142P - The survival impact of the addition of durvalumab to cisplatin/gemcitabine in advanced biliary tract cancer: A real-world, retrospective, multicentric study

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.