Evidence map›Paper›PMID 21750549›Full record

Trial reportBritish journal of cancer2011

Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies.

T Eisen, R Marais, A Affolter, P Lorigan, C Robert, P Corrie, C Ottensmeier, C Chevreau, D Chao, P D Nathan and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00492297 (A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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.

NCT00492297 phase2completednot on this map

A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.

TypeinterventionalSponsorBayerRan2005 to 2008Enrolled83ConditionsMelanomaArmsSorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Hypoxia-dependent drivers of melanoma progression.Journal of experimental & clinical cancer research : CR · 2021
    Review
  5. Treating Metastatic Brain Cancers With Stem Cells.Frontiers in molecular neuroscience · 2021
    Review
  6. Article
  7. Article
  8. Treatment ofTherapeutic advances in medical oncology · 2017
    Review
  9. KRAS, NRAS and BRAF mutations in colorectal cancer and melanoma.Medical oncology (Northwood, London, England) · 2017
    Review
  10. Oncoimmunology · 2015
    Article
  11. Review
  12. Emerging targeted therapies for melanoma treatment (review).International journal of oncology · 2014
    Review
  13. Article
  14. Review
  15. Review
  16. 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

20 authors at 14 institutions in 4 countries.

T EisenDepartment of Oncology (R4), Cambridge Biomedical Research Centre, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK. tgqe2@cam.ac.uk
R Marais
A Affolter
P Lorigan
C Robert
P Corrie
C Ottensmeier
C Chevreau
D Chao
P D Nathan
T Jouary
M Harries
S Negrier
E Montegriffo
T Ahmad
I Gibbens
M G James
U P Strauss
S Prendergast
M E Gore
Addenbrooke's Hospital · GBBayer (United Kingdom) · GBInstitute of Cancer Research · GBRoyal Marsden Hospital · GBRoyal Marsden NHS Foundation Trust · GBBayer (Germany) · DECentre Léon Bérard · FRHôpital Saint-André · FRInstitut Claudius Regaud · FRInstitut Gustave Roussy · FRMount Vernon Cancer Centre · GBSt Thomas' Hospital · GBThe Christie Hospital · GBThe Royal Free Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

methodThe safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study.

resultsIn the phase I study, three patients were treated with sorafenib 200 mg twice daily (b.i.d.) plus 1000 mg m(-2) dacarbazine on day 1 of a 21-day cycle and 15 patients had the sorafenib dose escalated to 400 mg b.i.d. without reaching the maximum tolerated dose of the combination. In the phase II study (n=83), the overall response rate was 12% (95% CI: 6, 21): one complete and nine partial, with median response duration of 46.7 weeks. Stable disease was the best response in 37%; median duration was 13.3 weeks. Median overall survival (OS) was 37.0 weeks (95% CI: 33.9, 46.0).

conclusionOral sorafenib combined with dacarbazine had acceptable toxicity and some antineoplastic activity against metastatic melanoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzenesulfonatesDacarbazineDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMaleMaximum Tolerated DoseMelanomaMiddle AgedNeoplasm MetastasisNiacinamidePhenylurea CompoundsBenzenesulfonatesDacarbazineNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID21750549
PMCPMC3172912
OpenAlexW2033457081

What OpenQuestion holds

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Registered trials

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.