Metastatic Renal Cell Carcinoma: CT-guided Immunotherapy as a Technically Feasible and Safe Approach to Delivery of Gene Therapy for Treatment

doi:10.1148/radiol.2312021754

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Molecular Imaging

Metastatic Renal Cell Carcinoma: CT-guided Immunotherapy as a Technically Feasible and Safe Approach to Delivery of Gene Therapy for Treatment¹

Robert D. Suh, MD, Jonathan G. Goldin, MD, Amanda B. Wallace, BS, Ramon E. Sheehan, MD, Stefan B. Heinze, MD, Barbara J. Gitlitz, MD and Robert A. Figlin, MD

¹ From the Department of Radiological Sciences, UCLA Medical Center, 10833 Le Conte Ave, B2–168 CHS, Los Angeles, CA 90095-1721. Received December 18, 2002; revision requested February 2, 2003; final revision received August 26; accepted September 29. Address correspondence to R.D.S. (e-mail: rsuh@mednet.ucla.edu).

PURPOSE: To assess the technical feasibility and safety of weeklyoutpatient percutaneous computed tomographic (CT)-guided intratumoralinjections of interleukin-2 (IL-2) plasmid DNA in a wide varietyof superficial and deep tumor sites.

MATERIALS AND METHODS: Twenty-nine patients with metastaticrenal cell carcinoma and a total of 30 lesions measuring 1.0cm² or greater in accessible thoracic (n = 15) or abdominal(n = 15) locations underwent up to three cycles of six weeklyintratumoral IL-2 plasmid DNA injections. CT was used to guideneedle placement and injection. After injection cycle 1, patientswhose tumors demonstrated stable ( $<=$ 25% increase and $<=$ 50% decreasein product of lesion diameters) or decreased size (>50% decreasein product of lesion diameters) advanced to injection cycle2. Patients whose lesions decreased in size by more than 50%over the course of injection cycle 2 were eligible to begininjection cycle 3. An acceptable safety and technical feasibilityprofile for this technique was deemed to be (a) a safety andfeasibility profile similar to that of single-needle biopsyand (b) an absence of serious adverse events (as defined inTitle 21 of the Code of Federal Regulations) and/or unacceptabletoxicities (as graded according to the National Cancer InstituteCommon Toxicity Criteria).

RESULTS: A total of 284 intratumoral injections were performed,with a mean of 9.8 injections (range, 6–18 injections)received by each patient. Technical success (needle placementand injection of gene therapy agent) was achieved in all cases.Complications were experienced after 42 (14.8%) of the 284 injections.The most common complication was pneumothorax (at 32 [28.6%]of 112 intrathoracic injections), for which only one patientrequired catheter drainage. Complications occurred randomlythroughout injection cycles and did not appear to increase aspatients received more injections (P = .532). No patient experiencedserious adverse events or unacceptable toxicities.

CONCLUSION: Percutaneous CT-guided intratumoral immunotherapyinjections are technically feasible and can be safely performed.