Evidence map›Paper›PMID 19933912›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: a phase II trial.

James C Yao, Catherine Lombard-Bohas, Eric Baudin, Larry K Kvols, Philippe Rougier, Philippe Ruszniewski, Sakina Hoosen, Jessica St Peter, Tomas Haas, David Lebwohl and 9 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 216 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 10 pooled it
39.7field-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

216 citing papers in PubMed, 10 syntheses or guidelines pooled it, 649 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
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  14. Additional hepaticBMC gastroenterology · 2018
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156 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

19 authors at 1 institution in 1 country.

James C YaoDepartment of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 426, Houston, TX 77030, USA. jyao@mdanderson.org
Catherine Lombard-Bohas
Eric Baudin
Larry K Kvols
Philippe Rougier
Philippe Ruszniewski
Sakina Hoosen
Jessica St Peter
Tomas Haas
David Lebwohl
Eric Van Cutsem
Matthew H Kulke
Timothy J Hobday
Thomas M O'Dorisio
Manisha H Shah
Guillaume Cadiot
Gabriele Luppi
James A Posey
Bertram Wiedenmann
The University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PURPOSE No established treatment exists for pancreatic neuroendocrine tumor (NET) progression after failure of chemotherapy. Everolimus (RAD001), an oral inhibitor of mammalian target of rapamycin, in combination with octreotide has demonstrated encouraging antitumor activity in patients with NETs. PATIENTS AND METHODS This open-label, phase II study assessed the clinical activity of everolimus in patients with metastatic pancreatic NETs who experienced progression on or after chemotherapy. Patients were stratified by prior octreotide therapy (stratum 1: everolimus 10 mg/d, n = 115; stratum 2: everolimus 10 mg/d plus octreotide long-acting release [LAR], n = 45). Tumor assessments (using Response Evaluation Criteria in Solid Tumors) were performed every 3 months. Chromogranin A (CgA) and neuron-specific enolase (NSE) were assessed monthly if elevated at baseline. Trough concentrations of everolimus and octreotide were assessed. Results By central radiology review, in stratum 1, there were 11 partial responses (9.6%), 78 patients (67.8%) with stable disease (SD), and 16 patients (13.9%) with progressive disease; median progression-free survival (PFS) was 9.7 months. In stratum 2, there were two partial responses (4.4%), 36 patients (80%) with SD, and no patients with progressive disease; median PFS was 16.7 months. Patients with an early CgA or NSE response had a longer PFS compared with patients without an early response. Coadministration of octreotide LAR and everolimus did not impact exposure to either drug. Most adverse events were mild to moderate and were consistent with those previously seen with everolimus. CONCLUSION Daily everolimus, with or without concomitant octreotide LAR, demonstrates antitumor activity as measured by objective response rate and PFS and is well tolerated in patients with advanced pancreatic NETs after failure of prior systemic chemotherapy.

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChromogranin ADisease-Free SurvivalEverolimusFemaleHumansMaleMiddle AgedNeuroendocrine TumorsOctreotidePancreatic NeoplasmsPhosphopyruvate HydrataseSirolimusChromogranin AEverolimusOctreotidePhosphopyruvate HydrataseSirolimus

Identifiers

PMID19933912
PMCPMC4295034
OpenAlexW2128267006

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.