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Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues.

Publication ,  Journal Article
Wolin, EM; Jarzab, B; Eriksson, B; Walter, T; Toumpanakis, C; Morse, MA; Tomassetti, P; Weber, MM; Fogelman, DR; Ramage, J; Poon, D; Gadbaw, B ...
Published in: Drug Des Devel Ther
2015

In a randomized, double-blind, Phase III study, we compared pasireotide long-acting release (pasireotide LAR) with octreotide long-acting repeatable (octreotide LAR) in managing carcinoid symptoms refractory to first-generation somatostatin analogues. Adults with carcinoid tumors of the digestive tract were randomly assigned (1:1) to receive pasireotide LAR (60 mg) or octreotide LAR (40 mg) every 28 days. Primary outcome was symptom control based on frequency of bowel movements and flushing episodes. Objective tumor response was a secondary outcome. Progression-free survival (PFS) was calculated in a post hoc analysis. Adverse events were recorded. At the time of a planned interim analysis, the data monitoring committee recommended halting the study because of a low predictive probability of showing superiority of pasireotide over octreotide for symptom control (n=43 pasireotide LAR, 20.9%; n=45 octreotide LAR, 26.7%; odds ratio, 0.73; 95% confidence interval [CI], 0.27-1.97; P=0.53). Tumor control rate at month 6 was 62.7% with pasireotide and 46.2% with octreotide (odds ratio, 1.96; 95% CI, 0.89-4.32; P=0.09). Median (95% CI) PFS was 11.8 months (11.0 - not reached) with pasireotide versus 6.8 months (5.6 - not reached) with octreotide (hazard ratio, 0.46; 95% CI, 0.20-0.98; P=0.045). The most frequent drug-related adverse events (pasireotide vs octreotide) included hyperglycemia (28.3% vs 5.3%), fatigue (11.3% vs 3.5%), and nausea (9.4% vs 0%). We conclude that, among patients with carcinoid symptoms refractory to available somatostatin analogues, similar proportions of patients receiving pasireotide LAR or octreotide LAR achieved symptom control at month 6. Pasireotide LAR showed a trend toward higher tumor control rate at month 6, although it was statistically not significant, and was associated with a longer PFS than octreotide LAR.

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Published In

Drug Des Devel Ther

DOI

EISSN

1177-8881

Publication Date

2015

Volume

9

Start / End Page

5075 / 5086

Location

New Zealand

Related Subject Headings

  • Tumor Burden
  • Treatment Outcome
  • Time Factors
  • Somatostatin
  • Proportional Hazards Models
  • Odds Ratio
  • Octreotide
  • Middle Aged
  • Male
  • Logistic Models
 

Citation

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MLA
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Wolin, E. M., Jarzab, B., Eriksson, B., Walter, T., Toumpanakis, C., Morse, M. A., … Öberg, K. (2015). Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues. Drug Des Devel Ther, 9, 5075–5086. https://doi.org/10.2147/DDDT.S84177
Wolin, Edward M., Barbara Jarzab, Barbro Eriksson, Thomas Walter, Christos Toumpanakis, Michael A. Morse, Paola Tomassetti, et al. “Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues.Drug Des Devel Ther 9 (2015): 5075–86. https://doi.org/10.2147/DDDT.S84177.
Wolin, Edward M., et al. “Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues.Drug Des Devel Ther, vol. 9, 2015, pp. 5075–86. Pubmed, doi:10.2147/DDDT.S84177.
Wolin EM, Jarzab B, Eriksson B, Walter T, Toumpanakis C, Morse MA, Tomassetti P, Weber MM, Fogelman DR, Ramage J, Poon D, Gadbaw B, Li J, Pasieka JL, Mahamat A, Swahn F, Newell-Price J, Mansoor W, Öberg K. Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues. Drug Des Devel Ther. 2015;9:5075–5086.

Published In

Drug Des Devel Ther

DOI

EISSN

1177-8881

Publication Date

2015

Volume

9

Start / End Page

5075 / 5086

Location

New Zealand

Related Subject Headings

  • Tumor Burden
  • Treatment Outcome
  • Time Factors
  • Somatostatin
  • Proportional Hazards Models
  • Odds Ratio
  • Octreotide
  • Middle Aged
  • Male
  • Logistic Models