reporting criteria reduced the number of equivocal reports (95% CI for the difference, 2.6% to 15.0%; P = .003). Test characteristics were not improved with the addition of lymph node CT morphology criteria. Conclusion FDG-PET/CT surveillance using Hopkins criteria 12 weeks after CCRT is reliable in LAHNSCC except for late manifesting residual disease, which may require an additional surveillance scan at 1 year after CCRT to be detected.
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http://dx.doi.org/10.1200/JCO.2017.73.5845DOI Listing
October 2017

The distress thermometer predicts subjective, but not objective, cognitive complaints six months after treatment initiation in cancer patients.

J Psychosoc Oncol 2017 Nov-Dec;35(6):741-757. Epub 2017 Aug 17.

a Division of Medical Oncology , Cancer Centre, General Hospital Groeninge , Kortrijk , Belgium.

Objectives: Research has indicated that cancer-related cognitive impairments (CRCI) may be influenced by psychosocial factors such as distress, worry and fatigue. Therefore, we aimed to validate the distress thermometer (DT) as a screening tool to detect CRCI six months post-treatment-initiation in a group of general cancer patients.

Methods: Patients (≥18 years, n = 125) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated at baseline (T0) and six months post-treatment-initiation (T1) for CRCI by a neuropsychological assessment, including patient-reported outcome measures (PROMs). Assessed cognitive domains included premorbid intelligence, attention, processing speed, flexibility, verbal and visual episodic memory and verbal fluency. PROMs entailed distress (DT, cut-off ≥4, range 0-10), anxiety and depression, fatigue (FACIT-fatigue scale) and subjective cognitive complaints.

Results: At T0, 60.4% of patients showed a DT score of ≥4, whereas 50% met this criterion at T1. According to the definition of the International Cognition and Cancer Task Force, 25.5% and 28.3% of patients presented with a CRCI at T0 and T1, respectively. When evaluating the DT as a screening tool for CRCI at T1, data showed an inverse relationship between the DT and CRCI. ROC-curve analysis revealed an AUC <0.5. ROC-curve analyses evaluating the DT and FACIT-fatigue scale as screening tools for subjective cognitive complaints showed an AUC ± SE of, respectively, 0.642 ± 0.067 and 0.794 ± 0.057.

Conclusions: The DT at T0 cannot be used to screen for objective CRCI at T1, but both the DT and FACIT-fatigue scale at T0 showed potential as screening tools for subjective cognitive complaints at T1.
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http://dx.doi.org/10.1080/07347332.2017.1365798DOI Listing
December 2017

PARTNER: An open-label, randomized, phase 2 study of docetaxel/cisplatin chemotherapy with or without panitumumab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck.

Oral Oncol 2016 10 20;61:31-40. Epub 2016 Aug 20.

Amgen Inc., Thousand Oaks, CA, USA.

Objective: This phase 2 estimation study evaluated docetaxel/cisplatin with/without panitumumab, an anti-epidermal growth factor receptor monoclonal antibody, as first-line therapy for recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).

Patients And Methods: Randomized patients received docetaxel/cisplatin (75mg/m(2) each) with/without panitumumab (9mg/kg) in 21-day cycles. Patients randomized to panitumumab+chemotherapy could continue panitumumab monotherapy after completing six chemotherapy cycles without progression; patients randomized to chemotherapy alone could receive second-line panitumumab after progression. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints included overall survival (OS), overall response rate (ORR), time to response (TTR), duration of response (DOR), and safety. A protocol amendment limited enrollment to patients <70years owing to excess toxicity in older patients and added mandatory pegfilgrastim/filgrastim support. Outcomes were also analyzed by human papillomavirus status.

Results: 103 of the 113 enrolled patients were evaluable and randomized to receive ⩾1 dose of first-line treatment. Median PFS for panitumumab+chemotherapy was 6.9 (95% CI=4.7-8.3) months versus 5.5 (95% CI=4.1-6.8) months for chemotherapy alone (hazard ratio [HR]=0.629; 95% CI=0.395-1.002; P=0.048). ORR for panitumumab+chemotherapy was 44% (95% CI=31-58%) versus 37% (95% CI=24-51%) for chemotherapy alone (odds ratio [OR]=1.37; 95% CI=0.57-3.33). Median OS for panitumumab+chemotherapy was 12.9 (95% CI=9.4-18.5) months versus 13.8 (95% CI=11.8-22.9) months for chemotherapy alone (HR=1.103; 95% CI=0.709-1.717). Median TTR for panitumumab+chemotherapy treatment was 6.9weeks versus 11.0weeks for chemotherapy alone. Median DOR was 8.0 (95% CI=5.7-11.1) months with panitumumab+chemotherapy versus 5.1 (95% CI=4.4-7.2) months with chemotherapy alone. Grade 3/4 adverse event incidence was 73% with panitumumab+chemotherapy versus 56% with chemotherapy alone. 41% and 55% of patients in the panitumumab+chemotherapy and chemotherapy-alone arms, respectively, received panitumumab monotherapy.

Conclusion: The addition of panitumumab to docetaxel/cisplatin may improve PFS in recurrent/metastatic SCCHN and has the potential to improve outcomes in these fully, or mostly, active patients.
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http://dx.doi.org/10.1016/j.oraloncology.2016.07.005DOI Listing
October 2016

Predictors of baseline cancer-related cognitive impairment in cancer patients scheduled for a curative treatment.

Psychooncology 2017 05 1;26(5):632-639. Epub 2016 Aug 1.

Division of Medical Oncology, Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.

Introduction: Recent research in the field of cancer-related cognitive impairments (CRCI) has shown CRCI presentation prior to treatment initiation. Some have attributed these problems to worry and fatigue, whereas others have suggested an influence of age, IQ, and other psychosocial and medical factors.

