TY  - BOOK
AU  - Barett, Christina
AU  - Bikas, Athanasios
AU  - Burman, Kenneth D
AU  - Clark, Brandon G
AU  - Desale, Sameer
AU  - Gandhi, Rahul
AU  - Jelinek, James S
AU  - Kundra, Priya
AU  - Mete, Mihriye
AU  - O'Keefe, Kaitlyn
AU  - Wartofsky, Leonard
AU  - Wexler, Jason
AU  - Wray, Lynette
TI  - Phase 2 clinical trial of sunitinib as adjunctive treatment in patients with advanced differentiated thyroid cancer
SN  - 0804-4643
PY  - 2016///
KW  - *Adenocarcinoma, Follicular/dt [Drug Therapy]
KW  - *Antineoplastic Agents/tu [Therapeutic Use]
KW  - *Bone Neoplasms/dt [Drug Therapy]
KW  - *Carcinoma/dt [Drug Therapy]
KW  - *Indoles/tu [Therapeutic Use]
KW  - *Iodine Radioisotopes/tu [Therapeutic Use]
KW  - *Lung Neoplasms/dt [Drug Therapy]
KW  - *Pyrroles/tu [Therapeutic Use]
KW  - *Radiotherapy
KW  - *Thyroid Neoplasms/dt [Drug Therapy]
KW  - Adenocarcinoma, Follicular/pa [Pathology]
KW  - Adult
KW  - Aged
KW  - Aged, 80 and over
KW  - Bone Neoplasms/sc [Secondary]
KW  - Carcinoma/pa [Pathology]
KW  - Chemotherapy, Adjuvant
KW  - Diarrhea/ci [Chemically Induced]
KW  - Disease-Free Survival
KW  - Fatigue/ci [Chemically Induced]
KW  - Female
KW  - Hand-Foot Syndrome/et [Etiology]
KW  - Humans
KW  - Leukopenia/ci [Chemically Induced]
KW  - Lung Neoplasms/sc [Secondary]
KW  - Male
KW  - Middle Aged
KW  - Nausea/ci [Chemically Induced]
KW  - Thyroid Neoplasms/pa [Pathology]
KW  - MedStar Health Research Institute
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Medicine/Endocrinology
KW  - Radiology
KW  - Clinical Trial, Phase II
KW  - Journal Article
KW  - Research Support, Non-U.S. Gov't
N2  - 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.Copyright © 2016 European Society of Endocrinology; DESIGN AND 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; 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; 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
UR  - http://dx.doi.org/10.1530/EJE-15-0930
ER  -