SORAFENIB TREATMENT FOR HEPATOCELLULAR CARCINOMA (HCC) IN PATIENTS WITH DIFFERENT PROFILE THAN SHARP: RESULTS IN TWO BRAZILIAN CENTERS ROGÉRIO ALVES,*,** DANIELE ALVES,* BETTY GUZZ,* RENATA MOUTINHO,* OTAVIO GAMPEL,* PAULA POLETTI* *HSPE, HOSPITAL DO SERVIDOR PUBLICO ESTADUAL.** AC CAMARGO, HOSPITAL AC CAMARGO. Hepatocellular carcinoma is a challenge to physicians, because the tumor arises from cirrhosis and the patient has 2 diseases and it is the most important cause of death in patients with liver cirrhosis. For patients with intermediate stage there were few options of treatment until the published results of Sharp study in July 2008. Eligible intermediate-advanced (according to Barcelona Cancer Liver Classification) Hcc patients from two Brazilian hepatology centers were prospectively followed up since the treatment start to evaluate safety of sorafenib in all Child’s subgroups. From May 2008, 37 patients initiated sorafenib 800 mg daily doses, 33 used more than 1 month and were recruited to data analysis on March 2010, regarding etiology of cirrhosis, treatment intervals, adverse events, response rates, and Child’s classification. The cirrhosis etiology of the 33 patients (25 men and 8 women), 62,03 years medium age were 51,54% hepatitis C, 15.1% cryptogenic cirrhosis and 9.0 % with hepatitis B and N.A.S.H each; 33.3% had A and 66.7% B or C Child’s classification (17 patients B and 4 C); the median treatment interval of sorafenib was 6,45 months (1-26 months) in all Child subgroups; The overall response rate was 66%: 53 % had stable disease and 13 % had partial response with tumor shrinkage by Recist criteria. Interestingly, some partial responses were more common on Child’s B or C subgroups, although this study was not designed for this evaluation. Adverse events were related in 48% of the patients and 5 of them needed to stop treatment. The common adverse events were diarrhea: 70.5%, nausea and vomiting: 44.2%, abdominal pain: 41.5%, hand-foot syndrome 18.1% and arterial hypertension 9%. The incidence of adverse events didn’t differ considering each Child’s subgroup. Our results demonstrated treatment safety of sorafenib within Hcc patients with more advanced liver disease. In this study population, 70% of the patients had advanced liver disease (child B/C) and sorafenib was well tolerated (48% had adverse events) in all subgroups. In the Sharp study only child’s A patients were eligible and the incidence of adverse events was higher. Similar response rate trend also was observed suggesting that patients with more advanced liver disease should be considered for sorafenib treatment in future and confirmatory studies.
2010-07-19 | 1,087 visitas | Evalua este artículo 0 valoraciones
Vol. 9 Núm.3. Julio-Septiembre 2010 Pags. 310-324 Ann Hepatol 2010; 9(3)