Methods: Patients (≥18 years) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated with a baseline neuropsychological assessment including Patient-Reported Outcome Measures (PROMs). PROMs entailed distress, anxiety and depression, fatigue, and cognitive complaints. The neuropsychological assessment comprised several cognitive domains such as premorbid IQ, attention, processing speed, flexibility, verbal and visual episodic memory, and verbal fluency.

Results: Cross-sectional data of 125 patients were collected. Patients had a mean age of 60.9 years (range: 30.0-85.0) and comprised primarily females (65.6%). Patients presented with cancer of following sites: breast (44.0%), digestive (28.8%), urological (11.2%), gynecologic (8.0%), hematologic malignancy (4.8%), and lung (3.2%). Patients presented with a premorbid IQ of 105.3 (range: 79.0-124.0). In 29.6% of patients, a CRCI was detected. Binary logistic regression analyses showed that a lower premorbid IQ (β = -.084, P < .01) and a higher level of fatigue (β = -.054, P < .05) predicted baseline CRCI. Premorbid IQ also predicted performance on individual cognitive domains. Some domains were also influenced by age, gender, having a breast cancer diagnosis, and an active treatment for hypertension.

Conclusion: Premorbid IQ and fatigue are important predictors of baseline CRCI. Therefore, we advise researchers to implement a short IQ test when conducting clinical trials on CRCI.
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http://dx.doi.org/10.1002/pon.4200DOI Listing
May 2017

Implementation of uHear™--an iOS-based application to screen for hearing loss--in older patients with cancer undergoing a comprehensive geriatric assessment.

J Geriatr Oncol 2016 Mar 26;7(2):126-33. Epub 2016 Feb 26.

Cancer Center, General Hospital Groeninge, Kortrijk, Belgium; Centre for Positive Ageing, University of Greenwich, London, UK; Faculty of Health, Social Care & Education, Anglia Ruskin University, Chelmsford, UK. Electronic address:

Objective: Validation of uHear™ as a screening tool to detect hearing loss in older patients with cancer without a known diagnosis of presbycusis, as part of a Comprehensive Geriatric Assessment (CGA).

Materials And Methods: Patients (≥70 years) with a histologically confirmed diagnosis of cancer, were enrolled at the time of CGA screening. Patients were evaluated by uHear™, which was compared to conventional audiometry as gold standard. We defined a pure-tone average (PTA) of ≥40dB HL as the pass or fail screening cut-off. Validation of uHear™ was defined in terms of diagnostic accuracy through Receiver Operating Characteristics (ROC)-analysis. To accept uHear™, we estimated that the Area Under the ROC-curve (AUC) had to differ significantly from 0.50 with an AUC of at least 0.70. The Whispered Voice Test and Hearing Handicap Inventory for the Elderly were also administered.

Results: Thirty-three patients consented for participation. In one patient, the results of one ear were excluded from the analysis as the patient was documented with a known hearing disorder in that ear. Significant hearing loss, defined by a PTA of ≥40dB HL calculated from the air conduction thresholds at 0.5, 1.0 and 2.0kHz, was found in 15.4% of tested ears. uHear™ showed excellent diagnostic accuracy with an AUC±SE of 0.98±0.14. It provided maximum sensitivity (100.0%) but poor specificity (36.4%) at our predefined cut-off score of ≥40dB HL.

Conclusion: uHear™ can be implemented as a screening tool to detect hearing loss in older patients with cancer within a CGA.
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http://dx.doi.org/10.1016/j.jgo.2016.01.008DOI Listing
March 2016

G-8 indicates overall and quality-adjusted survival in older head and neck cancer patients treated with curative radiochemotherapy.

BMC Cancer 2015 Nov 9;15:875. Epub 2015 Nov 9.

Kortrijk Cancer Centre, General Hospital Groeninge, campus loofstraat, Cancer Centre, Loofstraat 43, B-8500, Kortrijk, Belgium.

Background: Evidence-based guidelines concerning the older head and neck cancer (HNCA) patient are lacking. Accurate patient selection for optimal care management is therefore challenging. We examined if geriatric assessment is indicative of long-term health-related quality of life (HRQOL) and overall survival in this unique population.

Methods: All HNCA patients, aged ≥65 years, eligible for curative radio(chemo)therapy were evaluated with the Geriatric-8 (G-8) questionnaire and a comprehensive geriatric assessment (CGA). Euroqol-5 dimensions (EQ-5D) and survival were collected until 36 months post treatment start. Repeated measures ANOVA was applied to analyse HRQOL evolution in 'fit' and 'vulnerable' patients, defined by G-8. Kaplan-Meier curves and cox proportional hazard analysis were established for determination of the prognostic value of geriatric assessments. Quality-adjusted survival was calculated in both patient subgroups.

Results: One hundred patients were recruited. Seventy-two percent of patients were considered vulnerable according to CGA (≥2 abnormal tests). Fit patients maintained a relatively acceptable long-term HRQOL, whilst vulnerable patients showed significantly lower median health states. The difference remained apparent at 36 months. Vulnerability, as classified by G-8 or CGA, came forward as independent predictor for lower EQ-5D index scores. After consideration of confounders, a significantly lower survival was observed in patients defined vulnerable according to G-8, compared to fit patients. A similar trend was seen based on CGA. Calculation of quality-adjusted survival showed significantly less remaining life months in perfect health in vulnerable patients, compared to fit ones.

Conclusions: G-8 is indicative of quality-adjusted survival, and should be considered at time of treatment decisions for the older HNCA patient.
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http://dx.doi.org/10.1186/s12885-015-1800-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4640221PMC
November 2015
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