Background <p>Nonoperative management of rectal cancer in patients who achieve near-complete response following total neoadjuvant therapy remains controversial and understudied.</p> Methods <p>This retrospective cohort study conducted at a tertiary National Cancer Institute-designated cancer center included patients with rectal cancer who initiated active surveillance after achieving near-complete response following induction radiotherapy and consolidation chemotherapy. Near-complete response was determined based on restaging endoluminal evaluation and pelvic magnetic resonance imaging. Time-to-event analyses were used to estimate regrowth-free, proctectomy-free, disease-free, and overall survival.</p> Results <p>Of 61 patients who achieved near-complete response and initiated nonoperative management between February 2017 and March 2024, 36 (59.0%) maintained organ preservation with a median follow-up of 27.1 (interquartile range [IQR] 17.4–37.4) months. Twenty-five patients (41.0%) developed local regrowth by a median of 5.7 (IQR 3.2–8.2) months. All regrowths occurred within 17.5 months of initial restaging. Twenty-one patients with regrowth underwent salvage proctectomy, of which 20 (95.2%) achieved R0 resection margins. Following salvage proctectomy, four patients (19.0%) developed local recurrence. Disease-free and overall survival 2 years from restaging were 79.2% (95% confidence interval [CI] 67.0–93.6) and 93.3% (95% CI 86.3–100), respectively. Overall survival was not significantly different between patients with versus without local regrowth (log-rank <i>p</i> = 0.09).</p> Conclusions <p>Nonoperative management achieves clinically significant organ preservation rates without compromising oncologic outcomes in patients with near-complete response to total neoadjuvant therapy. Active surveillance allows time for continued evolution of tumor response and may substantially expand organ preservation in a patient population who otherwise would undergo avoidable radical surgery.</p>

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Nonoperative Management of Rectal Cancer: Is “Near-Complete” Response Safe to Surveil?

  • Catherine N. Zivanov,
  • Nathan S. Kau,
  • Harika Nalluri-Butz,
  • Oluseye K. Oduyale,
  • Ahmed A. Eltahir,
  • Jared T. Yee,
  • Austin R. Dosch,
  • Lindsey Zhang,
  • Hyun Kim,
  • Michael D. Iglesia,
  • Michelle L. Cowan,
  • Kerri A. Ohman,
  • Paul E. Wise,
  • Steven R. Hunt,
  • Matthew L. Silviera,
  • Matthew G. Mutch,
  • William C. Chapman Jr.

摘要

Background

Nonoperative management of rectal cancer in patients who achieve near-complete response following total neoadjuvant therapy remains controversial and understudied.

Methods

This retrospective cohort study conducted at a tertiary National Cancer Institute-designated cancer center included patients with rectal cancer who initiated active surveillance after achieving near-complete response following induction radiotherapy and consolidation chemotherapy. Near-complete response was determined based on restaging endoluminal evaluation and pelvic magnetic resonance imaging. Time-to-event analyses were used to estimate regrowth-free, proctectomy-free, disease-free, and overall survival.

Results

Of 61 patients who achieved near-complete response and initiated nonoperative management between February 2017 and March 2024, 36 (59.0%) maintained organ preservation with a median follow-up of 27.1 (interquartile range [IQR] 17.4–37.4) months. Twenty-five patients (41.0%) developed local regrowth by a median of 5.7 (IQR 3.2–8.2) months. All regrowths occurred within 17.5 months of initial restaging. Twenty-one patients with regrowth underwent salvage proctectomy, of which 20 (95.2%) achieved R0 resection margins. Following salvage proctectomy, four patients (19.0%) developed local recurrence. Disease-free and overall survival 2 years from restaging were 79.2% (95% confidence interval [CI] 67.0–93.6) and 93.3% (95% CI 86.3–100), respectively. Overall survival was not significantly different between patients with versus without local regrowth (log-rank p = 0.09).

Conclusions

Nonoperative management achieves clinically significant organ preservation rates without compromising oncologic outcomes in patients with near-complete response to total neoadjuvant therapy. Active surveillance allows time for continued evolution of tumor response and may substantially expand organ preservation in a patient population who otherwise would undergo avoidable radical surgery.