Impact of antibiotic therapy in patients with cholangiocarcinoma treated with chemoimmunotherapy.

IF 1.8 3区医学 Q3 ONCOLOGY

Oncology Pub Date : 2025-08-14 DOI:10.1159/000546856

Francesco Vitiello, Caterina Vivaldi, Mario Domenico Rizzato, Anna Saborowski, Lorenzo Antonuzzo, Federico Rossari, Francesca Salani, Jin Won Kim, Ilario Giovanni Rapposelli, Emiliano Tamburini, Margherita Rimini, Federica Lo Prinzi, Tomoyuki Satake, Frederik Peeters, Tiziana Pressiani, Jessica Lucchetti, Oluseyi Abidoye, Chiara Gallio, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Aitzaz Qaisar, Alessandro Pastorino, Florian Castet, Changhoon Yoo, Mario Scartozzi, Gerald W Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Alessandro Parisi, Anna Diana, Nuno Couto, Stephen Lam Chan, Ingrid Garajova, Ricardo Roque, Masafumi Ikeda, Monica Niger, Giuseppe Tonini, Vera Himmelsbach, Matteo Landriscina, Gianluca Masi, Arndt Vogel, Sara Lonardi, Lorenzo Fornaro, Lorenza Rimassa, Andrea Casadei-Gardini, Jorge Adeva, Gian Paolo Spinelli, Nicola Personeni, Maria Grazia Rodriguez, Silvana Leo, Cecilia Melo Alvim, Giovanni Farinea, Virginia Genovesi, Antonio De Rosa, Daniele Lavacchi, Silvia Camera, Jeroen Dekervel, Rita Balsano, Minsu Kang, Giulia Tesini, Luca Esposito, Alessandro Boccancino, Selma Ahcene Djaballah, Tanios Bekaii-Saab

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引用次数: 0

Abstract

Background: Patients with biliary tract cancers (BTC) often require antibiotic therapy before starting systemic treatment that includes an immune checkpoint inhibitor. This study aims to evaluate the prognostic impact of antibiotic therapy administered in the 15 days prior to the start of chemoimmunotherapy in patients with BTC.

Material and methods: The study population included patients with metastatic or locally advanced BTC from western and eastern populations treated with first-line chemoimmunotherapy. The aim of the study is to evaluate the impact of antibiotic therapy in the 15 days prior to starting oncological treatment (AT population) compared to patients who did not receive antibiotic therapy (NAT). Univariate and multivariate analyses were used to evaluate predictive factors for overall survival (OS) and progression free survival (PFS) while prognostic factors were analyzed by univariate and multivariate analysis using Cox regression model.

Results: 666 patients were enrolled in the study: 93 (14%) in AT cohort and 573 (86%) in NAT cohort. In the AT population, the incidence of cholangitis (p = 0.0017), ALT elevation (p = 0.0009), fever (p = 0.0021), decreased appetite (p = 0.0007), itching (p = 0.0081), and rash (p = 0.012) was significantly higher compared to the NAT. The median OS was 15.9 months (95% CI 13.8 - 18.3) in NAT cohort vs 10.1 months (95% CI 7.9 - 12.4) in AT cohort (NAT vs AT, HR 0.43,95% CI 0.27 - 0.70-15.6 p=0.0006) while median PFS was 8.5 months in NAT cohort vs 5.4 months in AT cohort (NAT vs AT, HR 0.49 ,95% CI 0.34 - 0.71 p=0.0001). Multivariate analysis confirmed the prognostic role of antibiotic for OS and PFS. Finally, NAT cohort showed better overall response rate compared with AT cohort (31.4% vs 20.4 %, p=0.03).

Conclusions: The use of antibiotic therapy in the 15 days prior to starting chemoimmunotherapy is an independent unfavorable prognostic factor for survival in our cohort of patients with advanced BTC treated with cisplatin, gemcitabine and durvalumab.

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抗生素治疗对化疗免疫治疗胆管癌患者的影响。

背景：胆道癌（BTC）患者在开始全身治疗前通常需要抗生素治疗，包括免疫检查点抑制剂。本研究旨在评估化疗免疫治疗开始前15天给予BTC患者抗生素治疗对预后的影响。材料和方法：研究人群包括来自西部和东部接受一线化学免疫治疗的转移性或局部晚期BTC患者。该研究的目的是评估开始肿瘤治疗前15天抗生素治疗（AT人群）与未接受抗生素治疗（NAT）的患者的影响。采用单因素和多因素分析评估总生存期（OS）和无进展生存期（PFS）的预测因素，采用Cox回归模型对预后因素进行单因素和多因素分析。结果：666例患者入组：AT组93例（14%），NAT组573例（86%）。在人口,胆管炎的发生率(p = 0.0017), ALT海拔(p = 0.0009),发热(p = 0.0021),食欲下降(p = 0.0007),瘙痒(p = 0.0081),和皮疹(p = 0.012)明显高于相比NAT。操作系统中值为15.9个月(95% CI 13.8 - 18.3)在NAT队列vs 10.1个月(95% CI 7.9 - 12.4)在队列(NAT vs,人力资源0.43,95%置信区间0.27 - 0.70 - -15.6 p = 0.0006)在NAT队列PFS中位数为8.5个月和5.4个月在队列(NAT和,HR 0.49,95% CI 0.34 - 0.71 p=0.0001)。多因素分析证实了抗生素对OS和PFS的预后作用。最后，NAT组的总有效率比AT组高（31.4% vs 20.4%, p=0.03）。结论：在我们的顺铂、吉西他滨和杜伐单抗治疗的晚期BTC患者队列中，在开始化学免疫治疗前15天使用抗生素治疗是一个独立的不利预后因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology 医学-肿瘤学

CiteScore

6.00

自引率

2.90%

发文量

审稿时长

6-12 weeks

期刊介绍： Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.