Efficacy of cidofovir versus bevacizumab in recurrent respiratory papillomatosis: A randomized, double-blind, placebo-controlled pilot study.

OBJECTIVES: After surgical resection of papilloma, adjuvant therapy may be recommended for the control of recurrent respiratory papillomatosis (RRP). As the efficacy of adjuvant therapy remains unproven, the aim of this study was to compare the efficacy of cidofovir versus bevacizumab used as adjuvant therapies for the control of RRP. METHODS: This randomized, double-blind, placebo-controlled pilot study was performed in a national respiratory disease referral centre. Patients with RRP were recruited prospectively and were divided into juvenile or adult RRP. Participants were randomly assigned to receive adjuvant therapy with cidofovir, bevacizumab or placebo. The study drug or placebo was administered after direct microlaryngoscopy with papilloma resection using cold instruments. The Derkay severity score and the Voice Handicap Index (VHI) were assessed at 3-6-week intervals, for a total of 3 visits. Follow-up included VHI and Derkay score assessments at 2-month intervals over the course of one year. Annual rates before and after surgical treatment were compared. RESULTS: Five children and 11 adults were enrolled in the study. After one year, the group treated with cidofovir had a significant decrease in Derkay score (p=.027). No difference between treatment arms was observed in the annual surgery rate. There was a significant decrease in the VHI score in all treatment groups (p<.001), and no significant difference was observed between groups (p=.32). CONCLUSION: While we observed a significant decrease in RRP severity with intralesional cidofovir, we were unable to provide proof of efficacy of intralesional bevacizumab. CLINICALTRIALS: gov Identifier: NCT02555800.

Efficacy of cidofovir versus bevacizumab in recurrent respiratory papillomatosis: A randomized, double-blind, placebo-controlled pilot study.

OBJECTIVES: After surgical resection of papilloma, adjuvant therapy may be recommended for the control of recurrent respiratory papillomatosis (RRP). As the efficacy of adjuvant therapy remains unproven, the aim of this study was to compare the efficacy of cidofovir versus bevacizumab used as adjuvant therapies for the control of RRP. METHODS: This randomized, double-blind, placebo-controlled pilot study was performed in a national respiratory disease referral centre. Patients with RRP were recruited prospectively and were divided into juvenile or adult RRP. Participants were randomly assigned to receive adjuvant therapy with cidofovir, bevacizumab or placebo. The study drug or placebo was administered after direct microlaryngoscopy with papilloma resection using cold instruments. The Derkay severity score and the Voice Handicap Index (VHI) were assessed at 3-6-week intervals, for a total of 3 visits. Follow-up included VHI and Derkay score assessments at 2-month intervals over the course of one year. Annual rates before and after surgical treatment were compared. RESULTS: Five children and 11 adults were enrolled in the study. After one year, the group treated with cidofovir had a significant decrease in Derkay score (p=.027). No difference between treatment arms was observed in the annual surgery rate. There was a significant decrease in the VHI score in all treatment groups (p<.001), and no significant difference was observed between groups (p=.32). CONCLUSION: While we observed a significant decrease in RRP severity with intralesional cidofovir, we were unable to provide proof of efficacy of intralesional bevacizumab. Clinicaltrials.gov Identifier: NCT02555800.

[Role of the ears, nose and throat specialist in the diagnosis and follow up of patients with primary vasculitidies]. / Papel del otorrinolaringólogo en el diagnóstico y seguimiento de pacientes con vasculitis primarias.

First manifestations of vasculitis can appear on the head and neck, still few physicians are aware of these diseases, as they are unspecific and because other conditions like infections and allergies are more frequent. Among them, signs and symptoms like epistaxis, nasal obstruction, discharge, burning pain of sinonasal region, headache, sinus polyps and crusts, the latter found in people who live in highly polluted cities with low humidity, in patients with respiratory scleroma, atrophy, those receiving local radiotherapy, and due to other conditions. Under the crusts, many infectious agents, like Staphylococcus aureus may grow and, in addition, other signs related to active vasculitis may be found. The ENT specialist is one of the first physicians visited by patients with these signs and symptoms. Their recognition is important to readily diagnose these diseases. We have selected three vasculitidies for discussion in this paper: granulomatosis with polyangiitis (Wegener), Churg-Strauss syndrome and relapsing polychondritis, since these three diseases present initial ENT problems with high frequency.