Short incubation PDT versus 5-FU in treating actinic keratoses. A clinical comparison and long-term follow-up of topical 5-fluorouracil versus laser resurfacing in the treatment of widespread actinic keratoses. Treatment of men with flat (FC) or acuminata (CA) condylomata with interferon alpha-2a. [A double-blind randomized comparative study of oral 5-fluorouracil (5-FU), cyclophosphamide (CPA), and 5-FU + CPA in advanced breast cancer]. Comparison of 5% 5-fluorouracil cream and 5% imiquimod cream in the management of actinic keratoses on the face and scalp. A pilot study to evaluate the treatment of basal cell carcinoma with 5-fluorouracil using phosphatidyl choline as a transepidermal carrier. A randomised study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up. Topical 5-fluorouracil has no additional benefit in treating common warts with cryotherapy: a single-centre, double-blind, randomized, placebo-controlled trial. 5-Fluorouracil versus folinic acid and 5-fluorouracil in advanced, hormone-resistant prostate cancer: a prospective randomized pilot trial.
The efficacy of photodynamic therapy (PDT) using broad area treatment with 5-aminolevulinic acid (ALA) has not been compared to topical 5-fluorouracil (5-FU) in the treatment of actinic keratoses (AK). The purpose of this study was to compare the efficacy and tolerability of PDT using short incubation time, broad area treatment with ALA plus activation with either blue light or laser light to topical 5-FU in the treatment of AK of the face and scalp. Thirty-six subjects with AK of either the face or scalp were randomized to receive either application of ALA for 1 hour followed by activation with blue light or pulsed dye laser or topical 5-FU. Efficacy was evaluated by grading AK lesions and photoaging signs. Tolerability was assessed by scoring crusting/erosions, erythema and stinging/burning. Treatment with PDT using ALA plus blue light was as effective as topical 5-FU in clearing AK. PDT using ALA plus laser light was the least effective treatment. All treatments made improvements in the signs of photoaging. Both PDT treatments were better tolerated than 5-FU. In conclusion, broad area PDT treatment with ALA plus activation with blue light appears to be as effective as 5-FU in the treatment of AK. ALA plus laser light is somewhat less effective than the above therapies. Efficacy could likely be improved with further study of laser parameters and incubation times. Many treatment modalities exist for actinic keratoses (AK). Topical 5-fluorouracil (5-FU) has been one of the standard treatments. Laser resurfacing is a more recent treatment option. In the literature prospective randomized studies comparing these treatments are lacking.
                Prospective randomized study to compare topical 5-FU with Er:YAG laser resurfacing. Fifty-five patients with multiple AK on the scalp and or the face were included. Clinical and histopathological evaluation took place at 3, 6, and 12 months after treatment.
                At 3, 6, and 12 months after treatment, there were significantly less recurrences in the laser group compared to the group of patients treated with 5-FU. Side effects did occur more frequently in the laser group, especially erythema and hypopigmentation.
                Compared to treatment with topical 5-FU, Er:YAG laser resurfacing is more effective regarding recurrence rates. Although significantly more side effects occur, laser resurfacing is a useful therapeutic option especially in patients with widespread AK.
