The clinical implications of sunitinib-induced hypothyroidism: a prospective evaluation

Br J Cancer. 2008 Aug 5;99(3):448-54. doi: 10.1038/sj.bjc.6604497.


Sunitinib is approved for the treatment of metastatic renal cell carcinoma (RCC) and imatinib-resistant or -intolerant gastrointestinal stromal tumours (GIST). Several studies have identified unexpected rates of thyroid dysfunction with sunitinib treatment. We performed a prospective observational study with the aim of more accurately defining the incidence and severity of hypothyroidism in RCC or GIST patients receiving sunitinib. Thyroid function was assessed at baseline and on days 1 and 28 of each treatment cycle. Thyroid antibodies were assessed at baseline and during follow-up if abnormal thyroid function tests were recorded. Sixteen patients (27%) developed sub- or clinical hypothyroidism and required hormone replacement and 20 patients (34%) showed at least one elevated thyroid-stimulating hormone not requiring therapeutic intervention. Twenty patients (34%) did not develop any biochemical thyroid abnormality. Thus, sunitinib can induce (sub-) clinical hypothyroidism, warranting close monitoring of thyroid function. We propose a new algorithm for managing this side effect in clinical practise.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / physiopathology
  • Female
  • Gastrointestinal Stromal Tumors / drug therapy*
  • Gastrointestinal Stromal Tumors / physiopathology
  • Humans
  • Hypothyroidism / chemically induced*
  • Hypothyroidism / physiopathology
  • Indoles / adverse effects*
  • Indoles / therapeutic use
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / physiopathology
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrroles / adverse effects*
  • Pyrroles / therapeutic use
  • Sunitinib
  • Thyroid Function Tests


  • Antineoplastic Agents
  • Indoles
  • Pyrroles
  • Sunitinib