Sequential therapy with anlotinib and radioiodine for distant metastatic differentiated thyroid cancer: a phase II clinical trial.
Hongjun Song, Chentian Shen, Youben Fan et al.
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In 30 seconds
This prospective, single-arm phase II trial evaluated sequential anlotinib and radioiodine (RAI) in patients with measurable distant metastatic differentiated thyroid cancer (DTC). Of 24 enrolled patients, 10 with RAI-avid target lesions received treatment; 14 were excluded because their lesions were not RAI-avid. Among treated patients, the objective response rate was 60%, with all responses partial, and the disease control rate was 100%. At a median follow-up of 34.5 months, no progression or deaths were reported. The findings are promising but hypothesis-generating and require randomized comparison with RAI alone.
Key findings
- Only 10 of 24 enrolled patients received sequential therapy; 14 were excluded because target lesions were not RAI-avid.
- Among treated patients, objective response rate was 60% (all partial responses) and disease control rate was 100%.
- At median follow-up of 34.5 months, no disease progression or death occurred.
- Grade 3 anlotinib-related adverse events occurred in 30%; no grade 4/5 toxicities or grade ≥2 RAI-related events were observed.
Why it matters
RAI alone has limited efficacy in distant metastatic DTC, and this trial suggests that anlotinib pretreatment followed by RAI may have antitumor activity in patients whose lesions are RAI-avid. The results also highlight an important selection constraint: most enrolled patients did not have RAI-avid target lesions and therefore did not receive the sequential regimen.
What to keep in mind
The trial was single-arm, and only 10 patients received sequential therapy. The authors state that the findings are hypothesis-generating and require validation against RAI monotherapy in a randomized trial.