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Войти в исследования International journal of radiation oncology, biology, physics · 2026
Organ Preservation With Total Neoadjuvant Therapy (OPTNT) for Early Low Rectal Cancer: Short-Term Outcomes of a Nonrandomized Phase 2 Clinical Trial.
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Xian Zhang, Feng Qingyang, Qian Yang, Wei Ye, Ren Li, Ye Lechi, Zhong Yunshi, Chang Wenju, Rao Shengxiang, Liu Liheng, Huang Lihong, Ji Yuan, Wang Yichen, Xu Jian-Min, Wang Jian
Аннотация
BACKGROUND: Total mesorectal excision (TME) is standard for low rectal cancer (≤5cm from anal verge) but causes permanent stomas, functional impairments and surgical risks. Local excision (LE) suits early tumors (cTis-T1N0) but has higher recurrence in cT2+; watch-and-wait (WW) after neoadjuvant chemoradiotherapy risks residual disease. Total neoadjuvant therapy (TNT) improves outcomes, but prior LE trials had limitations.
OBJECTIVE: To evaluate TNT combined with planned LE for organ preservation in selected low rectal adenocarcinoma patients.
DESIGN: Prospective single-arm phase 2 trial (June 2022-March 2024, tertiary center) enrolled 57/60 patients (cT1-3N0M0 nonmucinous adenocarcinoma, etc.). TNT: 50 Gy + 2 cycles of CapoX (standard capecitabine + oxaliplatin) + 4 consolidation CapoX. Clinical complete response (cCR)/near-complete clinical response (ncCR) patients had LE; others got TME. Patients with high-risk residual disease after LE also had additional TME.
RESULTS: Median age was 61 years (28-79); 66.7% were male. cT3 tumors were present in 78.9%, and 78.9% had tumors ≤3 cm from the anal verge. After TNT, 47.4% achieved cCR and 38.6% achieved ncCR. Among surgically treated patients, the pathological complete response (pCR) rate was 68.6%; in the overall population, with WW counted as non-pCR, it was 61.4%. The total complete response rate, including pCR and cCR managed with WW, was 68.4%. Sphincter preservation was 94.7%. LE was associated with lower median blood loss (7 vs 50 mL; P<0.001) and shorter median hospitalization (7 vs 14 days; P=0.001) than TME. Grade 3 adverse events occurred in 22.8%, most commonly lymphocytopenia; no grade 4 or 5 events occurred. Low anterior resection syndrome (LARS) scores were assessed after TNT and at 1, 3, and 6 months postoperatively. At 6 months, LARS outcomes favored LE (80.0% vs 53.8% reporting no LARS; P=0.027). Wexner incontinence scores did not differ significantly between groups at any time point.
CONCLUSION: TNT with planned LE is feasible in cT1-3N0M0 low rectal cancer, yielding a pCR rate of 61.4% in the overall population, 94.7% sphincter preservation, and acceptable toxicity. However, the non-randomized design and immature 3-year organ-preservation endpoint limit this study to a feasibility assessment and do not permit conclusions regarding comparative effectiveness versus WW.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05563922.
OBJECTIVE: To evaluate TNT combined with planned LE for organ preservation in selected low rectal adenocarcinoma patients.
DESIGN: Prospective single-arm phase 2 trial (June 2022-March 2024, tertiary center) enrolled 57/60 patients (cT1-3N0M0 nonmucinous adenocarcinoma, etc.). TNT: 50 Gy + 2 cycles of CapoX (standard capecitabine + oxaliplatin) + 4 consolidation CapoX. Clinical complete response (cCR)/near-complete clinical response (ncCR) patients had LE; others got TME. Patients with high-risk residual disease after LE also had additional TME.
RESULTS: Median age was 61 years (28-79); 66.7% were male. cT3 tumors were present in 78.9%, and 78.9% had tumors ≤3 cm from the anal verge. After TNT, 47.4% achieved cCR and 38.6% achieved ncCR. Among surgically treated patients, the pathological complete response (pCR) rate was 68.6%; in the overall population, with WW counted as non-pCR, it was 61.4%. The total complete response rate, including pCR and cCR managed with WW, was 68.4%. Sphincter preservation was 94.7%. LE was associated with lower median blood loss (7 vs 50 mL; P<0.001) and shorter median hospitalization (7 vs 14 days; P=0.001) than TME. Grade 3 adverse events occurred in 22.8%, most commonly lymphocytopenia; no grade 4 or 5 events occurred. Low anterior resection syndrome (LARS) scores were assessed after TNT and at 1, 3, and 6 months postoperatively. At 6 months, LARS outcomes favored LE (80.0% vs 53.8% reporting no LARS; P=0.027). Wexner incontinence scores did not differ significantly between groups at any time point.
CONCLUSION: TNT with planned LE is feasible in cT1-3N0M0 low rectal cancer, yielding a pCR rate of 61.4% in the overall population, 94.7% sphincter preservation, and acceptable toxicity. However, the non-randomized design and immature 3-year organ-preservation endpoint limit this study to a feasibility assessment and do not permit conclusions regarding comparative effectiveness versus WW.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05563922.