ONCOLOGIE

CENTRUM ONCOLOGIE

ARTIKELS

ABSTRACT 1

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

Cool L, Callewaert N, Van Eygen K, Tack L, Missiaen J,

Debruyne P, et al. Scandinavian Journal of Clinical and Laboratory Investigation, 2020, 80(3), 215-221

Het abstract is te vinden op pagina 21.

ABSTRACT 2

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

Cool L, Missiaen J, Debruyne P, Van Eygen K, Tack L, et al. Acta Clinica Belgica, 2019, 4, 1-8

OBJECTIVE 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.

MATERIALS/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.

ABSTRACT 3

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

Cool L, Debruyne P, Van Eygen K, De Jonghe PJ, Vergauwe P, et al. European Journal of Oncology Nursing, 2019, 40, 44-52

OBJECTIVE 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).

MATERIALS/METHODS An observational cohort study 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.

ABSTRACT 4

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

Tack L, Debruyne P, Ketelaars L, De Zutter J, Martens E, Stellamans K, Van Eygen K, Werbrouck P, Vergauwe P,

et al. Journal of Geriatric Oncology, 2020, 11(2), 320-326

OBJECTIVE 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.

MATERIALS/METHODS Trial and patient characteristics of older (≥70 years) 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 76.0 years 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).

CONCLUSION 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.

ABSTRACT 5

Effectiveness of adjunctive analgesics in head and neck cancer patients receiving curative (chemo-) radiotherapy: a systematic review.

Lefebvre T, Tack L, Debruyne P, Cool L, Goethals L, Van Eygen K, et al. Pain Medicine, 2020, Epub ahead of print, DOI: 10.1093/ pm/pnaa044

INTRODUCTION/BACKGROUND 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.”

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

MATERIALS/METHODS 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.

CONCLUSION 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.

ABSTRACT 6

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.

Quinten C, Kenis C, Debruyne P, et al. Journal of Geriatric Oncology, 2020, Epub ahead of print, DOI: 10.1016/j.jgo.2020.03.017

OBJECTIVE 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.

MATERIALS/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. ABSTRACT 7

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

Decoster L, Quinten C, Debruyne P, et al. Journal of Geriatric Oncology, 2019, 10(6), 895-903

OBJECTIVE 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.

MATERIALS/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.

ABSTRACT 8

Detection of alcohol abuse in older patients with cancer: the integration of alcohol screening questionnaires in the comprehensive geriatic assessment (CGA).

Martens E, Ketelaars L, Debruyne P, Van Eygen K, Cool L,

De zutter J, et al. Journal of Geriatric Oncology, 2019, 10(5), 819-823

OBJECTIVE 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/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.

CONCLUSION 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.

ABSTRACT 9

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

Debruyne P, Ketelaars L, Stellamans K, Van Eygen K,

Vergauwe P, Werbrouk P, Cool L, Liefhooghe N, et al. Journal of Pyschosocial Oncology, 2019, 37(4), 427-440 OBJECTIVE 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).

MATERIALS/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.

CONCLUSION 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.

ABSTRACT 10

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.

Ketelaars L, Martens E, Debruyne P, Van Eygen K, Cool

L, et al. Journal of Geriatric Oncology, 2019, 10(6), 931-936

OBJECTIVE 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/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.

CONCLUSION 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.

ABSTRACT 11

Determining clinically important differences in healthrelated quality of life in older patients with cancer undergoing chemotherapy or surgery.

Quinten C, Kenis C, Debruyne P, et al. Quality of Life Research, 2019, 28(3), 663–676

INTRODUCTION/BACKGROUND Using the EORTC Global Health Status (GHS) scale, we aimed to determine minimal clinically important differences (MCID) in health-related quality of life (HRQOL) changes for older cancer patients with a geriatric risk profile, as defined by the geriatric 8 (G8) health screening tool, undergoing treatment. Simultaneously, we assessed baseline patient characteristics prognostic for HRQOL changes.

MATERIALS/METHODS Our analysis included 1424 (G8 ≤ 14) older patients with cancer scheduled to receive chemotherapy (n = 683) or surgery (n = 741). Anchor-based methods, linking the GHS score to clinical indicators, were used to determine MCID between baseline and follow-up at 3 months. A threshold of 0.2 standard deviation (SD) was used to exclude MCID estimates too small for interpretation. Logistic regressions analysed baseline patient characteristics prognostic for HRQOL changes.

