title: Intratumoral chemotherapy with fluorouracil/epinephrine injectable gel: a nonsurgical treatment of cutaneous squamous cell carcinoma.
abstract: BACKGROUND
  We attempted to originate a nonsurgical treatment alternative for cutaneous squamous cell carcinoma (SCC), and we evaluated intratumoral modified-release chemotherapy with fluorouracil/epinephrine injectable gel (5-FU/epi gel).
  
  
  OBJECTIVE
  To assess the safety and efficacy, we conducted an open-label pilot study of 5-FU/epi gel in 25 patients with biopsy-proven SCC lesions on the face, head, neck, trunk, arms, and hands.
  
  
  METHODS
  Each tumor site was injected intradermally with up to 1.0 ml of 5-FU/epi gel. One SCC per patient was treated weekly for up to 6 weeks, then observed for 4 months at which time the tumor site and margins were excised for histologic examination.
  
  
  RESULTS
  Overall, 96% (22 of 23) of evaluable treated tumors had histologically confirmed complete tumor clearing. No clinically significant systemic reactions or unexplained treatment-related adverse medical events occurred. The evaluations of the cosmetic appearance of the treated sites, judged subjectively by clinicians and patients, were mostly good to excellent and generally in close agreement.
  
  
  CONCLUSIONS
  Treatment of superficial SCC with 5-FU/epi injectable gel results in a high rate of histologically confirmed complete tumor responses and may provide a nonsurgical treatment alternative in selected patients.
authors.affiliation: Georgia Clinical Research Center, Inc., Atlanta, USA.
authors.forename: S
authors.initials: S
authors.lastname: Kraus
authors.forename: B H
authors.initials: BH
authors.lastname: Miller
authors.forename: J M
authors.initials: JM
authors.lastname: Swinehart
authors.forename: J S
authors.initials: JS
authors.lastname: Shavin
authors.forename: K E
authors.initials: KE
authors.lastname: Georgouras
authors.forename: D A
authors.initials: DA
authors.lastname: Jenner
authors.forename: E
authors.initials: E
authors.lastname: Griffin
authors.forename: A
authors.initials: A
authors.lastname: Korey
authors.forename: E K
authors.initials: EK
authors.lastname: Orenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D004837:Epinephrine / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005782:Gels; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003692:Delayed-Action Preparations; D005782:Gels; D005472:Fluorouracil; D004837:Epinephrine