365P - Effectiveness and safety of human type 5 recombinant adenovirus (H101) in malignant tumor with malignant pleural effusion and ascites: A multicenter, observational, real-world study

Background

Human type 5 recombinant adenovirus (H101) has shown promising efficacy in malignant serous effusion (MSE), but evidence is limited. The purpose of this study was to analyze the effectiveness and safety of H101 in Chinese patients with malignant pleural effusion and ascites (MPE/MA) in the real world, so as to guide clinical use of H101.

Methods

This multicenter, observational, real-world study recruited patients with MPE or MA caused by malignant tumor receiving H101-containing treatment between January 2020 and June 2022 across 5 hospitals. Effectiveness was evaluated by overall remission rate (ORR), and safety was evaluated based on adverse events (AEs). Subgroup analysis was performed on patients grouped according to tumor type, the volume of MPE and MA, and dosage of H101.

Results

A total of 653 eligible patients were enrolled in this study, among whom 467 received H101 monotherapy and 176 received H101 combined with chemotherapy. In H101 monotherapy group, the decrease of MPE or MA was achieved in 282 (60.4 %) patients, 176 (37.7%) patients showed no change in volume of MPE or MA, and 9 (1.9%) patients showed an increase, yielding an ORR of 60.4% (282/467). The ORR for the combination therapy group was 60.2% (106/176), with 106 cases of PR, 69 cases of NC and 1 case of PD. Subgroup analyses based on tumor type, volume of MPE and MA, and dosage of H101 all showed high ORR, approximately 60%. The main AEs associated with H101-containing regimens were fever, nausea and vomiting. No serious AEs occurred in both groups.

Conclusions

Encouraging clinical benefits and manageable toxicity of H101 against MPE and MA were observed in the real-world clinical setting, indicating that the H101-containing regimen is reliable, safe, and feasible, providing a novel and effective option for the treatment of this disease.

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.