Evidence map›Paper›PMID 25613083›Full record

Trial reportInvestigational new drugs2015

Everolimus and pasireotide for advanced and metastatic hepatocellular carcinoma.

Hanna K Sanoff, Richard Kim, Anastasia Ivanova, Angela Alistar, Autumn J McRee, Bert H O'Neil

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

Trial report in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

10 citing papers in PubMed, 16 citations in OpenAlex.

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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

6 authors at 5 institutions in 1 country.

Hanna K SanoffDivision of Hematology and Oncology, University of North Carolina at Chapel Hill, 170 Manning Drive, CB 7305, Chapel Hill, NC, 27599, USA, hanna_sanoff@med.unc.edu.
Richard Kim
Anastasia Ivanova
Angela Alistar
Autumn J McRee
Bert H O'Neil
University of North Carolina at Chapel Hill · USIndiana University – Purdue University Indianapolis · USMoffitt Cancer Center · USUNC Lineberger Comprehensive Cancer CenterWake Forest University · US

Funding

UNC Oncology K12K12CA120780 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WILLIAM Y. KIM · 2007 to 2026
$9.6M
Integrative Molecular Epidemiology WorkshopR25CA174664 · NCI · AMERICAN ASSOCIATION FOR CANCER RESEARCH · PI Shelley S Tworoger · 2013 to 2026
$2.8M
Use and Comparative Effectiveness of Innovative Therapies for Hepatocellular CarcK07CA160722 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SANOFF, HANNA KELLY · 2011 to 2015
$851k
NCI NIH HHS K07 CA160722NCI NIH HHS K07CA160722NCI NIH HHS K12 CA120780NCI NIH HHS R25 CA174664
6 · The paper itself

Abstract

purposeFew treatment options are available for patients with advanced or metastatic hepatocellular carcinoma (HCC). Based on preclinical and early clinical efficacy signals and lack of overlapping toxicity, we undertook this multicenter phase II trial to estimate efficacy and safety of everolimus and pasireotide in advanced HCC.

methodsPatients with advanced HCC not amenable to locoregional therapy and Child-Pugh A cirrhosis received everolimus 7.5 mg PO daily and pasireotide LAR 60 mg IM every 28 days. The primary endpoint was time to progression (TTP), with 26 events needed to evaluate if everolimus + pasireotide improved TTP from 2.8 to 4.4 months, with 80% power and an alpha of 0.05. Secondary endpoints included response as measured by RECIST modified for HCC, treatment-emergent adverse events, and overall survival.

resultsAfter 24 patients were enrolled, results of a randomized trial showing no benefit of everolimus in HCC were released prompting an unplanned interim analysis that found the conditional probability of rejecting the null hypothesis based on events in those patients was 0.08. Therefore accrual was halted. Patients had a median age of 59 years, 21 (88%) had BCLC stage C cancer, and 11 (46%) metastatic disease. Median TTP was 3.5 months (95% CI 2-5.8) and median survival 6.7 months (95% CI 6-infinity). Best response was stable disease in ten patients. Grade 3 hyperglycemia occurred in 6 (25%). There were no grade 4 treatment-emergent events.

conclusionDespite promising early efficacy signals, we found no benefit for the combination of everolimus and pasireotide in HCC.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularDisease-Free SurvivalEverolimusFemaleHumansLiver NeoplasmsMaleMiddle AgedResponse Evaluation Criteria in Solid TumorsSomatostatinEverolimuspasireotideSomatostatin

Identifiers

PMID25613083
PMCPMC4487887
OpenAlexW2169298675

What OpenQuestion holds

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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.