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Anlotinib for the Treatment of Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer
Yongkun Sun1, Feng Du2, Ming Gao3
11 Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China .
Background:
The prognosis of advanced or metastatic medullary thyroid carcinoma (MTC) is poor, and there are few therapeutic options. Anlotinib has previously shown promising antitumor activity on MTC in preclinical models and a Phase I study. This Phase II clinical trial was devised to confirm the antitumor activity of anlotinib in patients with advanced or metastatic MTC.
Methods:
Patients with unresectable locally advanced or metastatic MTC received once daily oral anlotinib 12 mg, two weeks on/one week off, until disease progression, death, unacceptable toxicity, or withdrawal of consent for any reason. The dose was adjusted on the basis of observed toxicity. The primary endpoint was progression-free survival (PFS).
Results:
Fifty-eight patients received anlotinib treatment. The primary endpoint PFS has not yet been reached at the time of analysis. On the basis of investigator assessments, 56.9% of patients experienced a partial response. PFS rate at 48 weeks was 85.5%. Forty-five patients had a ≥50% decrease in serum calcitonin concentration from baseline. The most common adverse events were hand-foot syndrome, hypertriglyceridemia, cholesterol elevation, fatigue, and proteinuria.
Conclusions:
Anlotinib demonstrated a durable antitumor activity with a manageable adverse event profile in locally advanced or metastatic MTC.
Insights
Anlotinib shows promising results for advanced medullary thyroid carcinoma (MTC). This Phase II trial indicates durable antitumor activity and a manageable safety profile for patients with metastatic MTC.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Medullary thyroid carcinoma (MTC) has a poor prognosis with limited treatment options for advanced or metastatic disease.
- Anlotinib has demonstrated potential antitumor effects in preclinical and Phase I studies for MTC.
- This Phase II trial aimed to validate anlotinib's efficacy in patients with advanced or metastatic MTC.
Purpose of the Study:
- To confirm the antitumor activity of anlotinib in patients with advanced or metastatic medullary thyroid carcinoma.
- To evaluate the progression-free survival (PFS) in patients treated with anlotinib.
- To assess the safety and tolerability of anlotinib in this patient population.
Main Methods:
- A Phase II clinical trial involving patients with unresectable locally advanced or metastatic MTC.
- Anlotinib was administered orally at 12 mg daily (2 weeks on/1 week off) until disease progression or unacceptable toxicity.
- The primary endpoint was progression-free survival (PFS), with dose adjustments based on toxicity.
Main Results:
- Fifty-eight patients were treated with anlotinib; PFS has not yet been reached.
- Investigator assessments showed a partial response in 56.9% of patients, with an 85.5% PFS rate at 48 weeks.
- Forty-five patients achieved a ≥50% decrease in serum calcitonin; common adverse events included hand-foot syndrome and hypertriglyceridemia.
Conclusions:
- Anlotinib exhibits durable antitumor activity in patients with advanced or metastatic medullary thyroid carcinoma.
- The drug presents a manageable adverse event profile, supporting its potential as a therapeutic option.
- Further investigation may solidify anlotinib's role in MTC treatment strategies.
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