Aydın Okan, Öztürk Ahmet Emin, Erciyestepe Mert, Sonuşen Şermin Dinç, İşleyen Zehra Sucuoğlu, Dinçer Selvi Tabak, Çelik Emir, Ertürk Kayhan, Atcı Muhammed Mustafa
Department of Medical Oncology, Prof. Dr. Cemil Taşcıoğlu City Hospital, University of Health Sciences, İstanbul, Turkey.
Department of Medical Oncology, Prof. Dr. Cemil Taşcıoğlu City Hospital, University of Health Sciences, İstanbul, Turkey.
Clin Colorectal Cancer. 2025 Sep;24(3):369-377.e1. doi: 10.1016/j.clcc.2025.05.001. Epub 2025 May 22.
Total neoadjuvant therapy (TNT) has emerged as a promising approach in the treatment of locally advanced rectal cancer (LARC), aiming to improve pathological complete response (pCR) and survival by eradicating micrometastases.
We aimed to evaluate the effect of TNT, which has been applied to patients with LARC in our clinic since 2019, on pathological response and survival and to present real-life data.
The medical records of 116 patients with stage 3 locally advanced rectal cancer who were followed at our clinic between March 2019 and March 2024 and who received TNT were retrospectively analyzed. Patients with pCR and non-pCR and TRG 0-1 and 2-3 were compared.
The median follow-up period was 24.5. All of these 116 patients, were stage 3 (mostly stage 3B). Surgery was performed in 106 patients after TNT and 10 patients (8.6%) were followed with nonoperative management (NOM). Pathological complete response (pCR) was achieved in 28 (26.5%) of these 106 patients. The number of CAP-TRG 1 patients (near-pCR) was 35 (33%) and the number of CAP-TRG 2-3 patients was 43 (40.5%). Complete and near-complete responses (pCR and near-pCR) were achieved in approximately 60% of patients. Two parameters showed statistical significance in the univariate analysis of factors affecting pCR; tumor distance from the anal verge > 10 cm increased pCR 7.2-fold (P = .02) and CEA level at diagnosis ≤ 5 ng/ml increased pCR 4.4-fold (P = .008). During follow-up, 10 patients developed recurrence and/or metastasis and 5 of these 10 patients died. The majority of treatment-related toxicities were manageable grade 1-2 toxicities.
These single center, real-world data provide a perspective on the impact of TNT on pathological response and survival in patients with LARC. TNT is an effective and safe treatment and has become the standard of care with increased pathological complete response rates.
全新辅助治疗（TNT）已成为治疗局部晚期直肠癌（LARC）的一种有前景的方法，旨在通过根除微转移来提高病理完全缓解（pCR）率和生存率。
我们旨在评估自2019年起在我们诊所应用于LARC患者的TNT对病理反应和生存的影响，并呈现真实世界的数据。
回顾性分析了2019年3月至2024年3月在我们诊所接受TNT治疗的116例3期局部晚期直肠癌患者的病历。比较了达到pCR和未达到pCR以及肿瘤退缩分级（TRG）为0 - 1级和2 - 3级的患者。
中位随访期为24.5个月。这116例患者均为3期（大多为3B期）。106例患者在TNT后接受了手术，10例患者（8.6%）接受非手术治疗（NOM）随访。这106例患者中有28例（26.5%）实现了病理完全缓解（pCR）。CAP - TRG 1级（接近pCR）患者有35例（33%），CAP - TRG 2 - 3级患者有43例（40.5%）。约60%的患者实现了完全和接近完全缓解（pCR和接近pCR）。在影响pCR的因素单因素分析中，有两个参数具有统计学意义；距肛缘肿瘤距离> 10 cm使pCR增加7.2倍（P = .02），诊断时癌胚抗原（CEA）水平≤ 5 ng/ml使pCR增加4.4倍（P = .008）。随访期间，10例患者出现复发和/或转移，其中5例死亡。大多数治疗相关毒性为可控的1 - 2级毒性。
这些单中心的真实世界数据提供了关于TNT对LARC患者病理反应和生存影响的观点。TNT是一种有效且安全的治疗方法，随着病理完全缓解率的提高已成为标准治疗方案。
