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本文引用的文献

1
Feasibility of Neoadjuvant FOLFOX Therapy Without Radiotherapy for Baseline Resectable Rectal Cancer.新辅助FOLFOX方案不联合放疗用于基线可切除直肠癌的可行性
In Vivo. 2018 Jul-Aug;32(4):937-943. doi: 10.21873/invivo.11332.
2
A Multicenter Phase 2 Study on the Feasibility and Efficacy of Neoadjuvant Chemotherapy Without Radiotherapy for Locally Advanced Rectal Cancer.一项新辅助化疗而不进行放疗治疗局部进展期直肠癌的多中心 2 期研究。
Ann Surg Oncol. 2017 Nov;24(12):3587-3595. doi: 10.1245/s10434-017-5967-3. Epub 2017 Jul 6.
3
What has preoperative radio(chemo)therapy brought to localized rectal cancer patients in terms of perioperative and long-term outcomes over the past decades? A systematic review and meta-analysis based on 41,121 patients.在过去几十年中,术前放(化)疗给局部直肠癌患者的围手术期和长期预后带来了什么?一项基于41121例患者的系统评价和荟萃分析。
Int J Cancer. 2017 Sep 1;141(5):1052-1065. doi: 10.1002/ijc.30805. Epub 2017 Jun 8.
4
A comparison of the localization of rectal carcinomas according to the general rules of the Japanese classification of colorectal carcinoma (JCCRC) and Western guidelines.根据日本结直肠癌分类(JCCRC)的一般规则和西方指南对直肠癌定位的比较。
Surg Today. 2017 Sep;47(9):1086-1093. doi: 10.1007/s00595-017-1487-9. Epub 2017 Mar 7.
5
Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer: the FACT trial.奥沙利铂、5-氟尿嘧啶和亚叶酸钙新辅助化疗用于T3或T4期II/III期直肠癌的疗效和安全性:FACT试验
Cancer Chemother Pharmacol. 2017 Mar;79(3):519-525. doi: 10.1007/s00280-017-3243-7. Epub 2017 Feb 1.
6
Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial.术前放疗对直肠癌切除术后吻合口漏和狭窄的影响:一项随机对照试验的事后分析
Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.
7
Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial.改良 FOLFOX6 方案联合或不联合放疗对比氟尿嘧啶和亚叶酸钙联合放疗在局部进展期直肠癌新辅助治疗中的疗效:中国 FOWARC 多中心、开放标签、随机三臂 III 期临床试验的初步结果。
J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.
8
Prognostic impact of immune response in resectable colorectal liver metastases treated by surgery alone or surgery with perioperative FOLFOX in the randomised EORTC study 40983.单独手术或围手术期 FOLFOX 治疗可切除结直肠癌肝转移的随机 EORTC 研究 40983 中免疫反应对预后的影响。
Eur J Cancer. 2015 Nov;51(17):2708-17. doi: 10.1016/j.ejca.2015.08.014. Epub 2015 Sep 2.
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Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04.卡培他滨与奥沙利铂用于直肠癌术前多模式治疗:来自国家外科辅助乳腺和肠道项目R-04试验的手术终点
J Clin Oncol. 2014 Jun 20;32(18):1927-34. doi: 10.1200/JCO.2013.53.7753. Epub 2014 May 5.
10
Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial.局部进展期直肠癌患者新辅助化疗不常规应用放疗:一项初步试验。
J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13.

术前 mFOLFOX6 方案化疗治疗局部可切除的晚期直肠癌的安全性和有效性。

Safety and efficacy of preoperative mFOLFOX6 regimen chemotherapy for locally resectable advanced rectal cancer.

机构信息

Anorectal Department, Affiliated Nanhua Hospital, University of South China, Hengyang Hunan 421002.

Department of Thyroid and Breast Surgery, Affiliated Nanhua Hospital, University of South China, Hengyang Hunan 421002, China.

出版信息

Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Jan 28;46(1):32-38. doi: 10.11817/j.issn.1672-7347.2021.190256.

DOI:10.11817/j.issn.1672-7347.2021.190256
PMID:33678634
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10878283/
Abstract

OBJECTIVES

Neoadjuvant chemotherapy combined with radical surgery has become the treatment model for locally advanced rectal cancer. The purpose of this study was to evaluate the safety and efficacy of postoperative mFOLFOX6 regimen chemotherapy for locally resectable advanced rectal cancer.

