PMID- 21404570
OWN - NLM
STAT- MEDLINE
DCOM- 20110628
LR  - 20221207
IS  - 0022-7854 (Print)
IS  - 0022-7854 (Linking)
VI  - 47
IP  - 4
DP  - 2010 Nov
TI  - [Assessment of the efficacy, safety and pharmacokinetics of SKG-02 (recombinant 
      human TSH) in postoperative diagnosis of well-differentiated thyroid cancer--a 
      Japanese prospective, controlled, multicenter open-label study].
PG  - 479-96
AB  - OBJECTIVE: This study sought to assess the safety, efficacy, impact on 
      hypothyroid symptoms, and pharmacokinetics of SKG-02 (rhTSH, thyrotropin alfa) in 
      the diagnostic follow-up of Japanese patients with well-differentiated thyroid 
      carcinoma (WDTC). METHODS: Ten Japanese adults with WDTC were enrolled into a 
      prospective, multicenter, open-label trial comparing diagnostic whole-body 
      scintigraphy (dxWBS) and serum thyroglobulin (Tg) testing aided by SKG-02 versus 
      these procedures aided by thyroid hormone withdrawal (THW). Patients were their 
      own controls. Variables compared included scan set ability to detect radioiodine 
      uptake by remnant or malignant thyroid tissue, scan set quality, diagnostic 
      sensitivity of dxWBS and Tg testing alone or combined, frequency of hypothyroid 
      signs/symptoms, and adverse events (AEs). SKG-02 pharmacokinetic variables 
      including maximum concentration (Cmax), time to Cmax (Tmax) and the area under 
      the time-concentration curve (AUC) were calculated. RESULTS: In a blinded 
      evaluation by an independent committee of 3 nuclear medicine experts, 70% of 
      SKG-02 dxWBS scan sets were rated "equivalent" (n = 7) or "superior" (n = 0) to 
      their THW counterparts in ability to detect radioiodine uptake in healthy or 
      malignant thyroid tissue. Therefore the study exceeded its primary endpoint of a 
      60% equivalence/superiority rate. SKG-02 Tg testing identified 3/3 cases of 
      disease. Hypothyroid signs/symptoms were substantially more frequent during THW 
      than during euthyroidism permitted by SKG-02 use. SKG-02 was well-tolerated, with 
      no severe or serious drug-related AEs. Cmax was 240.8 +/- 65.9 microIU/ml, Tmax 
      was 28.75 +/- 14.21 hr after the first SKG-02 injection, and AUC was 11,414 +/- 
      3,462 microIU hr/ml in 9 patients evaluable for pharmacokinetics. CONCLUSIONS: 
      SKG-02 was safe and effective in the diagnostic follow-up of Japanese patients 
      with WDTC, avoiding hypothyroid morbidity relative to THW. These and the 
      pharmacokinetic findings were similar to those of overseas Phase III studies.
FAU - Konishi, Junji
AU  - Konishi J
AD  - Sugita Genpaku Memorial Obama Municipal Hospital.
FAU - Tamaki, Nagara
AU  - Tamaki N
FAU - Nakada, Kunihiro
AU  - Nakada K
FAU - Kusakabe, Kiyoko
AU  - Kusakabe K
FAU - Maki, Masako
AU  - Maki M
FAU - Kanbe, Masako
AU  - Kanbe M
FAU - Higashi, Tatsuya
AU  - Higashi T
FAU - Endo, Keigo
AU  - Endo K
FAU - Ikekubo, Katsuji
AU  - Ikekubo K
FAU - Yokoyama, Kunihiko
AU  - Yokoyama K
FAU - Kubo, Atsushi
AU  - Kubo A
FAU - Ishikawa, Naofumi
AU  - Ishikawa N
LA  - jpn
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - Japan
TA  - Kaku Igaku
JT  - Kaku igaku. The Japanese journal of nuclear medicine
JID - 2985202R
RN  - 0 (Iodine Radioisotopes)
RN  - 0 (Thyrotropin Alfa)
RN  - 9010-34-8 (Thyroglobulin)
SB  - IM
MH  - Aged
MH  - Asian People
MH  - Carcinoma/*diagnostic imaging
MH  - Female
MH  - Humans
MH  - Iodine Radioisotopes
MH  - Male
MH  - Middle Aged
MH  - Postoperative Period
MH  - Prospective Studies
MH  - Radionuclide Imaging
MH  - Thyroglobulin/blood
MH  - Thyroid Neoplasms/*diagnostic imaging
MH  - Thyroidectomy
MH  - Thyrotropin Alfa/pharmacokinetics/*pharmacology
MH  - Whole Body Imaging
EDAT- 2011/03/17 06:00
MHDA- 2011/06/29 06:00
CRDT- 2011/03/17 06:00
PHST- 2011/03/17 06:00 [entrez]
PHST- 2011/03/17 06:00 [pubmed]
PHST- 2011/06/29 06:00 [medline]
PST - ppublish
SO  - Kaku Igaku. 2010 Nov;47(4):479-96.