Evidence map›Paper›PMID 27992479›Full record

Trial reportPloS one2016

Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study.

Lukas Kirzinger, Sandra Boy, Jörg Marienhagen, Gerhard Schuierer, Reiner Neu, Michael Ried, Hans-Stefan Hofmann, Karsten Wiebe, Philipp Ströbel, Christoph May and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00332969 (Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.1field-weighted citation impact, top 20% 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.

NCT00332969 phase2completednot on this map

Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

TypeinterventionalSponsorNovartis PharmaceuticalsRan2005Enrolled25ConditionsThymomaArmsOctreotide
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Classification and staging of thymoma.Journal of thoracic disease · 2020
    Review
  12. [Treatment of Recurrent Thymoma].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2020
    Review
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

15 authors at 5 institutions in 1 country.

Lukas KirzingerDepartment of Neurology, University of Regensburg, Regensburg, Germany.
Sandra BoyDepartment of Neurology, University of Regensburg, Regensburg, Germany.
Jörg MarienhagenDepartment of Nuclear Medicine, University of Regensburg, Regensburg, Germany.
Gerhard SchuiererInstitute of Neuroradiology, BKR, Regensburg, Germany.
Reiner NeuDepartment of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
Michael RiedDepartment of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
Hans-Stefan HofmannDepartment of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
Karsten WiebeDepartment of Cardiac and Thoracic Surgery, University of Muenster, Muenster, Germany.
Philipp StröbelInstitute of Pathology, University of Goettingen, Goettingen, Germany.
Christoph MayNovartis Pharma GmbH, Nuremberg, Germany.
Julia Kleylein-SohnNovartis Pharma GmbH, Nuremberg, Germany.
Claudia BaierleinNovartis Pharma GmbH, Nuremberg, Germany.
Ulrich BogdahnDepartment of Neurology, University of Regensburg, Regensburg, Germany.
Alexander MarxInstitute of Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.
Berthold SchalkeDepartment of Neurology, University of Regensburg, Regensburg, Germany.
University of Regensburg · DENovartis (Germany) · DEHeidelberg University · DEUniversity of Göttingen · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Therapeutic options to cure advanced, recurrent, and unresectable thymomas are limited. The most important factor for long-term survival of thymoma patients is complete resection (R0) of the tumor. We therefore evaluated the response to and the induction of resectability of primarily or locally recurrent unresectable thymomas and thymic carcinomas by octreotide Long-Acting Release (LAR) plus prednisone therapy in patients with positive octreotide scans. In this open label, single-arm phase II study, 17 patients with thymomas considered unresectable or locally recurrent thymoma (n = 15) and thymic carcinoma (n = 2) at Masaoka stage III were enrolled. Octreotide LAR (30 mg once every 2 weeks) was administered in combination with prednisone (0.6 mg/kg per day) for a maximum of 24 weeks (study design according to Fleming´s one sample multiple testing procedure for phase II clinical trials). Tumor size was evaluated by volumetric CT measurements, and a decrease in tumor volume of at least 20% at week 12 compared to baseline was considered as a response. We found that octreotide LAR plus prednisone elicited response in 15 of 17 patients (88%). Median reduction of tumor volume after 12 weeks of treatment was 51% (range 20%-86%). Subsequently, complete surgical resection was achieved in five (29%) and four patients (23%) after 12 and 24 weeks, respectively. Octreotide LAR plus prednisone treatment was discontinued in two patients before week 12 due to unsatisfactory therapeutic effects or adverse events. The most frequent adverse events were gastrointestinal (71%), infectious (65%), and hematological (41%) complications. In conclusion, octreotide LAR plus prednisone is efficacious in patients with primary or recurrent unresectable thymoma with respect to tumor regression. Octreotide LAR plus prednisone was well tolerated and adverse events were in line with the known safety profile of both agents.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDelayed-Action PreparationsFemaleHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalOctreotidePrednisoneThymomaThymus NeoplasmsTreatment OutcomeDelayed-Action PreparationsOctreotidePrednisone

Identifiers

PMID27992479
PMCPMC5161359
OpenAlexW2567450389

What OpenQuestion holds

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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.