title: Phase 2 clinical trial of sunitinib as adjunctive treatment in patients with advanced differentiated thyroid cancer.
abstract: OBJECTIVE
  Our objective was to evaluate the efficacy and safety of sunitinib following at least one course of radioactive iodine treatment in patients with advanced differentiated thyroid cancer (DTC). The study endpoints included best response rate (including best objective response rate) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, measurement of serum thyroglobulin (Tg), and toxicity evaluation.
  
  
  METHODS
  This was a single center, nonrandomized, open-label, phase 2 clinical trial. In total, 23 patients were enrolled and were treated with a starting daily, oral dose of 37.5  mg sunitinib. Patients were evaluated with imaging, laboratory tests, and physical examination periodically per protocol.
  
  
  RESULTS
  The mean best response was a decrease of 17.2% (S.D. 22.8) in tumor sum from baseline. Six (26%) patients achieved a partial response (PR), and 13 (57%) had stable disease (SD) for a clinical benefit rate (PR+SD) of 83%. The overall median PFS was 241 days (interquartile limits, 114-518). No statistically significant difference was observed between the medians of the baseline and post-treatment Tg values (P=0.24). The most common adverse events included grades 1 and 2 decreases in blood cell counts (especially leukocytes), diarrhea, fatigue, hand-foot skin reaction, nausea, musculoskeletal pain, and hypertension.
  
  
  CONCLUSIONS
  These data demonstrate that sunitinib exhibits significant anti-tumor activity in patients with advanced DTC. Since sunitinib was relatively well-tolerated, there is the potential for clinical benefit in these patients, and further investigation of this agent is warranted.
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA Athanasios.Bikas@medstar.net.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Bikas
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Kundra
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Sameer
authors.initials: S
authors.lastname: Desale
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Mihriye
authors.initials: M
authors.lastname: Mete
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Kaitlyn
authors.initials: K
authors.lastname: O'Keefe
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Brandon G
authors.initials: BG
authors.lastname: Clark
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Lynette
authors.initials: L
authors.lastname: Wray
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Rahul
authors.initials: R
authors.lastname: Gandhi
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Barett
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: James S
authors.initials: JS
authors.lastname: Jelinek
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Wexler
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Leonard
authors.initials: L
authors.lastname: Wartofsky
authors.affiliation: Division of EndocrinologyDepartment of Medicine, MedStar Washington Hospital CenterMedStar Health Research InstituteDepartment of RadiologyMedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, District of Columbia 20010, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Burman
mesh_terms: D018263:Adenocarcinoma, Follicular / Q000188:drug therapy* / Q000473:pathology; D018249:Adenoma, Oxyphilic; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002291:Carcinoma, Papillary; D017024:Chemotherapy, Adjuvant; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011758:Pyrroles / Q000627:therapeutic use*; D011878:Radiotherapy; D000077210:Sunitinib; D000077273:Thyroid Cancer, Papillary; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D007457:Iodine Radioisotopes; D011758:Pyrroles; D000077210:Sunitinib