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A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes

Authors
 S. M. Lim  ;  H. Chang  ;  M. J. Yoon  ;  Y. K. Hong  ;  H. Kim  ;  W. Y. Chung  ;  C. S. Park  ;  K. H. Nam  ;  S. W. Kang  ;  M. K. Kim  ;  S. B. Kim  ;  S. H. Lee  ;  H. G. Kim  ;  I. I. Na  ;  Y. S. Kim  ;  M. Y. Choi  ;  J. G. Kim  ;  K. U. Park  ;  H. J. Yun  ;  J. H. Kim  ;  B. C. Cho 
Citation
 Annals of Oncology, Vol.24(12) : 3089-3094, 2013 
Journal Title
 Annals of Oncology 
ISSN
 0923-7534 
Issue Date
2013
Abstract
BACKGROUND: This phase II study investigated the efficacy and safety of everolimus, an inhibitor of mammalian target of rapamycin (mTOR), in locally advanced or metastatic thyroid cancer. PATIENTS AND METHODS: Patients with thyroid cancer of any histology that was resistant or not appropriate for (131)I received everolimus 10 mg daily orally until unacceptable toxicity or disease progression. The primary end point was disease control rate [partial response (PR) + stable response ≥12 weeks]. Secondary end points included response rates, clinical benefit (PD + durable stable disease (SD)], progression-free survival (PFS), overall survival, duration of response, and safety. RESULTS: Thirty-eight of 40 enrolled patients were evaluable for efficacy. The disease control rate was 81% and two (5%) patients achieved objective response; their duration of response was 21+ and 24+ weeks. Stable disease (SD) and progressive disease was reported in 76% and 17% of patients, respectively. Seventeen (45%) patients showed durable SD (≥24 weeks) and clinical benefit was reported in 19 (50%) patients. Median PFS was 47 weeks [95% confidence interval (CI) 14.9-78.5]. Calcitonin, CEA, and thyroglobulin concentrations were ≥50% lower than baseline in three (30%) and four (44%) patients with medullary thyroid cancer and five (33%) patients with PTC, respectively. The most common treatment-related adverse events were mucositis (84%), anorexia (44%), and aspartate transaminase/alanine transaminase elevation (26%). CONCLUSIONS: Everolimus had a limited activity with low response rate in locally advanced or metastatic thyroid cancer. Reasonable clinical benefit rate and safety profile may warrant further investigation.
Full Text
http://annonc.oxfordjournals.org/content/24/12/3089.long
DOI
10.1093/annonc/mdt379
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Yonsei Biomedical Research Center (연세의생명연구원)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Nuclear Medicine (핵의학교실)
Yonsei Authors
강상욱(Kang, Sang Wook) ORCID logo https://orcid.org/0000-0001-5355-833X
김주항(Kim, Joo Hang)
김현정(Kim, Hyun Jeong)
남기현(Nam, Kee Hyun) ORCID logo https://orcid.org/0000-0002-6852-1190
박정수(Park, Cheong Soo)
윤미진(Yun, Mi Jin) ORCID logo https://orcid.org/0000-0002-1712-163X
임선민(Lim, Sun Min)
정웅윤(Chung, Woung Youn)
조병철(Cho, Byoung Chul) ORCID logo https://orcid.org/0000-0002-5562-270X
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/89193
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