Currently, investigators are looking at additional uses for sorafenib. One published phase II study involving 37 patients with advanced melanoma found little or no antitumor activity with 400 mg b.i.d. sorafenib monotherapy (Brit. J. Cancer 2006;95:581–6), and a manufacturer-funded, phase II randomized trial of sorafenib or placebo in combination with carboplatin and paclitaxel as second-line therapy in 277 patients with advanced melanoma failed to reach its primary end point of progression-free survival.
Bayer and Onyx, however, are continuing to investigate the drug's use in melanoma. An ongoing phase II study using sorafenib in combination with dacarbazine as first-line therapy has thus far shown a 50% improvement in progression-free survival, Onyx spokesperson Julie Wood said in an interview.
At the same time, at least two other externally sponsored phase II studies are also looking at combination therapy with sorafenib in treating melanoma. Other trials are investigating its use for liver, lung, and breast cancer, she said.
In any case, Dr. Heald noted, “As use of this drug spreads out from renal cell carcinoma, we'll be seeing more and more hand-foot syndrome.”
'If you haven't seen this, I can tell you it's coming to a patient near you as the use of this drug picks up.' DR. HEALD
Grade 2 hand-foot syndrome, causing peeling on the plantar surface, is shown on a man who took sorafenib for 2 months.
Grade 3 syndrome appeared as hemorrhagic, pustular acral lesions on the hands of this patient who needed a lower dose. Photos courtesy Dr. Peter W. Heald