Evidence mapPaperPMID 27016228Full record

Trial reportGynecologic oncology2016

Tumor mutational analysis of GOG248, a phase II study of temsirolimus or temsirolimus and alternating megestrol acetate and tamoxifen for advanced endometrial cancer (EC): An NRG Oncology/Gynecologic Oncology Group study.

Andrea P Myers, Virginia L Filiaci, Yuping Zhang, Michael Pearl, Kian Behbakht, Vicky Makker, Parviz Hanjani, Susan Zweizig, James J Burke, Gordon Downey and 4 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 8% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
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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

14 authors at 12 institutions in 1 country.

Andrea P MyersDana Farber Cancer Institute, Boston, MA, United States. Electronic address: andrea.myers@novartis.com.
Virginia L FiliaciNRG Oncology Statistics and Data Management Center, Buffalo, NY, United States.
Yuping ZhangUniversity of Iowa Hospitals and Clinics, Iowa City, IA, United States.
Michael PearlStony Brook Medicine, Stony Brook, NY, United States.
Kian BehbakhtRush University Medical Center, Chicago, IL, United States.
Vicky MakkerMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, United States.
Parviz HanjaniAbington Memorial Hospital, Gladwyne, PA, United States.
Susan ZweizigUniversity of Massachusetts Memorial Health Care, Worcester, MA, United States.
James J BurkeMercer University School of Medicine, Savannah, GA, United States.
Gordon DowneyGynecologic Oncology of West Michigan, Grand Rapids, MI, United States.
Kimberly K LeslieUniversity of Iowa Hospitals and Clinics, Iowa City, IA, United States.
Paul Van HummelenDana Farber Cancer Institute, Boston, MA, United States.
Michael J BirrerMassachusetts General Hospital/Dana Farber Cancer Center, Boston, MA, United States.
Gini F FlemingThe University of Chicago Medical Center, Chicago, IL, United States.
Dana-Farber Cancer Institute · USUniversity of Iowa Hospitals and Clinics · USAbington Memorial Hospital · USGynecologic Oncology Group · USMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USMercer University · USNRG Oncology · USRush University Medical Center · USStony Brook Medicine · USUMass Memorial Health Care · USUniversity of Chicago Medical Center · US

Funding

The Patient-Reported Outcomes, Community-Engagement and Language (PRO-CEL) CoreP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · 1985 to 2025
$88.4M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · GYNECOLOGIC ONCOLOGY GROUP · 1985 to 2005
$57.9M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · ROSWELL PARK CANCER INSTITUTE CORP · 1985 to 2005
$29.0M
NRG Oncology Network Group Operations CenterU10CA180868 · NRG ONCOLOGY FOUNDATION, INC. · 2025 to 2025
$15.3M
Viral VectorP30CA086862 · UNIVERSITY OF IOWA · 2000 to 2025
$11.9M
Statistics CoreU10CA180822 · UNIVERSITY OF CHICAGO · 2025 to 2025
$10.2M
NRG Oncology Biospecimen BankU24CA196067 · NRG ONCOLOGY FOUNDATION, INC. · 2025 to 2025
$4.6M
NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10CA180822NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067
6 · The paper itself

Abstract

objectiveRapamycin analogs have reproducible but modest efficacy in endometrial cancer (EC). Identification of molecular biomarkers that predict benefit could guide clinical development.

methodsFixed primary tissue and whole blood were collected prospectively from patients enrolled on GOG 248. DNA was isolated from macro-dissected tumors and blood; next-generation sequence analysis was performed on a panel of cancer related genes. Associations between clinical outcomes [response rate (RR) 20%; progression-free survival (PFS) median 4.9months] and mutations (PTEN, PIK3CA, PIK3R1, KRAS, CTNNB1, AKT1, TSC1, TSC2, NF1, FBXW7) were explored.

resultsSequencing data was obtained from tumors of 55 of the 73 enrolled pts. Mutation rates were consistent with published reports: mutations in PTEN (45%), PIK3CA (29%), PIK3R1 (24%), K-RAS (16%), CTNNB1 (18%) were common and mutations in AKT1 (4%), TSC1 (2%), TSC2 (2%), NF1 (9%) and FBXW7 (4%) were less common. Increased PFS (HR 0.16; 95% CI 0.01-0.78) and RR (response difference 0.83; 95% CI 0.03-0.99) were noted for AKT1 mutation. An increase in PFS (HR 0.46; 95% CI 0.20-0.97) but not RR (response difference 0.00, 95% CI -0.34-0.34) was identified for CTNNB1 mutation. Both patients with TSC mutations had an objective response. There were no statistically significant associations between mutations in PIK3CA, PTEN, PIK3R1, or KRAS and PFS or RR.

conclusionsMutations in AKT1, TSC1 and TSC2 are rare, but may predict clinical benefit from temsirolimus. CTNNB1 mutations were associated with longer PFS on temsirolimus.

Indexed as

MutationClass I Phosphatidylinositol 3-KinasesEndometrial NeoplasmsFemaleHumansMegestrol AcetatePhosphatidylinositol 3-KinasesProspective StudiesProto-Oncogene Proteins c-aktPTEN PhosphohydrolaseSirolimusTamoxifenTuberous Sclerosis Complex 1 ProteinTumor Suppressor ProteinsAKT1 protein, humanClass I Phosphatidylinositol 3-KinasesMegestrol AcetatePhosphatidylinositol 3-KinasesPIK3CA protein, humanProto-Oncogene Proteins c-aktPTEN PhosphohydrolasePTEN protein, humanSirolimusTamoxifentemsirolimusTSC1 protein, humanTuberous Sclerosis Complex 1 ProteinTumor Suppressor Proteins

Identifiers

PMID27016228
PMCPMC5119517
OpenAlexW2308364408

What Socratic 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 Socratic graph.