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Published on: April 22, 2019
A phase II study evaluating axitinib in patients with unresectable, recurrent or metastatic head and neck cancer
Paul L Swiecicki1, Lili Zhao2, Emily Belile2
1University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA. pswiecic@med.umich.edu.
Background:
Axitinib is an oral, potent, small molecule tyrosine kinase inhibitor with selective inhibition of VEGFR 1,2, 3, as well as inhibition of potential downstream effectors of the EGFR pathway. Given the upregulation of EGFR and VEGFR in head and neck squamous cell carcinoma, treatment with axitinib holds promise as a rational targeted therapy.
Patients And Methods:
Patients with unresectable, recurrent or metastatic head and neck squamous cell carcinoma were included in this open label, single arm, phase II trial. Primary endpoint was 6 month progression free survival. All patients received single agent axitinib with planned dose escalation based on tolerability. A planned interim efficacy analysis was performed after enrollment of 30 patients.
Results:
Forty-two patients were registered, 30 were evaluable. While treatment was well-tolerated with no severe bleeding events, only 19 patients were able to achieve full planned dose. The best overall response rate was 6.7% (two partial responses) with a disease control rate of 76.7%. Median progression free survival was 3.7 months (95% Confidence Interval (CI): 3.5-5.7) and overall survival was 10.9 months (95% CI: 6.4-17.8). Exploratory analysis demonstrated that patients with a smaller sum of diameter of target lesions experienced improved response rates, and better progression-free and overall survival.
Conclusion:
Treatment with single agent axitinib should be considered due to acceptable toxicity profile and favorable median overall survival compared to standard therapies.
Insights
Axitinib shows promise for head and neck cancer, offering acceptable toxicity and improved survival. Further research into targeted therapies like axitinib is warranted for this patient population.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Axitinib is a tyrosine kinase inhibitor targeting VEGFR and EGFR pathways.
- EGFR and VEGFR are upregulated in head and neck squamous cell carcinoma (HNSCC).
- Axitinib presents a rational targeted therapy approach for HNSCC.
Purpose of the Study:
- To evaluate the efficacy and safety of single-agent axitinib in patients with unresectable, recurrent, or metastatic HNSCC.
- To determine the 6-month progression-free survival as the primary endpoint.
Main Methods:
- Open-label, single-arm, Phase II clinical trial.
- 30 evaluable patients with HNSCC received single-agent axitinib.
- Dose escalation was based on tolerability; interim analysis after 30 patients.
Main Results:
- Median progression-free survival was 3.7 months; median overall survival was 10.9 months.
- Best overall response rate was 6.7% with a disease control rate of 76.7%.
- Exploratory analysis indicated improved outcomes for patients with smaller target lesion diameters.
Conclusions:
- Single-agent axitinib demonstrates an acceptable toxicity profile in HNSCC.
- Favorable median overall survival suggests axitinib as a potential treatment option compared to standard therapies.
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