                (c) 2006 Wiley-Liss, Inc. This study was undertaken to assess the effect of CO2 laser vaporization, 5-fluorouracil 5% (5-FU) topical application and Interferon alpha-2a (IFA alpha-2a) in the treatment of C.A. or F.C. of the male genital tract. From March 1986 to September 1991, 1372 men, sexual partners of women with F.C. or C.A. or cervical intraepithelial neoplasia, were submitted to peoscopy. One thousand and nineteen (74.27%) men presented with various penile lesions caused by HPV (histologically confirmed); of these 505 were treated for C.A. or F.C. or a combination of F.C. and C.A. The best treatment modalities, irrespective of the kind of lesion, were found to be the combination of 5-FU plus IFN alpha-2a (high dose) (98.27%), the combination of CO2 laser vaporization plus 5-FU plus IFN alpha-2a (high dose) (93.93%) and the combination of CO2 laser vaporization plus 5-FU (87.23%). In conclusion we believe that IFN alpha-2a can be used with excellent results as first line treatment in combination with CO2 laser vaporization or/plus 5-FU in patients with C.A. or F.C. or combined condylomata. A randomized trial was performed comparing the effects of oral 5-fluorouracil (5-FU), 300 mg/day, cyclophosphamide (CPA), 150 mg/day and 5-FU + CPA in advanced breast cancer. Some 181 patients were entered in the trial, with 1 ineligible, and 14 incomplete cases. Then 166 were evaluated for their rates of response in the treatment groups: 14.0% (8/57) in 5-FU, 23.6% (13/55) in CPA, and 37.0% (20/54) in 5-FU + CPA, with a P value of 0.019. The difference in response rates between 5-FU and 5-FU + CPA was shown to be significant (p = 0.005). When long NC was included in the comparison, there was a significant difference (p = 0.006) between the groups. A higher incidence of adverse effects was noted in the combination group. A significant difference was noted in TTP (time to progression) among the 3 groups (p = 0.0144), and between 5-FU and 5-FU + CPA (p = 0.0061). There were no significant differences in the overall survival among the groups (p = 0.6808). In conclusion, the combination oral treatment of 5-FU and CPA appears effective as a first line therapy for advanced breast cancer, and also in the postoperative adjuvant setting. It is timely to compare the efficacy and tolerability of 2 actinic keratosis (AK) therapies--5% 5-fluorouracil (5-FU) cream and imiquimod cream. Thirty-six patients with 4 or more AKs were randomly assigned to receive 5% 5-FU cream twice daily for 2 to 4 weeks or 5% imiquimod cream twice weekly for 16 weeks. Five percent 5-FU was more effective than imiquimod in exposing what were presumed to be subclinical AKs, reducing the final AK count (total AK count declined during the 24-week study by 94% vs. 66%, P < .05), achieving complete clearance (incidence of 84% vs. 24% by week 24, P < .01), and achieving clearance rapidly. Tolerability was similar except for erythema, which was initially significantly higher with 5-FU than imiquimod but resolved rapidly and was significantly lower than imiquimod by week 16. Five percent 5-FU remains the gold standard field therapy for AKs. In certain situations, successful topical therapy of basal cell carcinoma (BCC) without the inconvenience, risk, and expense of surgery would be of great value to patients. Placing 5-fluorouracil (FU) in an appropriate carrier may solve these problems. Phosphatidyl choline (PC) penetrates effectively throughout the epidermis of shaved rabbits and may be able to carry small water-soluble molecules such as nucleotides across lipid barriers when applied topically.
                We propose that employing PC as a vehicle will facilitate the penetration of 5-FU and increase efficacy as compared to petrolatum-based 5-FU cream.
                This pilot study is a double-blinded and randomized therapeutic trial. Thirteen patients with 17 biopsy-proven, moderate thickness BCCs were randomized to receive either cream A (5% 5-FU in a PC vehicle) or cream B (Efudex(R): 5% 5-FU in a petrolatum base). Patients applied cream A or cream B twice a day for 4 weeks. The patients underwent an excisional biopsy of the treated BCC site at week 16.
                There was a 90% cure rate (9/10) in those lesions treated with 5% 5-FU in PC cream and a 57% cure rate (4/7) in those treated with 5% 5-FU in a petrolatum-based cream.
                Although the study was unable to detect any statistically significant differences in outcome between the study groups, this small pilot study shows preliminary findings which may indicate an increase in the short-term eradication of BCC using a PC-based vehicle as compared to conventional petrolatum-based formulations. Actinic keratoses (AK) frequently occur on sun-exposed skin and are considered as in situ squamous cell carcinoma. To date, no treatment algorithm exists for first or second line therapies due to the lack of comparative studies.
                This study compared the initial and 12-month clinical clearance, histological clearance, and cosmetic outcomes of topically applied 5% imiquimod (IMIQ) cream, 5% 5-fluorouracil (5-FU) ointment and cryosurgery for the treatment of AK.
