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Published on: April 17, 2013
[Efficacy and safety of vandetanib on advanced medullary thyroid carcinoma: single center result from a phase Ⅲ
Abstract:
Objective: There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib,a novel multitargeted receptor tyrosine kinase inhibitor, has previously shown antitumor activity in phase Ⅱ studies of patients with advanced MTC. This study was to evaluate the efficacy and the safety of vandetanib on advanced MTC. Methods: This study was an open, international multi-center phase Ⅲ clinical trial and the study number was NCT01298323. The single-center study was a sub-group analysis of the international study, which was conducted on 9 pathologically confirmed advanced MTC patients by Cancer Hospital Chinese Academy of Medical Sciences between March 2012 and October 2017. Vandetanib (300 mg) was orally administered daily till death or withdrawal. The efficacy was evaluated according to RECIST criteria and the adverse events were evaluated according to NCI criteria. Results: The objective response rate was 3/9,and the disease control rate was 4/9. The median progression-free survival was 44 months. All patients who had the elevated levels of calcitonin (CTN) and carcino-embryonic antigen (CEA) before treatment began to show the decreases in the level of CTN and CEA after 3 months and later showed again the increases in the levels of both tumor markers with tumor progression. By ROC curve analysis, CTN was of statistically significance(P<0.05, 95%CI 0.558-0.834), but CEA was not(P>0.05). Adverse events were generally mild (grade 1 or 2),including hypertension (9 cases),skin rash (9 cases), and diarrhea (6 cases). Two patients developed grade 3 elevation of serum glutamate pyruvate transaminase and one patient developed grade 3 elevation of drug-related bowel disease. No grade 4 drug-related adverse event occurred. Conclusions: Vandetanib is effective and well tolerated for patients with locally advanced or metastatic MTC who have no chance for surgery. This indicates the increase of CTN is clinically relevant to disease progression, but the number of patients are extremely low, and, therefore further research is needed. Long-term use of vandetanib may cause resistance.
Insights
Vandetanib shows efficacy in treating advanced medullary thyroid carcinoma (MTC) by improving progression-free survival and controlling disease. While generally well-tolerated, further research is needed to address potential resistance.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced medullary thyroid carcinoma (MTC) lacks effective therapies.
- Vandetanib, a multitargeted receptor tyrosine kinase inhibitor, demonstrated antitumor activity in prior phase II studies for advanced MTC.
Purpose of the Study:
- To evaluate the efficacy and safety of vandetanib in patients with advanced MTC.
- To assess vandetanib's impact on tumor markers calcitonin (CTN) and carcinoembryonic antigen (CEA) in advanced MTC.
Main Methods:
- A single-center subgroup analysis of an international phase III clinical trial (NCT01298323) involving 9 advanced MTC patients.
- Daily oral administration of vandetanib (300 mg) until disease progression or withdrawal.
- Efficacy assessed by RECIST criteria; adverse events evaluated by NCI criteria.
Main Results:
- Objective response rate of 3/9; disease control rate of 4/9.
- Median progression-free survival of 44 months.
- Calcitonin (CTN) levels showed statistically significant decreases correlating with treatment response, unlike CEA. Common adverse events included hypertension, rash, and diarrhea; no grade 4 events occurred.
Conclusions:
- Vandetanib is an effective and well-tolerated treatment option for advanced or metastatic MTC patients ineligible for surgery.
- Rising CTN levels correlate with disease progression, though further research with larger cohorts is necessary due to the small sample size.
- Potential for long-term resistance to vandetanib warrants further investigation.
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