TY - JOUR
T1 - International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer
AU - Fokas, Emmanouil
AU - Appelt, Ane
AU - Glynne-Jones, Robert
AU - Beets, Geerard
AU - Perez, Rodrigo
AU - Garcia-Aguilar, Julio
AU - Rullier, Eric
AU - Joshua Smith, J.
AU - Marijnen, Corrie
AU - Peters, Femke P.
AU - van der Valk, Maxine
AU - Beets-Tan, Regina
AU - Myint, Arthur S.
AU - Gerard, Jean Pierre
AU - Bach, Simon P.
AU - Ghadimi, Michael
AU - Hofheinz, Ralf D.
AU - Bujko, Krzysztof
AU - Gani, Cihan
AU - Haustermans, Karin
AU - Minsky, Bruce D.
AU - Ludmir, Ethan
AU - West, Nicholas P.
AU - Gambacorta, Maria A.
AU - Valentini, Vincenzo
AU - Buyse, Marc
AU - Renehan, Andrew G.
AU - Gilbert, Alexandra
AU - Sebag-Montefiore, David
AU - Rödel, Claus
N1 - Publisher Copyright:
© 2021, Springer Nature Limited.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
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U2 - 10.1038/s41571-021-00538-5
DO - 10.1038/s41571-021-00538-5
M3 - Review article
C2 - 34349247
AN - SCOPUS:85111908959
SN - 1759-4774
VL - 18
SP - 805
EP - 816
JO - Nature Reviews Clinical Oncology
JF - Nature Reviews Clinical Oncology
IS - 12
ER -