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Published on: April 22, 2019
A Phase II study of SU5416 in patients with advanced or recurrent head and neck cancers
Matthew G Fury1, Andrew Zahalsky, Richard Wong
1Head and Neck Medical Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Background:
SU5416 (semaxanib) is a synthetic small molecule inhibitor of the tyrosine kinase domain of vascular endothelial growth factor receptor 2 (VEGFR2). This Phase II study was conducted to determine the safety and efficacy of SU5416 in patients with recurrent or metastatic head and neck cancers.
Patients And Methods:
This was an open label, single arm, Phase 2 study for patients who had received no more than 2 cytotoxic regimens. Thirty-five patients received intravenous SU5416 (145 mg/m(2)) twice per week by intravenous catheter. Radiologic imaging for response assessment was planned at the conclusion of each 8 week cycle. Serum VEGF levels and power Doppler ultrasound tumor imaging were explored as potential surrogate markers for SU5416 activity.
Results:
Thirty-two patients had received prior radiotherapy, including 18 patients who received prior concurrent chemoradiotherapy. Twelve patients had received prior chemotherapy in the recurrent disease setting. Thirty-one patients were evaluable for response. There was one partial response and one minor response. The median number of 8-week cycles received was 1 (range 1-4). Median overall survival was 6.25 months. The most common > or = grade 3 toxicity was headache (31%). There was one fatal carotid artery hemorrhage. Fatigue, nausea, and vomiting were common grade 1-2 adverse events. Power Doppler ultrasound demonstrated decreased tumor vascularity in 5 of 7 patients.
Conclusions:
Treatment with SU5416 in patients with head and neck cancers is feasible, but objective responses are rare. Studies evaluating more potent anti-angiogenic agents in this disease are of interest.
Insights
SU5416 (semaxanib) showed feasibility in head and neck cancer patients but yielded rare objective responses. Further research into potent anti-angiogenic agents is recommended for this patient group.
Area of Science:
- Oncology
- Pharmacology
Background:
- SU5416 (semaxanib) is a novel small molecule inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR2).
- Recurrent or metastatic head and neck cancers represent a challenging clinical scenario with limited treatment options.
Purpose of the Study:
- To evaluate the safety and efficacy of SU5416 in patients with recurrent or metastatic head and neck cancers.
- To assess SU5416's potential as an anti-angiogenic therapy in this patient population.
Main Methods:
- An open-label, single-arm, Phase 2 study involving 35 patients with advanced head and neck cancer.
- Patients received intravenous SU5416 (145 mg/m²) twice weekly.
- Radiologic imaging, serum VEGF levels, and power Doppler ultrasound were used for response assessment and surrogate marker exploration.
Main Results:
- Thirty-one patients were evaluable for response, with one partial and one minor response observed.
- Median overall survival was 6.25 months; the most common grade ≥3 toxicity was headache (31%).
- Power Doppler ultrasound indicated decreased tumor vascularity in 5 of 7 patients, suggesting anti-angiogenic activity.
Conclusions:
- Treatment with SU5416 is feasible in head and neck cancer patients, though objective responses are infrequent.
- The study highlights the need for more potent anti-angiogenic agents in managing advanced head and neck cancers.
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