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Efudex (Fluorouracil Topical) - Summary

 

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EFUDEX SUMMARY

Efudex Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.

Efudex is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Efudex Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

EFUDEX NEWS HIGHLIGHTS

Published Studies Related to Efudex (Fluorouracil Topical)

Randomized phase 3 trial of Fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. [2008.06.04]

Influence of activation state of ErbB-2 (HER-2) on response to adjuvant cyclophosphamide, doxorubicin, and fluorouracil for stage II, node-positive breast cancer: study 8541 from the Cancer and Leukemia Group B. [2008.05.10]

Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. [2008.05.01]

Treatment of common warts with an intralesional mixture of 5-fluorouracil, lidocaine, and epinephrine: a prospective placebo-controlled, double-blind randomized trial. [2008.05]

Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. [2008.05]

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Clinical Trials Related to Efudex (Fluorouracil Topical)

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors [Active, not recruiting]

The Effect of Efudex Treatment on Photoaged Skin [Completed]

Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma [Active, not recruiting]

A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women [Completed]

Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck [Completed]

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Page last updated: 2008-08-10

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