METHODS

This was a prospective study. A total of 82 patients with locally advanced rectal cancer admitted to Affiliated Nanhua Hospital, University of South China from February 2015 to December 2017 were selected as the subjects. The patients received 4 courses of mFOLFOX6 chemotherapy and underwent surgery within 4-6 weeks after chemotherapy. The incidences of chemotherapy-related adverse reactions, postoperative complications, and clinical pathological reactions were analyzed.

RESULTS

In the period from mFOLFOX6 chemotherapy to preoperative, 82 patients with locally advanced rectal cancer was reported chemotherapy-related adverse reactions, including Grade 4 neutropenia (2.4%), catheter related infection (2.4%), and anorexia (2.4%), Grade 3 nausea (2.4%) and anorexia (2.4%), Grade 2 neutropenia (14.6%) and peripheral neuropathy (7.3%). Finally, 76 patients with locally advanced rectal cancer completed surgery, including 56 (73.7%) with anterior rectum resection, 16 (21.1%) with abdominal perineal resection, and 72 (94.7%) with pelvic nerve preservation. A total of 22 (28.9%) patients had surgical complications, including 8 (10.5%) with complications of Grade 3 or above. The complications with high incidence were intestinal obstruction, anastomotic leakage, and sepsis. Among the 76 patients who completed chemotherapy and surgery, T stage was decreased in 28 (36.8%) and N stage was decreased in 44 (57.9%); forty-two (55.3%) were in pathological Stage I, 20 (26.3%) in Stage IIA, 12 (15.8%) in Stage IIB, and 2 (2.6%) in Stage IIIA. Ten patients were suspected of tumor invasion of surrounding organs before chemotherapy, of which 4 patients did not need to extend the resection of surrounding organs after chemotherapy and achieved R0 resection of tumor; 2 in T stage before chemotherapy received extended resection of surrounding organs, and the postoperative pathological result was T, and achieved R0 resection; 1 diagnosed as poorly differentiated adenocarcinoma with seminal vesicle invasion in the evaluation before chemotherapy had T-stage progression after operation. There were 66 (86.8%) patients of partial response (PR), 9 (11.8%) of stable disease (SD) and 1 (1.3%) of progressive disease (PD). There was no complete response (CR) and no new lesion.

CONCLUSIONS

Preoperative mFOLFOX6 regimen chemotherapy for locally resectable advanced rectal cancer is a safe and feasible treatment strategy, and it is worthy of clinical application.

摘要

目的

新辅助化疗联合根治性手术已成为局部进展期直肠癌的治疗模式。本研究旨在评估可切除局部晚期直肠癌术后 mFOLFOX6 方案化疗的安全性和有效性。

方法

这是一项前瞻性研究。2015 年 2 月至 2017 年 12 月,南华大学附属南华医院共收治 82 例局部进展期直肠癌患者,均接受 4 个周期 mFOLFOX6 化疗,化疗后 4-6 周内进行手术。分析化疗相关不良反应、术后并发症及临床病理反应发生率。

结果

从 mFOLFOX6 化疗到术前,82 例局部晚期直肠癌患者出现化疗相关不良反应,其中 4 级中性粒细胞减少症(2.4%)、导管相关感染(2.4%)、厌食症(2.4%)、3 级恶心(2.4%)和厌食症(2.4%)、2 级中性粒细胞减少症(14.6%)和周围神经病(7.3%)。最终,76 例局部晚期直肠癌患者完成手术,其中前直肠切除术 56 例(73.7%)、腹会阴联合切除术 16 例(21.1%)、保留盆神经 72 例(94.7%)。22 例(28.9%)患者发生手术并发症,其中 8 例(10.5%)为 3 级及以上并发症。发生率较高的并发症为肠梗阻、吻合口漏和脓毒症。在完成化疗和手术的 76 例患者中,T 分期下降 28 例(36.8%),N 分期下降 44 例(57.9%);42 例(55.3%)为病理Ⅰ期,20 例(26.3%)为Ⅱ A 期,12 例(15.8%)为Ⅱ B 期,2 例(2.6%)为Ⅲ A 期。化疗前 10 例患者怀疑肿瘤侵犯周围器官,其中 4 例化疗后无需扩大周围器官切除,达到肿瘤 R0 切除;化疗前 2 例 T 期患者行扩大周围器官切除术,术后病理结果为 T,达到 R0 切除;1 例术前评估诊断为低分化腺癌伴精囊侵犯,术后 T 期进展。66 例(86.8%)患者部分缓解(PR),9 例(11.8%)病情稳定(SD),1 例(1.3%)病情进展(PD)。无完全缓解(CR)和新发病灶。

结论

可切除局部晚期直肠癌术前 mFOLFOX6 方案化疗是一种安全可行的治疗策略,值得临床应用。