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

 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 
 ANNALS OF ONCOLOGY, Vol.24(12) : 3089-3094, 2013 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use* ; Carcinoma, Medullary/drug therapy* ; Carcinoma, Medullary/mortality ; Carcinoma, Medullary/secondary ; Carcinoma, Papillary/drug therapy* ; Carcinoma, Papillary/mortality ; Carcinoma, Papillary/secondary ; Disease-Free Survival ; Everolimus ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Neoplasm Staging ; Sirolimus/analogs & derivatives* ; Sirolimus/therapeutic use ; Thyroid Neoplasms/drug therapy* ; Thyroid Neoplasms/mortality ; Thyroid Neoplasms/pathology ; Treatment Outcome
efficacy ; everolimus ; mTOR inhibitor ; safety ; thyroid cancer
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Nuclear Medicine (핵의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Yonsei Biomedical Research Center (연세의생명연구원) > 1. Journal Papers
Yonsei Authors
Kang, Sang Wook(강상욱) ORCID logo https://orcid.org/0000-0001-5355-833X
Kim, Joo Hang(김주항)
Kim, Hyun Jeong(김현정)
Nam, Kee Hyun(남기현) ORCID logo https://orcid.org/0000-0002-6852-1190
Park, Cheong Soo(박정수)
Yun, Mi Jin(윤미진) ORCID logo https://orcid.org/0000-0002-1712-163X
Lim, Sun Min(임선민)
Chung, Woong Youn(정웅윤)
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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