Evidence map›Paper›PMID 23226204›Full record

Trial reportPloS one2012

Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512.

Shailender Bhatia, James Moon, Kim A Margolin, Jeffrey S Weber, Christopher D Lao, Megan Othus, Ana M Aparicio, Antoni Ribas, Vernon K Sondak

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

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 6% 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

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
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  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Hypoxia-dependent drivers of melanoma progression.Journal of experimental & clinical cancer research : CR · 2021
    Review
  18. Article
  19. Review
  20. Accounting for All Patients in Waterfall Plots.JCO clinical cancer informatics · 2021
    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

9 authors at 7 institutions in 1 country.

Shailender BhatiaMedical Oncology, University of Washington, Seattle, WA, USA. sbhatia@uw.edu
James Moon
Kim A Margolin
Jeffrey S Weber
Christopher D Lao
Megan Othus
Ana M Aparicio
Antoni Ribas
Vernon K Sondak
Cancer Research And Biostatistics · USUniversity of Washington Medical Center · USMichigan United · USMoffitt Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Los Angeles · USUniversity of South Florida · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
SOUTHWEST ONCOLOGY GROUPU10CA020319 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI GOODMAN, GARY E · 1985 to 2013
$5.1M
SOUTHWEST ONCOLOGY GROUPU10CA027057 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SCHOTT, ANNE F · 1985 to 2013
$4.0M
UNIVERSITY OF COLORADO-SOUTHWEST ONCOLOGY GROUPU10CA042777 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 1988 to 2013
$3.2M
SOUTHWEST ONCOLOGY GROUPU10CA004919 · NCI · CLEVELAND CLINIC LERNER COM-CWRU · PI BUDD, GEORGE THOMAS · 1985 to 2009
$2.2M
SOUTHWEST ONCOLOGY GROUP (UTAH)U10CA058861 · NCI · UNIVERSITY OF UTAH · PI SAMLOWSKI, WOLFRAM E · 1993 to 2003
$1.1M
SOUTHWEST ONCOLOGY GROUPU10CA076429 · NCI · UNIVERSITY OF CINCINNATI · PI JAZIEH, ABDUL-RAHMAN · 1998 to 2003
$161k
NCI NIH HHS CA04919NCI NIH HHS CA20319NCI NIH HHS CA27057NCI NIH HHS CA32102NCI NIH HHS CA35178NCI NIH HHS CA38926NCI NIH HHS CA42777NCI NIH HHS CA58861NCI NIH HHS CA76429NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA038926NCI NIH HHS P30 CA015704NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA058861
6 · The paper itself

Abstract

backgroundSorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, inhibits the mitogen-activated protein kinase pathway that is activated in most uveal melanoma tumors. This phase II study was conducted by the SWOG cooperative group to evaluate the efficacy of sorafenib in combination with carboplatin and paclitaxel (CP) in metastatic uveal melanoma.

methodsTwenty-five patients with stage IV uveal melanoma who had received 0-1 prior systemic therapy were enrolled. Treatment included up to 6 cycles of carboplatin (AUC = 6) and paclitaxel (225 mg/m(2)) administered IV on day 1 plus sorafenib (400 mg PO twice daily), followed by sorafenib monotherapy until disease progression. The primary endpoint was objective response rate (ORR); a two-stage design was used with the study to be terminated if no confirmed responses were observed in the first 20 evaluable patients. Secondary efficacy endpoints included progression-free survival (PFS) and overall survival (OS).

resultsNo confirmed objective responses occurred among the 24 evaluable patients (ORR = 0% [95% CI: 0-14%]) and the study was terminated at the first stage. Minor responses (tumor regression less than 30%) were seen in eleven of 24 (45%) patients. The median PFS was 4 months [95% CI: 1-6 months] and the 6-month PFS was 29% [95% CI: 13%-48%]. The median OS was 11 months [95% CI: 7-14 months].

conclusionIn this study, the overall efficacy of CP plus sorafenib in metastatic uveal melanoma did not warrant further clinical testing when assessed by ORR, although minor tumor responses and stable disease were observed in some patients.

trial registrationClinicalTrials.govNCT00329641.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasm MetastasisAgedBiomarkers, PharmacologicalCarboplatinDisease-Free SurvivalDrug Administration ScheduleEye NeoplasmsFemaleHumansInjections, IntravenousMaleMelanomaMiddle AgedNeoplasm StagingNiacinamideBiomarkers, PharmacologicalCarboplatinNiacinamidePaclitaxelPhenylurea CompoundsSorafenib

Identifiers

PMID23226204
PMCPMC3511501
OpenAlexW2000255330

What OpenQuestion holds

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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.