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Original Investigation
February 2017

Initial Experience With Low-Dose Methotrexate as an Adjuvant Treatment for Rapidly Recurrent Nonvasculitic Laryngotracheal Stenosis

Author Affiliations
  • 1Department of Otolaryngology, University of Miami Miller School of Medicine, Miami, Florida
JAMA Otolaryngol Head Neck Surg. 2017;143(2):125-130. doi:10.1001/jamaoto.2016.2895
Key Points

Question  Does low-dose methotrexate improve the number of surgery-free days for patients with rapidly recurrent nonvasculitic laryngotracheal stenosis?

Findings  In this case series study of 10 patients, a substantial difference in the number of surgery-free days was seen before vs after starting methotrexate therapy.

Meaning  In patients with rapidly recurrent laryngotracheal stenosis, methotrexate may be used as an adjuvant treatment to reduce the frequency of surgical dilation.

Abstract

Importance  Adult laryngotracheal stenosis (LTS) is typically managed surgically, but some patients fail treatment because of rapid restenosis or granulation tissue formation. The need for frequent surgery or tracheostomy reduces the quality of life in these patients and poses a significant challenge for the treating physician. New adjuvant treatments are required to reduce the surgical burden of this condition.

Objective  To examine whether patients with rapidly recurrent nonvasculitic LTS who fail surgical management of their stenosis (ie, requiring dilation more frequently than every 6 months) experience longer intervals between surgical procedures when receiving adjuvant treatment with low-dose methotrexate.

Design, Setting, and Participants  This study was a retrospective case series study of patients treated with methotrexate from January 2014 to January 2016 at a tertiary academic medical center. Participants were 10 patients with LTS without any diagnosis of vasculitis or granulomatous disease who underwent low-dose methotrexate therapy.

Interventions  Once-weekly treatment with oral methotrexate, 15 or 20 mg.

Main Outcomes and Measures  The mean number of days between operations before and after starting methotrexate therapy was compared. Clinical courses and adverse effects of each patient were also reviewed.

Results  Among 10 patients, the mean (SD) age at the outset of study inclusion was 52 (19) years; 8 were female and 2 were male. All 10 patients experienced some clinical improvement. Three patients who were previously tracheostomy dependent were able to be decannulated. Two other patients who were tracheostomy dependent and had failed endoscopic management of their granulation tissue had complete resolution. In 6 patients who underwent at least 1 surgical procedure before and after the initiation of methotrexate treatment, the mean (SD) interval between operations increased from 61 (35) days (95% CI, 26-96 days) before starting methotrexate therapy to 312 (137) days (95% CI, 175-449 days) after starting methotrexate therapy, for an absolute difference of 251 (58) days (95% CI, 193-309 days). The median number of days between surgical procedures was 44 days before starting methotrexate therapy and 289 days after starting methotrexate therapy. Adverse effects observed included mild hair thinning and onychomycosis in 2 patients and herpes zoster infection in 1 patient.

Conclusions and Relevance  Low-dose methotrexate appears to be an effective adjunct to surgery in select patients with LTS that is resistant to surgical management and leads to a substantial increase in the number of days between surgical procedures. The patient and clinician must be aware of the adverse effects of methotrexate therapy and balance these factors against the risk of poorly controlled airway stenosis. Randomized, placebo-controlled, double-blind trials are needed to examine whether the clinical efficacy in this series of patients translates to a larger population.

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