Bananzadeh Alimohammad, Hafezi Ali Akbar, Nguyen NamPhong, Omidvari Shapour, Mosalaei Ahmad, Ahmadloo Niloofar, Ansari Mansour, Mohammadianpanah Mohammad
Colorectal Research Center, Department of Colorectal Surgery, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Radiat Oncol J. 2021 Dec;39(4):270-278. doi: 10.3857/roj.2021.00654. Epub 2021 Oct 26.
This study was performed to investigate the efficacy and safety of short-course radiation therapy (SCRT) and sequential chemotherapy followed by delayed surgery in locally advancer rectal cancer with subgroup analysis between the older and young patients.
In this single-arm phase II clinical trial, eligible patients with locally advanced rectal cancer (T3-4 and/or N1-2) were enrolled. All the patients received a median three sequential cycles of neoadjuvant CAPEOX (capecitabine + oxaliplatin) chemotherapy. A total dose of 25 Gy in five fractions during 1 week was prescribed to the gross tumor and regional lymph nodes. Surgery was performed about 8 weeks following radiotherapy. Pathologic complete response rate (pCR) and grade 3-4 toxicity were compared between older patients (≥65 years) and younger patients (<65 years).
Ninety-six patients with locally advanced rectal cancer were enrolled. There were 32 older patients and 64 younger patients. Overall pCR was 20.8% for all the patients. Older patients achieved similar pCR rate (18.7% vs. 21.8; p = 0.795) compared to younger patients. There was no statistically significance in terms of the tumor and the node downstaging or treatment-related toxicity between older patients and younger ones; however, the rate of sphincter-saving surgery was significantly more frequent in younger patients (73% vs. 53%; p=0.047) compared to older ones. All treatment-related toxicities were manageable and tolerable among older patients.
Neoadjuvant SCRT and sequential chemotherapy followed by delayed surgery was safe and effective in older patients compared to young patients with locally advanced rectal cancer.
本研究旨在探讨短程放疗（SCRT）联合序贯化疗后延迟手术在局部进展期直肠癌中的疗效和安全性，并对老年患者和年轻患者进行亚组分析。
在这项单臂II期临床试验中，纳入了符合条件的局部进展期直肠癌患者（T3-4和/或N1-2）。所有患者接受了中位三个周期的新辅助CAPEOX（卡培他滨+奥沙利铂）化疗。对大体肿瘤和区域淋巴结给予1周内分5次共25 Gy的总剂量放疗。放疗后约8周进行手术。比较老年患者（≥65岁）和年轻患者（<65岁）的病理完全缓解率（pCR）和3-4级毒性反应。
96例局部进展期直肠癌患者入组。其中老年患者32例，年轻患者64例。所有患者的总体pCR为20.8%。与年轻患者相比，老年患者的pCR率相似（18.7%对21.8%；p = 0.795）。老年患者和年轻患者在肿瘤降期、淋巴结降期或治疗相关毒性方面无统计学差异；然而，年轻患者保肛手术率显著高于老年患者（73%对53%；p = 0.047）。老年患者所有治疗相关毒性均可控且可耐受。
与年轻的局部进展期直肠癌患者相比，新辅助SCRT联合序贯化疗后延迟手术在老年患者中安全有效。
