Evidence map›Paper›PMID 22805325›Full record

ArticleBritish journal of cancer2012

Phase I study investigating the safety and feasibility of combining imatinib mesylate (Gleevec) with sorafenib in patients with refractory castration-resistant prostate cancer.

C Nabhan, D Villines, T V Valdez, K Tolzien, T M Lestingi, J D Bitran, S M Christner, M J Egorin, J H Beumer

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

Article in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 18% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Tr-KIT/c-KIT ratio in renal cell carcinoma.Molecular biology reports · 2019
    Article
  4. The stem cell factor (SCF)/c-KIT signalling in testis and prostate cancer.Journal of cell communication and signaling · 2017
    Article
  5. Article
  6. Article
  7. Ageing is a risk factor in imatinib mesylate cardiotoxicity.European journal of heart failure · 2014
    Article
  8. Novel therapeutic approaches for the treatment of castration-resistant prostate cancer.The Journal of steroid biochemistry and molecular biology · 2013
    Review
  9. 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

9 authors at 2 institutions in 1 country.

C NabhanDepartment of Medicine, Division of Hematology and Oncology, Advocate Lutheran General Hospital, Park Ridge, IL, USA. cnabhan@oncmed.net
D Villines
T V Valdez
K Tolzien
T M Lestingi
J D Bitran
S M Christner
M J Egorin
J H Beumer
Advocate Lutheran General Hospital · USUPMC Hillman Cancer Center · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA047904NCI NIH HHS P30-CA47904
6 · The paper itself

Abstract

backgroundDetermining the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of sorafenib (S) plus imatinib (IM) in castration-resistant prostate cancer (CRPC) patients.

methodsRefractory CRPC patients were enrolled onto this 3+3 dose escalation designed study. Imatinib pharmacokinetics (PK) were determined on day 15, 4 h post dose with a validated LC-MS assay.

resultsSeventeen patients were enrolled; 10 evaluable (6 at 400 mg S qd with 300 mg IM qd (DL0) and 4 at 400 mg S bid with 300 mg IM qd (DL1)); inevaluable patients received <1 cycle. The median age was 73 (57-89); median prostatic serum antigen was 284 ng ml(-1) (11.7-9027). Median number of prior non-hormonal therapies was 3 (1-12). Dose-limiting toxicities were diarrhoea and hand-foot syndrome. Maximum tolerated dose was 400 mg S and 300 mg IM both daily. No biochemical responses were observed. Two patients had stable disease by RECIST. Median time to progression was 2 months (1-5). Median OS was 6 months (1-30+) with 3/17 patients (17%) alive at 21 months median follow-up. Ten patients had PK data suggesting that S reduced IM clearance by 55%, resulting in 77% increased exposure (P=0.005; compared with historical data).

conclusionThis is the first report showing that S+IM can be administered in CRPC at a dose of 400 mg S and 300 mg IM, daily.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBenzenesulfonatesCastrationDrug Administration ScheduleHumansImatinib MesylateMaleMaximum Tolerated DoseMiddle AgedNiacinamidePhenylurea CompoundsPiperazinesBenzamidesBenzenesulfonatesImatinib MesylateNiacinamidePhenylurea CompoundsPiperazinesPyridinesPyrimidinesSorafenib

Identifiers

PMID22805325
PMCPMC3419960
OpenAlexW2087781978

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.