Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study.
Pasireotide (SOM230) is a novel multireceptor-targeted somatostatin (sst) analog with high binding affinity for sst receptor subtype 1, 2, 3 (sst(1,2,3)) and sst(5). Because of this binding profile, pasireotide may offer symptom control in patients with neuroendocrine tumors (NETs) and carcinoid syndrome no longer responsive to octreotide LAR. This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR. Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved. Forty-four patients were evaluated for efficacy and 45 for tolerability. Pasireotide 600-900 μg s.c. bid effectively controlled the symptoms of diarrhea and flushing in 27% of patients. Evaluation of tumor response in 23 patients showed 13 with stable disease and ten with progressive disease at study end. The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity. Pasireotide 600-900 μg s.c. bid was effective and generally well tolerated in controlling the symptoms of carcinoid syndrome in 27% of patients with advanced NET refractory or resistant to octreotide LAR therapy.
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, USA. larry.kvols@moffitt.org
Larry K
LK
Kvols
Kjell E
KE
Oberg
Thomas M
TM
O'Dorisio
Pharis
P
Mohideen
Wouter W
WW
de Herder
Rudolf
R
Arnold
Ke
K
Hu
Yilong
Y
Zhang
Gareth
G
Hughes
Lowell
L
Anthony
Bertram
B
Wiedenmann
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003967:Diarrhea / Q000188:drug therapy*; D019008:Drug Resistance, Neoplasm; D005260:Female; D005483:Flushing / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000188:drug therapy*; D015282:Octreotide / Q000627:therapeutic use; D011788:Quality of Life; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D005765:Gastrointestinal Agents; D013004:Somatostatin; C517782:pasireotide; D015282:Octreotide