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Clinical pharmacy and clinical trials (including case series)
The use of sunitinib in metastatic thyroid carcinoma: case report of an off-label treatment
  1. G. Bellavia,
  2. M.T. * Messina Denaro,
  3. F. Verderame,
  4. I. Uomo
  1. 1P.O. Giovanni Paolo II, Department of Pharmacy AG2, Sciacca, Italy
  2. 2P.O. Giovanni Paolo II, Unit of Medical Oncology, Sciacca, Italy


Background Thyroid cancer typically has a good outcome following standard treatments, which include surgery or radioactive iodine or systemic chemotherapy. During the last two years many randomised trials have demonstrated that multikinase inhibitors, such as sunitinib, are active in metastatic thyroid carcinoma.

In Italy, sunitinib is only approved for the treatment of metastatic renal carcinoma, GIST (gastrointestinal stromal tumour) or HCC (hepatocellular carcinoma), but if there are no other valid therapeutic options a Sicilian regional law allows clinicians to prescribe an off-label treatment and hospital pharmacies to dispense it.

Purpose To evaluate the treatment of a multikinase inhibitor, sunitinib, for an off-label indication and to assess the safety and efficacy of the treatment for an older patient, female, 80 years old, with metastatic thyroid cancer not responsive to cisplatin/epirubicin and gemcitabine.

Materials and methods The oncologist prepared a formal request, with the patient's informed consent and all the phase II and III trials available in literature. These documents were also evaluated by the hospital pharmacist and then finally approved by the hospital's medical director. After this procedure the pharmacy supplied and distributed the drug to the patient who was being treated at home.

Results Since April 2011, the patient took sunitinib at the standard dose of 50 mg/day for 8 weeks and the volume of the lesion reduced. The clinician monitored vigilantly for hypertension. Fatigue was the side effect that led to a reduction of dose to 25 mg/day for another 8 weeks. At present, six months later, the disease has regressed further.

Conclusions Our data support the use of sunitinib in metastatic thyroid cancer, demonstrating also a low incidence of adverse reactions. This case report can also demonstrate the advantages of using off-label treatments if they are supported by valid clinical evidence rather than updating the regulatory approval of some drugs.

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