Nan Chen, Minghe Zhao, Yunfeng Yao, Lin Wang, Yifan Peng, Tingting Sun, Tiancheng Zhan, Jun Zhao, Aiwen Wu
{"title":"卡培他滨联合奥沙利铂新辅助化疗治疗直肠中膜筋膜阴性的中低位局部晚期直肠癌:一项前瞻性试验(PKUCH-R03 试验)的长期结果。","authors":"Nan Chen, Minghe Zhao, Yunfeng Yao, Lin Wang, Yifan Peng, Tingting Sun, Tiancheng Zhan, Jun Zhao, Aiwen Wu","doi":"10.21147/j.issn.1000-9604.2024.04.05","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the safety and efficacy of neoadjuvant chemotherapy (NCT) in mid-low locally advanced rectal cancer with negative mesorectal fascia (MRF).</p><p><strong>Methods: </strong>This prospective, single-arm phase II trial was designed and conducted at Peking University Cancer Hospital. The patients who provided consent received 3 months of NCT (capecitabine and oxaliplatin, CapOX) followed by total mesorectal excision (TME). The primary endpoint was the rate of pathological complete response (pCR).</p><p><strong>Results: </strong>From January 2019 through December 2021, a total of 53 patients were enrolled, 7.5% of whom experienced grade 3-4 adverse events during NCT. The pCR rate was 17.0% for the entire cohort, and the overall rate of postoperative complications was 37.7% (1.9% of grade IIIa patients). The 3-year disease-free survival rate was 91.4%, and 23.5% (12/51) of the patients suffered from major low anterior resection syndrome (LARS). Postoperative complications were independently associated with major LARS.</p><p><strong>Conclusions: </strong>For patients with mid-low rectal cancer with negative MRF, 3 months of NCT were found to yield a favorable tumor response with acceptable toxicity. With fair long-term survival, the NCT regimen could be associated with low rates of perioperative complications as well as acceptable anal function.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":null,"pages":null},"PeriodicalIF":7.0000,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377882/pdf/","citationCount":"0","resultStr":"{\"title\":\"Neoadjuvant chemotherapy with capecitabine combined with oxaliplatin for mid-low locally advanced rectal cancer with negative mesorectal fascia: Long-term outcomes of a prospective trial (PKUCH-R03 trial).\",\"authors\":\"Nan Chen, Minghe Zhao, Yunfeng Yao, Lin Wang, Yifan Peng, Tingting Sun, Tiancheng Zhan, Jun Zhao, Aiwen Wu\",\"doi\":\"10.21147/j.issn.1000-9604.2024.04.05\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the safety and efficacy of neoadjuvant chemotherapy (NCT) in mid-low locally advanced rectal cancer with negative mesorectal fascia (MRF).</p><p><strong>Methods: </strong>This prospective, single-arm phase II trial was designed and conducted at Peking University Cancer Hospital. The patients who provided consent received 3 months of NCT (capecitabine and oxaliplatin, CapOX) followed by total mesorectal excision (TME). The primary endpoint was the rate of pathological complete response (pCR).</p><p><strong>Results: </strong>From January 2019 through December 2021, a total of 53 patients were enrolled, 7.5% of whom experienced grade 3-4 adverse events during NCT. The pCR rate was 17.0% for the entire cohort, and the overall rate of postoperative complications was 37.7% (1.9% of grade IIIa patients). The 3-year disease-free survival rate was 91.4%, and 23.5% (12/51) of the patients suffered from major low anterior resection syndrome (LARS). Postoperative complications were independently associated with major LARS.</p><p><strong>Conclusions: </strong>For patients with mid-low rectal cancer with negative MRF, 3 months of NCT were found to yield a favorable tumor response with acceptable toxicity. With fair long-term survival, the NCT regimen could be associated with low rates of perioperative complications as well as acceptable anal function.</p>\",\"PeriodicalId\":9882,\"journal\":{\"name\":\"Chinese Journal of Cancer Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":7.0000,\"publicationDate\":\"2024-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377882/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese Journal of Cancer Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21147/j.issn.1000-9604.2024.04.05\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese Journal of Cancer Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21147/j.issn.1000-9604.2024.04.05","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的评估新辅助化疗(NCT)对直肠系膜筋膜(MRF)阴性的中低位局部晚期直肠癌的安全性和有效性:这项前瞻性单臂 II 期试验由北京大学肿瘤医院设计和实施。征得同意的患者接受 3 个月的 NCT(卡培他滨和奥沙利铂,CapOX)治疗,然后进行全直肠系膜切除术(TME)。主要终点是病理完全反应率(pCR):从2019年1月到2021年12月,共有53名患者入组,其中7.5%的患者在NCT期间出现了3-4级不良事件。整个队列的病理完全反应率为17.0%,术后并发症总发生率为37.7%(IIIa级患者占1.9%)。3年无病生存率为91.4%,23.5%(12/51)的患者患有严重的低位前切除综合征(LARS)。术后并发症与严重低位前切除综合征密切相关:结论:对于MRF阴性的中低位直肠癌患者,3个月的NCT可产生良好的肿瘤反应,且毒性可接受。在长期生存率尚可的情况下,NCT疗法的围手术期并发症发生率低,肛门功能也可接受。
Neoadjuvant chemotherapy with capecitabine combined with oxaliplatin for mid-low locally advanced rectal cancer with negative mesorectal fascia: Long-term outcomes of a prospective trial (PKUCH-R03 trial).
Objective: To evaluate the safety and efficacy of neoadjuvant chemotherapy (NCT) in mid-low locally advanced rectal cancer with negative mesorectal fascia (MRF).
Methods: This prospective, single-arm phase II trial was designed and conducted at Peking University Cancer Hospital. The patients who provided consent received 3 months of NCT (capecitabine and oxaliplatin, CapOX) followed by total mesorectal excision (TME). The primary endpoint was the rate of pathological complete response (pCR).
Results: From January 2019 through December 2021, a total of 53 patients were enrolled, 7.5% of whom experienced grade 3-4 adverse events during NCT. The pCR rate was 17.0% for the entire cohort, and the overall rate of postoperative complications was 37.7% (1.9% of grade IIIa patients). The 3-year disease-free survival rate was 91.4%, and 23.5% (12/51) of the patients suffered from major low anterior resection syndrome (LARS). Postoperative complications were independently associated with major LARS.
Conclusions: For patients with mid-low rectal cancer with negative MRF, 3 months of NCT were found to yield a favorable tumor response with acceptable toxicity. With fair long-term survival, the NCT regimen could be associated with low rates of perioperative complications as well as acceptable anal function.
期刊介绍:
Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013.
CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.