Applying the ESMO-Magnitude of Clinical Benefit Scale in real life

Tabernero, Josep

doi:10.1136/esmoopen-2016-000090

Cited by 3 publications

(1 citation statement)

References 2 publications

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“…The ESMO-magnitude of clinical benefit scale (MCBS)-standardized to assess the therapeutic benefit of anti-neoplastic therapies-considers the study of primary and secondary endpoints; absolute gains in OS and PFS and the bottom portion of the 95% confidence interval of the corresponding hazard ratio; as well as QoL or toxicity [71,72]. The data are analyzed with respect to the duration of response or survival in the control arm.…”

Section: Clinical Benefit Of Controversial First-line Therapies For Advanced Stage Ovarian Cancer: Based On Esmo-mcbs Scoresmentioning

confidence: 99%

Measuring Quality of Life in Ovarian Cancer Clinical Trials—Can We Improve Objectivity and Cross Trial Comparisons?

Bhat

Karakasis

Oza

2020

Cancers

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Epithelial ovarian cancer (EOC) remains a lethal disease for the majority of women diagnosed with it worldwide. For the majority of patients, diagnosis occurs late, in the advanced setting. Disease-induced as well as treatment-related adverse events can negatively impact quality of life (QoL). Research to date has captured these data through use of patient-related outcomes (PROs) and, increasingly, has become an area of increased attention and focus in clinical trial reporting. QoL/PRO measurements in EOC clinical trials at different transition points in a patient’s journey are increasingly being recognized by patients, clinicians and regulatory agencies as the key determinants of treatment benefit. Various context-specific PROs and PRO endpoints have been described for clinical trials in EOC. Standardized approaches and checklists for incorporating PRO endpoints in clinical trials have been proposed. In a real-world clinical practice setting, PRO/QoL measures, which are meaningful, valid, reliable, feasible and acceptable to patients and clinicians, need to be implemented and used. These may assist by serving as screening tools; helping with the identification of patient preferences to aid in decision making; improving patient–provider communication; facilitating shared decision making. Importantly, they may also improve quality of care through an increasingly patient-centered approach. Potential areas of future research include assessment of anxiety, depression and other mental health issues. In good prognostic groups, such as maintenance clinical trials, following patients beyond progression will capture possible downstream effects related to delaying the psychological trauma of relapse, symptoms due to disease progression and side-effects of subsequent chemotherapy. Identifying PRO endpoints in next-generation-targeted therapies (including immunotherapies) also warrants investigation.

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Section: Clinical Benefit Of Controversial First-line Therapies For Advanced Stage Ovarian Cancer: Based On Esmo-mcbs Scoresmentioning

confidence: 99%