Nonsurgical treatment of basal cell carcinomas with intralesional 5-fluorouracil/epinephrine injectable gel.
BACKGROUND
To develop a nonsurgical treatment alternative for basal cell carcinomas (BCCs), we evaluated intralesional sustained-release chemotherapy with 5-fluorouracil/epinephrine injectable gel (5-FU/epi gel).


OBJECTIVE
To optimize the dose and treatment schedule, we compared the safety, tolerance, and efficacy of six treatment regimens of 5-FU/epi gel in patients with BCCs.


METHODS
Two doses and four treatment schedules of 5-FU/epi gel were compared in an open-label, randomized study of 122 patients with biopsy-proven BCCs. One BCC per patient was treated for up to 4 to 6 weeks, then observed for 3 months at which time the tumor site was completely excised for histologic examination.


RESULTS
Overall, 91% of evaluable treated tumors (106 of 116) in all regimens had histologically confirmed complete tumor resolution. No clinically significant treatment-related systemic adverse events occurred. The best response rate, tolerance, and patient compliance with assigned dose were in patients receiving 0.5 ml of 5-FU/epi gel three times a week for 2 weeks. The complete response rate based on histologic assessment in this group was 100%.


CONCLUSIONS
Results demonstrate that treatment of BCC with 5-FU/epi gel is both safe and effective, may result in histologically confirmed complete response rates comparable to surgery, and provides a nonsurgical treatment alternative in selected patients.
Miller
B H
BH
Dermatology Service, University of Arizona Health Sciences Center, USA.
Shavin
J S
JS
Cognetta
A
A
Taylor
R J
RJ
Salasche
S
S
Korey
A
A
Orenberg
E K
EK
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002985:Clinical Protocols; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004837:Epinephrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012074:Remission Induction; D012449:Safety; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000964:Antimetabolites, Antineoplastic; D003692:Delayed-Action Preparations; D005782:Gels; D014665:Vasodilator Agents; D005472:Fluorouracil; D004837:Epinephrine