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

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.

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

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.

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.

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.

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

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.

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

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.