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 Antonietta Gambacorta, Vincenzo Valentini, Marc Buyse, Andrew G. Renehan, Alexandra Gilbert, David Sebag-Montefiore, Claus Rödel

Risultato della ricerca: Contributo in rivistaArticolo in rivista


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.
Lingua originaleEnglish
pagine (da-a)805-816
Numero di pagine12
Stato di pubblicazionePubblicato - 2021


  • Chemoradiotherapy
  • Consensus
  • Delphi Technique
  • Humans
  • Organ Preservation
  • Rectal Neoplasms


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