AbstractAdjuvant oxaliplatin plus capecitabine (XELOX) therapy is recommended for patients with curatively resected colon cancer. However, prospective data on its practical application in Japanese patients are limited. Therefore, we aimed to conduct a long-term clinical evaluation of the efficacy and safety of adjuvant XELOX in patients with curatively resected stage III colon cancer (MCSCO-1024).

摘要推荐奥沙利铂联合卡培他滨（XELOX）辅助治疗结肠癌。然而，关于其在日本患者中实际应用的前瞻性数据有限。因此，我们旨在对辅助XELOX在治疗性切除的III期结肠癌（MCSCO-1024）患者中的疗效和安全性进行长期临床评估。

This prospective, multi-center, open-label, single-arm, phase II study enrolled patients with curatively resected stage III colon cancer. The treatment protocol consisted of a 120-minute intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and two divided doses oral capecitabine (2000 mg/m2/day) for 14 days in a 3-week cycle, totaling eight cycles (24 weeks).

这项前瞻性，多中心，开放标签，单臂，II期研究招募了治疗性切除的III期结肠癌患者。治疗方案包括在第1天静脉输注奥沙利铂（130 mg/m2）120分钟，在3周的周期内分两次口服卡培他滨（2000 mg/m2/天）14天，共8个周期（24周）。

The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints were 5-year overall survival and long-term prognosis of peripheral sensory neuropathy. A total of 196 patients were enrolled between November 2011 and August 2014 (34 months). The 3-year DFS rate was 73%, and the 5-year overall survival rate was 87%.

主要终点是3年无病生存期（DFS），次要终点是5年总生存期和周围感觉神经病的长期预后。2011年11月至2014年8月（34个月）共招募了196名患者。3年DFS率为73%，5年总生存率为87%。

The overall incidence of peripheral sensory neuropathy was 17%, with a 1% rate of grade 3 neuropathy after 5 years. Adjuvant XELOX demonstrated utility and safety in the clinical management of Japanese patients with stage III colon cancer..

周围感觉神经病的总发生率为17%，5年后3级神经病的发生率为1%。佐剂XELOX在日本III期结肠癌患者的临床管理中显示出实用性和安全性。。

IntroductionAlthough studies have assessed the safety and tolerability of adjuvant XELOX therapy in Asian patients with curatively resected colon cancer1,2, there are limited reports on long-term outcomes, including peripheral neuropathy, in Japanese individuals. We previously published interim safety data from this study3.

。我们之前发表了这项研究的中期安全数据3。

The aim of the present study was to present the long-term efficacy of adjuvant XELOX therapy and peripheral sensory neuropathy (PSN) associated with it for Japanese patients who underwent curative resection for stage III colon cancer (MCSCO-1024). In this study, the primary endpoint was 5-year Disease-Free Survival (DFS), whereas the secondary endpoints included degree of peripheral neuropathy after 5-years of treatment and 5-year overall survival (OS).

本研究的目的是介绍辅助XELOX治疗及其相关的周围感觉神经病（PSN）对接受III期结肠癌根治性切除术（MCSCO-1024）的日本患者的长期疗效。在这项研究中，主要终点是5年无病生存期（DFS），而次要终点包括5年治疗后的周围神经病变程度和5年总生存期（OS）。

Andre et al. reported that peripheral neuropathy at four years occurred in 15.4% of cases4. Hence, in the present study, we assumed that peripheral neuropathy is about 12% after five years.Patients and methodsEligibility criteriaEligible patients were 20 years or older with a histologically confirmed diagnosis of colon adenocarcinoma, specifically stage III colon cancer, which included cancers of the rectosigmoid region.

Andre等人报道，四年时周围神经病变发生率为15.4%。因此，在本研究中，我们假设五年后周围神经病变约为12%。患者和方法合格标准符合条件的患者年龄在20岁或以上，经组织学确诊为结肠癌，特别是III期结肠癌，其中包括直肠乙状结肠区域的癌症。

They underwent colectomy with D2 or D3 lymph node dissection and achieved curative resection (curative level A) without macroscopic or microscopic residual tumors. Other eligibility criteria included an Eastern Clinical Oncology Group (ECOG) performance status of 0 or 1, no prior chemotherapy or radiotherapy, adequate oral food intake, and proper functioning of vital organs (e.g., white blood cell count ≥ 3000/mm3, neutrophil count ≥ 1500/mm3, platelet count ≥ 100,000/mm3, serum creatinine ≥ 1.5 × the institutional upper limit of normal (ULN), serum total bilirubin ≥ 2.5 × ULN, and se.

