Evidence map›Paper›PMID 20203173›Full record

Trial reportThe oncologist2010

Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06).

Dieter Koeberle, Michael Montemurro, Panagiotis Samaras, Pietro Majno, Mathew Simcock, Andreas Limacher, Stefanie Lerch, Katalin Kovàcs, Roman Inauen, Vivianne Hess and 4 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT00514228 phase2completednot on this map

Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial

TypeinterventionalSponsorSwiss Cancer InstituteRan2007 to 2009Enrolled45ConditionsLiver CancerArmssunitinib malate
NCT00699374 phase3terminatednot on this map

A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled1,075ConditionsCarcinoma, HepatocellularArmssunitinib malate, sorafenib
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 92 citations in OpenAlex.

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  15. Clinical trials of antiangiogenic therapy for hepatocellular carcinoma.International journal of clinical oncology · 2016
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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 9 institutions in 2 countries.

Dieter KoeberleDepartment of Internal Medicine, Division Oncology/Hematology, Kantonsspital St. Gallen, CH-9007 St. Gallen, Switzerland. dieter.koeberle@kssg.ch
Michael Montemurro
Panagiotis Samaras
Pietro Majno
Mathew Simcock
Andreas Limacher
Stefanie Lerch
Katalin Kovàcs
Roman Inauen
Vivianne Hess
Piercarlo Saletti
Markus Borner
Arnaud Roth
György Bodoky
Swiss Group For Clinical Cancer Research · CHKantonsspital St. Gallen · CHUnified Szent István and Szent László Hospital · HUUniversity Hospital of Geneva · CHInstitute of Oncology Research · CHUniversity Hospital of Basel · CHUniversity Hospital of Bern · CHUniversity Hospital of Zurich · CHUniversity of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSunitinib (SU) is a multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activity. The objective of this trial was to demonstrate antitumor activity of continuous SU treatment in patients with hepatocellular carcinoma (HCC). PATIENTS AND

methodsKey eligibility criteria included unresectable or metastatic HCC, no prior systemic anticancer treatment, measurable disease, and Child-Pugh class A or mild Child-Pugh class B liver dysfunction. Patients received 37.5 mg SU daily until progression or unacceptable toxicity. The primary endpoint was progression-free survival at 12 weeks (PFS12).

resultsForty-five patients were enrolled. The median age was 63 years; 89% had Child-Pugh class A disease and 47% had distant metastases. PFS12 was rated successful in 15 patients (33%; 95% confidence interval, 20%-47%). Over the whole trial period, one complete response and a 40% rate of stable disease as the best response were achieved. The median PFS duration, disease stabilization duration, time to progression, and overall survival time were 1.5, 2.9, 1.5, and 9.3 months, respectively. Grade 3 and 4 adverse events were infrequent. None of the 33 deaths were considered drug related.

conclusionContinuous SU treatment with 37.5 mg daily is feasible and has moderate activity in patients with advanced HCC and mild to moderately impaired liver dysfunction. Under this trial design (>13 PFS12 successes), the therapy is considered promising. This is the first trial describing the clinical effects of continuous dosing of SU in HCC patients on a schedule that is used in an ongoing, randomized, phase III trial in comparison with the current treatment standard, sorafenib (ClinicalTrials.gov identifier, NCT00699374).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularDisease-Free SurvivalFemaleHumansIndolesLiver NeoplasmsMaleMiddle AgedPyrrolesSunitinibTreatment OutcomeAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID20203173
PMCPMC3227954
OpenAlexW2100297634

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.