isotretinoin and Carcinoma--Basal-Cell

Three patients developed erosive pustular dermatosis of the scalp (EPDS). Two of them, both males, had previously undergone surgical excision for squamous cell carcinoma and basal cell carcinoma, and a female experienced avulsive trauma of the scalp. The erosive lesions and crusts were located at the site of a skin graft; microbiological cultures were negative for bacterial and fungal growth. Histological examination ruled out pustular bullous disorders. Topical therapy with corticosteroids and antibiotics resulted in clinical remission in only 2 cases. The third case showed a tendency to recur despite numerous therapeutic attempts with oral dapsone and isotretinoin. We conclude that surgical trauma is a possible cause of EPDS. Our patients seem to be the first reported cases of EPDS in skin grafts following plastic surgical procedures.

Topics: Administration, Cutaneous; Administration, Oral; Aged; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Bacteria; Betamethasone; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Dapsone; Female; Fungi; Gentamicins; Humans; Isotretinoin; Keratolytic Agents; Male; Middle Aged; Recurrence; Remission Induction; Scalp; Scalp Dermatoses; Skin Diseases, Vesiculobullous; Skin Neoplasms; Skin Transplantation

Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Antineoplastic Agents; Bowen's Disease; Carcinoma; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Evaluation Studies as Topic; Female; Humans; Interferon-alpha; Interferons; Isotretinoin; Keratolytic Agents; Male; Neoplasm Metastasis; Photochemotherapy; Photosensitizing Agents; Retinoids; Skin Neoplasms

Topics: Adult; Benzoates; Bowen's Disease; Carcinoma, Basal Cell; Child; Etretinate; Female; Humans; Isotretinoin; Male; Precancerous Conditions; Psoriasis; Retinoids; Skin Diseases; Skin Neoplasms; Tretinoin; Xeroderma Pigmentosum

Using data from a randomized, double blind, study of the efficacy of retinol or isotretinoin vs. placebo on recurrence of nonmelanoma skin cancer in high-risk subjects, a reanalysis of the original intent to treat analysis was performed in a dose-response format. Cox proportional hazards models describe the relationship between dose quartiles of isotretinoin and retinol use and time to first occurrence of squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) in crude and adjusted models. Neither the isotretinoin nor retinol models showed any significance at any quartile for reduction in first BCC or SCC occurrence. Crude and adjusted retinol models show a statistically significant increase in risk of developing an SCC in the first quartile, whereas only the crude model shows a statistically significant increase in risk in the first quartile of the isotretinoin model. For retinol and SCC, hazard ratios (HRs) for the first quartile were as follows: HR = 2.92, 95% confidence interval (CI) = 1.67-5.10 crude; HR = 1.95, 95% CI = 1.00-3.80 adjusted. For isotretinoin and SCC, HRs for the first quartile were as follows: HR = 2.38, 95% CI = 1.35-4.19 crude; HR = 1.69, 95% CI = 0.87-3.31 adjusted. Test for trend was not significant in any of the models. These analyses confirm the results of the original intent to treat analyses and raise an interesting question related to the potential for increased risk for patients in the first quartile of retinol dose.

Topics: Aged; Antineoplastic Agents; Arizona; California; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Isotretinoin; Male; Middle Aged; Neoplasm Recurrence, Local; Patient Dropouts; Proportional Hazards Models; Skin Neoplasms; Vitamin A

The combination of interferon alfa (IFNalpha) and isotretinoin has shown a direct antiproliferative effect on human melanoma cell lines, but it remained unclear whether this combination is more effective than IFNalpha alone in patients with metastatic melanoma. We evaluated safety and efficacy of IFNalpha and isotretinoin compared with IFNalpha alone as adjuvant treatment in patients with primary malignant melanoma stage IIA and IIB.. In a prospective, randomized, double-blind, placebo-controlled trial, 407 melanoma patients in stage IIA (301 patients) and IIB (106 patients) were randomly assigned to either IFNalpha and isotretinoin (isotretinoin group; 206 patients) or IFNalpha and placebo (placebo group; 201 patients) after excision of the primary tumor. IFNalpha was administered three times a week at a dose of 3 million units subcutaneously for 24 months. Isotretinoin at a dose of 20 mg for patients < or = 73 kg, 30 mg for patients greater than 73 kg, or placebo daily for 24 months.. A scheduled interim analysis revealed no significant differences in survival rates, with the isotretinoin group and the placebo group showing 5-year disease-free survival rates of 55% (95% CI, 46% to 65%) and 67% (95% CI, 59% to 75%), respectively, and overall 5-year survival rates of 76% (95% CI, 67% to 84%) and 81% (95% CI, 74% to 88%), respectively. The trial was stopped for futility.. The addition of isotretinoin to an adjuvant treatment of low-dose IFNalpha in patients with stage IIA and IIB melanoma had no significant effect on disease-free or overall survival and is therefore not recommended.

Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Chemotherapy, Adjuvant; Disease-Free Survival; Double-Blind Method; Europe; Female; Head and Neck Neoplasms; Humans; Hyperlipidemias; Interferon-alpha; Isotretinoin; Male; Melanoma; Middle Aged; Multivariate Analysis; Neoplasm Staging; Prognosis; Prospective Studies; Quality of Life; Skin Diseases; Treatment Outcome

The objective of this study was to examine the effect of retinol and isotretinoin on the incidence of nonmelanoma skin cancer in high-risk subjects. A total of 525 participants with a history of at least four basal cell carcinomas (BCCs) and/or cutaneous squamous cell carcinomas (SCCs) were entered into a randomized, double-blind, placebo-controlled trial, performed in free-standing study clinics. Participants were randomly assigned to receive oral retinol (25,000 units), isotretinoin (5-10 mg), or placebo supplementation daily for 3 years. The time to first new occurrence of BCC or cutaneous SCC was used as the outcome measure. During the study period, 319 BCCs and 125 cutaneous SCCs were diagnosed clinically and pathologically. There were no differences between those who received retinol, isotretinoin, or the placebo, with regard to the time to first occurrence or to the total number of tumors noted. No beneficial effects were noted with regard to the prevention of nonmelanoma skin cancer with either retinol or isotretinoin.

Topics: Adult; Aged; Blood Chemical Analysis; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Double-Blind Method; Female; Humans; Isotretinoin; Keratolytic Agents; Liver Function Tests; Male; Middle Aged; Proportional Hazards Models; Skin Neoplasms; Vitamin A

In this report, we examine the potential risk factors for both the incidence and the number of placebo adverse reactions among patients who were enrolled in the placebo control group in a multicenter clinical trial (n = 491). Of the nine baseline covariates analyzed, only clinical center was significantly related to both the presence and the number of adverse reactions. Placebo group patients at clinical centers 5 and 7 were more than twice as likely to experience an adverse reaction than were patients at clinical center 1. This finding, in light of the intensive effort we made to standardize the methods for adverse reaction detection and management, points out the difficulty in controlling for the inherent differences in the characteristics of the patient populations and clinic personnel at the clinical centers in a multicenter trial, and reinforces the need to stratify by clinical center prior to randomization.

Topics: Adult; Aged; Carcinoma, Basal Cell; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Isotretinoin; Male; Middle Aged; Multicenter Studies as Topic; Placebos; Randomized Controlled Trials as Topic; Risk Factors

Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Calcitriol; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Female; Humans; Isotretinoin; Male; Middle Aged; Precancerous Conditions; Skin Neoplasms

This 36-month prospective study of a group of 61 people at high risk to develop multiple basal cell carcinomas (BCC) examined the circulating lymphocyte subsets of the population, patterns of sun exposure, and the longitudinal development of basal cell carcinoma. Sun exposure status was highly correlated with immune status defined by the CD4/CD8 T-lymphocyte ratio. There were significantly more BCC at 18 and 36 months in the 35 patients with high sun exposure and low CD4/CD8 ratio than in the 20 patients with low sun exposure and high CD4/CD8 ratio. A multivariate analysis assessed the relative importance of prior basal cell carcinoma, sun exposure, and immune status on the development of the skin cancer. Basal cell carcinoma developing in the previous 18 months and sun exposure during those 18 months were the first and second most important variables in determining development of basal cell carcinoma during the next 18 months. CD4/CD8 ratio had no additional predictive ability once prior skin cancers and sun exposure were accounted for. A low ratio of CD4/CD8 cells correlated with high sun exposure during the preceding 18 months.

