Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: An Exploratory Analysis of Real-World Data.

BACKGROUND: The combination of gemcitabine and cisplatin (gem/cis) with the anti-PD-L1-antibody durvalumab was recently approved as first line therapy for biliary tract cancer (BTC) based on the results of the TOPAZ-1 trial. OBJECTIVE: We aim to analyse the feasibility and efficacy of the triple combination therapy in patients with BTC in a real-world setting and in correspondence with the genetic alterations of the cancer. METHODS: In this single-centre retrospective analysis, all patients with BTC and treated with durvalumab plus gem/cis from April 2022 to September 2023 were included. Survival and treatment response were investigated, within the context of the inclusion and exclusion criteria of TOPAZ-1 and in correspondence with genetic alterations of the cancer. RESULTS: In total, 35 patients, of which 51% met the inclusion criteria of the TOPAZ-1 trial, were analysed. Patients treated within TOPAZ-1 criteria did not have a significantly different median overall survival and progression free survival than the rest of the patients (10.3 versus 9.7 months and 5.3 versus 5 months, respectively). The disease control rate of patients within the TOPAZ-1 criteria was 61.1%, in comparison to 58.8% in the rest of patients. A total of 51 grade 3 and 4 adverse events were observed without significant differences in the subgroups. No specific correlating patterns of genetic alterations with survival and response were observed. CONCLUSIONS: The treatment of advanced patients with BTC with durvalumab and gem/cis, even beyond the inclusion criteria of the TOPAZ-1 trial, shows promising safety.

Pulmonary emphysema is a predictor of pneumothorax after CT-guided transthoracic pulmonary biopsies of pulmonary nodules.

PURPOSE: Pneumothoraces are the most frequently occurring complications of CT-guided percutaneous transthoracic pulmonary biopsies (PTPB). The aim of this study was to evaluate the influence of pre-diagnostic lung emphysema on the incidence and extent of pneumothoraces and to establish a risk stratification for the evaluation of the pre-procedure complication probability. MATERIAL AND METHODS: CT-guided PTPB of 100 pre-selected patients (mean age 67.1±12.8 years) were retrospectively enrolled from a single center database of 235 PTPB performed between 2012-2014. Patients were grouped according to pneumothorax appearance directly after PTPB (group I: without pneumothorax, n = 50; group II: with pneumothorax, n = 50). Group II was further divided according to post-interventional treatment (group IIa: chest tube placement, n = 24; group IIb: conservative therapy, n = 26). For each patient pre-diagnostic percentage of emphysema was quantified using CT density analysis. Emphysema stages were compared between groups using bivariate analyses and multinomial logistic regression analyses. RESULTS: Emphysema percentage was significantly associated with the occurrence of post-interventional pneumothorax (p = 0.006). Adjusted for potential confounders (age, gender, lesion size and length of interventional pathway) the study yielded an OR of 1.07 (p = 0.042). Absolute risk of pneumothorax increased from 43.4% at an emphysema rate of 5% to 73.8% at 25%. No differences could be seen in patients with pneumothorax between percentage of emphysema and mode of therapy (p = 0.721). CONCLUSION: The rate of lung emphysema is proportionally related to the incidence of pneumothorax after CT-guided PTPB and allows pre-interventional risk stratification. There is no association between stage of emphysema and post-interventional requirement of chest tube placement.

Predictors of technical success and rate of complications of image-guided percutaneous transthoracic lung needle biopsy of pulmonary tumors.

PURPOSE: To investigate predictors of technical success and complications of computed tomography (CT)-guided percutaneous transthoracic needle biopsy of potentially malignant pulmonary tumors. MATERIAL AND METHODS: From 2008 to 2009, technical success and rate of complications of CT-guided percutaneous transthoracic lung needle biopsies of patients with suspicious pulmonary tumors were retrospectively evaluated. The influence on technical success and rate of complications was assessed for intervention-related predictors (lesion diameter, length of biopsy pathway, number of pleural transgressions, and needle size) and patient-related predictors (age, gender, reduced lung function). In addition, technical success and rate of complications were compared between different interventional radiologists. RESULTS: One hundred thirty-eight patients underwent biopsies by 15 interventional radiologists. The overall technical success rate was 84.1% and was significantly different between interventional radiologists (range 25%-100%; p<0.01). Intervention-related and patient-related predictors did not influence the technical success rate. The overall complication rate was 59.4% with 39.1% minor complications and 21.0% major complications. The rate of complications was influenced by lesion diameter and distance of biopsy pathway. Interventional radiologist-related rates of complications were not statistically different. CONCLUSIONS: Technical success of percutaneous, transthoracic lung needle biopsies of pulmonary tumors is probably dependent on the interventional radiologist. In addition, lesion diameter and length of biopsy pathway are predictors of the rate of complications.