title: Metastatic renal cell carcinoma: CT-guided immunotherapy as a technically feasible and safe approach to delivery of gene therapy for treatment.
abstract: OBJECTIVE
  To assess the technical feasibility and safety of weekly outpatient percutaneous computed tomographic (CT)-guided intratumoral injections of interleukin-2 (IL-2) plasmid DNA in a wide variety of superficial and deep tumor sites.
  
  
  METHODS
  Twenty-nine patients with metastatic renal cell carcinoma and a total of 30 lesions measuring 1.0 cm(2) or greater in accessible thoracic (n = 15) or abdominal (n = 15) locations underwent up to three cycles of six weekly intratumoral IL-2 plasmid DNA injections. CT was used to guide needle placement and injection. After injection cycle 1, patients whose tumors demonstrated stable (< or =25% increase and < or =50% decrease in product of lesion diameters) or decreased size (>50% decrease in product of lesion diameters) advanced to injection cycle 2. Patients whose lesions decreased in size by more than 50% over the course of injection cycle 2 were eligible to begin injection cycle 3. An acceptable safety and technical feasibility profile for this technique was deemed to be (a) a safety and feasibility profile similar to that of single-needle biopsy and (b) an absence of serious adverse events (as defined in Title 21 of the Code of Federal Regulations) and/or unacceptable toxicities (as graded according to the National Cancer Institute Common 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 placement and 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 patient required catheter drainage. Complications occurred randomly throughout injection cycles and did not appear to increase as patients received more injections (P =.532). No patient experienced serious adverse events or unacceptable toxicities.
  
  
  CONCLUSIONS
  Percutaneous CT-guided intratumoral immunotherapy injections are technically feasible and can be safely performed.
authors.affiliation: Department of Radiological Sciences, UCLA Medical Center, 10833 Le Conte Ave, B2-168 CHS, Los Angeles, CA 90095-1721, USA. rsuh@mednet.ucla.edu
authors.forename: Robert D
authors.initials: RD
authors.lastname: Suh
authors.forename: Jonathan G
authors.initials: JG
authors.lastname: Goldin
authors.forename: Amanda B
authors.initials: AB
authors.lastname: Wallace
authors.forename: Ramon E
authors.initials: RE
authors.lastname: Sheehan
authors.forename: Stefan B
authors.initials: SB
authors.lastname: Heinze
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Gitlitz
authors.forename: Robert A
authors.initials: RA
authors.lastname: Figlin
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000556:secondary* / Q000628:therapy*; D004247:DNA / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D007267:Injections; D007376:Interleukin-2 / Q000235:genetics; D007680:Kidney Neoplasms / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010957:Plasmids; D014057:Tomography, X-Ray Computed
chemical_list: D007376:Interleukin-2; D004247:DNA