Evidence map›Paper›PMID 27261467›Full record

Trial reportThe oncologist2016

A Phase II Trial of a Histone Deacetylase Inhibitor Panobinostat in Patients With Low-Grade Neuroendocrine Tumors.

Ning Jin, Sam J Lubner, Daniel L Mulkerin, Saurabh Rajguru, Lakeesha Carmichael, Herb Chen, Kyle D Holen, Noelle K LoConte

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
3.8field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 44 citations in OpenAlex.

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  13. Role of Somatostatin Signalling in Neuroendocrine Tumours.International journal of molecular sciences · 2022
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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

8 authors at 2 institutions in 1 country.

Ning JinDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA njin@uwhealth.org.
Sam J LubnerDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA Carbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA.
Daniel L MulkerinDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA Carbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA.
Saurabh RajguruDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA.
Lakeesha CarmichaelCarbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA Department of Biostatistics, University of Wisconsin, Madison, Wisconsin, USA.
Herb ChenCarbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA Department of Surgery, University of Wisconsin, Madison, Wisconsin, USA.
Kyle D HolenDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA Carbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA.
Noelle K LoConteDivision of Hematology/Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA Carbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA.
University of Wisconsin Carbone Cancer Center · USUniversity of Wisconsin–Madison · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
NCI NIH HHS P30 CA014520
6 · The paper itself

Abstract

lessons learnedPancreatic neuroendocrine tumors versus carcinoid tumors should be examined separately in clinical trials.Progression-free survival is more clinically relevant as the primary endpoint (rather than response rate) in phase II trials for low-grade neuroendocrine tumors.

backgroundThe most common subtypes of neuroendocrine tumors (NETs) are pancreatic islet cell tumors and carcinoids, which represent only 2% of all gastrointestinal malignancies. Histone deacetylase (HDAC) inhibitors have already been shown to suppress tumor growth and induce apoptosis in various malignancies. In NET cells, HDAC inhibitors have resulted in increased Notch1 expression and subsequent inhibition of growth. We present here a phase II study of the novel HDAC inhibitor panobinostat in patients with low-grade NET.

methodsAdult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.

resultsFifteen patients were accrued, and 13 were evaluable for response. No responses were seen, but the stable disease rate was 100%. The median progression-free survival (PFS) was 9.9 months, and the median overall survival was 47.3 months. Fatigue (27%), thrombocytopenia (20%), diarrhea (13%), and nausea (13%) were the most common related grade 3 toxicities. There was one grade 4 thrombocytopenia (7%). These results did not meet the prespecified criteria to open the study to full accrual.

conclusionThe HDAC inhibitor panobinostat has a high stable disease rate and reasonable PFS in low-grade NET, but has a low response rate.

Indexed as

AdultAgedAged, 80 and overFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsIndolesMaleMiddle AgedNeuroendocrine TumorsPanobinostatHistone Deacetylase InhibitorsHydroxamic AcidsIndolesPanobinostat

Identifiers

PMID27261467
PMCPMC4943400
OpenAlexW2409400193

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.