Evidence map›Paper›PMID 26941843›Full record

Trial reportTheranostics2016

[(177)Lu-DOTA](0)-D-Phe(1)-Tyr(3)-Octreotide ((177)Lu-DOTATOC) For Peptide Receptor Radiotherapy in Patients with Advanced Neuroendocrine Tumours: A Phase-II Study.

Richard P Baum, Andreas W Kluge, Harshad Kulkarni, Ulrike Schorr-Neufing, Karin Niepsch, Norman Bitterlich, Cees J A van Echteld

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Theranostics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04790708 (Peptide Receptor Radionuclide Therapy), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
9.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04790708 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors

TypeinterventionalSponsorUniversity Hospital of FerraraRan2018 to 2023Enrolled250ConditionsNeuroendocrine Tumors, Peptide Receptor Radionuclide Therapy (PRRT)ArmsLutetium-177 (177Lu)-DOTATOC, Yttrium-90 (90Y)-DOTATOC, 177Lu-DOTATOC + 90Y-DOTATOC, Re-treatment 177Lu-DOTATOC, Re-treatment 90Y-DOTATOC
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Long-term toxicity of tandem radioligand therapy using [European journal of nuclear medicine and molecular imaging · 2026
    Article
  5. Review
  6. Article
  7. Review
  8. Pancreatic neuroendocrine tumors: A case-based evidence review.World journal of gastrointestinal pathophysiology · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2023
    Article
  13. Application of nano-radiosensitizers in combination cancer therapy.Bioengineering & translational medicine · 2023
    Review
  14. Preclinical Evaluation of [Molecules (Basel, Switzerland) · 2023
    Article
  15. Pharmaceutics · 2023
    Review
  16. Relevance of Volumetric Parameters Applied to [Diagnostics (Basel, Switzerland) · 2023
    Article
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Richard P Baum1. Zentralklinik Bad Berka GmbH, THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging (PET/CT), Robert-Koch-Allee 9, D-99437 Bad Berka, Germany.
Andreas W Kluge2. ABX-CRO Forschungsgesellschaft m.b.H., Blasewitzer Strasse 78 - 80, D-01307 Dresden, Germany.
Harshad Kulkarni1. Zentralklinik Bad Berka GmbH, THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging (PET/CT), Robert-Koch-Allee 9, D-99437 Bad Berka, Germany.
Ulrike Schorr-Neufing2. ABX-CRO Forschungsgesellschaft m.b.H., Blasewitzer Strasse 78 - 80, D-01307 Dresden, Germany.
Karin Niepsch1. Zentralklinik Bad Berka GmbH, THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging (PET/CT), Robert-Koch-Allee 9, D-99437 Bad Berka, Germany.
Norman Bitterlich2. ABX-CRO Forschungsgesellschaft m.b.H., Blasewitzer Strasse 78 - 80, D-01307 Dresden, Germany.
Cees J A van Echteld2. ABX-CRO Forschungsgesellschaft m.b.H., Blasewitzer Strasse 78 - 80, D-01307 Dresden, Germany.
ABX-CRO Advanced Pharmaceutical Services (Germany) · DEZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo characterise efficacy and safety of (177)Lu-DOTATOC as agent for peptide receptor radiotherapy (PRRT) of advanced neuroendocrine tumours (NET). PATIENTS AND

methodsFifty-six subjects with metastasized and progressive NET (50% gastroenteral, 26.8% pancreatic, 23.2% other primary sites) treated consecutively with (177)Lu-DOTATOC were analysed retrospectively. Subjects were administered (177)Lu-DOTATOC (mean 2.1 cycles; range 1-4) as 7.0GBq (median) doses at three-monthly intervals. Efficacy was analysed using CT and/or MRI according to RECIST 1.1 criteria and results were stratified for the number of administered cycles and the primary tumour origin.

resultsIn the total NET population (A), median progression-free (PFS) and overall survival (OS) were 17.4 and 34.2 months, respectively, assessed in a follow-up time (mean ± SD) of 16.1 ± 12.4 months. In patients receiving more than one cycle, mean follow-up time was 22.4 ± 11.0 months for all NETs (B) and PFS was 32.0 months for all NETs (B), 34.5 months for GEP-NET (C), and 11.9 months for other NETs (D). Objective response rates (Complete/Partial Responses) were 33.9%, 40.6%, 54.2%, and 0% for A, B, C, and D groups, respectively, while disease control rates in the same were 66.1%, 93.8%, 100%, and 75%. Complete responses (16.1%, 18.8% and 25.0% for groups A, B and C) were high, 78% of which were maintained throughout the follow up. There were no serious adverse events. One case of self-limiting grade 3 myelotoxicity was reported. Although 20% of patients had mild renal insufficiency at baseline, there was no evidence of exacerbated or de novo renal toxicity after treatment.

conclusion(177)Lu-DOTATOC is a novel agent for PRRT with major potential to induce objective tumour responses and sustained disease control in progressive neuroendocrine tumours, even when administered in moderate activities. The observed safety profile suggests a particularly favourable therapeutic index, including in patients with impaired bone marrow or renal function, which reflects a uniquely low uptake of (177)Lu-DOTATOC by normal organs.

Indexed as

AgedCarcinoma, NeuroendocrineFemaleHumansLutetiumMaleMiddle AgedOctreotideRadiopharmaceuticalsReceptors, PeptideTomography, X-Ray ComputedTreatment Outcome3-Tyr-octreotideLutetiumOctreotideRadiopharmaceuticalsReceptors, PeptideNeuroendocrine tumourpeptide receptorradionuclide therapyradiotherapysomatostatin analogue.somatostatin receptor

Identifiers

PMID26941843
PMCPMC4775860
OpenAlexW2411559315

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.