Poster Presentations

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

SORAFENIB PLUS OCTREOTIDE IN ADVANCED HEPATOCELLULAR CARCINOMA: UPDATED RESULTS OF A MULTICENTER STUDY

S. Del Prete¹, R. Addeo¹, M. Caraglia², L. Maiorino³, V. Montesarchio⁴, G. Cennamo¹, R. Guarrasi¹, V. Faiola¹, L. Leo⁵, A. Febbraro⁶, B. Vincenzi⁷, C. Savastano⁸, L. Tarantino⁹, A. Sabia¹⁰, E. Capasso¹¹, G. Palmieri¹², A. Giorgio¹³, M. Bianco¹⁴, L. Montella^1
1Medical Oncology, 'San Giovanni di Dio' Hospital, Frattaminore, ²Department of Biochemistry and Biophysics, Second University of Naples, ³“San Gennaro” Hospital, ⁴“Cotugno” Hospital, Naples, ⁵Piedimonte Matese, Caserta, ⁶Medical Oncology, Fatebenefratelli, Benevento, ⁷Medical Oncology Campus Biomedico, Rome, ⁸Medical Oncology “Ruggi d'Aragona” Hospital, Salerno, ⁹Hepatology and Interventional Ultrasound Unit, 'San Giovanni di Dio' Hospital, Frattaminore, ¹⁰Medical Oncology Unit, “S.Maria della Pietà”, Nola, ¹¹Senology Unit, ASL NA3, Arzano, ¹²Department of Molecular and Clinical Endocrinology & Oncology, University “Federico II”, ¹³UO di Ecografia Interventistica IX Divisione, “Cotugno” Hospital, Naples, ¹⁴Medical Oncology, ASL NA5, Castellammare di Stabia, Italy

Background and aims: Advanced hepatocellular carcinoma (HCC) not amenable to local therapies has limited chances of cure and has a poor prognosis. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is already used in this setting with conflicting but usually interesting results. An original schedule with sorafenib and long-acting octreotide was tested in advanced HCC patients enrolled to evaluate safety and activity of this combination.
Methods: Patients with advanced HCC not amenable to local therapies, Child-Pugh A or B, received sorafenib at the dose of 800 mg/day continuous dosing for 28 days followed by one week of rest, and long acting octreotide at the dose of 40 mg monthly administered. Cycles were repeated until progression or unacceptable toxicity. The disease-control rate was defined as the percentage of patients who had a best-response rating of complete response, partial response, or stable disease (according to RECIST criteria) lasting for at least 28 days after the first appearance on the basis of independent radiologic review.
Results: At November 1^st, 2008, 87 patients have been screened and 77 have been enrolled. At this date, 43 patients were considered evaluable (sex: 36M/7F; age range: 50-82 years; HCV: 28 pts, HBV: 10 pts, HCV+HBV:1 pt; unknown etiology: 4; Child A/B: 34/9, BCLC B/C:17/26). Sixteen patients out of 43 (37%) were naïve from other therapies, while the remaining had been previously treated with local and/or systemic treatments. We registered 1 partial response (2.3%), 32 stable diseases (74%) and 11 progressions (23.7%). Median time to progression (TTP) was 7.0 months (95% CI, 3.0-10.9 months) while the median overall survival was not yet reached. Mean overall survival was 9.9 months (95% CI, 8.2 to 11.6 months). Treatment was generally well tolerated. Grade 3/4 toxicities observed were diarrhoea and hypertension in 4.6% of treated patients, hand-foot syndrome and proctalgia in 2.3% of patients.
Conclusions: Sorafenib plus octreotide appears a feasible option in advanced HCC patients. In the attempt to improve the results obtained with sorafenib alone, this association deserves further investigations in the context of randomized studies.