Neoadjuvant Chemotherapy Versus Adjuvant Chemotherapy for Very Low-Lying Clinical T3 Rectal Cancer: The NAIR Phase 2/3 Randomized Clinical Trial

Neoadjuvant Chemotherapy Versus Adjuvant Chemotherapy for Very Low-Lying Clinical T3 Rectal Cancer: The NAIR Phase 2/3 Randomized Clinical Trial

Objective:. To determine whether neoadjuvant chemotherapy (NAC) followed by total mesorectal excision (TME) and adjuvant chemotherapy (AC) is superior to TME followed by AC for very low-lying clinical (c) T3 rectal cancer. Background:. Preoperative radiation is widely used for preoperative treatment...

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Main Authors: Yuichiro Tsukada, MD, PhD, Norio Saito, MD, PhD, Yuji Nishizawa, MD, PhD, Riki Ohno, MD, PhD, Fumihiko Fujita, MD, PhD, Keiji Koda, MD, PhD, Masayuki Ohue, MD, PhD, Eiji Shinto, MD, PhD, Akihiko Murata, MD, PhD, Yoshikazu Koide, MD, PhD, Koji Ikeda, MD, PhD, Hideaki Bando, MD, PhD, Motoko Suzuki, Toshihiro Misumi, PhD, Takayuki Yoshino, MD, PhD, Masaaki Ito, MD, PhD
Format: Article
Language:English
Published: Wolters Kluwer Health 2025-06-01
Series:Annals of Surgery Open
Online Access:http://journals.lww.com/10.1097/AS9.0000000000000579
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Summary:Objective:. To determine whether neoadjuvant chemotherapy (NAC) followed by total mesorectal excision (TME) and adjuvant chemotherapy (AC) is superior to TME followed by AC for very low-lying clinical (c) T3 rectal cancer. Background:. Preoperative radiation is widely used for preoperative treatment of cT3 rectal cancer; however, it worsens patient-reported outcomes (PROs). Preoperative treatment without radiation is expected to preserve PROs. Methods:. Patients with cT3N-anyM0 rectal cancer located within 5 cm from the anal verge were randomly assigned (1:1) to the NAC group (3 months of NAC followed by TME and 3 months of AC) or AC group (TME followed by 6 months of AC). NAC and AC comprised mFOLFOX6 (oxaliplatin, l-folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine). The primary endpoint was the 3-year recurrence-free survival (RFS). PROs were analyzed. Results:. Between February 2013 and March 2019, 130 patients were randomly assigned to the NAC (n = 65) or AC (n = 65) groups; of these, 127 were evaluable (NAC, n = 65; AC, n = 62). At a median follow-up of 37.4 months, the 3-year RFS was 75.5% and 70.9% in NAC and AC groups, respectively [hazard ratio (HR) = 0.67, 60% confidence interval (CI) = 0.48–0.86, 95% CI = 0.34–1.32; P = 0.098 by log-rank test] and the primary endpoint was met. There was no significant intergroup difference in the local recurrence rate (LRR) or overall survival. Histologically, good responders to NAC showed a trend toward better RFS than poor responders. The study groups showed similar PROs. Conclusions:. NAC for very low-lying cT3 rectal cancer improved RFS without worsening PROs although LRR remained high. Trial Registration:. UMIN Clinical Trials Registry: UMIN000009510/Japan Registry of Clinical Trials: jRCTs031180278.
ISSN:2691-3593

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