Outcome measures in multimodal rectal cancer trials Review
| Authors: | Fokas, E.; Glynne-Jones, R.; Appelt, A.; Beets-Tan, R.; Beets, G.; Haustermans, K.; Marijnen, C.; Minsky, B. D.; Ludmir, E.; Quirke, P.; Sebag-Montefiore, D.; Garcia-Aguilar, J.; Gambacorta, M. A.; Valentini, V.; Buyse, M.; Rödel, C. |
| Review Title: | Outcome measures in multimodal rectal cancer trials |
| Abstract: | 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. © 2020 Elsevier Ltd |
| Keywords: | cancer survival; overall survival; review; cancer recurrence; disease free survival; cancer staging; quality of life; clinical decision making; rectum cancer; chemoradiotherapy; clinical outcome; patient-reported outcome; cancer prognosis; human; priority journal |
| Journal Title: | Lancet Oncology |
| Volume: | 21 |
| Issue: | 5 |
| ISSN: | 1470-2045 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2020-05-01 |
| Start Page: | e252 |
| End Page: | e264 |
| Language: | English |
| DOI: | 10.1016/s1470-2045(20)30024-3 |
| PROVIDER: | scopus |
| PUBMED: | 32359501 |
| DOI/URL: | |
| Notes: | Review -- Export Date: 1 June 2020 -- Source: Scopus |
