mFOLFOX6作为可切除结直肠癌肝转移围手术期化疗的疗效与安全性：一项病例对照研究

Efficacy and Safety of mFOLFOX6 as Perioperative Chemotherapy for Resectable Liver Metastases from Colorectal Cancer: A Case-Control Study.

作者信息

Wada Takahiro, Katsumata Kenji, Kasahara Kenta, Mazaki Junichi, Shigoka Masatoshi, Kawakita Hideaki, Enomoto Masanobu, Ishizaki Tetsuo, Nagakawa Yuichi, Tsuchida Akihiko

机构信息

Department of Pediatric Gastrointestinal Surgery, Tokyo Medical University, Tokyo, Japan.

Department of Gastrointestinal Surgery and Transplantation Surgery, Hachioji Medical Center, Tokyo Medical University, Tokyo, Japan.

出版信息

Cancer Diagn Progn. 2022 May 3;2(3):300-304. doi: 10.21873/cdp.10108. eCollection 2022 May-Jun.

DOI:10.21873/cdp.10108

PMID:35530640

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9066534/

Abstract

BACKGROUND/AIM: Although resection is effective for managing resectable liver metastases from colorectal cancer, the clinical significance of chemotherapy for such metastases has remained undetermined. Therefore, we conducted a phase II trial of perioperative chemotherapy with mFOLFOX6 to examine its efficacy.

PATIENTS AND METHODS

A total of 41 patients were examined. The liver resection rate was the primary endpoint, whereas the response rate, adverse events, completion rate, liver injury rate, R0 resection rate, and histological results were the secondary endpoints.

RESULTS

Overall, 34 (82.9%) patients underwent liver resection, and 77.4% and 100% had synchronous and metachronous liver metastases, respectively. The seven remaining patients did not undergo resection because of progressive disease. Moreover, 2, 15, 17, and 7 patients had a complete response, partial response, stable disease, and progressive disease, respectively, which indicated that the response rate was 41.5%. Regarding adverse events, three patients exhibited Grade 3 myelosuppression and one patient had gastrointestinal symptoms. On the basis of histopathological examination, 27, 5, and 2 patients belonged to grades 1a:1b, 2, and 3, respectively. Regarding liver injury, 29.4% had liver sinusoidal injury, whereas 11.7% had steatohepatitis. Meanwhile, all patients underwent postoperative chemotherapy.

CONCLUSION

mFOLFOX6 is safe and yields favorable therapeutic effects. The indication for liver resection after a certain waiting period is clinically significant.

摘要

背景/目的：尽管手术切除对于治疗可切除的结直肠癌肝转移有效，但此类转移灶化疗的临床意义仍未明确。因此，我们开展了一项使用mFOLFOX6进行围手术期化疗的II期试验，以检验其疗效。

患者与方法

共检查了41例患者。肝切除率为主要终点，而缓解率、不良事件、完成率、肝损伤率、R0切除率和组织学结果为次要终点。

结果

总体而言，34例（82.9%）患者接受了肝切除，其中同步肝转移和异时性肝转移患者分别占77.4%和100%。其余7例患者因疾病进展未接受手术。此外，分别有2例、15例、17例和7例患者达到完全缓解、部分缓解、疾病稳定和疾病进展，这表明缓解率为41.5%。关于不良事件，3例患者出现3级骨髓抑制，1例患者有胃肠道症状。根据组织病理学检查，27例、5例和2例患者分别属于1a:1b级、2级和3级。关于肝损伤，29.4%的患者有肝窦损伤，而11.7%的患者有脂肪性肝炎。同时，所有患者均接受了术后化疗。