Radiolabeled somatostatin analog [177Lu-DOTA0,Tyr3]octreotate in patients with endocrine gastroenteropancreatic tumors

J Clin Oncol. 2005 Apr 20;23(12):2754-62. doi: 10.1200/JCO.2005.08.066.


Purpose: There are few treatment options for patients with metastasized or inoperable endocrine gastroenteropancreatic (GEP) tumors. Chemotherapy can be effective, but the response is usually less than 1 year. Here, we present the results of treatment with a radiolabeled somatostatin analog, [177Lu-DOTA0,Tyr3]octreotate (177Lu-octreotate).

Patients and methods: One hundred thirty-one patients with somatostatin receptor-positive tumors were treated with up to a cumulative dose of 600 to 800 mCi (22.2 to 29.6 GBq) of 177Lu-octreotate.

Results: One patient developed renal insufficiency, and another patient developed hepatorenal syndrome. Creatinine clearance did not change significantly in the other patients. WHO hematologic toxicity grade 3 or 4 occurred after less than 2% of the administrations. We observed complete remission in three patients (2%), partial remission in 32 patients (26%), minor response (tumor diameter decrease of 25% to 50%) in 24 patients (19%), stable disease (SD) in 44 patients (35%), and progressive disease (PD) in 22 patients (18%). Higher remission rates were positively correlated with high uptake on pretherapy somatostatin receptor imaging and a limited number of liver metastases, whereas PD was significantly more frequent in patients with a low performance score and extensive disease. Median time to progression in 103 patients who either had SD or tumor regression was more than 36 months.

Conclusion: Treatment with 177Lu-octreotate results in tumor remission in a high percentage of patients with GEP tumors. Serious side effects are rare. The median time to progression compares favorably with chemotherapy. Results are better in patients with a limited tumor load. Therefore, early treatment, even in patients who have no PD, may be better.

Publication types

  • Clinical Trial

MeSH terms

  • Adenoma, Islet Cell / drug therapy*
  • Adenoma, Islet Cell / pathology
  • Adult
  • Aged
  • Aged, 80 and over
  • Carcinoid Tumor / drug therapy*
  • Carcinoid Tumor / pathology
  • Disease Progression
  • Endocrine Gland Neoplasms / drug therapy*
  • Endocrine Gland Neoplasms / pathology
  • Female
  • Humans
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / secondary
  • Male
  • Middle Aged
  • Octreotide / analogs & derivatives
  • Organometallic Compounds / adverse effects*
  • Organometallic Compounds / pharmacokinetics
  • Organometallic Compounds / therapeutic use*
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / pathology
  • Receptors, Somatostatin
  • Treatment Outcome


  • Organometallic Compounds
  • Receptors, Somatostatin
  • lutetium Lu 177 dotatate
  • Octreotide