RESULTS The 15-item Geriatric Depression Scale (GDS15), Visual Analogue Scale (VAS) for Fatigue and ECOG Performance Status (PS) were selected as clinical anchors. In the surgery group, MCID estimates for improvement and deterioration were ECOG PS (5*, 11*), GDS15 (5*, 2) and VAS Fatigue (3, 9*). In the chemotherapy group, MCID estimates for improvement and deterioration were ECOG PS (8*, 7*), GDS15 (5, 4) and VAS Fatigue (5, 5*). Estimates with * were > 0.2 SD threshold. Patients experiencing pain or malnutrition (surgery group) or fatigue (chemotherapy group) at baseline showed a significantly stable or improved HRQOL (p < 0.05) after their treatment.

CONCLUSION The reported MCID for improvement and deterioration depended on the anchor used and treatment received. The estimates can be used to evaluate significant changes in HRQOL and to determine sample sizes in clinical trials.

ABSTRACT 12

The financial impact of SBRT for oligometastatic disease: A population-level analysis in Belgium.

Nevens D, Lievens Y, Kindts I, et al. Radiotherapy and Oncology, 2020, 145, 215-222

INTRODUCTION/BACKGROUND There is a steady rise in Stereotactic Body RadioTherapy (SBRT) utilization in oligometastatic disease (OMD). This may generate important financial consequences for radiotherapy budgets. The National Institute for Health and Disability Insurance of Belgium (NIHDI) initiated a coverage with evidence development (CED) project for innovative radiotherapy, including SBRT, in 2011. A cost calculation

and budget estimation for SBRT in the OMD setting was carried out.

MATERIALS/METHODS Predictive growth scenarios for future uptake of SBRT for OMD in Belgium were developed using demographics and CED data. The provider cost of SBRT for OMD in Belgium was calculated using the Time-Driven Activity-Based Costing (TD-ABC) model developed by ESTRO-HERO, alimented with national data on resources, treatments and operational parameters, and compared to the new reimbursement. Combining these, the future financial impact of this novel treatment indication for healthcare providers and payers in Belgium was evaluated.

RESULTS The number of 428 OMDs treated with SBRT in Belgium in 2017 is expected to increase between 484 and 2073 courses annually by 2025. A provider cost of €4360 per SBRT was calculated (range: €3488–€5654), whereas the reimbursement covers between €4139 and €4654. Large variations in potential extra provider costs by 2025 ensue from the different scenarios, ranging between €1,765,993 and €9,038,754. Provider costs and reimbursement show good agreement.

CONCLUSION Although the financial impact of SBRT for OMD in Belgium is forecasted to remain acceptable, even in extreme scenarios, further clinical trials and real-life clinical and financial monitoring with prospective data gathering are necessary to refine the data.

PRESENTATIES/ CONGRESSEN

ABSTRACT 1

Validation of a prognostic scoring system for postmastectomy locoregional recurrence in breast cancer.

American Society for Radiation Oncology (ASTRO) Van der Vorst A, Kindts I, Laenen A, Janssens H, et al. September 2019, Chicago – USA

INTRODUCTION/BACKGROUND To date, it remains unclear which breast cancer (BC) patients benefit from post-mastectomy radiotherapy (PMRT). Current international guidelines state that PMRT is recommended for high-risk patients only. However, more recent studies suggest we should also consider PMRT in intermediate-risk patients with 1 to 3 positive axillary lymph nodes. In this respect, Cheng et al. developed and validated a prognostic scoring system based on 4 prognostic factors for locoregional recurrence (LRR) to identify patients most in need for PMRT. These factors include age, estrogen receptor status, lymphovascular status and number of affected axillary lymph nodes. The purpose of this retrospective study is to validate the prognostic scoring system for LRR in BC developed by Cheng et al. By using an independent BC database.

MATERIALS/METHODS We included 1586 BC cases treated with mastectomy from 2000 until 2007. Equivalent to the validation of Cheng et al., patients were classified conform the LRR scoring system and the influence of PMRT on the 5-year locoregional control (LRC) rate was determined by subgroup analysis.

RESULTS Median follow-up time was 11.4 years. After excluding patients with missing variables, 1103 patients remained eligible for classification according to the LRR scoring system. 688 (62.38%) patients were at low risk of recurrence (LRR score 0-1), 335 (30.37%) patients were at intermediate risk of recurrence (LRR score 2-3) and 80 (7.25%) patients were at high risk of recurrence (LRR score ≥ 4). 5-year LRC rates with and without PMRT were 99.20% versus 99.21% (p=0.43) in the low-risk group; 98.24% versus 85.74% (p<0.0001) in the intermediate-risk group and 96.87% versus 85.71% (p=0.10) in the high-risk group respectively.

CONCLUSION Our validation of the LRR scoring system by Cheng et al. suggests it can be used to point out patients that would benefit from PMRT. We recommend further validation of this scoring system by other independent institutions before application in clinical practice.