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)

中文翻译：

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比较接受根治性切除的胆囊癌患者辅助化疗与不化疗的前瞻性随机对照试验

 背景

即使在根治性切除后，胆囊癌（GBC）的预后也很差。该研究的目的是在随机对照试验（RCT）中评估辅助化疗对接受根治性切除的 GBC 患者的效果。

 方法

2012 年 1 月至 2018 年 6 月进行了一项单中心开放标记前瞻性随机对照试验。R0 治愈性切除 GBC 患者以 1:1 的比例随机分配至单独监测组（对照组）或辅助化疗组（吉西他滨和顺铂（GemCis 组））。 6 个周期。主要结局是无病生存期（DFS），次要结局是总生存期（OS）和毒性特征。

 结果

在对 362 名 GBC 患者进行评估时，每个对照组或 GemCis 组纳入 50 名患者。根据方案 (PP)，它包含 96 名患者。两组之间的人口统计学和临床​​特征相似，但在较低的淋巴结阶段除外，对照组中患者的比例较高（ p = 0.01）。各组之间的复发率相似（对照组为 44%，GemCis 为 56%； p = 0.23）。关于意向治疗 (ITT)，组间中位 DFS（未达到与 24 个月， p = 0.14）和 OS（未达到与 31 个月， p = 0.10）分析相似。在 PP 上，组间中位 DFS（未达到与 24 个月， p = 0.16）和 OS（未达到与 31 个月， p = 0.09）分析相似。常见的毒性特征是血液学毒性，其次是胃肠道症状。

 结论

与单独 R0 手术的 GBC 患者相比，6 个周期的辅助 GemCis 治疗并未改善 DFS 或 OS。

 试用注册

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