Topics: Aged; Carcinoma, Basal Cell; CD4-CD8 Ratio; Cell Count; Environmental Exposure; Humans; Isotretinoin; Killer Cells, Natural; Lymphocytes, Tumor-Infiltrating; Middle Aged; Neoplasm Recurrence, Local; Skin Neoplasms; Sunlight; T-Lymphocytes, Helper-Inducer; T-Lymphocytes, Regulatory; Time Factors

We conducted a prospective roentgenographic survey of patients participating in a randomized, placebo-controlled, multicenter clinical trial that evaluated the effectiveness of chronic, very-low-dose (approximately 0.14 mg/kg per day for 3 years) isotretinoin in preventing the subsequent occurrences of new basal cell carcinoma in patients with previous basal cell carcinoma. To assess potential skeletal changes, a sample of 269 patients from among a total of 981 enrollees were randomly selected for comparative roentgenographic review. Baseline and 36-month roentgenograms of the cervical and thoracic spine of each patient were read side by side by a radiologist, masked to treatment group, who noted both the presence and extent of abnormalities at each vertebral level at baseline and the progression of existing or occurrence of new abnormalities at previously unaffected levels at 36 months.. In comparison with the placebo group, significantly more patients in the isotretinoin group exhibited progression of existing hyperostotic abnormalities (40% vs 18%; P less than .001) and new hyperostotic involvement at previously unaffected vertebral levels (8% vs 1%; P = .015).. Our findings indicate that chronic, very-low-dose isotretinoin can induce hyperostotic axial skeletal changes similar to those reported in patients taking higher doses.

Topics: Adult; Aged; Carcinoma, Basal Cell; Cervical Vertebrae; Female; Humans; Hyperostosis, Diffuse Idiopathic Skeletal; Isotretinoin; Male; Middle Aged; Neoplasm Recurrence, Local; Prospective Studies; Radiography; Skin Neoplasms; Thoracic Vertebrae

High-dose isotretinoin has been reported to have a prophylactic effect on nonmelanoma skin cancer, although it is associated with significant toxicity.. To test the effectiveness of the long-term administration of low-dose isotretinoin in reducing the occurrence of basal cell carcinoma at a new site in patients with previously treated basal cell carcinomas and to measure the toxicity associated with this regimen, we conducted a clinical trial at eight cancer centers.. Nine hundred and eighty-one patients with two or more previously confirmed basal cell carcinomas were randomly assigned to receive either 10 mg of isotretinoin or a placebo daily. Patients were followed for 36 months and monitored at 6-month intervals for skin cancer and toxic effects.. After 36 months of treatment, no statistically significant difference in either the cumulative percent of patients with an occurrence of basal cell carcinoma at a new site or the annual rate of basal cell carcinoma formation existed between patients receiving isotretinoin and those receiving the placebo. Elevated serum triglycerides, hyperostotic axial skeletal changes, and mucocutaneous reactions were more frequent in the group receiving isotretinoin than in the control group, and these differences were all statistically significant (P less than .001).. This low-dose regimen of isotretinoin not only is ineffective in reducing the occurrence of basal cell carcinoma at new sites in patients with two or more previously treated basal cell carcinomas but also is associated with significant adverse systemic effects.. The toxicity associated with the long-term administration of isotretinoin, even at the low dose used in this trial, must be weighted in planning future prevention trials.

Topics: Aged; Anticarcinogenic Agents; Carcinoma, Basal Cell; Female; Humans; Isotretinoin; Male; Middle Aged; Skin Neoplasms

The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.

Topics: Adult; Aged; Carcinoma, Basal Cell; Double-Blind Method; Epidemiologic Methods; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Mass Screening; Middle Aged; Research Design; Risk Factors; Skin Neoplasms

To confirm reports that skin cancer can be prevented with retinoids, we conducted a three-year controlled prospective study of oral isotretinoin (also called 13-cis retinoic acid) in five patients with xeroderma pigmentosum who had a history of multiple cutaneous basal-cell or squamous-cell carcinomas. Patients were treated with isotretinoin at a dosage of 2 mg per kilogram of body weight per day for two years and then followed for an additional year, without the drug. Before, during, and after treatment, biopsies of all suspicious lesions were performed, and skin cancers were surgically removed. The patients had a total of 121 tumors (mean, 24; range, 8 to 43) in the two-year interval before treatment. During two years of treatment with isotretinoin, there were 25 tumors (mean, 5; range, 3 to 9), with an average reduction in skin cancers of 63 percent (P = 0.019). After the drug was discontinued, the tumor frequency increased a mean of 8.5-fold (range, 2- to 19-fold) over the frequency during treatment (P = 0.007). Although all patients experienced mucocutaneous toxic effects, and triglyceride, liver-function, or skeletal abnormalities developed in some, high-dose oral isotretinoin was effective in the chemoprophylaxis of skin cancers in patients with xeroderma pigmentosum.

