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
373P - Investigating the impact of treatment on geriatric patients with locally advanced head and neck squamous cell carcinoma
Presenter: Yen Ting Liu
Session: Poster Display
Resources:
Abstract
374P - Immunohistochemical evaluation of oral lichen planus: A prospective clinical study
Presenter: Saravanan Sampoornam Pape
Session: Poster Display
Resources:
Abstract
375P - Survival and prognostic factors of head and neck squamous cell carcinoma patients treated with either definitive CCRT or post operative CCRT with platinum-based chemotherapy in Rajavithi hospital, Thailand
Presenter: wanit samadee
Session: Poster Display
Resources:
Abstract
376P - Nutrition as an independent prognostic factor in locally advanced nasopharyngeal carcinoma: A retrospective cohort study and propensity score-matched analysis
Presenter: haizhen yi
Session: Poster Display
Resources:
Abstract
377P - Oropharyngeal squamous cell carcinomas in Indian population: P16 positivity and treatment outcomes following chemoradiotherapy
Presenter: Parth Verma
Session: Poster Display
Resources:
Abstract
378P - A real-world retrospective analysis of the efficacy of pembrolizumab combined with chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA HNSCC)
Presenter: zhu Liu
Session: Poster Display
Resources:
Abstract
379P - Nimotuzumab in combination with chemoradiation for patients with intermediate stage and locally advanced nasopharyngeal carcinoma: A retrospective comparative analysis using 5-year real-world survival data
Presenter: Andhika Rachman
Session: Poster Display
Resources:
Abstract
380P - An epidemiological analysis on the prevalence of oral cancer and its awareness among Irula tribes of South India
Presenter: Delfin Lovelina Francis
Session: Poster Display
Resources:
Abstract
381P - P16INK4 over-expression, early stages, keratinization, and surgical margin-free status are associated with better prognosis of oral squamous cell carcinoma (OSCC)
Presenter: Sumadi Lukman Anwar
Session: Poster Display
Resources:
Abstract
382P - Oral health disparities in privileged and underprivileged tribes of south India: A study of the prevalence of precancerous oral lesions
Presenter: Shanavas Palliyal
Session: Poster Display
Resources:
Abstract