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ESTRO consensus guidelines on GTV delineation and dose-escalation in rectal cancer.

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Does the benefit of neoadjuvant chemotherapy at six months predict long-term outcomes in colon or rectal cancer? A meta-analysis of randomised studies.

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Does prior endoscopic intramuscular dissection for rectal cancer increase the risk of permanent stoma in patients requiring completion total mesorectal excision?

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Updated: May 31, 2026

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Rethinking endpoints for the watch-and-wait strategy in rectal cancer.

Bartłomiej Skrzypiec1, Agnieszka Żółciak-Siwińska1, Lucyna Pietrzak1

  • 1Department of Radiotherapy I, M. Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.

Cancer Treatment Reviews
|January 7, 2026
PubMed
Summary

Standardizing endpoints for watch-and-wait strategies is crucial for comparing treatment benefits and risks. Current methods for assessing clinical complete response (cCR) and regrowth rates need refinement to accurately reflect patient outcomes and the true risks of deferring surgery.

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Area of Science:

  • Oncology
  • Clinical Trial Methodology
  • Surgical Oncology

Background:

  • The watch-and-wait strategy requires standardized endpoints for benefit-risk ratio comparison across trials.
  • Accurate assessment of both treatment benefit and the primary risk (regrowth) is essential.

Purpose of the Study:

  • To critically analyze existing endpoints for evaluating watch-and-wait strategies.
  • To identify and propose standardized endpoints for future research and clinical practice.

Main Methods:

  • Conducted a literature search to identify and analyze endpoints used in watch-and-wait strategy evaluations.
  • Critically appraised the suitability of commonly used benefit and risk assessment methods.

Main Results:

  • Identified four benefit endpoints and four regrowth rate calculation methods across nine studies, highlighting a lack of standardization.
  • Common endpoints like clinical complete response (cCR) rate and organ preservation rate have limitations.
  • Current regrowth rate calculations may underestimate risk by excluding certain patient groups.

Conclusions:

  • Proposed standardized endpoints: sustained cCR rate post-radiochemotherapy and regrowth rate calculation including all relevant patient groups.
  • Standardization is needed to enable reliable cross-trial comparisons of watch-and-wait strategies.
  • Refined endpoints will improve the accurate assessment of the benefit-risk profile in rectal cancer management.