Age: 67.0
Sex: M
Vaccine: HPV4
Symptoms: Off label use, Therapeutic response unexpected
Clinical narrative: Information has been received from a published literature article, titled as below. Recurrent respiratory papillomatosis (RRP) is characterized by benign wart-like growths within the aerodigestive tract. This article seeks to examine the effectiveness of GARDASIL as an adjuvant therapy in the treatment of active RRP. This retrospective chart review looked at 20 RRP patients by the senior author. Each received three GARDASIL injections per the standard approved dosing protocol by their primary care physicians in addition to standard of care. Standard of care included surgical excision with pulse dye laser, KTP (potassium titanyl phosphate) laser, or microdebrider, with or without adjuvant treatment with cidofovir or bevacizumab. The study population included 12 men, eight women, and ranged in age from 9 to 77 years (median: 47 years). Of these 20 patients, 17 had adequate documentation with which to evaluate their pre-vaccine and post-vaccine course of the disease. Of the other three patients (one male and two females), one received the vaccine at the beginning of therapy; the other two were newer patients and had received fewer than three interventions before the vaccine. Analysis of all patients for whom there was insufficient data (n =17) showed a mean interval between interventions/ISI of 4.86 months (SD = 2.36) before receiving the vaccine, and a mean ISI of 7.96 months (SD = 3.71) after receiving the vaccine. A paired t test comparing before and after ISI showed a significant increase in the ISI of 3.1 months (95% confidence interval [C1]: 1.02-5.19, P = 0.0061). Analysis of only the male patients (n = 11) showed a mean increase in the ISI of 4.2 months (95% CI: 1.6-6.7, P =0.0048. Analysis of only the female patients (n = 6) showed a non-significant increase in ISI of 1.2 months (95% CI: 3.1-5.4, P=0.51). Complete remission, defined as complete absence of disease, was achieved in eight patients (40%) overall (six male and two female). Partial remission (defined as a period greater than 12 months where no appreciable growth of papilloma was noted on laryngeal examination) was achieved in five patients (25%) overall (three male and two female). Complete or partial remission was achieved in a total of 13 (65%) patients (nine male and four female). The GARDASIL vaccine can modulate the severity of RRP and induce remission in some patients. The effect was much greater in males and in females in low estrogen states. This case refers to a 67 year old male patient with respiratory papilloma. There was 5.5 years length of treatment pre-vaccine. On unknown dates the patient was vaccinated with 3 doses of GARDASIL (dose, lot# and route were not reported) for respiratory papilloma (off label use) per the standard approved dosing protocol by their primary care physicians, respectively. It was reported no other adjuvant therapies. After the vaccination, complete remission of recurrent respiratory papillomatosis was found (unexpected therapeutic effect). This is one of several cases received from the same literature. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.