Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer

被引：474

作者：

Schlumberger, Martin ^{[1
,2
,3
]}

Catargi, Bogdan ^{[6
]}

Borget, Isabelle ^{[4
,5
]}

Deandreis, Desiree ^{[1
,2
,3
]}

Zerdoud, Slimane ^{[8
]}

Bridji, Boumediene ^{[9
]}

Bardet, Stephane ^{[10
]}

Leenhardt, Laurence ^{[11
]}

Bastie, Delphine ^{[13
]}

Schvartz, Claire ^{[14
]}

Vera, Pierre ^{[15
]}

Morel, Olivier ^{[16
]}

Benisvy, Danielle ^{[17
]}

Bournaud, Claire ^{[18
]}

Bonichon, Francoise ^{[7
]}

Dejax, Catherine ^{[19
]}

Toubert, Marie-Elisabeth ^{[12
]}

Leboulleux, Sophie ^{[1
,2
,3
]}

Ricard, Marcel ^{[1
,2
,3
]}

Benhamou, Ellen ^{[4
,5
]}

机构：

[1] Inst Gustave Roussy, Dept Nucl Med, Villejuif, France

[2] Inst Gustave Roussy, Dept Endocrine Oncol, Villejuif, France

[3] Univ Paris 11, Villejuif, France

[4] Inst Gustave Roussy, Dept Biostat, Villejuif, France

[5] Inst Gustave Roussy, Dept Epidemiol, Villejuif, France

[6] CHU, Dept Endocrinol, Bordeaux, France

[7] Inst Bergonie, Dept Nucl Med, Bordeaux, France

[8] Ctr Claudius Regaud, Dept Nucl Med, Toulouse, France

[9] Ctr Rene Gauducheau, Dept Nucl Med, F-44035 Nantes, France

[10] Ctr Francois Baclesse, Dept Nucl Med, F-14021 Caen, France

[11] Hop La Pitie Salpetriere, Dept Endocrinol, Paris, France

[12] Hop St Louis, Dept Nucl Med, Paris, France

[13] CHU, Dept Nucl Med, Toulouse, France

[14] Inst Jean Godinot, Dept Nucl Med, Reims, France

[15] Ctr Henri Becquerel, Dept Nucl Med, F-76038 Rouen, France

[16] Inst Cancerol Ouest Paul Papin, Dept Nucl Med, Angers, France

[17] Ctr Antoine Lacassagne, Dept Nucl Med, F-06054 Nice, France

[18] CHU, Dept Endocrinol, Lyon, France

[19] Ctr Jean Perrin, Dept Nucl Med, Clermont Ferrand, France

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2012年 / 366卷 / 18期

关键词：

RECOMBINANT HUMAN THYROTROPIN; SERUM THYROGLOBULIN LEVELS; QUALITY-OF-LIFE; REMNANT ABLATION; HORMONE WITHDRAWAL; STIMULATED THYROGLOBULIN; RADIOACTIVE IODINE; FOLLOW-UP; CARCINOMA PATIENTS; PREDICTIVE-VALUE;

D O I：

10.1056/NEJMoa1108586

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background It is not clear whether the administration of radioiodine provides any benefit to patients with low-risk thyroid cancer after a complete surgical resection. The administration of the smallest possible amount of radioiodine would improve care. Methods In our randomized, phase 3 trial, we compared two thyrotropin-stimulation methods (thyroid hormone withdrawal and use of recombinant human thyrotropin) and two radioiodine (I-131) doses (i.e., administered activities) (1.1 GBq and 3.7 GBq) in a 2-by-2 design. Inclusion criteria were an age of 18 years or older; total thyroidectomy for differentiated thyroid carcinoma; tumor-node-metastasis (TNM) stage, ascertained on pathological examination (p) of a surgical specimen, of pT1 (with tumor diameter <= 1 cm) and N1 or Nx, pT1 (with tumor diameter >1 to 2 cm) and any N stage, or pT2N0; absence of distant metastasis; and no iodine contamination. Thyroid ablation was assessed 8 months after radioiodine administration by neck ultrasonography and measurement of recombinant human thyrotropin-stimulated thyroglobulin. Comparisons were based on an equivalence framework. Results There were 752 patients enrolled between 2007 and 2010; 92% had papillary cancer. There were no unexpected serious adverse events. In the 684 patients with data that could be evaluated, ultrasonography of the neck was normal in 652 (95%), and the stimulated thyroglobulin level was 1.0 ng per milliliter or less in 621 of the 652 patients (95%) without detectable thyroglobulin antibodies. Thyroid ablation was complete in 631 of the 684 patients (92%). The ablation rate was equivalent between the I-131 doses and between the thyrotropin-stimulation methods. Conclusions The use of recombinant human thyrotropin and low-dose (1.1 GBq) postoperative radioiodine ablation may be sufficient for the management of low-risk thyroid cancer. (Funded by the French National Cancer Institute [INCa] and the French Ministry of Health; ClinicalTrials.gov number, NCT00435851; INCa number, RECF0447.)

引用

页码：1663 / 1673

页数：11