PMID- 23186033
OWN - NLM
STAT- MEDLINE
DCOM- 20131114
LR  - 20211021
IS  - 1557-9077 (Electronic)
IS  - 1050-7256 (Print)
IS  - 1050-7256 (Linking)
VI  - 23
IP  - 5
DP  - 2013 May
TI  - Evaluation of romidepsin for clinical activity and radioactive iodine reuptake in 
      radioactive iodine-refractory thyroid carcinoma.
PG  - 593-9
LID - 10.1089/thy.2012.0393 [doi]
AB  - BACKGROUND: Historically, systemic therapy for radioactive iodine 
      (RAI)-refractory thyroid cancer has been understudied. Available drugs have 
      modest efficacy. Romidepsin is a histone deacetylase inhibitor with potent 
      antitumor effects both in vitro and in vivo. In thyroid cancer cell lines, 
      romidepsin increases expression of both thyroglobulin and the sodium iodide 
      symporter messenger RNAs, suggesting the possibility of improved iodine 
      concentrating ability of RAI-resistant tumors. METHODS: This was a 
      single-institution Simon 2-stage phase II clinical study. Eligible patients had 
      progressive, RAI-refractory, recurrent/metastatic, nonmedullary, nonanaplastic 
      thyroid cancer. Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 
      measurable disease and adequate organ/marrow function were required. Romidepsin 
      13 mg/m(2) was administered intravenously on days 1, 8, and 15, in cycles of 28 
      days. The primary endpoint was the response rate by RECIST; change in RAI avidity 
      was a secondary endpoint. The study closed after the first stage due to the lack 
      of response. RESULTS: Twenty patients were enrolled: female, 50%; median age, 64 
      years; histology, 8 papillary/1 follicular/11 Hurthle. Grade 4-5 adverse events 
      (AEs) possibly related to the drug: grade 5, 1 sudden death; grade 4, 1 pulmonary 
      embolus. Twelve of 20 subjects had a reported adverse event. No RECIST major 
      responses have been seen. Response per protocol: stable disease, 13; disease 
      progression, 7. Restoration of RAI avidity was documented in two patients. Median 
      overall survival and time on study was 33.2 (1-71+) and 1.7 (0.46-12) months, 
      respectively. CONCLUSIONS: We observed preliminary signs of in vivo reversal of 
      RAI resistance after treatment with romidepsin. However, no major responses were 
      observed and accrual was poor after the grade 5 AE.
FAU - Sherman, Eric J
AU  - Sherman EJ
AD  - Department of Medicine, Memorial Sloan-Kettering Cancer Center , New York, NY 
      10065, USA. shermane@mskcc.org
FAU - Su, Yungpo Bernard
AU  - Su YB
FAU - Lyall, Ashima
AU  - Lyall A
FAU - Schoder, Heiko
AU  - Schoder H
FAU - Fury, Matthew G
AU  - Fury MG
FAU - Ghossein, Ronald A
AU  - Ghossein RA
FAU - Haque, Sofia
AU  - Haque S
FAU - Lisa, Donna
AU  - Lisa D
FAU - Shaha, Ashok R
AU  - Shaha AR
FAU - Tuttle, R Michael
AU  - Tuttle RM
FAU - Pfister, David G
AU  - Pfister DG
LA  - eng
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - N01 CM 62206/CM/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - Thyroid
JT  - Thyroid : official journal of the American Thyroid Association
JID - 9104317
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (Depsipeptides)
RN  - 0 (Histone Deacetylase Inhibitors)
RN  - 0 (Iodine Radioisotopes)
RN  - 0 (Radiopharmaceuticals)
RN  - CX3T89XQBK (romidepsin)
RN  - Thyroid cancer, Hurthle cell
SB  - IM
MH  - Adenoma, Oxyphilic
MH  - Adult
MH  - Aged
MH  - Antibiotics, Antineoplastic/adverse effects/*therapeutic use
MH  - Carcinoma/diagnostic imaging/*drug therapy/physiopathology/radiotherapy
MH  - Carcinoma, Papillary
MH  - Depsipeptides/adverse effects/*therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Histone Deacetylase Inhibitors/adverse effects/therapeutic use
MH  - Humans
MH  - *Iodine Radioisotopes/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Radiation Tolerance
MH  - Radionuclide Imaging
MH  - *Radiopharmaceuticals/therapeutic use
MH  - Survival Analysis
MH  - Thyroid Cancer, Papillary
MH  - Thyroid Gland/diagnostic imaging/*drug effects/physiopathology
MH  - Thyroid Neoplasms/diagnostic imaging/*drug therapy/physiopathology/radiotherapy
MH  - Whole Body Imaging
PMC - PMC3643228
EDAT- 2012/11/29 06:00
MHDA- 2013/11/15 06:00
PMCR- 2014/05/01
CRDT- 2012/11/29 06:00
PHST- 2012/11/29 06:00 [entrez]
PHST- 2012/11/29 06:00 [pubmed]
PHST- 2013/11/15 06:00 [medline]
PHST- 2014/05/01 00:00 [pmc-release]
AID - 10.1089/thy.2012.0393 [pii]
AID - 10.1089/thy.2012.0393 [doi]
PST - ppublish
SO  - Thyroid. 2013 May;23(5):593-9. doi: 10.1089/thy.2012.0393.