Outcome measures in multimodal rectal cancer trials

There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically...

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Vydané v:The lancet oncology Ročník 21; číslo 5; s. e252 - e264
Hlavní autori: Fokas, Emmanouil, Glynne-Jones, Robert, Appelt, Ane, Beets-Tan, Regina, Beets, Geerard, Haustermans, Karin, Marijnen, Corrie, Minsky, Bruce D, Ludmir, Ethan, Quirke, Phil, Sebag-Montefiore, David, Garcia-Aguilar, Julio, Gambacorta, Maria Antonietta, Valentini, Vincenzo, Buyse, Marc, Rödel, Claus
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England Elsevier Ltd 01.05.2020
Elsevier Limited
Predmet:
Cancer
Cancer therapies
Chemotherapy
Clinical decision making
Clinical trials
Colorectal cancer
Decision making
Hematology, Oncology, and Palliative Medicine
Lymphatic system
Medical prognosis
Metastases
Metastasis
Patients
Preservation
Radiation therapy
Rectum
Response rates
Surgery
ISSN:1470-2045, 1474-5488, 1474-5488
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Popis
Shrnutí:There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
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ISSN:1470-2045
1474-5488
1474-5488
DOI:10.1016/S1470-2045(20)30024-3