Related Experiment Video
Updated: Dec 20, 2025

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
Published on: January 7, 2019
Efficacy and Safety of Oncolytic Viruses in Randomized Controlled Trials: A Systematic Review and Meta-Analysis
Zengbin Li1,2, Zeju Jiang1, Yingxuan Zhang1
1Department of Medical Microbiology, School of Medicine, Nanchang University, Nanchang 330006, China.
Abstract:
Oncolytic virotherapy is a promising antitumor therapeutic strategy. It is based on the ability of viruses to selectively kill cancer cells and induce host antitumor immune responses. However, the clinical outcomes of oncolytic viruses (OVs) vary widely. Therefore, we performed a meta-analysis to illustrate the efficacy and safety of oncolytic viruses. The Cochrane Library, PubMed, and EMBASE databases were searched for randomized controlled trials (RCTs) published up to January 31, 2020. The data for objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were independently extracted by two investigators from 11 studies that met the inclusion criteria. In subgroup analyses, the objective response rate benefit was observed in patients treated with oncolytic DNA viruses (odds ratio (OR) = 4.05; 95% confidence interval (CI): 1.96-8.33; p = 0.0002), but not in those treated with oncolytic RNA viruses (OR = 1.00, 95% CI: 0.66-1.52, p = 0.99). Moreover, the intratumoral injection arm yielded a statistically significant improvement (OR = 4.05, 95% CI: 1.96-8.33, p = 0.0002), but no such improvement was observed for the intravenous injection arm (OR = 1.00, 95% CI: 0.66-1.52, p = 0.99). Among the five OVs investigated in RCTs, only talimogene laherparepvec (T-VEC) effectively prolonged the OS of patients (hazard ratio (HR), 0.79; 95% CI: 0.63-0.99; p = 0.04). None of the oncolytic virotherapies improved the PFS (HR = 1.00, 95% CI: 0.85-1.19, p = 0.96). Notably, the pooled rate of severe AEs (grade ≥3) was higher for the oncolytic virotherapy group (39%) compared with the control group (27%) (risk difference (RD), 12%; risk ratio (RR), 1.44; 95% CI: 1.17-1.78; p = 0.0006). This review offers a reference for fundamental research and clinical treatment of oncolytic viruses. Further randomized controlled trials are needed to verify these results.
Insights
Oncolytic virotherapy shows promise, with DNA viruses and intratumoral injections improving objective response rates. However, severe adverse events were more frequent, and overall survival benefits were limited to specific treatments like talimogene laherparepvec.
Area of Science:
- Oncology
- Virology
- Immunotherapy
Background:
- Oncolytic virotherapy utilizes viruses to selectively destroy cancer cells and stimulate anti-tumor immune responses.
- Clinical efficacy of oncolytic viruses (OVs) is variable, necessitating further investigation.
Purpose of the Study:
- To conduct a meta-analysis evaluating the efficacy and safety of oncolytic virotherapy.
- To identify factors influencing treatment outcomes in patients receiving OVs.
Main Methods:
- A systematic search of Cochrane Library, PubMed, and EMBASE databases for randomized controlled trials (RCTs) up to January 31, 2020.
- Extraction of data on objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) from 11 included studies.
- Subgroup analyses based on virus type (DNA vs. RNA) and administration route (intratumoral vs. intravenous).
Main Results:
- Oncolytic DNA viruses and intratumoral injections significantly improved ORR (OR = 4.05; p = 0.0002).
- Talimogene laherparepvec (T-VEC) was the only OV to significantly prolong OS (HR = 0.79; p = 0.04).
- No significant improvement in PFS was observed across all OVs (HR = 1.00; p = 0.96).
- Severe adverse events (grade ≥3) were more common in the OV group (39%) compared to controls (27%) (RR = 1.44; p = 0.0006).
Conclusions:
- Oncolytic virotherapy, particularly with DNA viruses administered intratumorally, demonstrates potential for improving cancer treatment response.
- While T-VEC shows survival benefits, the overall efficacy and safety profile require careful consideration due to increased severe adverse events.
- Further RCTs are warranted to validate these findings and optimize oncolytic virus therapy.
Related Concept Videos
Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
Clinical Trials: Overview
Mechanisms of Retrovirus-induced Cancers
Tumor Immunotherapy
Clinical Trials
There are four phases in a clinical trial. A phase one...
Treatment Resistant Cancers

