Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study.
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.
Prete
Salvatore Del
SD
Medical Oncology Unit, San Giovanni di Dio Hospital, Via Giovanni XXII, 80020, Frattaminore, Naples, Italy. saldelprete@yahoo.it
Montella
Liliana
L
Caraglia
Michele
M
Maiorino
Luigi
L
Cennamo
Gregorio
G
Montesarchio
Vincenzo
V
Piai
Guido
G
Febbraro
Antonio
A
Tarantino
Luciano
L
Capasso
Elena
E
Palmieri
Giovannella
G
Guarrasi
Rosario
R
Bianco
Maddalena
M
Mamone
Rosanna
R
Savastano
Clementina
C
Pisano
Agata
A
Vincenzi
Bruno
B
Sabia
Antonietta
A
D'Agostino
Alberto
A
Faiola
Vincenzo
V
Addeo
Raffaele
R
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
D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib; D015282:Octreotide