A phase II clinical trial of sunitinib following hepatic transarterial embolization for metastatic neuroendocrine tumors.

  • Strosberg J
  • Weber J
  • Choi J
 et al. 
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Abstract

BACKGROUND: The liver is the predominant site of metastases among patients with advanced neuroendocrine tumors (NETs). Prior retrospective studies have reported high response rates in patients treated with transarterial embolization (TAE). NETs are highly vascular and are known to express vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR). We hypothesized that administration of sunitinib, a VEGFR inhibitor, following TAE would extend progression-free survival (PFS).

PATIENTS AND METHODS: Patients with metastatic NETs to the liver underwent a series of selective TAEs followed by sunitinib (until disease progression or maximum of 12 months). Radiographic response (by RECIST), survival, and safety parameters were monitored.

RESULTS: Thirty-nine patients were enrolled. The overall response rate was 72% [95% confidence interval (CI), 0.58-0.86]. Median PFS was 15.2 months. Rates of overall survival (OS) at 1 and 4 years were 95% (95% CI, 0.88-1.00) and 59% (95% CI, 0.38-0.80), respectively. A significant 34% rise in serum VEGF was observed following the initial TAE (P = 0.03).

CONCLUSIONS: Hepatic TAE is a highly active treatment option for patients with metastatic NETs to the liver. Embolization stimulates release of VEGF into the circulation. Sunitinib, an oral VEGFR inhibitor, can be safely administered following embolization. The high rates of PFS and OS associated with this sequence of therapies are encouraging.

Author-supplied keywords

  • Acrylic Resins
  • Acrylic Resins: therapeutic use
  • Adult
  • Aged
  • Angiogenesis Inhibitors
  • Angiogenesis Inhibitors: pharmacology
  • Angiogenesis Inhibitors: therapeutic use
  • Disease-Free Survival
  • Embolization, Therapeutic
  • Female
  • Gelatin
  • Gelatin: therapeutic use
  • Hepatic Artery
  • Humans
  • Indoles
  • Indoles: pharmacology
  • Indoles: therapeutic use
  • Intestinal Neoplasms
  • Intestinal Neoplasms: blood
  • Intestinal Neoplasms: mortality
  • Intestinal Neoplasms: pathology
  • Intestinal Neoplasms: therapy
  • Kaplan-Meier Estimate
  • Liver Neoplasms
  • Liver Neoplasms: blood
  • Liver Neoplasms: mortality
  • Liver Neoplasms: secondary
  • Liver Neoplasms: therapy
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Neuroendocrine Tumors
  • Proportional Hazards Models
  • Pyrroles
  • Pyrroles: pharmacology
  • Pyrroles: therapeutic use
  • Statistics, Nonparametric
  • Treatment Outcome
  • Tumor Burden
  • Tumor Burden: drug effects
  • Vascular Endothelial Growth Factor A
  • Vascular Endothelial Growth Factor A: blood

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Authors

  • J R Strosberg

  • J M Weber

  • J Choi

  • T L Campos

  • T L Valone

  • G Han

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