。其他资格标准包括东部临床肿瘤组（ECOG）的表现状态为0或1，既往无化疗或放疗，口服食物摄入充足，重要器官功能正常（如白细胞计数≥3000/mm3，中性粒细胞计数≥1500/mm3，血小板计数≥100000/mm3，血清肌酐≥1.5×正常上限（ULN），血清总胆红素≥2.5×ULN和se。（笑声）。

Data availability

数据可用性

The supporting data are available from the corresponding author on reasonable request.

根据合理的要求，通讯作者可以提供支持数据。

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Download referencesAcknowledgementsThis study was supported by the Multicenter Clinical Study Group of the Osaka Colorectal Cancer Treatment Group.Author informationAuthor notesTaishi Hata and Mamoru Uemura have contributed equally to this work.Authors and AffiliationsDepartment of Surgery, Japan Organization of Occupational Health and Safety, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511, JapanTaishi Hata & Kohei MurataDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, JapanMamoru Uemura, Takayuki Ogino, Norikatsu Miyoshi, Hirofumi Yamamoto, Yuichiro Doki & Hidetoshi EguchiDepartment of Surgery, Minoh City Hospital, Mino, Osaka, JapanKatsuki DannoDepartment of Surgery, Yao Municipal Hospital, Osaka, JapanShinichi YoshiokaDepartment of Surgery, Osaka Police Hospital, Osaka, JapanChu MatsudaDepartment of Surgery, Osaka General Medical Center, Osaka, JapanYoshinori KagawaDepartment of Surgery, Saiseikai Senri Hospital, Suita, JapanTatsushi ShingaiDepartment of Surgery, Toyonaka Municipal Hospital, Toyonaka, JapanYozo SuzukiDepartment of Surgery, Osaka Rosai Hospital, Sakai, JapanMitsuyoshi TeiDepartment of Surgery, Higashiosaka City Medical Center, Higashiosaka , JapanTsukasa TanidaDepartment of Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, JapanTakamichi KomoriDepartment of Gastroenterological Surgery, Suita Municipal Hospital, Suita, JapanShu OkamuraDepartment of Surgery, Ikeda City Hospital, Ikeda, JapanHirofumi OtaDepartment of Surgery, Kinki Central Hospital of the Mutual Aid Association of Public School Teachers, Itami, JapanHiroyoshi TakemotoAuthorsTaishi HataView author publicationsYou can also search for this author in.

下载参考文献致谢本研究得到了大阪结直肠癌治疗组多中心临床研究小组的支持。作者信息作者注：Hata和Uemura对这项工作做出了同样的贡献。作者和附属机构日本职业健康与安全组织外科，关西罗西医院，3-1-69 Inabaso，Amagasaki，Hyugo，660-8511，JapanTaishi Hata＆Kohei Muratada大阪大学医学研究生院胃肠外科，大阪Suita，JapanMamoru Uemura，Takayuki Ogino，Norikatsu Miyoshi，Hirofumi Yamamoto，Yuicro Doki＆Hidetoshi EguchiDepartment外科，大阪市Mino市Minoh市立医院，日本大阪市Yao市立医院外科，大阪市Yao市立医院外科，日本国立吉冈市外科，大阪市警察医院，日本松下市外科，大阪市普通医学中心，大阪市，日本小森里Kagawa外科，日本东京市丰中市医院外科，日本佐佐佐铃木外科，大阪罗赛医院，酒井，日本三好市东大阪市医学中心外科，日本东大阪市，日本田田市，兵库县西宫医院外科，日本西宫市，日本小村市，Suita市立医院，Suita市立医院，Suita，日本冈村外科，池田市医院，池田市，日本大田市立医院外科，近畿中央医院，公立学校教师互助协会，Itami，JapanHiroyoshi TakemotoAuthorsTaishi HataView作者出版物您也可以在中搜索该作者。

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Reprints and permissionsAbout this articleCite this articleHata, T., Uemura, M., Danno, K. et al. Phase II trial evaluating the long-term efficacy and peripheral sensory neuropathy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer..

转载和许可本文引用本文Hata，T.，Uemura，M.，Danno，K。等人的II期试验，评估卡培他滨联合奥沙利铂（XELOX）作为日本III期结肠癌手术患者辅助治疗的长期疗效和周围感觉神经病。。

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KeywordsXELOXAdjuvant chemotherapyJapanesePeripheral sensory neuropathy

关键词Xeloxadjuvant化疗日本外周感觉神经病