Topics: Administration, Oral; Adolescent; Adult; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Child; Clinical Trials as Topic; Female; Humans; Isotretinoin; Male; Prospective Studies; Skin Neoplasms; Tretinoin; Xeroderma Pigmentosum

In several studies between 1962 and 1978, topical tretinoin was proved capable of producing complete regression of actinic keratosis and basal cell carcinoma. But because its efficacy is not comparable to that of other modalities, topical tretinoin is currently used only as an adjunct to topical 5-fluorouracil in the treatment of actinic keratosis. One recent report found topical tretinoin ineffective in the chemoprevention of actinic keratosis. Although the oral synthetic retinoids isotretinoin and etretinate have been used in the prevention and treatment of cutaneous malignancy, the potential exists for chronic toxicity from the prolonged systemic therapy that appears necessary for maintaining the chemopreventive effect. For this reason, it may be appropriate to study further the preventive as well as therapeutic effects of topical tretinoin and other retinoids for actinic keratosis and skin cancer. If they prove safe and effective, the use of topical retinoids in the prevention and treatment of cutaneous tumors may be the most significant clinical application of these drugs.

Topics: Carcinoma, Basal Cell; Clinical Trials as Topic; Etretinate; Humans; Isotretinoin; Keratosis; Photosensitivity Disorders; Skin Neoplasms; Tretinoin; Urinary Bladder Neoplasms

Topics: Aged; Carcinoma, Basal Cell; Child, Preschool; Colitis; Combined Modality Therapy; Eyelid Neoplasms; Female; Homeopathy; Humans; Isotretinoin; Mistletoe; Patient Compliance; Phytotherapy; Plant Extracts; Recurrence; Xeroderma Pigmentosum

Small open studies of patients at high risk for squamous cell carcinoma (SCC) of the skin suggest that oral retinoid use reduces the risk of these tumors. Among patients at lower risk, randomized trials of low doses of retinoids did not demonstrate significant chemopreventive effects. Patients with psoriasis treated with oral psoralen-UVA have a high risk of SCC development. Oral retinoids are used to treat psoriasis. We performed a nested cohort study to assess whether oral retinoids reduce skin cancer risk among patients with psoriasis exposed to psoralen-UVA.. From 1985 to 2000, 135 patients (11.3% of surviving patients in our cohort) used retinoids for at least 26 weeks in 1 year or more. For these 135 patients, we compared each person's SCC and basal cell carcinoma incidence during years of substantial oral retinoid use and other years. We used Poisson regression models to adjust for potential confounders.. In a paired analysis, which compared each patient's own tumor experience while using and not using retinoids, retinoid use was associated with a 30% reduction in SCC incidence (196 SCCs/1000 and 302 SCCs/1000 years of use and no use, respectively; P =.002). After adjusting for other factors associated with SCC risk, the incidence of SCC was significantly decreased during years of substantial retinoid use (incidence rate ratio = 0.79; 95% confidence interval = 0.65, 0.95). Oral retinoid use and basal cell carcinoma incidence were not significantly associated.. In patients with psoriasis treated with psoralen-UVA, systemic retinoid use reduced SCC risk but did not significantly alter basal cell carcinoma incidence.

Topics: Adult; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Case-Control Studies; Chemoprevention; Female; Humans; Incidence; Isotretinoin; Male; Middle Aged; Multivariate Analysis; Prospective Studies; Psoriasis; PUVA Therapy; Retinoids

Patients with xeroderma pigmentosum (XP) frequently develop sunlight-induced skin cancer. Infrequently, internal neoplasms may also occur. A 21-year-old patient with XP, who had many skin cancers, developed a rare internal tumour - a grade II diffuse fibrillary spinal cord astrocytoma - during a break in a therapeutic trial of isotretinoin for skin cancer prevention. Treatment of neoplasms in XP patients presents special difficulties because of their defect in DNA repair.. The study objective was to raise awareness of the cancer surveillance process in XP patients and the concerns involved in choice of therapy.. Since the spinal cord tumour was inoperable, the patient was treated with x-radiation, continued on isotretinoin treatment and was followed closely for tumour response.. Despite sensitivity to sunlight, the patient had a normal acute response to the x-ray treatment without excessive skin reaction. Serial examinations by magnetic resonance imaging (MRI) starting 8 months after x-ray treatment was initiated, showed a marked gadolinium enhancement followed by regression. This clearing was first seen at 2 years after biopsy and persisted to at least 9 years after treatment.. In contrast to the exaggerated sensitivity to UV radiation, XP patients may tolerate therapeutic doses of x-radiation. Isotretinoin treatment may have contributed to the good response of this spinal cord astrocytoma.

