Efudex (Fluorouracil Topical) - Summary

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.

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NEWS HIGHLIGHTS

Published Studies Related to Efudex (Fluorouracil Topical)

Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. [2012]
practicability... CONCLUSIONS: Topical 0.5% 5-FU/SA demonstrated superior sustained clinical

A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. [2012]
maintenance therapy for metastatic colorectal cancer (MCRC)... CONCLUSIONS: Enzastaurin combined with bevacizumab-based therapy is tolerable,

Comparison of the efficacy of intralesional triamcinolone acetonide and 5-fluorouracil tattooing for the treatment of keloids. [2012]
for treatment of keloids... CONCLUSION: 5-FU tattooing was more effective than intralesional TAC for the

Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma with portal venous invasion. [2011.11.09]
BACKGROUND: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) alpha-2b in patients with advanced HCC... CONCLUSIONS: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNalpha-2b, this new combination therapy may be useful for patients with advanced HCC. Cancer 2011;. (c) 2011 American Cancer Society. Copyright (c) 2011 American Cancer Society.

Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. [2011.11]
BACKGROUND: Actinic keratoses (AKs) arise after chronic sun exposure. Because long-term ultraviolet (UV) damage may induce proliferation of atypical keratinocytes, treatment of AKs is recommended. OBJECTIVES: To compare 5-fluorouracil 0.5%/salicylic acid 10.0% [low-dose 5-FU/SA (Actikerall(R))] with diclofenac 3% in hyaluronic acid (diclofenac HA) and vehicle for the treatment of AKs... CONCLUSIONS: Topical low-dose 5-FU/SA demonstrated higher histological and clinical clearance rates vs. diclofenac HA or vehicle. Low-dose 5-FU/SA is an effective lesion-directed treatment for AKs. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.

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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]
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

The Effect of Efudex Treatment on Photoaged Skin [Completed]
The researchers propose that skin improvements may be seen following a course of Efudex, (5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These improvements could be the result of both a reduction of actinic keratoses (small red horny growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or the sun) and improvement of sun-damaged skin.

In addition, this research study is being done to determine if the expression of p53, a tumor suppressor gene (its activity stops the formation of tumors), is decreased following Efudex treatment. Mutations (abnormal changes) in the gene, called p53, are associated with a certain type of skin cancer. In addition, p53-mutated genes are known to exist in non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker for both sun damage and an elevated risk of developing skin cancer.

Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma [Active, not recruiting]
This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM) combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV). This study will evaluate the safety and tolerability of the combination of these drugs when they are used in the treatment of metastatic colorectal cancer.

This is a pilot clinical trial which will be studying the reactions of the patient's body and tumor to the experimental treatment described above. The purpose of this study is to find out what kind of side effects this experimental treatment causes and see how often these side effects occur.

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]
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.

Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

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]
To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

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Reports of Suspected Efudex (Fluorouracil Topical) Side Effects

Abdominal Pain Upper (6),  Blood Urine Present (5),  Vomiting (5),  Diffuse Large B-Cell Lymphoma (4),  Incorrect Route of Drug Administration (2),  Pain (2),  Death (2),  Disseminated Intravascular Coagulation (1),  Drug Administration Error (1),  Rash Generalised (1), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Efudex review by 54 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Skin cancers
Dosage & duration:		Topical Cream (dosage frequency: twice a day) for the period of 3 to 4 weeks
Other conditions:		Solar keratosis basal cell squasanoma
Other drugs taken:		none
		Reported Results
Benefits:		It removes boyh visible a nd unseen sun damage from the skin
Side effects:		There seem to beno side effects it produces ulceration of the skin where there are changed cells but this is how the drug works
Comments:		Topically applied cream that ulcerates the changed or damaged skin cells that are considered precanerous it creates red welts that take antwhere from two to 6 weeks to develop then when you stop using the cream it takes to 14 days to heal any flake off leaving very clear clean skin.

Efudex review by 41 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		actinic keratoses
Dosage & duration:		.05 (dosage frequency: every day) for the period of 1 month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		hopefully it got rid of many actinic keratoses permanently, but hard to say. I think it made my skin look better, though.
Side effects:		extremely red, irritated, sore skin, extreme sun sentitivity. One are even blistered, eventually so badly that my dr. said stop using it.
Comments:		applied to face and chest sparingly daily after washing. My face and chest both became very red, and my face especially got so bad it looked like hamburger meat. My chest had many small red spots. One area under my eye blistered and then became infected. I did not even want to see sunlight, I became so sun sensitive. After I stopped using the medication it took at least a week to feel anything like normal. a horrible experience. but I do think it made my skin look better.

Efudex review by 41 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		actinic keratoses
Dosage & duration:		.05 (dosage frequency: every day) for the period of 1 month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		hopefully it got rid of many actinic keratoses permanently, but hard to say. I think it made my skin look better, though.
Side effects:		extremely red, irritated, sore skin, extreme sun sentitivity. One are even blistered, eventually so badly that my dr. said stop using it.
Comments:		applied to face and chest sparingly daily after washing. My face and chest both became very red, and my face especially got so bad it looked like hamburger meat. My chest had many small red spots. One area under my eye blistered and then became infected. I did not even want to see sunlight, I became so sun sensitive. After I stopped using the medication it took at least a week to feel anything like normal. a horrible experience. but I do think it made my skin look better.