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Title: International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer
Authors: Fokas, Emmanouil
Appelt, Ane
Glynne-Jones, Robert
Beets, Geerard
Perez, Rodrigo
Garcia-Aguilar, Julio
Rullier, Eric
Joshua Smith, J.
Marijnen, Corrie
Peters, Femke P.
van der Valk, Maxine
Beets-Tan, Regina
Myint, Arthur S.
Gerard, Jean-Pierre
Bach, Simon P.
Ghadimi, Michael
Hofheinz, Ralf D.
Bujko, Krzysztof
Haustermans, Karin
Minsky, Bruce D.
Ludmir, Ethan
West, Nicholas P.
Gambacorta, Maria A.
Valentini, Vincenzo
BUYSE, Marc 
Renehan, Andrew G.
Gilbert, Alexandra
Sebag-Montefiore, David
Roedel, Claus
Gani, Cihan
Issue Date: 2021
Source: Nature Reviews Clinical Oncology, Aug 2021
Abstract: Multimodal treatment strategies for patients with rectal cancer are increasingly including the possibility of organ preservation, through nonoperative management or local excision. Organ preservation strategies can enable patients with a complete response or near-complete clinical responses after radiotherapy with or without concomitant chemotherapy to safely avoid the morbidities associated with radical surgery, and thus to maintain anorectal function and quality of life. However, standardization of the key outcome measures of organ preservation strategies is currently lacking; this includes a lack of consensus of the optimal definitions and selection of primary end points according to the trial phase and design; the optimal time points for response assessment; response-based decision-making; follow-up schedules; use of specific anorectal function tests; and quality of life and patient-reported outcomes. Thus, a consensus statement on outcome measures is necessary to ensure consistency and facilitate more accurate comparisons of data from ongoing and future trials. Here, we have convened an international group of experts with extensive experience in the management of patients with rectal cancer, including organ preservation approaches, and used a Delphi process to establish the first international consensus recommendations for key outcome measures of organ preservation, in an attempt to standardize the reporting of data from both trials and routine practice in this emerging area. Patients with early-stage rectal cancer might potentially benefit from treatment with an organ-sparing approach, which preserves quality of life owing to avoidance of the need for permanent colostomy. Trials conducted to investigate this have so far been hampered by considerable inter-trial heterogeneity in several key features. In this Consensus Statement, the authors provide guidance on the optimal end points, response assessment time points, follow-up procedures and quality of life measures in an attempt to improve the comparability of clinical research in this area.
Notes: Fokas, E (corresponding author), Goethe Univ Frankfurt, Dept Radiotherapy Oncol, Frankfurt, Germany.; Fokas, E (corresponding author), German Canc Res Ctr, Heidelberg, Germany.; Fokas, E (corresponding author), German Canc Consortium DKTK, Frankfurt, Germany.; Fokas, E (corresponding author), Frankfurt Canc Inst FCI, Frankfurt, Germany.
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ISSN: 1759-4774
e-ISSN: 1759-4782
DOI: 10.1038/s41571-021-00538-5
ISI #: WOS:000681157100001
Rights: © Springer Nature Limited 2021
Category: A1
Type: Journal Contribution
Appears in Collections:Research publications

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