辅助治疗可能改善高危胰周腺癌患者的总生存期 - 一项来自多机构队列研究（MIPPAP 研究）的匹配对分析。

Adjuvant therapy may improve overall survival in high-risk periampullary adenocarcinomas patients - A match-pair analysis from a multi-institutional cohort study (The MIPPAP study).

机构信息

Dept. of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, 400012, India.

Dept. of GI & HPB Surgery, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, 400 012, India.

出版信息

HPB (Oxford). 2024 Oct;26(10):1261-1269. doi: 10.1016/j.hpb.2024.06.010. Epub 2024 Jul 2.

DOI:10.1016/j.hpb.2024.06.010

PMID:39019675

Abstract

BACKGROUND

The role of adjuvant therapy in resected periampullary adenocarcinomas is equivocal due to contrasting data and limited prospective trials.

METHODS

The Multicentre Indian Pancreatic & Periampullary Adenocarcinoma Project (MIPPAP), included data from 8 institutions across India. Of the 1679 pancreatic resections, 736 patients with T3/T4 and/or Node positive adenocarcinomas (considered as high risk for recurrence) were included for analysis. Three (adjuvant): one (observation) matching, using T3/T4 T staging, nodal positivity and ampullary subtype was performed by using the nearest neighbour matching method.

RESULTS

Of 736 patients eligible for inclusion, 621 patients were matched of which 458 patients received adjuvant therapy (AT) (predominantly gemcitabine-based) and 163 patients were observed (O). With a median follow-up of 42 months, there was a statistical difference in overall survival in favour of patients receiving AT as compared to those on observation [68.7 months vs. 61.1 months, Hazard ratio: 0.73 (95% CI: 0.54-0.97); p = 0.03]. Besides AT, presence of nodal involvement (median OS: 65.4 months vs not reached; p = 0.04) predicted for inferior OS.

CONCLUSIONS

The results of the match-pair analysis suggest that adjuvant therapy improves overall survival in periampullary adenocarcinomas at high risk of recurrence with a greater benefit in T3/T4, node-positive and ampullary subtypes.

摘要

背景

由于数据相互矛盾以及前瞻性试验有限，辅助治疗在切除的胰头十二指肠腺癌中的作用仍存在争议。

方法

多中心印度胰腺和胰头十二指肠腺癌项目（MIPPAP）纳入了来自印度 8 家机构的数据。在 1679 例胰腺切除术中，纳入了 736 例 T3/T4 和/或阳性淋巴结的腺癌患者（被认为有复发高风险）进行分析。采用最近邻匹配法，通过 T3/T4 T 分期、淋巴结阳性和壶腹亚型对 736 例符合纳入标准的患者进行了 3（辅助）：1（观察）匹配。

结果

在 736 例符合纳入条件的患者中，有 621 例患者进行了匹配，其中 458 例患者接受了辅助治疗（主要是吉西他滨为基础的方案），163 例患者进行了观察。中位随访 42 个月后，与观察组相比，接受辅助治疗的患者的总生存有显著统计学差异[68.7 个月比 61.1 个月，风险比：0.73（95%置信区间：0.54-0.97）；p = 0.03]。除了辅助治疗外，淋巴结受累（中位 OS：65.4 个月比未达到；p = 0.04）也预示着 OS 较差。