Poster Presentations

Session Title: LIVER TUMORS b) CLINICAL (EPIDEMIOLOGY, DIAGNOSIS, MANAGEMENT)
Presentation Date: Apr 25, 2009

SKIN TOXICITY AS A PREDICTIVE FACTOR FOR TUMOR CONTROL IN ADVANCED HCC PATIENTS TREATED WITH SORAFENIB

B. Vincenzi¹, D. Santini¹, A. Frezza¹, L. Montella², R. Addeo², S. Del Prete², G. Tonini^1
1Medical Oncology, University Campus Bio-Medico, Rome, ²Medical Oncology, San Giovanni di Dio Hospital, Frattaminore, Italy

Introduction: Sorafenib (Nexavar®), an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, has recently been proved to increase median survival and time to progression in patients with advanced HCC. Skin rash represents one of the most common sorafenib associated side effects, occurring in almost 8% of treated patients. This study was conducted to assess the link between the antitumour efficacy of sorafenib and cutaneous side-effects: a confirm of this connection could lead to the identification of an important predictive factor for tumour control in patients with advanced HCC.
Materials and methods: We retrospectively analysed the incidence of skin toxicity (rash and hand and foot syndrome) as defined by NCI-CTC v3.0 grading criteria. All patients received 400 mg of sorafenib and treatment continued until the occurrence of radiologic progression as defined by RECIST criteria or the occurrence of either unacceptable adverse events or death. We compared tumor control rate (partial response + stable disease) and PFS in patients who developed at least Grade 1 rash or hand and foot syndrome. Until now, the data of OS are not still mature.
Results: We included in this analysis 46 HCC patients treated with sorafenib monotherapy. 29 patients (63%) received sorafenib after failure of other systemic treatment, while 17 (37%) received it as first line. In 31 (67%) patients HCC was limited to the liver and in 15 (33%) the tumor was diffuse to other organs. Moreover, 70% of patients showed an increase alpha-fetoprotein circulating levels vs 30% of patients who did not. All patients were classified as Child A and B. In patients who developed skin toxicity the tumor control rate as 80% vs 47.7% in patients without (P=0.03). Median PFS was 7 months (95% C.I.: 4.5-8.6) in the group of patients with skin toxicity vs 3.2 months (95% C.I.: 2.1-4.1) in patients who did not developed skin toxicity (P=0.003).
Conclusions: The present results suggest that skin toxicity should be closely monitored in HCC patients treated with sorafenib also in relation with its potential role as predictive factor of efficacy.