                Patients were randomised to one of the following three treatment groups: one or two courses of cryosurgery (20-40 s per lesion), topical 5-FU (twice daily for 4 weeks), or one or two courses of topical imquimod (three times per week for 4 weeks each).
                Sixty-eight per cent (17/25) of patients treated with cryosurgery, 96% (23/24) of patients treated with 5-FU, and 85% (22/26) of patients treated with IMIQ achieved initial clinical clearance, p = 0.03. The histological clearance rate for cryosurgery was 32% (8/25), 67% (16/24) for 5-FU, and 73% (19/26) in the IMIQ group, p = 0.03. The 12-month follow-up showed a high rate of recurrent and new lesions in the 5-FU and cryosurgery arms. The sustained clearance rate of initially cleared individual lesions was 28% (7/25) for cryosurgery, 54% (13/24) for 5-FU and 73% (19/26) for IMIQ (p < 0.01). Sustained clearance of the total treatment field was 4% (1/25), 33% (8/24), and 73% (19/26) of patients after cryosurgery, 5-FU, and IMIQ, respectively (p < 0.01). The patients in the IMIQ group were judged to have the best cosmetic outcomes (p = 0.0001).
                Imiquimod treatment of AK resulted in superior sustained clearance and cosmetic outcomes compared with cryosurgery and 5-FU. It should be considered as a first line therapy for sustained treatment of AK. The role of topical 5-fluorouracil (5-FU) in treating common warts is not well defined. We tried to evaluate the efficacy and adverse effects of combination cryotherapy and topical 5% 5-FU ointment in the treatment of common warts. The study was a single-centre, double-blind randomized placebo-controlled trial. In the study, 80 patients with common warts were randomized into two groups and underwent two 10-second freeze/thaw cycles of cryotherapy with liquid nitrogen once every three weeks for a maximum of five treatments. Between treatments, patients applied either topical 5% 5-FU ointment (group A) or placebo aqueous cream (group B) twice daily. The mean +/- SD reduction in wart area was 58.57 +/- 0.06% in group A and 65.29 +/- 0.06% in group B. In total, 19 patients in group A and 24 patients in group B had wart size reduced by 75% or more (P = 0.50), while 12 patients in group A and 17 patients in group B had clearance of their warts (P = 0.245). Logistic regression with age, sex, smoking status, immune status, site, duration and number of warty lesions, history of previous treatment, and treatment group found that only a history of previous treatment and acral lesions were significant adverse predictors of improvement. There was no significant difference in the number of adverse events between the two groups, although there was a trend towards more pain and blistering associated with topical 5-FU. We concluded that topical 5-FU has no added benefit in treating common warts with cryotherapy. Results of cytotoxic chemotherapy for hormone-resistant prostate cancer are not impressive. One of the substances which seems to have a therapeutic benefit is 5-fluorouracil (5-FU). The effect of 5-FU can be modulated by addition of folinic acid (FA). We tested in a prospective, randomized phase II trial monotherapy with 5-FU versus the combination of 5-FU and high-dose FA.
                25 patients received 600 mg/m2 5-FU, and 24 patients 400 mg/m2 FA plus 600 or 400 mg/m2 5-FU. They were treated for two cycles for 5 days in a 21-day interval followed by a weekly single-day application until progression occurred. Pain remission, toxicity, time to progression and survival were evaluated.
                Both regimens led to a pain remission in nearly 70% of the patients. Mucosal side effects like diarrhea and stomatitis occurred more often in the combination arm, whereas leukopenias were more frequent in the monotherapy are. We observed no statistically significant difference between the two treatment arms regarding time to progression and survival.
                Although both regimens led to a pain remission, side effects are too severe to recommend these protocols for standard treatment of hormone-resistant prostate cancer.
The reviewed trials were highly variable in methods and quality, and the evidence provided by these studies was weak. Cure rates with several treatments were variable, and although 5-FU presents therapeutic results that are inferior to those seen with 5-FU + Inf α-2a (high dose) and 5-FU + CO2 Laser + Inf α-2a (high dose), the treatment should not be abandoned. Topical treatment with 5-FU has a therapeutic effect; however, the benefits and risks have not been determined clearly and further studies are needed.