Article

Ablation with Low-Dose Radioiodine and Thyrotropin Alfa in Thyroid Cancer

Northern Centre for Cancer Care, Freeman Hospital, Level 4, Freeman Rd., Newcastle upon Tyne, NE7 7DN United Kingdom.
New England Journal of Medicine (Impact Factor: 54.42). 05/2012; 366(18):1674-85. DOI: 10.1056/NEJMoa1109589
Source: PubMed

ABSTRACT 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.
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.
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).
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.).

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    • "While patients can benefit from high activities through the ablation of the large thyroid remnants after complete thyroidectomy and by the eradication of micro-metastases, the treatment presents several possible side effects, such as salivary gland disorder or induction of a second cancer. During a recent clinical phase 3-trial (HiLo), two different activities (1.1 GBq and 3.7 GBq) were administered to low-risk (T 1 M 0 to T 3 M 0 , according to the TNM** staging system, with possible spread to nearby lymph nodes) thyroid cancer patients (Mallick et al. 2012), concluding that low-activity radiodine administration plus thyroyropin alfa was as effective as high activity administration , presenting a lower rate of immediate adverse effects. Under these considerations, two different sets of patients were studied: patients with T 1 N 0 M 0 and T 2 N 0 M 0 treated with 1.85 GBq, and patients with T 3 , T 4 , N 1 or M 1 were treated with 3.7 GBq. "
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    • "The trials were designed to compare the efficacies of rhTSH and THW prior to RRA. Two studies (5, 11) included patients treated with high RRA doses (3.7 GBq), two studies (7, 12) with low RRA doses (1.1 or 2 GBq), and two studies (13, 14) with low (1.1 GBq) and high (3.7 GBq) RRA doses. Follow-up with stimulated Tg, 131I-WBS, or ultrasonography (US) was performed 6 to 12 months after RRA. "
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    • "Les recommandations actuelles plaident en faveur de l'administration d'une activité d'iode 131 adaptée au but recherché et d'une utilisation adaptée aux facteurs pronostiques, comme préconisé il y a plusieurs décennies par Maurice Tubiana. L'activité administrée pour l'ablation chez les patients à faible risque a été déterminée par deux études randomisées sur de grandes séries de patients qui ont montré l'équivalence en termes d'efficacité pour l'ablation de l'administration de 1,1 GBq et de 3,7 GBq, d'une part, et de la préparation par rhTSH et par sevrage prolongé en hormone thyroïdienne, d'autre part [11] [12]. L'administration de 1,1 GBq après rhTSH est donc devenue un standard thérapeutique chez ces patients après thyroïdectomie totale : il n'y a pas d'hypothyroïdie et la qualité de vie est maintenue, la toxicité salivaire est moindre, la dose délivrée à l'organisme est environ 5 fois plus faible que celle délivrée par le protocole utilisé jusque-là (3,7 GBq après sevrage prolongé), la durée d'hospitalisation peut être raccourcie et le coût n'est pas plus élevé. "
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