Abstract 142P
Background
The TOPAZ-1 phase III trial reported a survival benefit with the anti-programmed death cell ligand 1 (anti-PD-L1) durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC). The present study investigated for the first time the survival impact resulted from the addition of durvalumab to cisplatin/gemcitabine in a real-world setting.
Methods
The analyzed population included patients with unresectable, locally advanced, or metastatic BTC treated with durvalumab in combination with cisplatin/gemcitabine or cisplatin/gemcitabine alone. The impact of the addition of durvalumab to chemotherapy in terms of both overall survival (OS) and progression free survival (PFS) was investigated with uni- and multivariate analysis.
Results
Overall, 358 patients were included in the analysis: 213 received cisplatin/gemcitabine alone, 145 received cisplatin/gemcitabine plus durvalumab. At the univariate analysis, the addition of durvalumab resulted to have a survival impact, since the median OS was 11.2 Vs 12.9 months (HR 1.8, 95% CI 1.3-2.5, p=0.0005) in patients who received cisplatin/gemcitabine alone compared to those who received cisplatin/gemcitabine plus durvalumab. Moreover, patients who received cisplatin/gemcitabine alone showed worse PFS compared to those who received cisplatin/gemcitabine plus durvalumab (mPFS 6.0 Vs 8.9 months, HR 1.8, 95% CI 1.4-2.3, p<0.0001). The multivariate analysis confirmed that the addition of durvalumab to cisplatin/gemcitabine is a independent prognostic factor for both OS and PFS. Finally, an exploratory analysis of the prognostic factors in the cohort of patients who received durvalumab was performed: NLR>3 and ECOG PS>0 resulted to be independent prognostic factors in terms of both OS and PFS in this cohort of patients. The interaction tests highlighted NLR>3 and ECOG>1 as predictive factors of response to cisplatin/gemcitabine plus durvalumab.
Conclusions
Accordingly, to the results of the TOPAZ-1, the addition of durvalumab to cisplatin/gemcitabine has been confirmed to confer a survival benefit in terms of both OS and PFS in a real-world setting of advanced BTC patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
194P - Real-world outcomes of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus chemotherapy as first-line treatment in advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS≤5
Presenter: Qi Xu
Session: Poster Display
Resources:
Abstract
195P - Ferroptosis signatures in pancreatic ductal adenocarcinomas and their role in patient survival: A translational unsupervised clustering analysis
Presenter: Quoc-Huy Trinh
Session: Poster Display
Resources:
Abstract
196P - Clinical significance of circulating CD8+ and CD4+ T cell proliferation in advanced gastric cancer receiving first-line chemotherapy
Presenter: In-Ho Kim
Session: Poster Display
Resources:
Abstract
197P - Treatment patterns and clinical outcomes of patients with unresectable advanced or metastatic (UAM) gastric/gastroesophageal junction adenocarcinoma (GA/GEJA) in China: A multicenter real-world study
Presenter: Yanqiao Zhang
Session: Poster Display
Resources:
Abstract
198P - Effectiveness of lenvatinib in patients with unresectable hepatocellular carcinoma: A multicenter observational study in Japan
Presenter: Namiki Izumi
Session: Poster Display
Resources:
Abstract
199P - Efficacy of endostar in combination with concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of esophagus: A randomized, open-label, phase II trial
Presenter: Yuexiao Qi
Session: Poster Display
Resources:
Abstract
200P - Prognosis of patients with hepatocellular carcinoma treated with transarterial chemoembolization: Development and validation of the ALFP score
Presenter: Baocuo Gong
Session: Poster Display
Resources:
Abstract
201P - A phase II study of serplulimab (a programmed death-1 inhibitor) with or without HLX04 (a bevacizumab biosimilar) for the treatment of advanced hepatocellular carcinoma
Presenter: Zhenggang Ren
Session: Poster Display
Resources:
Abstract
202P - Comparison of liver injury after transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy for intermediate and advanced hepatocellular carcinoma
Presenter: Yongru Chen
Session: Poster Display
Resources:
Abstract
203P - Neoadjuvant durvalumab plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (ESCC)
Presenter: Jia He
Session: Poster Display
Resources:
Abstract