Abstract
e15223 Background: Intratumoral (IT) delivery of immunotherapeutic agents is a compelling approach to overcoming the systemic barriers of toxicity and lack of efficacy associated with many novel agents. In this context, the application of IT delivery is growing rapidly, however the feasibility and safety profile of these interventions for lesions that require real time radiological image-guidance remains unknown. Methods: Patients who underwent IT injections of immunotherapeutic agents across several clinical trials over a 5 year period at a single tertiary cancer center were included in this analysis. Technical success & procedure related adverse events of the IT injection and the frequently accompanying concomitant or sequential image-guided biopsy of injected (adscopal) and non-injected (abscopal) sites were analyzed. Results: A total of 256 patients with metastatic &/or unresectable solid malignancies underwent a total of 1096 (median 5) image-guided IT investigational agent injections during the study period. There were no adverse events attributable to the technical component of the procedure, specifically during the needle insertions or 3862 concomitant biopsies. Soft tissue and nodal lesions in the extraparietal locations & visceral lesions in deeper, intraparietal locations and solid organs were also injected (adrenal, liver and lung). The median injected lesion tumor length was 3.3cm. Serious adverse events (NCI CTC AE ≥ 3) including dyspnea and severe flu-like symptoms developing within 24 hours of the injection & required hospitalization following 1.5% of injections. Conclusions: Intratumoral immunotherapeutic injections & tissue sampling with real time radiological image guidance are feasible across a wide range of regions and organs irrespective of agent and histology. Post-delivery anticipated & adverse events were rare & manageable.
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