Evidence map›Paper›PMID 21538343›Full record

Trial reportCancer2011

Phase 1/2 study of everolimus in advanced hepatocellular carcinoma.

Andrew X Zhu, Thomas A Abrams, Rebecca Miksad, Lawrence S Blaszkowsky, Jeffrey A Meyerhardt, Hui Zheng, Alona Muzikansky, Jeffrey W Clark, Eunice L Kwak, Deborah Schrag and 5 more

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

Trial report in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 4 pooled it
12.5field-weighted citation impact, top 1% 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

94 citing papers in PubMed, 4 syntheses or guidelines pooled it, 195 citations in OpenAlex.

  1. Pooled it
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  3. Treatment-related fatigue with everolimus and temsirolimus in patients with cancer-a meta-analysis of clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
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  18. [The dual mTORC1/2 inhibitor AZD2014 inhibits acute graft rejection in a rat liver transplantation model].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2022
    Article
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34 more citing papers are in PubMed but not listed here.

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 3 institutions in 1 country.

Andrew X ZhuMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts, USA. azhu@partners.org
Thomas A Abrams
Rebecca Miksad
Lawrence S Blaszkowsky
Jeffrey A Meyerhardt
Hui Zheng
Alona Muzikansky
Jeffrey W Clark
Eunice L Kwak
Deborah Schrag
Kathryn R Jors
Charles S Fuchs
A John Iafrate
Darrell R Borger
David P Ryan
Harvard University · USMassachusetts General Hospital · USDana-Farber Cancer Institute · US

Funding

Optimizing localized therapy for primary liver cancer: a clinical trial and modelK23CA139005 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI MIKSAD, REBECCA ANNE · 2009 to 2013
$847k
NCI NIH HHS K23 CA139005
6 · The paper itself

Abstract

backgroundThe phosphoinositide 3-kinase/Akt/mammalian target of rapamycin pathway plays a critical role in the pathogenesis of hepatocellular carcinoma (HCC). We performed a single-arm, phase 1/2 study of everolimus in patients with advanced HCC.

methodsPatients with histologically confirmed measurable advanced HCC, 0-2 prior regimens, and adequate hematologic, hepatic, and renal functions received everolimus at 5 mg/day or 10 mg/day orally (6 weeks/cycle). The primary end points were determination of a safe dosage of everolimus (phase 1) and progression-free survival (PFS) at 24 weeks (phase 2).

resultsTwenty-eight patients were enrolled and evaluable for efficacy and toxicity. No dose-limiting toxicities were observed at the 5 mg/day (n = 3) or 10 mg/day (n = 6) dosage level in phase 1. Twenty-five patients received everolimus at 10 mg/day. Grade 3-4 adverse events included lymphopenia (n = 3), aspartate transaminase (n = 3), hyponatremia (n = 2), and 1 patient each with anemia, alanine transaminase, hyperglycemia, proteinuria, rash, and hypoxia. One patient (4%) had partial response (95% confidence interval [CI], 0.9%-19.6%). The median PFS and overall survival were 3.8 months (95% CI, 2.1-4.6) and 8.4 months (95% CI, 3.9-21.1), respectively. The estimated PFS rate at 24 weeks was 28.6% (95% CI, 7.9%-49.3%).

conclusionEverolimus was well tolerated in patients with advanced HCC, and 10 mg/day was defined as the phase 2 dosage. Although the study did not proceed to the second stage of phase 2, preliminary antitumor activity was observed with everolimus in patients with advanced HCC, most of whom had prior systemic treatment.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularEverolimusFemaleHumansLiver NeoplasmsMaleMiddle AgedSirolimusAntineoplastic AgentsEverolimusSirolimus

Identifiers

PMID21538343
PMCPMC3417818
OpenAlexW2165901246

What OpenQuestion holds

Textmetadata
LicenceTDM
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.