Topics: Adult; Astrocytoma; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Humans; Isotretinoin; Keratolytic Agents; Male; Skin Neoplasms; Spinal Cord Neoplasms; Xeroderma Pigmentosum

It is well known that patients with heritable cutaneous diseases may have excess tumors during their lifetime. This relationship has been shown for such diverse conditions as xeroderma pigmentosum, Bloom syndrome, basal cell nevus syndrome, and psoriasis. However, multiple cutaneous tumors have not been previously described in people with lamellar ichthyosis. This article describes the cases of two such patients, possible treatment, and a previously undescribed ichthyosis syndrome.

Topics: Adolescent; Adult; Biopsy; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Etretinate; Humans; Ichthyosis; Isotretinoin; Male; Neoplasms, Second Primary; Scalp; Skin Neoplasms

Topics: Carcinoma, Basal Cell; Humans; Isotretinoin; Skin Neoplasms

Xeroderma pigmentosum is a rare recessive disease with sun sensitivity, increased freckling and defective DNA repair. Xeroderma pigmentosum patients have more than a 1000-fold increased risk of developing skin cancer including basal cell carcinoma, squamous cell carcinoma and melanoma. We studied chemoprevention of new skin cancers with oral retinoids in xeroderma pigmentosum patients who had multiple skin cancers. Xeroderma pigmentosum patients were cleared of all pre-existing tumors surgically and then treated with high dose (2 mg/kg/day) oral isotretinoin (13-cis retinoic acid, Accutane) for two years and then for one year off treatment. Patients were examined at regular intervals for new tumor formation and for side effects. Five xeroderma pigmentosum patients had a total of 121 basal or squamous cell carcinomas in 2 years before treatment and only 25 tumors during 2 years of treatment. The tumor frequency increased 8.5-fold after the drug was discontinued (New Engl J Med 318: 1633-1637, 1988). Toxicity (cutaneous, triglyceride, liver-function or skeletal abnormalities) prompted subsequent use of a low dose protocol. Patients were treated initially with 0.5 mg/kg/day oral isotretinoin and the dose was increased sequentially to 1.0 or 1.5 mg/kg/day. We found that toxicity was less with the lower doses. The lowest effective, least toxic dose varied among the xeroderma pigmentosum patients.

Topics: Administration, Oral; Adolescent; Adult; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Child; Female; Humans; Isotretinoin; Male; Middle Aged; Skin Neoplasms; Xeroderma Pigmentosum

Topics: Adult; Aged; Carcinoma, Basal Cell; Female; Humans; Hyperostosis; Isotretinoin; Male; Middle Aged; Prospective Studies; Radiography; Skin Neoplasms

Topics: Carcinoma, Basal Cell; Clinical Trials as Topic; Double-Blind Method; Humans; Isotretinoin; Multicenter Studies as Topic; Skin Neoplasms

Topics: Anticarcinogenic Agents; beta Carotene; Carcinoma, Basal Cell; Carotenoids; Humans; Isotretinoin; Skin Neoplasms

Topics: Adult; Basal Cell Nevus Syndrome; Carcinoma, Basal Cell; Diseases in Twins; Humans; Isotretinoin; Male; Skin Neoplasms; Twins; Twins, Monozygotic

Twelve patients with multiple basal cell carcinomas resulting from varying causes were treated with high-dose oral isotretinoin (mean daily dosage: 3.1 mg/kg/day) for a mean of 8 months. Of the 270 tumors monitored in these patients, only 8% underwent complete clinical and histologic regression. All patients developed moderate to severe acute toxicities, leading five patients to withdraw from the study. Retinoid skeletal toxicity was identified in two patients who were examined after long-term therapy. Lower doses of isotretinoin (0.25 to 1.5 mg/kg/day) were ineffective for chemotherapy but demonstrated a chemopreventive effect in a subset of three patients who received these lower doses for 3 to 8 years. Two of these three patients have been observed after discontinuation of therapy. In one patient with a history of arsenic exposure, only one new tumor has appeared in a 27-month posttreatment observation period; in the other patient with the nevoid basal cell carcinoma syndrome, 29 new tumors have appeared within a 13-month period. This suggests that the need for long-term maintenance therapy with isotretinoin for chemoprevention of basal cell carcinoma may depend on the underlying cause of the skin cancers.

