title: Hyperlipidemia and hypothyroidism among metastatic renal cell carcinoma patients taking sunitinib malate. Related or unrelated adverse events?
abstract: BACKGROUND
  In recent years, new-onset hypothyroidism was extensively reported in patients receiving sunitinib for malignancy. Effects of sunitinib on serum lipids are not described, however a hyperlipidemic state is commonly observed in hypothyroid patients. Here we report about the incidence and severity of hypercholesterolemia and hypertriglyceridemia in a cohort of patients receiving sunitinib for metastatic renal cell carcinoma.
  
  
  METHODS
  Thyroid function tests, serum triglycerides, and cholesterol were prospectively evaluated in 39 consecutive metastatic renal cell carcinoma patients, who were receiving sunitinib as a first-line treatment. Incidence of hyperlipidemia, thyroid function impairment, and their possible relationship were investigated.
  
  
  RESULTS
  Thyroid function tests, serum cholesterol, and triglycerides were assessed at baseline and before the beginning of each sunitinib cycle. During treatment, median triglyceride levels increased up to 271.3 mg/dL, and median cholesterol increased up to 234.7 mg/dL (+113% and +22%, respectively). A hyperlipidemic state developed in 27 patients (69.2%) within a mean time of 1.8 six-week cycles (range, 1-5 cycles) and persisted during treatment. Hypothyroidism was observed in 20 patients (51.2%) and usually developed within 2.3 cycles. Because hypothyroidism and hyperlipidemia developed at different time points of treatment and among different patients, our results failed to demonstrate a correlation between these adverse events.
  
  
  CONCLUSIONS
  New-onset hyperlipidemia was observed in an increased percentage of patients taking sunitinib. The mechanism of this side effect is still unclear. We recommend careful monitoring of serum lipid levels during sunitinib administration to recognize possible consequences, especially on cardiovascular health.
authors.affiliation: Second Medical Oncology Unit and First Urology Unit, Università degli Studi di Firenze, Department of Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. Electronic address: renato.tassi@virgilio.it.
authors.forename: Renato
authors.initials: R
authors.lastname: Tassi
authors.affiliation: Medical Oncology Unit, Department of Oncology, Ospedale Santa Maria Annunziata, Azienda Sanitaria di Firenze, Florence, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Baldazzi
authors.affiliation: Second Medical Oncology Unit and First Urology Unit, Università degli Studi di Firenze, Department of Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Lapini
authors.affiliation: Second Medical Oncology Unit and First Urology Unit, Università degli Studi di Firenze, Department of Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Carini
authors.affiliation: Second Medical Oncology Unit and First Urology Unit, Università degli Studi di Firenze, Department of Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Mazzanti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D002784:Cholesterol / Q000097:blood; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000139:chemically induced* / Q000453:epidemiology / Q000378:metabolism; D007037:Hypothyroidism / Q000139:chemically induced* / Q000453:epidemiology / Q000378:metabolism; D015994:Incidence; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects* / Q000627:therapeutic use; D000077210:Sunitinib; D014280:Triglycerides / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D014280:Triglycerides; D002784:Cholesterol; D000077210:Sunitinib
keywords: Angiogenesis inhibitors; Elevated serum cholesterol; Elevated serum triglycerides; Hypercholesterolemia; Hypertriglyceridemia; Kidney cancer; Thyroid function test; mRCC