title: Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study.
abstract: OBJECTIVE
  Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity.
  
  
  METHODS
  Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days.
  
  
  RESULTS
  All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities.
  
  
  CONCLUSIONS
  Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.
authors.affiliation: Medical Oncology Unit, San Giovanni di Dio Hospital, Via Giovanni XXII, 80020, Frattaminore, Naples, Italy. saldelprete@yahoo.it
authors.forename: Salvatore Del
authors.initials: SD
authors.lastname: Prete
authors.forename: Liliana
authors.initials: L
authors.lastname: Montella
authors.forename: Michele
authors.initials: M
authors.lastname: Caraglia
authors.forename: Luigi
authors.initials: L
authors.lastname: Maiorino
authors.forename: Gregorio
authors.initials: G
authors.lastname: Cennamo
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Montesarchio
authors.forename: Guido
authors.initials: G
authors.lastname: Piai
authors.forename: Antonio
authors.initials: A
authors.lastname: Febbraro
authors.forename: Luciano
authors.initials: L
authors.lastname: Tarantino
authors.forename: Elena
authors.initials: E
authors.lastname: Capasso
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Rosario
authors.initials: R
authors.lastname: Guarrasi
authors.forename: Maddalena
authors.initials: M
authors.lastname: Bianco
authors.forename: Rosanna
authors.initials: R
authors.lastname: Mamone
authors.forename: Clementina
authors.initials: C
authors.lastname: Savastano
authors.forename: Agata
authors.initials: A
authors.lastname: Pisano
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Antonietta
authors.initials: A
authors.lastname: Sabia
authors.forename: Alberto
authors.initials: A
authors.lastname: D'Agostino
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Faiola
authors.forename: Raffaele
authors.initials: R
authors.lastname: Addeo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000008:administration & dosage; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000503:physiopathology; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D015282:Octreotide / Q000008:administration & dosage; D010671:Phenylurea Compounds; D011725:Pyridines / Q000008:administration & dosage; D000077157:Sorafenib; D013534:Survival; D016896:Treatment Outcome
chemical_list: D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib; D015282:Octreotide