Gastrointestinal neuroendocrine tumors treated with high dose octreotide-LAR: A systematic literature review

Table 3 Safety of octreotide long-acting repeatable > 30 mg/mo

Ref.	Safety
Anthony et al[11] 2011	NA/NR (adverse events not broken down by SLAR dose); of 392 pts., 8.7% had hyperglycemia, 6.4% had cholelithiasis, 2.8% had cholecystitis, 2.3% had steatorrhea, and 1.5% had hypoglycemia, and 22% had ≥ 1 adverse event during SLAR use
Chadha et al[12] 2009	p 4129: “No treatment related toxicities were reported.”
Ferolla et al[14] 2012	p 329: “No additional toxicity was recorded for the schedule treatment with LAR 30 mg every 21 d when compared with standard LAR dose and no treatment discontinuation or dose modification was required. Adverse events observed in patients in treatment with LAR 30 mg every 21 d were diarrhea in 1, abdominal pain in 1, cholelithiasis in 2, pyrexia in 1 patient. No constipation, dizziness, arterial hypertension or any other adverse event was observed.”
Koumarianou et al[15] 20101	“Patients reported no significant symptoms related to treatment adverse events. Two patients experienced a grade I neutropenia and one patient a grade II thrombocytopenia. One patient did not receive treatment due to persistent nausea and vomiting resistant to metoclopramide.”
Ludlam et al[21] 2011	p 838: “A trial designed to compare two dose levels of octreotide LAR (30 and 40 mg/mo) highlighted the ability of octreotide LAR to control diarrhea in patients with active or prior chemotherapy-induced diarrhea. Fewer patients in the 40 mg/mo group compared with those in the 30 mg/mo group experienced severe diarrhea (62% vs 48%; P = 0.14), required intravenous fluid (32% vs 19%; P = 0.10), or had diarrhea-related unscheduled healthcare visits (42% vs 28%; P = 0.11). Most importantly, adverse events were balanced between the two groups.”
Markovich et al[16] 20121	"Tolerability of long-acting octreotide in a dose of 30-40 mg was satisfactory for all pts.”
Valle et al[17] 20011	"All patients found the long-acting analogue acceptable and none requested a change back to conventional daily octreotide. Sandostatin LAR is an alternative somatostatin analogue that is highly acceptable to patients; doses may be safely escalated if required.”
Wolin et al[19] 20131	“Hyperglycemia (11% vs 0%), diarrhea (9% vs 7%), and abdominal pain (2% vs 9%) were the most common grade 3/4 AEs in the pasireotide-LAR (P) vs octreotide-LAR (O) arms in the core phase, and 7 (13%) and 4 (7%) patients discontinued due to AE. P and O showed a similar safety profile except for the higher frequency of hyperglycemia in P.”

¹Conference abstract. NA/NR: Not applicable/not reported.