Randomized Surgical Adjuvant Trial of Interferon Alfa-n1 in Recurrent Papillomatosis

Abstract

\s=b\ Sixty-six patients with recurrent respiratory papillomatosis of juvenile onset were treated for six months with interferon alfa-n1 (Wellferon) in a randomized crossover trial. Half received interferon alfa-n1 intramuscularly at a dosage of 5 megaunits per square meter daily for 28 days and then thrice weekly for five months, followed by six months of observation. The other half were observed for six months and then treated. Operations were performed every two months to assess disease extent by a scale developed for this purpose. The score for the patients during the first observation period was stable. There was a statistically significant lowering of score in patients receiving interferon alfa-n1 during both periods of drug administration. Eight of 57 patients with assessable airway disease achieved complete remission, as did one additional patient with disease limited to the nasopharynx. No patients achieved complete remission during six months of observation alone. This difference was statistically significant. Patients without tracheostomy were significantly more likely to achieve remission than those with a tracheostomy. The patients who were observed after discontinuation of the drug therapy showed a significant rise in score within four months. Symptoms of toxicity included transient fever, fatigue, nausea, and headache. Elevations in serum aspartate aminotransferase levels occurred in 64% of the patients. There was an inverse correlation between age and the ability to tolerate the medication. The dose studied may be close to the maximum tolerated dose. It appears that interferon alfa-n1 as an adjuvant to routine surgical management is effective in slowing the growth of respiratory papillomas.(Arch Otolaryngol Head Neck Surg

Pegylated interferon for treating severe recurrent respiratory papillomatosis in a child: case report

“…Alpha-interferon is an immunomodulatory cytokine with antiviral and antiproliferative properties and was the first widely used adjuvant drug for treating RRP, with diverse results ranging from better prognosis to absence of response. 6,9 The evidence has failed to support its use, since the reports have mostly been based on case reports and clinical trials have shown varied results with limited follow-up. 6,9,10 The association between interferon and polyethylene glycol, which is called pegylated interferon, increases the half-life of the drug, eliminates immunogenicity and improves the pharmacokinetics of the protein, such that it can be administered once a week.…”

Activation of liver disease in healthy hepatitis B surface antigen carriers during interferon-alpha treatment

“…In this context no significant differences in the frequency of HBsAg negativization or serum HBV DNA clearance were observed between treated and control healthy HBsAg carriers. Finally, several investigators [Real et al, 1986;Kabbash et al, 1988;Leventhal et al, 1988] found that IFN alpha treatment may lead to liver toxicity, with an ALT increase in different diseases. In this sense, it has been reported that IFN alpha may increase ALT levels in as many as 64% of patients with recurrent respiratory papillomatosis who had normal base line ALT values and were treated with a similar dose and type of IFN alpha as were used in our study, and for the same treatment period [Leventhal et al, 1988].…”

“…Finally, several investigators [Real et al, 1986;Kabbash et al, 1988;Leventhal et al, 1988] found that IFN alpha treatment may lead to liver toxicity, with an ALT increase in different diseases. In this sense, it has been reported that IFN alpha may increase ALT levels in as many as 64% of patients with recurrent respiratory papillomatosis who had normal base line ALT values and were treated with a similar dose and type of IFN alpha as were used in our study, and for the same treatment period [Leventhal et al, 1988]. Moreover, IFN alpha has been used to treat the AIDS-associated Karposi's sarcoma, and a direct relation between ALT increase and IFN treatment was reported in these patients [Real et al, 1986;Kabbash et al, 1988].…”

Can zinc be an adjuvant therapy for juvenile onset recurrent respiratory papillomatosis?

“…Interferon is one of the initial adjuvant therapies introduced to treat JORRP and has been tried on a large number of patients [9][10][11][12][13][14][15][16][17][18][19][20].…”

“…Prolonged treatment seems to be more favorable as it may lead to sustained response and decreased relapses. Side effects included neutropenia [9,10,13,17,18], thrombocytopenia [10], liver dysfunction [10,11,[13][14][15]17,18], nausea [11,13], anorexia [11,13,14,17,18], fatigue [10,13,16,17], vomiting [11], chills [13,18], myalgia [18], weight loss [18], malaise [10], headache [13,[16][17][18], mild to moderate alopecia [14,17], palmar erythema [15], flu-like syndrome [15], depression [16], mild lethargy [17], disorientation [18], seizure [18], febrile seizure [17], drowsiness [18], and increased bronchial secretions [18].…”