International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer

Emmanouil Fokas*, Ane Appelt, Robert Glynne-Jones, Geerard Beets, Rodrigo Perez, Julio Garcia-Aguilar, Eric Rullier, J. Joshua Smith, Corrie Marijnen, Femke P. Peters, Maxine van der Valk, Regina Beets-Tan, Arthur S. Myint, Jean Pierre Gerard, Simon P. Bach, Michael Ghadimi, Ralf D. Hofheinz, Krzysztof Bujko, Cihan Gani, Karin HaustermansBruce D. Minsky, Ethan Ludmir, Nicholas P. West, Maria A. Gambacorta, Vincenzo Valentini, Marc Buyse, Andrew G. Renehan, Alexandra Gilbert, David Sebag-Montefiore, Claus Rödel

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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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.

Original languageEnglish
JournalNature Reviews Clinical Oncology
Early online date4 Aug 2021
Publication statusE-pub ahead of print - 4 Aug 2021

Bibliographical note

Funding Information:
The work of A.A. is supported by Yorkshire Cancer Research Academic Fellowship funding (grant L389AA). The work of N.P.W. was supported by grants from Yorkshire Cancer Research while the study was conducted. The work of A.G. is funded by a Cancer Research UK clinical trials fellowship (CRUK/28301).

Publisher Copyright:
© 2021, Springer Nature Limited.

ASJC Scopus subject areas

  • Oncology


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