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Robot-assisted Total Mesorectal Excision and Lateral Pelvic Lymph Node Dissection for Locally Advanced Middle-low Rectal Cancer
Published on: February 12, 2022
Preoperative Treatment of Locally Advanced Rectal Cancer
Deborah Schrag1, Qian Shi1, Martin R Weiser1
1From the Departments of Medicine (D.S., L.B.S., E.M.O.), Surgery (M.R.W.), and Radiology (M.J.G.), Memorial Sloan Kettering Cancer Center, and the Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai (K.A.G.) - both in New York; Alliance Statistics and Data Management Center (Q.S., G.D.N., B.C., A.C.D.) and the Department of Oncology (R.R.M.), Mayo Clinic, Rochester, MN; SWOG Cancer Research Network and the Department of Medicine, Baylor College of Medicine (B.L.M.), and the Department of Colon and Rectal Surgery, M.D. Anderson Cancer Center (G.J.C.) - both in Houston; the Departments of Surgery (J.G.) and Radiation Oncology (H.J.M.), Brigham and Women's Hospital, and the Department of Medical Oncology, Dana-Farber Cancer Institute (J.A.M.) - both in Boston; IHA Hematology Oncology, Ypsilanti, MI (T.A.B.); ECOG-ACRIN Cancer Research Network and Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia (J.M.F.); NRG Oncology and the University of Florida Health Cancer Center, Gainesville (T.J.G.); Canadian Cancer Trials Group, Kingston, ON (H.F.K.), and the Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg (V.G.) - both in Canada; Alliance Protocol Office, Chicago (A.S.); the Swiss Group for Clinical Cancer Research, Bern, Switzerland (M.M.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (A.P.V.); and the Department of Medical Oncology and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.).
Neoadjuvant FOLFOX chemotherapy is a viable alternative to chemoradiotherapy for locally advanced rectal cancer, demonstrating noninferior disease-free survival. This finding offers a new treatment option for patients undergoing sphincter-sparing surgery.
Area of Science:
- Oncology
- Surgical Oncology
- Clinical Trials
Background:
- Standard treatment for locally advanced rectal cancer involves neoadjuvant chemoradiotherapy (pelvic radiation plus fluoropyrimidine chemotherapy).
- The efficacy of neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) as an alternative to chemoradiotherapy remains uncertain.
Purpose of the Study:
- To determine if neoadjuvant FOLFOX is noninferior to standard chemoradiotherapy for disease-free survival in patients with locally advanced rectal cancer.
- To evaluate secondary endpoints including overall survival, local recurrence, pathological resection, and treatment toxicities.
Main Methods:
- A multicenter, unblinded, noninferiority, randomized trial compared neoadjuvant FOLFOX with chemoradiotherapy.
- Eligible participants had locally advanced rectal cancer and were candidates for sphincter-sparing surgery.
- The primary endpoint was disease-free survival, with noninferiority defined by a hazard ratio upper limit of 1.29.
Main Results:
- FOLFOX was found to be noninferior to chemoradiotherapy for disease-free survival (hazard ratio: 0.92; 90.2% CI, 0.74 to 1.14).
- Five-year disease-free survival rates were 80.8% for FOLFOX and 78.6% for chemoradiotherapy.
- Overall survival and local recurrence rates were similar between the two treatment groups.
Conclusions:
- Neoadjuvant FOLFOX is a noninferior alternative to neoadjuvant chemoradiotherapy for locally advanced rectal cancer in patients eligible for sphincter-sparing surgery.
- This study provides evidence supporting FOLFOX as a potentially less toxic or more convenient neoadjuvant treatment option.
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