前瞻性随机对照临床试验比较胆囊癌根治术后辅助化疗与无化疗患者的疗效。

Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection.

机构信息

Department of Gastrointestinal Surgery, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, India.

Department of Radiotherapy, Maulana Azad Medical College, New Delhi, India.

出版信息

J Gastrointest Surg. 2022 Feb;26(2):398-407. doi: 10.1007/s11605-021-05143-6. Epub 2021 Sep 20.

DOI:10.1007/s11605-021-05143-6

PMID:34545545

Abstract

BACKGROUND

Gallbladder carcinoma (GBC) has a dismal prognosis even after curative resection. The objective of the study was to evaluate the effect of adjuvant chemotherapy in patients with GBC undergoing curative resection in a randomized control trial (RCT).

METHODS

A single-center open-labeled prospective RCT was done from January 2012 to June 2018. R0 curative resected GBC patients were randomized in 1:1 to either surveillance alone (control group) or adjuvant chemotherapy (gemcitabine and cisplatin (GemCis group)) for 6 cycles. The primary outcome was disease-free survival (DFS), and the secondary outcomes were overall survival (OS) and toxicity profile.

RESULTS

On the evaluation of 362 patients with GBC, 50 patients were enrolled in each control or GemCis group. Per protocol (PP), it comprised 96 patients. The demographic and clinical profile was similar between the two groups except in the lower nodal stage where patients were higher in the control group (p = 0.01). Recurrences were similar between groups (control 44% vs GemCis 56%; p = 0.23). On the intention to treat (ITT), analyses of median DFS (not reached vs. 24 months, p = 0.14) and OS (not reached vs. 31 months, p = 0.10) were similar between groups. On PP, analyses of median DFS (not reached vs. 24 months, p = 0.16) and OS (not reached vs. 31 months, p = 0.09) were similar between groups. The common toxicity profile was hematological followed by gastrointestinal symptoms.

CONCLUSIONS

Adjuvant GemCis therapy for 6 cycles does not improve DFS or OS than R0 surgery alone patients with GBC.

TRIAL REGISTRATION

NCT02778308 ( https://www.clinicaltrials.gov ).

摘要

背景

即使在根治性切除术后，胆囊癌（GBC）的预后仍然很差。本研究的目的是在一项随机对照试验（RCT）中评估辅助化疗对接受根治性切除术的 GBC 患者的影响。

方法

一项单中心开放标签前瞻性 RCT 于 2012 年 1 月至 2018 年 6 月进行。R0 根治性切除的 GBC 患者按 1:1 随机分为单独监测（对照组）或辅助化疗（吉西他滨和顺铂（GemCis 组））6 个周期。主要终点是无病生存期（DFS），次要终点是总生存期（OS）和毒性谱。

结果

在对 362 例 GBC 患者的评估中，对照组和 GemCis 组各纳入 50 例患者，按方案（PP）纳入 96 例患者。两组的人口统计学和临床特征相似，但在淋巴结分期较低的情况下，对照组患者较多（p=0.01）。两组的复发情况相似（对照组 44%比 GemCis 组 56%；p=0.23）。在意向治疗（ITT）分析中，中位 DFS（未达到比 24 个月，p=0.14）和 OS（未达到比 31 个月，p=0.10）无显著差异。在 PP 分析中，中位 DFS（未达到比 24 个月，p=0.16）和 OS（未达到比 31 个月，p=0.09）无显著差异。常见的毒性谱是血液学毒性，其次是胃肠道症状。