Assessment of Image-Guided Intratumoral Delivery of Immunotherapeutics in Patients With Cancer

This case series study examines the feasibility and safety of intratumoral delivery of immunotherapy among patients undergoing cancer care in clinical trials. Question What is the feasibility and safety of image-guided intratumoral delivery of immunotherapies in patients with advanced solid organ malignancies? Findings In this case series study that included 85 patients, there were no adverse events related to the technical component of the procedure, specifically needle insertion or biopsy. Major adverse events due to immune-related systemic toxic effects occurred in 2% of investigational agents and 4% of standard-of-care procedures (4%). Meaning Intratumoral delivery of immunotherapies is technically feasible with low major complication rates. Importance Direct intratumoral delivery of immunotherapies is a compelling approach to overcoming barriers to systemic immunotherapy efficacy. While the use of intratumoral delivery of immunotherapy drugs is increasing rapidly in both the investigational and standard of care domains, the feasibility and safety of these interventions, particularly for deeper lesions that require image-guidance, remain unknown. Objective To address current knowledge gaps in image-guided techniques for intratumoral immunotherapy delivery and the safety of these interventions. Design, Setting, and Participants This case series study was performed at a single tertiary cancer center over a 2-year period from January 2016 to January 2018. Patients were followed until January 2019. All patients who underwent image-guided intratumoral delivery of immunotherapy agents in the standard of care, off-label, or investigational setting during the study period were included. Data were analyzed from February 1 to June 1, 2019. Exposures Image-guided biopsies and intratumoral injections of immunotherapies across several clinical trials as well as standard of care talimogene laherparepvec therapy. Main Outcomes and Measures Technical success, defined as the delivery of the prescribed injectate volume in its entirety, for image-guided biopsy and injections and procedure-related adverse events. Results A total of 85 patients (median [interquartile range] age, 61 [47-71] years; 42 [52%] men) underwent 498 encounters during the study period. These encounters comprised 327 image-guided intratumoral investigational agent injections in 67 patients in clinical trials, including 33 patients with melanoma (50%), 14 patients with sarcoma (21%), 3 patients with o