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法国胆道癌的真实世界数据:来自法国ACABi GERCOR PRONOBIL回顾性前瞻性观察队列的嵌套琥珀研究。

Real-life data on biliary tract cancers in France: The nested Amber study from the French ACABi GERCOR PRONOBIL retro-prospective, observational cohort.

作者信息

Delaye Matthieu, Boilève Alice, Henriques Julie, Rouault Antoine, Paccard Jane Rose, Fares Nadim, Assenat Eric, Lecomte Thierry, Hautefeuille Vincent, Tougeron David, Edeline Julien, Boileau Christine, Ducroux Aline, Hollebecque Antoine, Vernerey Dewi, Turpin Anthony, Neuzillet Cindy

机构信息

Department of Medical Oncology, Gastrointestinal Oncology, Institut Curie, Université Versailles Saint-Quentin-Université Paris-Saclay, Saint-Cloud, France; Association pour l'étude des Cancers et Affections des voies Biliaires (ACABi), France; GERCOR, Paris, France.

Department of Medical Oncology, Gustave Roussy Hospital, Villejuif, France; Paris-Saclay University, Orsay, France.

出版信息

Dig Liver Dis. 2025 Jan;57(1):111-117. doi: 10.1016/j.dld.2024.06.032. Epub 2024 Jul 14.

Abstract

BACKGROUND AND AIMS

To gather real-life data on biliary tract cancer (BTC) in France, an ambispective ACABi GERCOR Pronobil cohort was initiated. This nested study, Amber, utilized data from this cohort to document clinical practices in this setting.

METHODS

Inclusion criteria encompassed patients with locally advanced/metastatic BTC managed between 2019 and 2021 in nine French referral hospitals. Objectives included describing demographic and clinical data, treatments outcomes (safety and efficacy), and overall survival.

RESULTS

Of the 138 patients (median age 65 years, a balanced sex ratio) included, most displayed ECOG 0-1 (83 %), at least one comorbidity (79 %), and had intrahepatic (56 %) and metastatic (82 %) BTC. Among surgically-resected patients, 60 % received adjuvant chemotherapy, mainly capecitabine (67 %). CisGem, the primary first-line palliative chemotherapy (69 %), showed a 23 % objective response rate, a median progression-free survival of 5.3 months, and a median overall survival of 13.4 months. Second-, third-, and fourth-line were given to 75 % (FOLFOX: 35 %, targeted therapy: 14 %), 32 %, and 13 % of patients. In total, 67 % of patients had a molecular profile (IDH1 mutations and FGFR2 fusions: accounting for 21 % each in intrahepatic cholangiocarcinoma).

CONCLUSION

BTC patients were predominantly treated according to international recommendations. The obtained demographic, tumor, and molecular data were consistent with existing literature.

摘要

背景与目的

为收集法国胆管癌(BTC)的真实数据,启动了一项前瞻性-回顾性的ACABi GERCOR Pronobil队列研究。这项嵌套研究“Amber”利用该队列的数据记录了该环境下的临床实践。

方法

纳入标准包括2019年至2021年在法国9家转诊医院接受治疗的局部晚期/转移性BTC患者。目标包括描述人口统计学和临床数据、治疗结果(安全性和有效性)以及总生存期。

结果

纳入的138例患者(中位年龄65岁,性别比例均衡)中,大多数患者ECOG评分为0 - 1(83%),至少有一种合并症(79%),患有肝内(56%)和转移性(82%)BTC。在接受手术切除的患者中,60%接受了辅助化疗主要是卡培他滨(67%)。一线主要姑息化疗方案CisGem(69%)的客观缓解率为23%,中位无进展生存期为5.3个月,中位总生存期为13.4个月。75%的患者接受了二线治疗(FOLFOX方案:35%,靶向治疗:14%),32%的患者接受了三线治疗,13%的患者接受了四线治疗。共有67%的患者有分子特征(IDH突变和FGFR2融合:在肝内胆管癌中各占21%)。

结论

BTC患者主要按照国际推荐进行治疗。获得的人口统计学、肿瘤学和分子数据与现有文献一致。

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