Cutaneous squamous cell carcinoma and inflammation of actinic keratoses associated with sorafenib: A single institution experience

Abstract

16101 Background: Sorafenib-induced dermatologic toxicity is common and consists primarily of dry skin, maculopapular rash, hand/foot skin reaction, and alopecia. Cutaneous squamous cell carcinoma (SCC) and inflammation of actinic keratosis (AK) were reported in two patients treated with sorafenib (Lacouture et al), but the scope of this observation has not been evaluated. Methods: We reviewed medical records of 131 patients treated with single-agent sorafenib for metastatic renal cell carcinoma (MRCC) at our institution from June 1st, 2005 through April 4, 2007. Results: Seven cases of cutaneous SCC, 2 cases of SCC- (keratoacanthoma) type, 2 cases of focal squamous atypia, and 3 cases of AKs were identified. The median time to development of SCC or AK from the start of sorafenib was 23 weeks (range 4–183). One patient discontinued therapy altogether due to dermatological toxicity, whereas 7 patients discontinued drug due to disease progression and 2 discontinued sorafenib for non-dermatological toxicity. Four patients continue taking sorafenib at reduced doses for non-dermatological toxicity, such as diarrhea and fatigue. One patient, who is still on the drug at a 25% dose reduction developed a second invasive SCC lesion on his forearm six months following the initial resection. Conclusions: These data suggest that there may be an association between sorafenib therapy and the development of cutaneous SCC and inflammation of AK. This adverse event has important therapeutic implications. Full appraisal of this observation in prospective studies is warranted. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer, Pfizer Oncology, Wyeth Bayer, Pfizer Oncology Hoffman-La Roche, Lilly Oncology, Pfizer Oncology