isotretinoin and Penile-Neoplasms

Combined biological therapy with 13-cis-retinoic acid (13-cRA) and interferon alpha-2a (IFN alpha-2a) was reported to be highly effective in squamous cell carcinoma of the cervix and skin. Squamous cell carcinoma of the penis is rare in the United States, accounting for less than 1/2% of all male malignancies. Because of the association of infection with human papillomavirus with both carcinomas of the cervix and penis and their shared squamous cell histology, we carried out a phase II study of 13-cRA and IFN alpha-2a in carcinoma of the penis.. Eighteen ambulatory patients with surgically unresectable, recurrent, and/or metastatic squamous cell carcinoma of the penis were treated with IFN alpha-2a, 3MU/day administered subcutaneously and 13-cRA, 1 mg/kg orally daily for at least eight weeks, unless intolerable toxicity occurred.. One patient was ineligible; one patient withdrew prior to treatment. Among the 16 eligible, treated patients, there was one complete response. Fourteen patients had progressive disease as their only treatment effect. Two patients were unevaluable for tumor response because they had no follow-up tumor measurements. No unexpected treatment-related toxicities were found on study. The only common form of grade 3 toxicity was hypertriglyceridemia found in eight of the 17 patients (47%). No toxicities above grade 3 were observed.. In contrast to its benefit in squamous cell carcinomas of the cervix and skin, the combination of 13-cRA and IFN alpha-2a has low efficacy in advanced carcinoma of the penis.

Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Disease Progression; Fatigue; Fever; Humans; Hypertriglyceridemia; Interferon alpha-2; Interferon-alpha; Isotretinoin; Life Tables; Male; Middle Aged; Penile Neoplasms; Recombinant Proteins; Survival Analysis; Treatment Failure

This study evaluated the effectiveness of systemic interferon alfa-nl versus isotretinoin in the treatment of condylomata acuminata. Patients were randomly assigned interferon alfa-nl, 5 million units, subcutaneously daily for 2 weeks then twice weekly for 4 weeks, or isotretinoin, 1 mg/kg by mouth daily for 6 weeks. Seventeen otherwise healthy men with histologically confirmed condylomata acuminata refractory to standard treatment completed 6 study weeks. Five of nine men (56%) treated with interferon alfa-nl had an objective clinical response (greater than or equal to 50% clearance of baseline disease), with one patient clearing completely. None of the patients treated with isotretinoin alone had an objective response (p = 0.009). Those whose clearing was incomplete with interferon alone were then assigned to interferon therapy three times weekly in combination with daily isotretinoin for 6 weeks, and those receiving isotretinoin were switched to interferon three times weekly for 6 weeks. There was continued clearing in all patients in the combination treatment group but in only three of seven in the sequential treatment group. Side effects were common and generally predictable for each drug but were generally not exacerbated when interferon and isotretinoin were used in combination. Parenteral interferon alfa-nl is an effective alternative treatment modality for patients with refractory condylomata acuminata.

Topics: Adult; Condylomata Acuminata; Drug Evaluation; Drug Therapy, Combination; Humans; Interferon Type I; Isotretinoin; Male; Middle Aged; Penile Neoplasms; Random Allocation

Topics: Administration, Oral; Erythroplasia; Humans; Isotretinoin; Male; Middle Aged; Neoplasm Recurrence, Local; Penile Neoplasms