Evidence map›Paper›PMID 19862815›Full record

Trial reportCancer2010

Upfront, randomized, phase 2 trial of sorafenib versus sorafenib and low-dose interferon alfa in patients with advanced renal cell carcinoma: clinical and biomarker analysis.

Eric Jonasch, Paul Corn, Lance C Pagliaro, Carla L Warneke, Marcella M Johnson, Pheroze Tamboli, Chaan Ng, Ana Aparicio, Robynne G Ashe, John J Wright and 1 more

Abstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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

61 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
    Pooled it
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  5. Immunotherapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2017
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  12. Targeted therapy for advanced renal cell carcinoma.The Cochrane database of systematic reviews · 2008
    Pooled it
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  14. Trial
  15. A randomized phase 2 study of MK-2206 versus everolimus in refractory renal cell carcinoma.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Eric JonaschDepartment of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. ejonasch@mdanderson.org
Paul Corn
Lance C Pagliaro
Carla L Warneke
Marcella M Johnson
Pheroze Tamboli
Chaan Ng
Ana Aparicio
Robynne G Ashe
John J Wright
Nizar M Tannir

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThe objective of this study was to independently evaluate the objective response rate of sorafenib and sorafenib plus low-dose interferon-alfa 2b (IFN) as frontline therapy in patients with metastatic renal cell carcinoma (mRCC).

methodsUntreated patients with clear cell mRCC were randomized to receive sorafenib 400 mg orally twice daily or sorafenib 400 mg orally twice daily plus subcutaneous IFN 0.5 million U (MU) twice daily. Primary endpoints included the objective response rate (ORR) and safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Exploratory endpoints included the predictive value of tumor tissue biomarkers.

resultsEighty patients were enrolled. The median follow-up was 19.7 months (range, 0-34.2 months). The ORR was 30% (95% confidence interval [CI], 16.6%-46.5%) in the sorafenib arm and 25% (95% CI, 12.7%-41.2%) in the combination arm. The median PFS was 7.39 months in the sorafenib-alone arm (95% CI, 5.52-9.20 months) and 7.56 months in the sorafenib plus IFN arm (95% CI, 5.19-11.07 months). The median OS was 27.04 months in the combination arm (95% CI, from 22.31 to not attained) and was not reached in the sorafenib arm. Toxicities were comparable in both arms. In a multivariate model, increased phosphorylated protein kinase B (pAKT) levels were associated with poorer PFS (hazard ratio, 1.04; 95% CI, 1.00-1.08; P = .0411) and OS (hazard ratio, 1.15; 95% CI, 1.02-1.29; P = .0173).

conclusionsThe addition of low-dose IFN to sorafenib resulted in efficacy outcomes that were comparable to those achieved with sorafenib monotherapy. The current results indicated that pAKT levels may predict for clinical outcome, but further mechanistic study is required.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzenesulfonatesBiomarkers, TumorCarcinoma, Renal CellDisease-Free SurvivalFemaleHumansInterferon-alphaKidney NeoplasmsMaleMiddle AgedNiacinamidePhenylurea CompoundsPyridinesBenzenesulfonatesBiomarkers, TumorInterferon-alphaNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID19862815
PMCPMC4636203

What OpenQuestion holds

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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.