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一项针对结直肠癌肝转移完全切除术后树突状细胞疫苗接种的随机 II 期临床试验。

A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis.

机构信息

Clinica Universidad de Navarra, Avenida Pio XII, 36, 31008, Pamplona, Spain.

CIBERONC, Madrid, Spain.

出版信息

J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.

Abstract

Surgically resectable synchronic and metachronic liver metastases of colon cancer have high risk of relapse in spite of standard-of-care neoadjuvant and adjuvant chemotherapy regimens. Dendritic cell vaccines loaded with autologous tumor lysates were tested for their potential to avoid or delay disease relapses (NCT01348256). Patients with surgically amenable liver metastasis of colon adenocarcinoma (n = 19) were included and underwent neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. Fifteen patients with disease-free resection margins were randomized 1:1 to receive two courses of four daily doses of dendritic cell intradermal vaccinations versus observation. The trial had been originally designed to include 56 patients but was curtailed due to budgetary restrictions. Follow-up of the patients indicates a clear tendency to fewer and later relapses in the vaccine arm (median disease free survival -DFS-) 25.26 months, 95% CI 8.74-n.r) versus observation arm (median DFS 9.53 months, 95% CI 5.32-18.88).

摘要

尽管采用了标准的辅助化疗方案,结肠癌的可手术同步和异时性肝转移仍有很高的复发风险。用自体肿瘤裂解物负载的树突状细胞疫苗被测试其是否具有避免或延迟疾病复发的潜力(NCT01348256)。纳入了 19 例可手术切除的结肠腺癌肝转移患者,并接受了新辅助化疗、手术和辅助化疗。15 例无疾病残留切缘的患者以 1:1 的比例随机分为两组,分别接受两疗程四次每日剂量的皮内树突状细胞疫苗接种或观察。该试验最初设计纳入 56 例患者,但由于预算限制而提前终止。对患者的随访表明,疫苗组的复发率较低且较晚(中位无病生存期-DFS-25.26 个月,95%CI 8.74-n.r),而观察组的中位 DFS 为 9.53 个月,95%CI 5.32-18.88)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b480/6164167/4b4d1e4af297/40425_2018_405_Fig1_HTML.jpg

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