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Published on: February 12, 2022
Total Neoadjuvant Therapy with FOLFOX Followed by Short-Course Radiation in Locally Advanced Rectal Cancer-An
Janice Zhao1, Andrea M Baran2, Larissa K F Temple3
1Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
Journal of Clinical Medicine
|May 13, 2026
Summary
Total neoadjuvant therapy (TnT) using FOLFOX chemotherapy followed by short-course radiation therapy (SCRT) is safe for locally advanced rectal cancer. While 33% of patients achieved clinical response for non-operative management, this sequence may not be optimal for organ preservation.
Area of Science:
- Oncology
- Surgical Oncology
- Gastroenterology
Background:
- Locally advanced rectal cancer (LARC) treatment is evolving with total neoadjuvant therapy (TnT).
- Evaluating chemotherapy followed by short-course radiation therapy (SCRT) for complete clinical response (cCR) and non-operative management (NOM) is crucial.
- Few studies have specifically assessed this sequence for organ preservation in LARC.
Purpose of the Study:
- To evaluate the rate of cCR or near-complete clinical response (nCR) after neoadjuvant FOLFOX chemotherapy followed by SCRT in LARC patients.
- To assess the feasibility of offering NOM to patients achieving cCR or nCR.
- To determine secondary endpoints including disease-free survival (DFS), overall survival (OS), and R0 resection rates.
Main Methods:
- Phase II, open-label, single-arm clinical trial involving treatment-naïve adults with non-metastatic LARC.
- Patients received mFOLFOX6 chemotherapy followed by SCRT.
- Primary endpoint was the rate of cCR or nCR, with NOM offered to responders; others underwent total mesorectal excision (TME).
Main Results:
- The study enrolled 12 of 40 planned patients and was closed early.
- Four out of twelve patients (33%) achieved cCR or nCR and were offered NOM.
- One patient with NOM experienced local regrowth; all others remained disease-free at a median follow-up of 4.1 years. 1-year DFS was 100%.
Conclusions:
- Neoadjuvant FOLFOX followed by SCRT is a safe and potentially effective approach for select LARC patients.
- The 33% NOM rate is lower than other reported sequences, suggesting this order may not be optimal for organ preservation.
- Further research is needed to optimize neoadjuvant strategies for maximizing NOM rates in LARC.
