Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China.
Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China.
Eur J Surg Oncol. 2023 Dec;49(12):107115. doi: 10.1016/j.ejso.2023.107115. Epub 2023 Oct 11.
Stratified treatment has been recommended for rectal cancer. Our previous multicenter randomized trial showed that low-/intermediate-risk rectal cancer patients did not benefit much from neoadjuvant chemoradiotherapy. In our phase II study, we found that stage II/III rectal cancer patients with low-/intermediate risks can be managed by neoadjuvant chemotherapy alone and achieve a good response. The current study aimed to report the long-term survival outcomes in the expanded phase II trial.
Consecutive patients diagnosed with mid-low stage II/III rectal cancer with low/intermediate risk factors were included. Four cycles of neoadjuvant chemotherapy (CAPOX) were given, and MRI was used for tumour response detection. The primary endpoint was disease-free survival. The secondary endpoints were tumour response to NCT, tumour-related death, and overall survival.
This study enrolled 121 eligible patients. The good tumour response rate based on MRI was 82.6 %, with a pathological complete response (pCR) rate of 18.3 %. The disease-free survival rate was 82.6 %, and the overall survival rate was 96.7 % after a median follow-up time of 40 months. Two patients (1.7 %) suffered local recurrence, and 15 patients (12.4 %) suffered distant metastasis. The median disease-free survival and overall survival were 37 (9-60) and 40 (16-60) months, respectively. Tumour longitudinal length reduction and tumour regression grade on MRI were identified as predictors for poor tumour response to neoadjuvant chemotherapy.
In stage II/III rectal cancer patients with low-/intermediate risks, neoadjuvant chemotherapy alone may result in an acceptable tumour response and disease-free survival. Tumour response might be predicted early.
分层治疗已被推荐用于直肠癌。我们之前的多中心随机试验表明，低/中危直肠癌患者从新辅助放化疗中获益不大。在我们的 II 期研究中，我们发现低/中危 II/III 期直肠癌患者可以单独接受新辅助化疗，并获得良好的反应。本研究旨在报告扩大的 II 期试验中的长期生存结果。
连续纳入中低期 II/III 期直肠癌且具有低/中危因素的患者。给予 4 个周期的新辅助化疗（CAPOX），并使用 MRI 检测肿瘤反应。主要终点为无病生存。次要终点为 NCT 的肿瘤反应、肿瘤相关死亡和总生存。
本研究共纳入 121 例符合条件的患者。根据 MRI 评估，肿瘤良好反应率为 82.6%，病理完全缓解（pCR）率为 18.3%。无病生存率为 82.6%，中位随访 40 个月后总生存率为 96.7%。2 例（1.7%）患者发生局部复发，15 例（12.4%）患者发生远处转移。无病生存和总生存的中位数分别为 37（9-60）和 40（16-60）个月。MRI 上肿瘤纵向长度减少和肿瘤消退分级被确定为新辅助化疗肿瘤反应不良的预测因素。
在低/中危 II/III 期直肠癌患者中，单独使用新辅助化疗可能会获得可接受的肿瘤反应和无病生存。肿瘤反应可能可以早期预测。
