title: Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer.
abstract: BACKGROUND
  It is not known whether low-dose radioiodine (1.1 GBq [30 mCi]) is as effective as high-dose radioiodine (3.7 GBq [100 mCi]) for treating patients with differentiated thyroid cancer or whether the effects of radioiodine (especially at a low dose) are influenced by using either recombinant human thyrotropin (thyrotropin alfa) or thyroid hormone withdrawal.
  
  
  METHODS
  At 29 centers in the United Kingdom, we conducted a randomized noninferiority trial comparing low-dose and high-dose radioiodine, each in combination with either thyrotropin alfa or thyroid hormone withdrawal before ablation. Patients (age range, 16 to 80 years) had tumor stage T1 to T3, with possible spread to nearby lymph nodes but without metastasis. End points were the rate of success of ablation at 6 to 9 months, adverse events, quality of life, and length of hospital stay.
  
  
  RESULTS
  A total of 438 patients underwent randomization; data could be analyzed for 421. Ablation success rates were 85.0% in the group receiving low-dose radioiodine versus 88.9% in the group receiving the high dose and 87.1% in the thyrotropin alfa group versus 86.7% in the group undergoing thyroid hormone withdrawal. All 95% confidence intervals for the differences were within ±10 percentage points, indicating noninferiority. Similar results were found for low-dose radioiodine plus thyrotropin alfa (84.3%) versus high-dose radioiodine plus thyroid hormone withdrawal (87.6%) or high-dose radioiodine plus thyrotropin alfa (90.2%). More patients in the high-dose group than in the low-dose group were hospitalized for at least 3 days (36.3% vs. 13.0%, P<0.001). The proportions of patients with adverse events were 21% in the low-dose group versus 33% in the high-dose group (P=0.007) and 23% in the thyrotropin alfa group versus 30% in the group undergoing thyroid hormone withdrawal (P=0.11).
  
  
  CONCLUSIONS
  Low-dose radioiodine plus thyrotropin alfa was as effective as high-dose radioiodine, with a lower rate of adverse events. (Funded by Cancer Research UK; ClinicalTrials.gov number, NCT00415233.).
authors.affiliation: Northern Centre for Cancer Care, Freeman Hospital, Level 4, Freeman Rd., Newcastle upon Tyne, NE7 7DN United Kingdom. ujjal.mallick@nuth.nhs.uk
authors.forename: Ujjal
authors.initials: U
authors.lastname: Mallick
authors.forename: Clive
authors.initials: C
authors.lastname: Harmer
authors.forename: Beng
authors.initials: B
authors.lastname: Yap
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wadsley
authors.forename: Susan
authors.initials: S
authors.lastname: Clarke
authors.forename: Laura
authors.initials: L
authors.lastname: Moss
authors.forename: Alice
authors.initials: A
authors.lastname: Nicol
authors.forename: Penelope M
authors.initials: PM
authors.lastname: Clark
authors.forename: Kate
authors.initials: K
authors.lastname: Farnell
authors.forename: Ralph
authors.initials: R
authors.lastname: McCready
authors.forename: James
authors.initials: J
authors.lastname: Smellie
authors.forename: Jayne A
authors.initials: JA
authors.lastname: Franklyn
authors.forename: Rhys
authors.initials: R
authors.lastname: John
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Nutting
authors.forename: Kate
authors.initials: K
authors.lastname: Newbold
authors.forename: Catherine
authors.initials: C
authors.lastname: Lemon
authors.forename: Georgina
authors.initials: G
authors.lastname: Gerrard
authors.forename: Abdel
authors.initials: A
authors.lastname: Abdel-Hamid
authors.forename: John
authors.initials: J
authors.lastname: Hardman
authors.forename: Elena
authors.initials: E
authors.lastname: Macias
authors.forename: Tom
authors.initials: T
authors.lastname: Roques
authors.forename: Stephen
authors.initials: S
authors.lastname: Whitaker
authors.forename: Rengarajan
authors.initials: R
authors.lastname: Vijayan
authors.forename: Pablo
authors.initials: P
authors.lastname: Alvarez
authors.forename: Sandy
authors.initials: S
authors.lastname: Beare
authors.forename: Sharon
authors.initials: S
authors.lastname: Forsyth
authors.forename: Latha
authors.initials: L
authors.lastname: Kadalayil
authors.forename: Allan
authors.initials: A
authors.lastname: Hackshaw
mesh_terms: D055011:Ablation Techniques / Q000009:adverse effects / Q000523:psychology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007037:Hypothyroidism / Q000209:etiology; D007457:Iodine Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011879:Radiotherapy Dosage; D013963:Thyroid Hormones / Q000097:blood / Q000627:therapeutic use; D013964:Thyroid Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D013965:Thyroidectomy; D057073:Thyrotropin Alfa / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007457:Iodine Radioisotopes; D013963:Thyroid Hormones; D057073:Thyrotropin Alfa