Evidence map›Paper›PMID 27544129›Full record

Trial reportBMC cancer2016

SPARC expression in patients with high-risk localized soft tissue sarcoma treated on a randomized phase II trial of neo/adjuvant chemotherapy.

Elizabeth J Davis, Lili Zhao, David R Lucas, Scott M Schuetze, Laurence H Baker, Mark M Zalupski, Dafydd Thomas, Rashmi Chugh

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00189137 (Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 32% 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.

NCT00189137 phase2completednot on this map

Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2004 to 2015Enrolled84ConditionsSarcoma, Soft TissueArmsifosfamide and doxorubicin vs gemcitabine and docetaxel
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

8 authors at 2 institutions in 1 country.

Elizabeth J DavisDivision of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA. davieliz@med.umich.edu.
Lili ZhaoDepartment of Biostatistics, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
David R LucasDepartment of Pathology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
Scott M SchuetzeDivision of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
Laurence H BakerDivision of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
Mark M ZalupskiDivision of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
Dafydd ThomasDepartment of Pathology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
Rashmi ChughDivision of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.
University of Michigan–Ann Arbor · USMichigan Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment for localized soft tissue sarcoma includes surgery and radiation, while the role of chemotherapy is controversial. Biomarkers that could predict therapeutic response or prognosticate overall survival (OS) are needed to define patients most likely to benefit from systemic treatment. Serum protein acidic and rich in cysteine (SPARC) is a matricellular glycoprotein that has been evaluated as a potential biomarker in numerous malignancies given its involvement in cell adhesion, proliferation, migration, and tissue remodeling.

methodsUsing primary biopsy and resection specimens from patients with high-risk localized, soft tissue sarcoma treated on a neo/adjuvant chemotherapy study, SPARC expression was assessed and compared to patient and tumor characteristics, treatment, and outcomes. Survival functions were estimated using the Kaplan-Meier method and compared using the log-rank test. The Cox model was used for multivariate analysis.

resultsFifty patients had primary tumor specimens available. High, low, and no SPARC expression was found in 22, 13, and 15 patients, respectively. There was no significant difference in time to recurrence or OS between patients in these three groups. Comparing lack of SPARC expression with any SPARC expression, there was no significant difference in time to recurrence in patients without SPARC expression (n = 15) compared to patients with SPARC expression (n = 35). Likewise, there was no statistically significant difference in OS in patients without SPARC expression versus patients whose tumors expressed SPARC.

conclusionsAlthough we did not find a statistically significant difference in time to recurrence and OS in patients with high-risk soft tissue sarcoma, we did identify a trend toward improved time to recurrence and OS in patients whose tumors lacked SPARC expression. However, SPARC did not demonstrate the ability to discern which high-risk patients may have a worse prognosis or greater benefit from chemotherapy.

trial registrationThe trial was registered on September 13, 2005 with ClinicalTrials.gov, number https://clinicaltrials.gov/ct2/show/NCT00189137?term=sarcoma&id=NCT00189137&state1=NA%3AUS%3AMI&phase=1&rank=1 .

Indexed as

AdultAgedAged, 80 and overBiomarkers, TumorChemotherapy, AdjuvantDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansMaleMiddle AgedOsteonectinPrognosisSarcomaSurvival AnalysisTreatment OutcomeBiomarkers, TumorOsteonectinSPARC protein, humanBiomarkerChemotherapySoft tissue sarcomaSPARC

Identifiers

PMID27544129
PMCPMC4992190
OpenAlexW2514751924

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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.