End Points and Trial Design in Geriatric Oncology Research: A Joint European Organisation for Research and Treatment of Cancer–Alliance for Clinical Trials in Oncology–International Society of Geriatric Oncology Position Article
Abstract:Selecting the most appropriate end points for clinical trials is important to assess the value of new treatment strategies. Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact of therapy on global functioning and quality of life. This article discusses specific clinical end points and their advantages and disadvantages for older individuals. Randomized or single-arm pha… Show more
“…Another option might be to enroll older patients in smaller "sub-trials" within bigger trials or to design end points specifically for older patients, which could include HRQOL endpoints such as physical functioning which are equally important for the elderly than extending survival. 17 However more longitudinal and observational studies, with no stringent inclusion criteria, are needed to confirm these statements.…”
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confidence: 99%
“…15,16,17 The availability of new molecularly targeted agents and newly improved existing agents has expanded the range of treatments options available for elderly cancer patients. 18 Some of these agents have shown better tolerability and a better safety profile 19 and may therefore provide new options for systemic therapy suitable to the elderly cancer population.…”
“…Another option might be to enroll older patients in smaller "sub-trials" within bigger trials or to design end points specifically for older patients, which could include HRQOL endpoints such as physical functioning which are equally important for the elderly than extending survival. 17 However more longitudinal and observational studies, with no stringent inclusion criteria, are needed to confirm these statements.…”
Section: Insert Tablementioning
confidence: 99%
“…15,16,17 The availability of new molecularly targeted agents and newly improved existing agents has expanded the range of treatments options available for elderly cancer patients. 18 Some of these agents have shown better tolerability and a better safety profile 19 and may therefore provide new options for systemic therapy suitable to the elderly cancer population.…”
“…Surgery and chemotherapy are the major treatment methods for breast cancer. To extend survival as much as possible, chemotherapy without surgical treatment is more appropriate for late-stage breast cancer [3,4]. The most preferred chemotherapeutic drugs are anthracyclines and taxanes, but their toxicity and side effects can severely reduce treatment effectiveness andquality of life for elderly patients most such patients are intolerant of combined chemotherapy.…”
“…TTFS was shown to be adapted to an older population of patients with advanced disease (13). But this composite endpoint taking into account not only treatment efficacy but also treatment toxicity is not a good endpoint for advanced NSCLC, as this patients with poor prognosis are more likely to die of lung cancer than of other causes.…”
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