Evidence map›Paper›PMID 27213589›Full record

ArticleOncotarget2016

Phase I study of pemetrexed with sorafenib in advanced solid tumors.

Andrew Poklepovic, Sarah Gordon, Danielle A Shafer, John D Roberts, Prithviraj Bose, Charles E Geyer, William P McGuire, Mary Beth Tombes, Ellen Shrader, Katie Strickler and 7 more

Open access · diamondAbstract readClinical Trial, Phase I
In one paragraph

Article in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
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

17 authors at 2 institutions in 1 country.

Andrew PoklepovicDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Sarah GordonDepartments of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
Danielle A ShaferDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
John D RobertsDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Prithviraj BoseDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Charles E GeyerDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
William P McGuireDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Mary Beth TombesDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Ellen ShraderDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Katie StricklerDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Maria QuigleyDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Wen WanDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Maciej KmieciakDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
H Davis MasseyDepartments of Pathology, Virginia Commonwealth University, Richmond, Virginia, USA.
Laurence BoothDepartments of Biochemistry and Molecular Biology, Virginia Commonwealth University, Richmond, Virginia, USA.
Richard G MoranDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Paul DentDepartments of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Virginia Commonwealth University · USYale University · US

Funding

Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
Pemetrexed and sildenafil for lung cancerR01CA192613 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI DENT, PAUL · 2015 to 2019
$1.6M
NCATS NIH HHS UL1 TR000058NCI NIH HHS R01 CA192613
6 · The paper itself

Abstract

purposeTo determine if combination treatment with pemetrexed and sorafenib is safe and tolerable in patients with advanced solid tumors.

resultsThirty-seven patients were enrolled and 36 patients were treated (24 in cohort A; 12 in cohort B). The cohort A dose schedule resulted in problematic cumulative toxicity, while the cohort B dose schedule was found to be more tolerable. The maximum tolerated dose (MTD) was pemetrexed 750 mg/m2 every 14 days with oral sorafenib 400 mg given twice daily on days 1-5. Because dosing delays and modifications were associated with the MTD, the recommended phase II dose was declared to be pemetrexed 500 mg/m2 every 14 days with oral sorafenib 400 mg given twice daily on days 1-5. Thirty-three patients were evaluated for antitumor activity. One complete response and 4 partial responses were observed (15% overall response rate). Stable disease was seen in 15 patients (45%). Four patients had a continued response at 6 months, including 2 of 5 patients with triple-negative breast cancer. EXPERIMENTAL

designA phase I trial employing a standard 3 + 3 design was conducted in patients with advanced solid tumors. Cohort A involved a novel dose escalation schema exploring doses of pemetrexed every 14 days with continuous sorafenib. Cohort B involved a modified schedule of sorafenib dosing on days 1-5 of each 14-day pemetrexed cycle. Radiographic assessments were conducted every 8 weeks.

conclusionsPemetrexed and intermittent sorafenib therapy is a safe and tolerable combination for patients, with promising activity seen in patients with breast cancer.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCohort StudiesFemaleHumansInflammationMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNiacinamidePemetrexedPhenylurea CompoundsAntineoplastic AgentsBiomarkers, TumorNiacinamidePemetrexedPhenylurea CompoundsPTEN PhosphohydrolasePTEN protein, humanSorafenibclinical trialpemetrexedsolid tumorssorafenib

Identifiers

PMID27213589
PMCPMC5173162
OpenAlexW2406454314

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.