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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.

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。

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