Effectiveness and side-effects of peptide receptor radionuclide therapy for neuroendocrine neoplasms in Germany: A multi-institutional registry study with prospective follow-up

Eur J Cancer. 2016 May:58:41-51. doi: 10.1016/j.ejca.2016.01.009. Epub 2016 Mar 2.

Abstract

Background: Monocentric and retrospective studies indicate effectiveness of peptide receptor radionuclide therapy targeting somatostatin receptors of neuroendocrine neoplasms. We assessed overall and progression-free survival and adverse events of peptide receptor radionuclide therapy by a multi-institutional, board certified registry with prospective follow-up in five centres in Germany.

Methods: A total of 450 patients were included and followed for a mean of 24.4 months. Most patients had progressive low- or intermediate grade neuroendocrine neoplasms and 73% were pretreated with at least one therapy. Primary neuroendocrine neoplasms were mainly derived of pancreas (38%), small bowel (30%), unknown primary (19%) or bronchial system (4%). Patients were treated with Lutetium-177 in 54%, with Yttrium-90 in 17% and with both radionuclides in 29%. Overall and progression-free survival was determined with Kaplan-Meier curves and uni-variate log rank test Cox models.

Findings: Median overall survival of all patients was 59 (95% confidence interval [CI] 49-68.9) months. Overall survival was significantly inferior in the patients treated with Yttrium-90 solely (hazard ratio, 3.22; 95% CI, 1.83-5.64) compared to any peptide receptor radionuclide therapy with Lutetium-177. Grade II (hazard ratio, 2.06; 95% CI, 0.79-5.32) and grade III (hazard ratio, 4.22; 95% CI, 1.41-12.06) neuroendocrine neoplasms had significantly worse overall survival than grade I neuroendocrine neoplasms. Patients with small neuroendocrine neoplasms of small bowel had significantly increased survival (hazard ratio, 0.39; 95% CI, 0.18-0.87) compared to neuroendocrine neoplasms of other locations. Median progression-free survival was 41 (35.9-46.1) months and significantly inferior in patients treated with Yttrium solely (hazard ratio, 2.7; 95% CI, 1.71-4.55). Complete remission was observed in 5.6% of patients, 22.4% had a partial remission, 47.3% were stable and 4% were progressive as best response. Adverse events of bone marrow and kidney function higher than grade III occurred in 0.2-1.5% of patients.

Interpretation: These results indicate that peptide receptor radionuclide therapy is a highly effective therapy for patients with low to intermediate grade neuroendocrine neoplasms with minor adverse events.

Keywords: Functional syndromes; Neuroendocrine neoplasm; Oncology; Peptide receptor radionuclide therapy; Radiotherapy.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Gallium Radioisotopes / adverse effects
  • Gallium Radioisotopes / metabolism
  • Gallium Radioisotopes / therapeutic use*
  • Deutschland
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neuroendocrine Tumors / metabolism
  • Neuroendocrine Tumors / mortality
  • Neuroendocrine Tumors / radiotherapy*
  • Octreotide / adverse effects
  • Octreotide / analogs & derivatives*
  • Octreotide / metabolism
  • Octreotide / therapeutic use
  • Organometallic Compounds / adverse effects
  • Organometallic Compounds / metabolism
  • Organometallic Compounds / therapeutic use*
  • Proportional Hazards Models
  • Prospective Studies
  • Radiopharmaceuticals / adverse effects
  • Radiopharmaceuticals / metabolism
  • Radiopharmaceuticals / therapeutic use*
  • Receptors, Somatostatin / metabolism*
  • Registries
  • Remission Induction
  • Time Factors
  • Treatment Outcome

Substances

  • Gallium Radioisotopes
  • Organometallic Compounds
  • Radiopharmaceuticals
  • Receptors, Somatostatin
  • 90Y-octreotide, DOTA-Tyr(3)-
  • lutetium Lu 177 dotatate
  • Octreotide
  • Edotreotide