Octreotide LAR doses used in clinical practice: Results from an internet survey and a clinical practice

Objective-Octreotide is used to treat patients with neuroendocrine tumors. Previous reports show that octreotide long-acting repeatable (LAR) dose and patient body weight affect nadir plasma octreotide levels (approximately 1250, 2500, 5000, and 11,000 pg/mL for LAR doses of 10, 20, 30 and 60 mg/mo). However, plasma octreotide levels have decreased over time in patients receiving these doses of LAR. Methods-FromNovember 2004 until July 2007, trough plasma octreotide levels were determined in 86 patients on long-term octreotide LAR therapy at doses of 30, 60, and 120 mg/mo. Changes in plasma drug levels were analyzed over time using random effects models.Results-Current plasma octreotide levels for octreotide LAR doses of 30, 60, and 120 mg/mo are approximately 2200, 5200, and 6500 pg/mL, respectively, representing a decrease of approximately 50% to 70% compared with previously reported plasma octreotide levels. The decreases in octreotide levels over time with the 30-and 60-mg/mo LAR doses are highly statistically significant (P = 0.0067, 0.0149, respectively).Conclusions-Current plasma octreotide values are significantly lower than previously reported for 30-, 60-, and 120-mg/mo LAR doses. Serial plasma octreotide value measurements should be used to determine if increasing symptoms or tumor growth are associated with suboptimal octreotide levels.

Section: Discussionmentioning

confidence: 52%

mentioning

confidence: 99%

Clinical Value of Monitoring Plasma Octreotide Levels During Chronic Octreotide Long-Acting Repeatable Therapy in Carcinoid Patients

Woltering¹,

Salvo²,

O'Dorisio³

et al. 2008

“…This often leads to slow increases in dose for most patients. 4,7 Very few patients in this study were on the manufacturer's recommended starting dose, most patients being on either 30 or 60 mg/mo. This highlights the significant differences in octreotide LAR dosing that patients require for adequate symptom control.…”

Section: Discussionmentioning

confidence: 97%

“…3 When octreotide LAR is used for the long term for the control of carcinoid syndrome, it is not uncommon for patients to require increases in their monthly LAR doses or more frequent use of rescue (aqueous octreotide) over time. 4–6 …”

Section: Discussionmentioning

confidence: 99%

A Prospective Trial on the Effect of Body Mass Index and Sex on Plasma Octreotide Levels in Patients Undergoing Long-Term Octreotide LAR Therapy

Joseph

Chen²,

Lindholm³

et al. 2010

Objectives Octreotide long acting repeatable (LAR) is commonly used to control the symptoms of patients with functional neuroendocrine tumors. Unfortunately, most patients escape control over time and require higher LAR doses or more frequent rescue therapy to remain asymptomatic. Previous work has shown that body weight and monthly LAR dose will significantly affect circulating plasma octreotide levels in patients undergoing therapy. Methods To determine if other parameters change circulating plasma octreotide levels, we prospectively studied 82 patients undergoing long-term LAR therapy. Results Multivariate analysis demonstrated that the plasma octreotide levels decrease by approximately 3.4% for each unit of body mass index (BMI) increase (P = 0.03), adjusting for sex and monthly LAR dose. Plasma octreotide levels for females were approximately 47.6% higher than those for males (P = 0.045), adjusting for BMI and monthly LAR dose. Initial and subsequent octreotide LAR doses should take into consideration sex and BMI. Males are estimated to require 14.1-mg (SD, 7.25) higher monthly LAR doses than females with the same BMI. Conclusions We have shown that plasma octreotide levels are affected by not only monthly LAR dose but also BMI and sex. We hope these observations will make choosing initial and subsequent octreotide LAR doses easier for physicians.

“…38 The need for short-acting rescue medication for optimal symptom management is further supported by the data from the registration study for octreotide LAR. In the United States, octreotide is the only somatostatin congener currently approved for the treatment of carcinoid syndrome.…”

Section: Somatostatin Analogsmentioning

confidence: 98%

The NANETS Consensus Guideline for the Diagnosis and Management of Neuroendocrine Tumors

Boudreaux¹,

Klimstra²,

Hassan³

et al. 2010

461

213

Well-differentiated neuroendocrine tumors (NETs) of the jejunum, ileum, and appendix are also collectively known as midgut carcinoids. Similar to NETs in general, the diagnosed incidence of the midgut NETs is on the rise. Their presenting symptoms vary depending on stage and primary site. Local-regional NETs often present with vague and nonspecific symptoms. Classic carcinoid syndrome is more likely to appear in patients with advanced disease. Local-regional NETs of the small bowel should be resected whenever possible. With the exception of small well-differentiated NETs of the appendix, NETs of the midgut have substantial risk of relapse after resection and need to be followed for at least 7 years.Metastatic/advanced NETs of the midgut are incurable. Optimal management requires a multidisciplinary approach. Somatostatin analogs are effective in the management of carcinoid syndrome. Octreotide long-acting release has also recently been shown to delay disease progression. Liver-directed therapy and surgical debulking can improve quality of life in selected patients. Pivotal phase 3 studies with bevacizumab targeting vascular endothelial growth factor and everolimus targeting mTOR (mammalian target of rapamycin) are ongoing and may lead to improved outcome. Further studies of novel approaches such as peptide receptor radiotherapy are also warranted.