Evidence map›Paper›PMID 19047305›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer.

Brian M Wolpin, Aram F Hezel, Thomas Abrams, Lawrence S Blaszkowsky, Jeffrey A Meyerhardt, Jennifer A Chan, Peter C Enzinger, Brittany Allen, Jeffrey W Clark, David P Ryan and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00409292 (Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer), which is not on this map. Cited by 156 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed, 2 pooled it
9.0field-weighted citation impact, top 2% 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.

NCT00409292 phase2completednot on this map

Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2007 to 2009Enrolled33ConditionsPancreatic CancerArmsRAD001
3 · Its place in the literature

Who cites it

156 citing papers in PubMed, 2 syntheses or guidelines pooled it, 291 citations in OpenAlex.

  1. 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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  14. Molecular insights into immune evasion and therapeutic paradigms in pancreatic cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2025
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  15. Autophagy: The convergence point of aging and cancer.Biochemistry and biophysics reports · 2025
    Review
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96 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

11 authors at 5 institutions in 1 country.

Brian M WolpinDepartment of Medical Oncology, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115, USA. bwolpin@partners.org
Aram F Hezel
Thomas Abrams
Lawrence S Blaszkowsky
Jeffrey A Meyerhardt
Jennifer A Chan
Peter C Enzinger
Brittany Allen
Jeffrey W Clark
David P Ryan
Charles S Fuchs
Brigham and Women's Hospital · USDana-Farber Brigham Cancer Center · USHarvard University · USDana-Farber Cancer Institute · USMassachusetts General Hospital · US

Funding

Statistical MethodsP01CA087969 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI TWOROGER, SHELLEY S · 2000 to 2019
$77.8M
Validity of Diet and Activity Measures in WomenP01CA055075 · NCI · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLETT, WALTER C. · 1991 to 2009
$41.8M
Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI EL-BARDEESY, NABEEL, SELLERS, WILLIAM R · 2007 to 2023
$33.2M
Training Program in Cancer EpidemiologyT32CA009001 · NCI · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI A. Heather Eliassen, Meir Stampfer · 1985 to 2026
$17.3M
Prospective Cohort Collaborative in Pancreatic Cancer Epidemiology & PathogenesisR01CA124908 · NCI · DANA-FARBER CANCER INST · PI FUCHS, CHARLES S · 2007 to 2012
$4.3M
NCI NIH HHS P01 CA124908NCI NIH HHS P01 CA55075NCI NIH HHS P01 CA87969NCI NIH HHS P50 CA127003NCI NIH HHS T32 CA09001
6 · The paper itself

Abstract

purposeThe PI3K/Akt/mTOR pathway is activated in the majority of pancreatic cancers, and inhibition of this pathway has antitumor effects in preclinical studies. We performed a multi-institutional, single-arm, phase II study of RAD001(everolimus), an oral inhibitor of mTOR, in patients who experienced treatment failure on first-line therapy with gemcitabine. PATIENTS AND

methodsThirty-three patients with gemcitabine-refractory, metastatic pancreatic cancer were treated continuously with RAD001 at 10 mg daily. Prior treatment with fluorouracil in the perioperative setting was allowed. Patients were observed for toxicity, treatment response, and survival.

resultsTreatment with single-agent RAD001 was well-tolerated; the most common adverse events were mild hyperglycemia and thrombocytopenia. No patients were removed from the study because of drug-related adverse events. No complete or partial treatment responses were noted, and only seven patients (21%) had stable disease at the first restaging scans performed at 2 months. Median progression-free survival and overall survival were 1.8 months and 4.5 months, respectively. One patient (3%) had a biochemical response, defined as > or = 50% reduction in serum CA19-9.

conclusionAlthough well-tolerated, RAD001 administered as a single-agent had minimal clinical activity in patients with gemcitabine-refractory, metastatic pancreatic cancer. Future studies in metastatic pancreatic cancer should assess the combination of mTOR inhibitors with other agents and/or examine inhibitors of other components of the PI3K/Akt/mTOR pathway.

Indexed as

Administration, OralAdultAgedDeoxycytidineDrug Resistance, NeoplasmEverolimusFemaleGemcitabineHumansMaleMiddle AgedOncogene Protein v-aktPancreatic NeoplasmsPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsProtein KinasesDeoxycytidineEverolimusGemcitabineMTOR protein, humanOncogene Protein v-aktPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsProtein KinasesSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID19047305
PMCPMC2645085
OpenAlexW2154108823

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.