Ding Miaomiao, Zhang Jianwei, Hu Huabin, Cai Yue, Ling Jiayu, Wu Zehua, Xie Xiaoyu, Li Jianxia, Li Weiwei, Deng Yanhong
Department of Medical Oncology, Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P.R. China; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P.R. China.
Department of Medical Oncology, Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P.R. China; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P.R. China.
Clin Colorectal Cancer. 2022 Mar;21(1):e12-e20. doi: 10.1016/j.clcc.2021.11.009. Epub 2021 Nov 28.
BACKGROUND: Preoperative chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC). However, CRT failed to impact metastatic recurrence and the risk of side effects on bowel and genitourinary remained a concern. Neoadjuvant chemotherapy alone with mFOLFOX6 or FOLFOXIRI had been investigated in LARC. Here, we tried to compare the efficacy of mFOLFOXIRI with mFOLFOX6 as neoadjuvant chemotherapy in LARC. PATIENTS AND METHODS: Between January 2014 and December 2019, patients with LARC receiving neoadjuvant chemotherapy with mFOLFOXIRI or mFOLFOX6 were retrospective analyzed, including data from a prospective trial (NCT02217020). All patients underwent total mesorectal excision (TME). The propensity-score matching was preformed to adjust baseline potential confounders and to estimate differences in outcomes between patients receiving mFOLFOXIRI and mFOLFOX6. Survival analysis was done using Kaplan-Meier analysis and Cox proportional regression analysis. RESULTS: The median follow-up time was 31.1 months. After propensity score matching, 156 patients were available for comparison in each group. The pathological complete response (pCR) rate was 17.9% vs. 5.1% (P< .001), the incidence rate of anastomotic fistula was 3.2% vs. 9% (P = .03), the 3 year disease-free survival (DFS) rate was 75% vs. 66.7% (P = .047) and the distant metastasis rate was 16.4% versus 26.6% (P = .013) for mFOLFOXIRI and mFOLFOX6 group, respectively. Patients receiving mFOLFOXIRI had higher incidence of grade III and/or IV nausea and/or vomiting (7.6% vs. 2.5%, P = .04). CONCLUSIONS: Neoadjuvant mFOLFOXIRI regimens improved pCR rate and survival outcome, reduced the rate of distant metastasis and anastomotic fistula when comparing with propensity-score matched controls of mFOLFOX6 neoadjuvant chemotherapy. MICROABSTRACT: This trial assessed the short-term and long-term effects of neoadjuvant chemotherapy with mFOLFOXIRI and mFOLFOX6 in patients with locally advanced rectal cancer. Comparing with propensity-score matched historical control of chemoradiotherapy, neoadjuvant mFOLFOXIRI chemotherapy was well tolerated and led to higher rates of 3 year disease-free survival in patients with locally advanced rectal cancer.
背景：术前放化疗（CRT）是局部晚期直肠癌（LARC）的标准治疗方法。然而，CRT未能影响转移性复发，且肠道和泌尿生殖系统的副作用风险仍是一个问题。已对LARC单独使用新辅助化疗mFOLFOX6或FOLFOXIRI进行了研究。在此，我们试图比较mFOLFOXIRI与mFOLFOX6作为LARC新辅助化疗的疗效。 患者与方法：回顾性分析2014年1月至2019年12月接受mFOLFOXIRI或mFOLFOX6新辅助化疗的LARC患者，包括一项前瞻性试验（NCT02217020）的数据。所有患者均接受全直肠系膜切除术（TME）。进行倾向评分匹配以调整基线潜在混杂因素，并估计接受mFOLFOXIRI和mFOLFOX6的患者之间的结局差异。使用Kaplan-Meier分析和Cox比例回归分析进行生存分析。 结果：中位随访时间为31.1个月。倾向评分匹配后，每组有156例患者可供比较。mFOLFOXIRI组与mFOLFOX6组的病理完全缓解（pCR）率分别为17.9%和5.1%（P<0.001），吻合口瘘发生率分别为3.2%和9%（P = 0.03），3年无病生存率（DFS）分别为75%和66.7%（P = 0.047），远处转移率分别为16.4%和26.6%（P = 0.013）。接受mFOLFOXIRI的患者III级和/或IV级恶心和/或呕吐的发生率更高（7.6%对2.5%，P = 0.04）。 结论：与倾向评分匹配的mFOLFOX6新辅助化疗对照组相比，新辅助mFOLFOXIRI方案提高了pCR率和生存结局，降低了远处转移率和吻合口瘘发生率。 微摘要：本试验评估了mFOLFOXIRI和mFOLFOX6新辅助化疗对局部晚期直肠癌患者的短期和长期影响。与倾向评分匹配的放化疗历史对照相比，新辅助mFOLFOXIRI化疗耐受性良好，可提高局部晚期直肠癌患者的3年无病生存率。
Clin Colorectal Cancer. 2019-7-11
Int J Colorectal Dis. 2024-3-16
Clin Colon Rectal Surg. 2023-4-16
Zotero 插件