首页|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)

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)

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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.

Neoadjuvant chemotherapyrectal cancermesorectal fasciadisease-free survivalanal function

Nan Chen、Minghe Zhao、Yunfeng Yao、Lin Wang、Yifan Peng、Tingting Sun、Tiancheng Zhan、Jun Zhao、Aiwen Wu

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Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Gastrointestinal Cancer Center,Unit Ⅲ,Peking University Cancer Hospital & Institute,Beijing 100142,China

State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing Key Laboratory of Carcinogenesis and Translational Research,Gastrointestinal Cancer Center,Unit Ⅲ,Peking University Cancer Hospital & Institute,Beijing 100142,China

Beijing Municipal Administration of Hospitals Incubating ProgramBeijing Talent Incubating FundingNational Natural Science Foundation of ChinaBeijing Hospitals Authority Clinical Medicine Development of Special Funding Support2019 Major and Difficult Diseases Chinese and Western Medicine Coordination Capacity Colorectal Cancer ProjectScience Foundation of Peking University Cancer Hospital-2023

PZ20200272019-481773214ZYLX2021162018275JC202310

2024

10.21147/j.issn.1000-9604.2024.04.05

中国癌症研究(英文版)
中国抗癌协会 北京市肿瘤研究所

中国癌症研究(英文版)

CSTPCD
影响因子：1.592
ISSN：1000-9604
年,卷(期)：2024.36(4)