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Two-Year Outcomes after Direct-to-Surgery in Good Prognosis Margin-Clear Stage II or III Rectal Cancer: The
Erin D Kennedy1,2,3, Marko Simunovic4,5, Selina Schmocker6
1Division of General Surgery, Department of Surgery, Mount Sinai Hospital, Toronto, ON, Canada. erin.kennedy@sinaihealth.ca.
Annals of Surgical Oncology
|June 17, 2026
Summary
Patients with margin-clear, Stage II or III rectal cancer can safely avoid neoadjuvant treatment with a direct-to-surgery approach. This strategy shows excellent 2-year oncologic outcomes and low radiation use for rectal cancer.
Area of Science:
- Oncology
- Surgical Oncology
- Radiology
Background:
- Neoadjuvant radiotherapy and chemotherapy are standard for Stage II/III rectal cancer.
- Pelvic MRI may identify patients who can avoid neoadjuvant treatment.
- This study evaluated outcomes for margin-clear Stage II/III rectal cancer treated with upfront surgery.
Purpose of the Study:
- To assess 2-year oncologic outcomes in Stage II/III rectal cancer patients undergoing direct low anterior resection.
- To determine the feasibility of avoiding neoadjuvant treatment in select rectal cancer patients.
Main Methods:
- Prospective, non-randomized phase II trial across 12 Canadian hospitals.
- Patients with "good prognosis" rectal cancer (MRI criteria: distance >1mm to mesorectal fascia) proceeded directly to low anterior resection.
- Primary outcomes: 2-year local recurrence, disease-free survival (DFS), and overall survival (OS).
Main Results:
- 139 patients recruited; 80 had Stage II/III rectal cancer.
- For Stage II/III patients: 2-year local recurrence 1%, DFS 85%, OS 99%.
- Only 8% received adjuvant radiotherapy; MRI over-staged 51% of pathology-confirmed Stage I patients.
Conclusions:
- A direct-to-surgery approach for margin-clear, Stage II/III rectal cancer yields excellent 2-year oncologic outcomes.
- This strategy significantly reduces the need for neoadjuvant treatment and radiation.
- MRI staging is crucial for identifying suitable candidates for upfront surgery.
