Evidence map›Paper›PMID 35681620›Full record

ArticleCancers2022

A Multicenter Randomized Phase II Study of Single Agent Efficacy and Optimal Combination Sequence of Everolimus and Pasireotide LAR in Advanced Thyroid Cancer.

Julie E Bauman, Zhengjia Chen, Chao Zhang, James P Ohr, Robert L Ferris, Gerald M McGorisk, Stephen Brandt, Sumathi Srivatsa, Amy Y Chen, Conor E Steuer and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Article
  4. Review
  5. Review
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 2 institutions in 1 country.

Julie E BaumanDepartment of Medicine, Division of Hematology/Oncology, UPMC Hillman Cancer Institute, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID 0000-0002-1398-6636
Zhengjia ChenWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA.
Chao ZhangWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA.
James P OhrDepartment of Medicine, Division of Hematology/Oncology, UPMC Hillman Cancer Institute, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Robert L FerrisDepartment of Otolaryngology, Hillman Cancer Institute, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Gerald M McGoriskDepartment of Medicine, Division of Cardiology, Emory University, Atlanta, GA 30322, USA.
Stephen BrandtDepartment of Medicine, Division of Endocrinology, Emory University, Atlanta, GA 30322, USA.
Sumathi SrivatsaDepartment of Medicine, Division of Endocrinology, Emory University, Atlanta, GA 30322, USA.
Amy Y ChenDepartment of Otolaryngology, Emory University, Atlanta, GA 30322, USA.
Conor E SteuerDepartment of Hematology/Medical Oncology, Emory University, Atlanta, GA 30322, USA.
Dong M ShinWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA.ORCID 0000-0002-8245-4174
Nabil F SabaWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA.ORCID 0000-0003-4972-1477
Fadlo R KhuriWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA.
Taofeek K OwonikokoDepartment of Medicine, Division of Hematology/Oncology, UPMC Hillman Cancer Institute, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID 0000-0002-7724-7728
Emory University · USUPMC Hillman Cancer Center · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
Winship Cancer Institute Cancer Center Support GrantP30CA138292 · NCI · EMORY UNIVERSITY · PI Suresh S Ramalingam · 2009 to 2026
$47.5M
NCI NIH HHS P30 CA047904NCI NIH HHS P30 CA138292Novartis CRAD001LUS141T
6 · The paper itself

Abstract

purposeAberrant mTOR pathway and somatostatin receptor signaling are implicated in thyroid cancer and offer potential therapeutic targets. We assessed the clinical efficacy of everolimus and Pasireotide long-acting release (LAR) in radioiodine-refractory differentiated thyroid cancer (DTC) and medullary thyroid cancer (MTC). PATIENTS AND

methodsAdults with progressive MTC and DTC untreated or treated with no more than one systemic agent were eligible. The trial was designed to establish the most promising regimen and the optimal combination sequence. Patients were randomized to start treatment with single agent everolimus (10 mg QD; Arm A), pasireotide-LAR (60 mg intramuscular injection, Q4 weeks; Arm B), or the combination (Arm C). At initial progression (PFS1), patients on Arm A or B switched to the combination and continued until progression (PFS2). Efficacy was measured by RECIST criteria.

resultsStudy enrolled 42 patients: median age 65 years; female 17 (40.5%); White 31 (73.8%), African American 6 (14.3%), others 5 (11.9); DTC 32 (76.2%); MTC 10 (23.8%). There was no objective response by RECIST criteria across the three arms. Median and 1-year PFS1 rates were 8.3, 1.8, 8.1 months and 49.9%, 36.4%, 25.0% for Arms A, B, C, respectively. Median and 1-year PFS2 rates were 26.3, 17.5, 8.1 months and 78.4%, 70.0%, 25% for Arms A, B, C, respectively. The most frequent adverse events were anemia, stomatitis, fatigue, hyperglycemia, and hypercholesterolemia.

conclusionsThe combination of everolimus and pasireotide-LAR showed promising efficacy over single agent. The delayed combination of everolimus and pasireotide-LAR following progression on single agent everolimus appeared intriguing as a combination strategy.

Indexed as

combinationeverolimusmedullary carcinomapasireotidesomatostatin receptorthyroid cancerTOR Serine–Threonine Kinases

Identifiers

PMID35681620
PMCPMC9179856
OpenAlexW4281571090

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.