94P - First-line chemotherapy plus immunotherapy versus chemotherapy alone for advanced gallbladder carcinoma

Background

Gallbladder carcinoma (GBC) is a highly malignant tumor of the biliary tract. The prognosis for advanced GBC is generally very poor with scarce evidence on effective treatment options. In light of the limited therapeutic strategies, this study aims to shed light on the outcomes of using chemotherapy alone or in combination with PD-1 inhibitor as the first-line therapy.

Methods

All the patients who received systematic treatment for unresectable or recurrent GBC were included in this study from January 2018 to December 2022. The systematic treatment involved either chemotherapy alone or combination therapy. Clinical data were collected, including baseline characteristics, therapeutic response to the treatment, overall survival, and progression-free survival. Additionally, adverse events (AEs) during the treatment period were carefully documented to access the safety of the treatment.

Results

The eligible patients were divided into two groups: one group received combination therapy consisting of chemotherapy and PD-1 inhibitor (n=31), while the other group received mono-chemotherapy (n=19). The results of the study showed that the overall survival (OS) and progression-free survival (PFS) were longer in the combination therapy group compared to the mono-chemotherapy group. The patients who received combination therapy had a median OS of 18.2 months, whereas those who received mono-chemotherapy had a median OS of 6.1 months (P=0.016). The median PFS for combination therapy was 11.3 months, compared to 5.5 months for mono-chemotherapy, with a p-value of 0.008. The overall response rate (ORR) was 35.5% in the combination therapy group and 5.3% in the mono-chemotherapy group (P=0.037). Despite these favorable outcomes, the combination therapy did not demonstrate a significant advantage over mono-chemotherapy in terms of disease control rate (DCR). The DCR was 74.2% in the combination therapy group and 57.9% in the mono-chemotherapy group (P=0.230).

Conclusions

The present findings imply that combining chemotherapy and PD-1 inhibitor may be an effective and safe first-line treatment option for patients with unresectable or recurrent GBC, offering improved OS, PFS and ORR compared to chemotherapy alone.

Clinical trial identification

SYSKY-2022-282-01.

Legal entity responsible for the study

Sun Yat-sen Memorial Hospital.

Funding

This work was supported by the Special Research Foundation of the National Nature ScienceFoundation of China (82273476, 81972262, 81972255, 82173195); Grant [2013]163 from Key Laboratory of Malignant Tumor Molecular Mechanism and Translational Medicine of Guangzhou Bureau of Science and Information Technology; Grant KLB09001 from the Key Laboratory of Malignant Tumor Gene Regulation and Target Therapy of Guangdong Higher Education Institutes; Grant from Guangdong Science and Technology Department (2015B050501004, 2017B030314026); Sun Yat-sen University Clinical Research 5010 Program (2018008).

Disclosure

All authors have declared no conflicts of interest.