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研究报道新辅助纳布联合吉西他滨联合改良FOLFIRINOX治疗可切除胰腺癌癌症
作者:小柯机器人 发布时间:2025/10/11 20:11:00

新辅助纳布联合吉西他滨联合改良FOLFIRINOX治疗可切除胰腺癌癌症,这一成果由浙江大学医学院梁廷波研究组经过不懈努力而取得。相关论文于2025年10月9日发表在《癌细胞》杂志上。

这项单中心、随机3期试验(NCT03750669)评估了324例可切除胰腺癌患者的序贯新辅助nab-紫杉醇联合吉西他滨和改良FOLFIRINOX术前手术。新辅助组患者术前接受nab-紫杉醇+吉西他滨+改良FOLFIRINOX,然后进行1个周期的辅助治疗(最好是吉西他滨+卡培他滨),而术前组患者立即切除,然后进行6个周期的辅助治疗。主要终点为无事件生存期。值得注意的是,50%的患者在胰腺体或胰腺尾有肿瘤。中位无事件生存期为15.3个月(95%可信区间[CI], 12.6-19.3) vs . 10.9个月(95% CI, 9.1-13.5;风险比[HR], 0.71; 95% CI, 0.54-0.93; p = 0.0136)。中位总生存期为35.4个月对27.2个月(HR, 0.73; 95% CI, 0.53-1.00;名义p = 0.0477)。发生≥3级不良事件的患者占47.6%,而不良事件发生率为30.7%。这种新辅助方案提高了无事件生存和可控的安全性。

附:英文原文

Title: Neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX for resectable pancreatic cancer: A randomized phase 3 trial

Author: Xueli Bai, Xiang Li, Yiwen Chen, Guoliang Qiao, Qi Zhang, Tao Ma, Shunliang Gao, Min Zhang, Yan Shen, Jian Wu, Jun Yu, Risheng Que, Xiaochen Zhang, Ke Sun, Wenbo Xiao, Tian’an Jiang, Tingbo Liang

Issue&Volume: 2025-10-09

Abstract: This single-center, randomized phase 3 trial (NCT03750669) evaluated sequential neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX versus upfront surgery in 324 patients with resectable pancreatic cancer. Patients in the neoadjuvant group received nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX before surgery and then four cycles of adjuvant therapy (preferably gemcitabine plus capecitabine), while those in the upfront surgery group underwent immediate resection followed by six cycles of adjuvant therapy. The primary endpoint was event-free survival. Notably, 50% of patients had tumors in the pancreatic body or tail. Median event-free survival was 15.3 months (95% confidence interval [CI], 12.6–19.3) versus 10.9 months (95% CI, 9.1–13.5; hazard ratio [HR], 0.71; 95% CI, 0.54–0.93; p = 0.0136). Median overall survival was 35.4 months versus 27.2 months (HR, 0.73; 95% CI, 0.53–1.00; nominal p = 0.0477). Grade ≥3 adverse events occurred in 47.6% versus 30.7% of patients. This neoadjuvant regimen improves event-free survival with manageable safety.

DOI: 10.1016/j.ccell.2025.09.009

Source: https://www.cell.com/cancer-cell/abstract/S1535-6108(25)00401-5

期刊信息

Cancer Cell:《癌细胞》,创刊于2002年。隶属于细胞出版社,最新IF:38.585
官方网址:https://www.cell.com/cancer-cell/home
投稿链接:https://www.editorialmanager.com/cancer-cell/default.aspx