The lancet oncology
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The lancet oncology · Oct 2024
ReviewInterchangeability of immune checkpoint inhibitors: an urgent need for action.
Prevailing uncertainties regarding the therapeutic interchangeability of PD-1 and PD-L1 inhibitors affect both clinical decision making and health-care budgeting. This Personal View presents a comprehensive assessment of the fragmented regulatory landscape of PD-1 and PD-L1 inhibitors, highlighting the complex dynamics of market competition, pricing, and the effect on health-care budgets. ⋯ To address these challenges, research that will inform us of the extent of interchangeability of PD-1 and PD-L1 inhibitors is needed. We recommend head-to-head randomised controlled trials, standardised study designs for indirect comparisons, trials with monotherapy groups, post-approval trials funded from private or public sources, and adoption of a near-equivalence framework in both conducting and evaluating trials.
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The lancet oncology · Oct 2024
ReviewDevelopment of a conceptual framework for an electronic patient-reported outcome (ePRO) system measuring symptoms and impacts of CAR T-cell therapies in patients with haematological malignancies.
Chimeric antigen receptor (CAR) T-cell therapy is associated with potentially severe toxicities that create a substantial burden for patients. Patient-reported outcomes (PROs) offer valuable insights into symptoms, functioning, and other complex constructs of interest. In this Review, we aimed to identify symptom and impact concepts important to patients receiving CAR T-cell therapy, construct a conceptual framework for an electronic patient-reported outcome (ePRO) system, and identify timepoints to capture PRO data for CAR T-cell therapies. ⋯ Six health-care professionals and 11 patients and caregiver partners verified construct relevance to clinical management and lived experience, respectively. 109 constructs were sorted according to the four domains of conceptual framework: symptom burden, impact of disease and treatment, tolerability, and health-related quality of life. The identification of concepts beyond symptom burden underscores the importance of PRO measurement for long-term monitoring, to align outcomes with patient concerns. The framework will facilitate PRO measure selection for systematic gathering of PROs from individuals with haematological malignancies receiving CAR T-cell therapies.
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The lancet oncology · Oct 2024
Multicenter StudyRisk-prediction models in postmenopausal patients with symptoms of suspected ovarian cancer in the UK (ROCkeTS): a multicentre, prospective diagnostic accuracy study.
Multiple risk-prediction models are used in clinical practice to triage patients as being at low risk or high risk of ovarian cancer. In the ROCkeTS study, we aimed to identify the best diagnostic test for ovarian cancer in symptomatic patients, through head-to-head comparisons of risk-prediction models, in a real-world setting. Here, we report the results for the postmenopausal cohort. ⋯ UK National Institute of Heath Research.
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The lancet oncology · Oct 2024
Multicenter StudySintilimab combined with bevacizumab in relapsed or persistent ovarian clear cell carcinoma (INOVA): a multicentre, single-arm, phase 2 trial.
Ovarian clear cell carcinoma rarely responds to second-line chemotherapy, the recommended treatment for relapsed epithelial ovarian cancer. Here, we report the activity and safety of sintilimab in combination with bevacizumab in patients with relapsed or persistent ovarian clear cell carcinoma. ⋯ For the Chinese translation of the abstract see Supplementary Materials section.