Evidence map›Paper›PMID 19451436›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Phase II study of sorafenib in patients with metastatic or recurrent sarcomas.

Robert G Maki, David R D'Adamo, Mary L Keohan, Michael Saulle, Scott M Schuetze, Samir D Undevia, Michael B Livingston, Matthew M Cooney, Martee L Hensley, Monica M Mita and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01308034 (Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy), which is not on this map. Cited by 260 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
260citing papers in PubMed, 6 pooled it
19.5field-weighted citation impact, top 1% 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.

NCT01308034 phase1completednot on this mapstarted 2011, after this paper: background citation

Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy

TypeinterventionalSponsorCentre Leon BerardRan2011 to 2016Enrolled25ConditionsNon GIST SarcomasArmssunitinib
3 · Its place in the literature

Who cites it

260 citing papers in PubMed, 6 syntheses or guidelines pooled it, 569 citations in OpenAlex.

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  15. A phase II study of tivozanib in patients with metastatic and nonresectable soft-tissue sarcomas.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
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200 more citing papers are in PubMed but not listed here.

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 1 institution in 1 country.

Robert G MakiMelanoma-Sarcoma Program, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, Howard 909, New York, NY 10065, USA. makir@mskcc.org
David R D'Adamo
Mary L Keohan
Michael Saulle
Scott M Schuetze
Samir D Undevia
Michael B Livingston
Matthew M Cooney
Martee L Hensley
Monica M Mita
Chris H Takimoto
Andrew S Kraft
Anthony D Elias
Bruce Brockstein
Nathalie E Blachère
Mark A Edgar
Lawrence H Schwartz
Li-Xuan Qin
Cristina R Antonescu
Gary K Schwartz
Memorial Sloan Kettering Cancer Center · US

Funding

SOFT TISSUE SARCOMA PROGRAM PROJECTP01CA047179 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI LADANYI, MARC · 1989 to 2010
$17.3M
NCI NIH HHS N01 CM062202NCI NIH HHS P01 CA047179
6 · The paper itself

Abstract

PURPOSE Since activity of sorafenib was observed in sarcoma patients in a phase I study, we performed a multicenter phase II study of daily oral sorafenib in patients with recurrent or metastatic sarcoma. PATIENTS AND METHODS We employed a multiarm study design, each representing a sarcoma subtype with its own Simon optimal two-stage design. In each arm, 12 patients who received 0 to 1 prior lines of therapy were treated (0 to 3 for angiosarcoma and malignant peripheral-nerve sheath tumor). If at least one Response Evaluation Criteria in Solid Tumors (RECIST) was observed, 25 further patients with that sarcoma subtype were accrued. Results Between October 2005 and November 2007, 145 patients were treated; 144 were eligible for toxicity and 122 for response. Median age was 55 years; female-male ratio was 1.8:1. The median number of cycles was 3. Five of 37 patients with angiosarcoma had a partial response (response rate, 14%). This was the only arm to meet the RECIST response rate primary end point. Median progression-free survival was 3.2 months; median overall survival was 14.3 months. Adverse events (typically dermatological) necessitated dose reduction for 61% of patients. Statistical modeling in this limited patient cohort indicated sorafenib toxicity was correlated inversely to patient height. There was no correlation between phosphorylated extracellular signal regulated kinase expression and response in six patients with angiosarcoma with paired pre- and post-therapy biopsies. CONCLUSION As a single agent, sorafenib has activity against angiosarcoma and minimal activity against other sarcomas. Further evaluation of sorafenib in these and possibly other sarcoma subtypes appears warranted, presumably in combination with cytotoxic or kinase-specific agents.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm Recurrence, LocalNiacinamidePhenylurea CompoundsPyridinesAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID19451436
PMCPMC2716936
OpenAlexW2144530818

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.