Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Department of Surgery, Kawasaki Municipal Hospital, Kawasaki, Japan.
Cancer Med. 2024 Jul;13(14):e7459. doi: 10.1002/cam4.7459.
Although adjuvant gemcitabine (GEM) monotherapy improves the overall survival (OS) of patients with resected pancreatic cancer, its efficacy requires further improvement. This multicenter, phase II study investigated the efficacy of adjuvant portal vein infusion (PVI) chemotherapy followed by GEM therapy in patients with resected pancreatic cancer.
5-fluorouracil (250 mg/day) and heparin (2000 IU/day) PVI chemotherapy were combined with systemic administration of mitomycin C (4 mg; days 6, 13, 20, and 27) and cisplatin (10 mg; days 7, 14, 21, and 28) for 4 weeks (PI4W), followed by GEM (1000 mg/m2; days 1, 8, and 15 every 4 weeks for 6 months). The primary endpoint was relapse-free survival (RFS) and the secondary endpoints were OS and treatment completion.
Between November 2010 and August 2013, 53 patients who underwent complete resection were enrolled, including 30, 20, and 3 patients who underwent pancreaticoduodenectomies and distal and total pancreatectomies, respectively. In total, 51 (96.2%) patients underwent R0 resection, of whom 3, 2, 12, 35, 0, and 1 had stages IA, IB, IIA, IIB, III, and IV cancer, respectively, and 47 (88.7%) patients completed PI4W. The median RFS was 22.0 months (1-, 3-, 5, and 10 years RFS: 64.9%, 38.1%, 38.1%, and 38.1%, respectively), whereas the median OS was 32.0 months (1-, 3-, 5, and 10 years OS:86.6%, 47.2%, 44.4%, and 44.4%, respectively).
Treatment with PI4W followed by GEM for 6 months after surgery may be beneficial in patients undergoing curative resection of pancreatic cancer.
吉西他滨（GEM）辅助治疗可改善可切除胰腺癌患者的总生存期（OS），但其疗效仍需进一步提高。本多中心、II 期研究旨在探讨辅助门静脉输注（PVI）化疗联合 GEM 治疗在可切除胰腺癌患者中的疗效。
5-氟尿嘧啶（250mg/天）和肝素（2000IU/天）PVI 化疗联合全身应用丝裂霉素 C（4mg；第 6、13、20 和 27 天）和顺铂（10mg；第 7、14、21 和 28 天）4 周（PI4W），随后 GEM（1000mg/m2；每 4 周第 1、8 和 15 天，共 6 个月）。主要终点是无复发生存期（RFS），次要终点是 OS 和治疗完成情况。
2010 年 11 月至 2013 年 8 月期间，共纳入 53 例接受完全切除术的患者，其中胰十二指肠切除术、远端和全胰切除术分别占 30%、20%和 3%。共有 51 例（96.2%）患者行 RO 切除，其中 3 例、2 例、12 例、35 例、0 例和 1 例分别为 IA 期、IB 期、IIA 期、IIB 期、III 期和 IV 期癌症，47 例（88.7%）患者完成了 PI4W。中位 RFS 为 22.0 个月（1 年、3 年、5 年和 10 年 RFS：64.9%、38.1%、38.1%和 38.1%），中位 OS 为 32.0 个月（1 年、3 年、5 年和 10 年 OS：86.6%、47.2%、44.4%和 44.4%）。
在根治性切除胰腺癌患者中，术后接受 PI4W 联合 GEM 治疗 6 个月可能有益。
