Symptoms from treatment with sunitinib or sorafenib: a multicenter explorative cohort study to explore the influence of patient-reported outcomes on therapy decisions

Koldenhof, J.J.; Witteveen, Petronella O.; Vos, Rien de; Walraven, Maudy; Tillier, C; Verheul, Henk M.W.; Teunissen, Saskia

doi:10.1007/s00520-014-2223-2

Cited by 11 publications

(22 citation statements)

References 34 publications

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“…When patient-reported symptoms of this cohort were compared to our previous findings in patients on standard sunitinib treatment at a standard dose of 50 mg, 4 weeks on 2 weeks off treatment, we found a comparable prevalence of 9/21 measured symptoms, just as for decreased well-being (difference of < 10%) [6]. However, fatigue, anorexia, pain, dry skin, HFSR, vomiting, hair changes, skin changes, sleeping problems, diarrhea, gastric complaints, and inactivity were reported more often by patients in this cohort.…”

Section: Discussionmentioning

confidence: 57%

“…In this study, symptom assessment was performed by using a treatment-specific module of the USD, the USD sunitinib (Appendix A). In 2007, the USD sunitinib was developed, based on generic disease-related complaints and all AEs with a prevalence ≥ 10% and all grade 3–4 AEs as mentioned in the investigator’s brochure on sunitinib, to measure symptom prevalence and intensity in patients on sunitinib treatment [6]. …”

Section: Methodsmentioning

confidence: 99%

“…A decreased HRQL is a serious risk of patient non-adherence and dose modifications (DMs), such as early discontinuation [6–9]. …”

Section: Introductionmentioning

confidence: 99%

“…The application of patient-reported outcome measures (PROMs) enhances early recognition of symptoms and improves clinician-patient communications and quality of care [6, 10–12]. A meaningful and feasible for clinical use of PROMs requires a brief, precise, and accurate symptom assessment system [13].…”

Section: Introductionmentioning

confidence: 99%

“…A meaningful and feasible for clinical use of PROMs requires a brief, precise, and accurate symptom assessment system [13]. The Utrecht Symptom Diary (USD) is such a PROM that also measures patient experiences [6]. The USD is a Dutch translation and adapted version of the Edmonton Symptom Assessment System (ESAS), which has been proven to be a strong and highly sensitive tool for symptom experience for more than 25 years [14, 15].…”

Section: Introductionmentioning

confidence: 99%

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Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

Koldenhof

Lankheet

Steeghs

et al. 2018

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PurposeDuring treatment with tyrosine kinase inhibitors, such as sunitinib, patients experience treatment and/or disease-related symptoms. Although application of patient-reported outcome measures (PROMs) enhances early recognition of symptoms, early clinical trials are focused on symptom severity objectified by the Common Terminology Criteria for Adverse Events (CTCAE) in order to evaluate drug safety and to determine a personalized and/or safe dosage range. To gain insight into patient-reported symptoms in addition to healthcare professional-reported adverse events (AEs), a substudy was conducted in an ongoing pharmacokinetic-guided sunitinib dosing study.MethodsIn patients for whom sunitinib was considered standard therapy or patients with advanced/metastatic tumors for whom no standard therapy was available, patient-reported symptoms and well-being besides healthcare professional-reported AEs were assessed.ResultsTwenty-nine patients were included for analysis. Over 50% of them experienced a decreased well-being, caused by symptoms of mild and moderate intensity. Compared to healthcare professionals, all measured symptoms, with the exception of fatigue and vomiting, were reported statistically significantly more often by patients.ConclusionsApplication of PROMs in early clinical trials on personalized or individualized oral targeted anticancer agents is feasible and enhances early recognition of symptom burden due to multiple CTCAE grade 1–2 AEs, just as pro-active symptom management and effect evaluation of interventions performed. Application of PROMs in these trials might be clinically relevant in obtaining dose-limiting toxicities.Electronic supplementary materialThe online version of this article (10.1007/s00520-018-4075-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 57%

Section: Methodsmentioning

confidence: 99%

“…A decreased HRQL is a serious risk of patient non-adherence and dose modifications (DMs), such as early discontinuation [6–9]. …”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

Koldenhof

Lankheet

Steeghs

et al. 2018

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Validation of the Dutch version of the Edmonton Symptom Assessment System

et al. 2020

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Background The Utrecht Symptom Diary (USD) is a Dutch and adapted version of the Edmonton Symptom Assessment System, a patient‐reported outcome measurement (PROM) tool to asses and monitor symptoms in cancer patients. This study analyses the validity and responsiveness of the USD and the cutoff points to determine the clinical significance of a symptom score. Methods Observational longitudinal cohort study including adult in‐ and outpatients treated in an academic hospital in the Netherlands who completed at least one USD as part of routine care (2012‐2019). The distress thermometer and problem checklist (DT&PC) was used as a reference PROM. Content, construct and criterion validity, responsiveness, and cutoff points are shown with prevalences, area under receiver operating characteristic (ROC) curve, Chi‐squared test, Wilcoxon signed‐rank test, and positive and negative predictive values, respectively. Results A total of 3913 patients completed 22 400 USDs. Content validity was confirmed for all added USD items with prevalences of ≥22%. All USD items also present on the DT&PC demonstrated a good criterion validity (ROC >0.8). Construct validity was confirmed for the USD as a whole and for the items dry mouth, dysphagia and well‐being (P < .0001). USD scores differed significantly for patients when improving or deteriorating on the DT&PC which confirmed responsiveness. Optimal cutoff points (3 or 4) differed per symptom. Conclusion The USD is a valid 12‐item PROM for the most prevalent symptoms in cancer patients, which has content, criterion, and construct validity, and detects clinically important changes over time, in both curative and palliative phase.

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Prevalence of symptoms in glioma patients throughout the disease trajectory: a systematic review

et al. 2018

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BackgroundGlioma patients suffer from a wide range of symptoms which influence quality of life negatively. The aim of this review is to give an overview of symptoms most prevalent in glioma patients throughout the total disease trajectory, to be used as a basis for the development of a specific glioma Patient Reported Outcome Measure (PROM) for early assessment and monitoring of symptoms in glioma patients.MethodsA systematic review focused on symptom prevalence in glioma patients in different phases of disease and treatment was performed in MEDLINE, CINAHL and EMBASE according to PRISMA recommendations. We calculated weighted means for prevalence rates per symptom.ResultsThe search identified 2.074 unique papers, of which 32 were included in this review. In total 25 symptoms were identified. The ten most prevalent symptoms were: seizures (37%), cognitive deficits (36%), drowsiness (35%), dysphagia (30%), headache (27%), confusion (27%), aphasia (24%), motor deficits (21%), fatigue (20%) and dyspnea (20%).ConclusionsEight out of ten of the most prevalent symptoms in glioma patients are related to the central nervous system and therefore specific for glioma. Our findings emphasize the importance of tailored symptom care for glioma patients and may aid in the development of specific PROMs for glioma patients in different phases of the disease.Electronic supplementary materialThe online version of this article (10.1007/s11060-018-03015-9) contains supplementary material, which is available to authorized users.

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Symptoms from treatment with sunitinib or sorafenib: a multicenter explorative cohort study to explore the influence of patient-reported outcomes on therapy decisions

Cited by 11 publications

References 34 publications

Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

Validation of the Dutch version of the Edmonton Symptom Assessment System

Prevalence of symptoms in glioma patients throughout the disease trajectory: a systematic review

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