Topics: Administration, Oral; Adult; Aged; Carcinoma, Basal Cell; Female; Humans; Isomerism; Isotretinoin; Male; Middle Aged; Neoplasms, Multiple Primary; Remission Induction; Skin Neoplasms; Tretinoin

A group of 50 patients with basal cell carcinoma of the face was treated by 13-cis-retinoic acid. The treatment resulted in diminution of the tumors. Complete regression was observed in 4 cases. Histological examination revealed necrosis of cancer cells and mononuclear infiltration into the treated tumors. In the group with weak clinical and histological reaction to the treatment all basal cell carcinomas were of adenoid type. A better effect was observed in the group with lower serum retinol level. This treatment method seems to be supplementary to surgery in prevention of the tumor recurrence.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Carcinoma, Basal Cell; Female; Humans; Isotretinoin; Male; Middle Aged; Skin Neoplasms; Tretinoin; Vitamin A

Two patients with multiple basal cell carcinomas, due either to the nevoid basal cell carcinoma syndrome (NBCCS) or arsenical insecticide exposure, were treated with oral isotretinoin for 7 or 8 years, respectively. Gradually decreasing dosage levels were employed. During the initial courses of therapy, high doses (2.0-3.0 mg/kg/day) were intended as chemotherapy. In these patients only 6 of 40 (15%) lesions underwent complete clinical regression. In subsequent courses aimed at chemoprevention, the dose was progressively reduced from 1.5 to 0.25 mg/kg/day. During therapy, no new lesions were observed in the patient with the arsenical exposure. The NBCCS patient developed 1 new lesion during therapy at 1.0 mg/kg/day, 1 new lesion at 0.5 mg/kg/day and 5 new lesions at 0.25 mg/kg/day. Treatment was discontinued and the patient with the arsenic exposure developed his first new tumor 17 months afterwards; in contrast, the NBCCS patient developed 29 tumors within 13 months. These findings suggest that long-term therapy with isotretinoin is needed for the continuation of the cancer chemopreventive effect. However, the need for continuous rather than intermittent maintenance therapy, and the determination of the optimal dose for this purpose may depend on the etiology of the multiple carcinomas and on the tolerability of the lowest effective dose by the individual patient. With these encouraging data, it now appears appropriate to expand this pilot study and perform larger trials to determine the usefulness of isotretinoin in the chemoprevention of basal cell carcinoma in patients with multiple tumors.

Topics: Basal Cell Nevus Syndrome; Carcinoma, Basal Cell; Humans; Isotretinoin; Male; Middle Aged; Neoplasms, Multiple Primary; Prognosis; Skin Neoplasms; Tretinoin

Patients with basal cell carcinoma were treated locally with 13-cis-retinoic acid. Disappearance of the tumors was observed in two of fifteen patients. Thirteen patients whose tumors diminished after the treatment were finally managed surgically. Biopsy specimens were examined histopathologically and by autoradiography. Treated tumors showed reduction of labeling indices as compared with the nontreated group.

Topics: Adult; Aged; Carcinoma, Basal Cell; Female; Humans; Isotretinoin; Male; Middle Aged; Skin Neoplasms; Tretinoin

Three patients with multiple basal cell carcinomas, due either to excessive sunlight exposure, the nevoid basal cell carcinoma syndrome, or arsenical insecticide exposure, were treated with oral isotretinoin for 2 1/2 to 4 years. Although higher doses were used initially, approximately 1.5 mg/kg/day was used for long-term therapy in all three patients. Therapeutic effects on existing tumors varied between each patient, and only nine of sixty-five lesions underwent complete clinical regression. No tumors enlarged in two patients; a few tumors enlarged slightly in the third patient, particularly during the later courses of therapy when isotretinoin was given at lower dosage. No new lesions have been observed in any of these three patients. With these encouraging preliminary data, it now may be appropriate to perform larger trials for longer periods of time to determine the usefulness of isotretinoin in the chemoprevention of basal cell carcinoma in patients with multiple tumors.

Topics: Aged; Carcinoma, Basal Cell; Humans; Isomerism; Isotretinoin; Male; Middle Aged; Neoplasms, Multiple Primary; Skin Neoplasms; Tretinoin