Safety of sirolimus.
pulmonary embolism, asthenia, pleural effusion, death, diarrhea, cutaneous rash, toxicity, toxicities, familial cardiac ischemic, breast cancer, early-stage pancreatic cancer, pleuro-pericardial effusions, pericardial effusion, mucositis, cerebral stroke, headache
PULMONARY EMBOLISM, PLEURAL EFFUSION, CARDIAC FAILURE, HYPERCHOLESTEROLEMIA, GASTROESOPHAGEAL REFLUX, BREAST CANCER, EVENT, PERICARDIAL EFFUSION, EXUDATIVE ENTEROPATHY, REMISSION, MUCOSITIS, CEREBRAL STROKE, MASSIVE BLEEDING, HYPERTENSION
Sirolimus induced AEs in 127 patients, resulting in a toxicity rate of 96% (The most common toxicities were asthenia (70% grade 1–2, 4% grade 3–4), mucositis (66% grade 1–2, 8% grade 3–4), diarrhea (40% grade 1–2, 2% grade 3–4), headache (25% grade 1–2, 5% grade 3–4), cutaneous rash (31% grade 1–2, 1% grade 3–4), and gastroesophageal reflux (21% grade 1–2, 0% grade 3–4) (Six patients (5%) developed a serious AE during the treatment period.A 52-year-old woman with an orbital VM was diagnosed with an early-stage pancreatic cancer that was diagnosed on follow-up laboratory analysis 15 months after initiation of sirolimus. Sirolimus was stopped and surgery resulted in a complete remission after 36 months.A 40-year-old woman with an extensive VM of the lower limb had a pulmonary embolism 2 months after sirolimus onset; it resolved after therapeutic low molecular weight heparin. Sirolimus was stopped.A 48-year-old woman with a lower limb capillaro-venous malformation (CVM) and with preexisting, but controlled cardiovascular risk factors (hypertension, hypercholesterolemia, and familial cardiac ischemic event) had a transient ischemic cerebral stroke 1 year after initiation of sirolimus. She completely recovered after a few days.A 46-year-old woman with a thoracic VM was diagnosed with breast cancer after 9 months of sirolimus. Sirolimus was continued during neoadjuvant chemotherapy, surgery, and radiotherapy, due to clinical benefit.A 61-year-old patient with advanced GLA died due to progression of the preexisting pleural effusion and subsequent cardiac failure, despite a 6-month sirolimus treatment.A 23-month-old boy was treated with sirolimus for pleuro-pericardial effusions and exudative enteropathy with a rapid clinical response (withdrawal of assisted ventilation, a decrease in pleural drainage, and decrease in parenteral nutrition). Twelve months after sirolimus initiation, pericardial drainage was performed in another institution for an asymptomatic pericardial effusion detected on cardiac ultrasonography during an elective consultation. The procedure resulted in massive bleeding and death.