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See Latest ArticlesA phase II study of sunitinib in patients with recurrent and/or metastatic non-nasopharyngeal head and neck cancer
Cancer Chemotherapy and Pharmacology, 08/13/09
Fountzilas G et al. - In a study to evaluate the activity and safety of sunitinib in pts with recurrent and/or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN), it was shown that sunitinib monotherapy was not proven active in RM-SCCHN, and no further development of the drug in this indication is warranted.
Methods- 17 pts were treated with sunitinib 50 mg per day administrated in 4-wk cycles followed by a rest period of 2 wks.
- Sunitinib and SU012662 plasma levels were determined based on a validated liquid chromatography-tandem mass spectrometry method and pharmacokinetic data were fitted in a non-compartmental analysis.
- 28 6-wk cycles of treatment with sunitinib were administered (median, 2 cycles).
- Only 3 pts demonstrated stabilization of the disease; thus, the study had to be terminated prematurely due to futility.
- Grade 3 toxicities, apart from fatigue, were infrequent.
- Other frequently reported side effects were skin discoloration, neutropenia, and thrombocytopenia.
- 10 various bleeding complications were reported in 7 pts.
- Mean maximum concentrations (C max) were reached during the first day of treatment for sunitinib at 38.98 (±22.66) ng/ml and for SU012662 at 11.12 (±24.57) ng/ml.
- SU012662 has a longer half-life and a larger volume of distribution than the parent drug sunitinib.
- None of the biological markers tested was of any prognostic value.
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