Evidence map›Paper›PMID 25605745›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2015

Utility of ¹⁸fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma.

S Horwitz, B Coiffier, F Foss, H M Prince, L Sokol, M Greenwood, D Caballero, F Morschhauser, L Pinter-Brown, S P Iyer and 5 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00426764 (A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT00426764 phase2completednot on this map

A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)

TypeinterventionalSponsorCelgeneRan2007 to 2018Enrolled131ConditionsPeripheral T-cell LymphomaArmsRomidepsin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

15 authors.

S HorwitzLymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA. Electronic address: horwitzs@mskcc.org.
B CoiffierDepartment of Hematology, Hospices Civils de Lyon, Lyon, France.
F FossHematology Department, Yale Cancer Center, New Haven, USA.
H M PrinceDivision of Cancer Medicine, Department of Haematology, Peter MacCallum Cancer Centre and University of Melbourne, Australia.
L SokolDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, USA.
M GreenwoodDepartment of Haematology, Royal North Shore Hospital, Sydney, Australia.
D CaballeroHematology Department, Hospital Universitario de Salamanca, Salamanca, Spain.
F MorschhauserDepartment of Hematology, Hôpital Claude Huriez, CHU de Lille, France.
L Pinter-BrownDivision of Hematology-Oncology, UCLA Medical Center, Los Angeles.
S P IyerMalignant Hematology, Houston Methodist Cancer Center, Houston.
A ShustovDivision of Hematology, University of Washington, Seattle.
J NicholsJNichols LLC, Swampscott.
J BalserVeristat, LLC, Holliston.
B BalserVeristat, LLC, Holliston.
B ProDivision of Hematology, Thomas Jefferson University, Philadelphia, USA.

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

backgroundFor patients with peripheral T-cell lymphoma (PTCL), the value of (18)fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a planned exploratory end point in the pivotal phase 2 trial of romidepsin for the treatment of relapsed/refractory PTCL. PATIENTS AND

methodsPatients received romidepsin at a dose of 14 mg/m(2) on days 1, 8, and 15 of 28-day cycles. The primary end point was the rate of confirmed/unconfirmed complete response (CR/CRu) as assessed by International Workshop Criteria (IWC) using conventional radiology. For the exploratory PET end point, patients with at least baseline FDG-PET scans were assessed by IWC + PET criteria.

resultsOf 130 patients, 110 had baseline FDG-PET scans, and 105 were PET positive at baseline. The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology. Durations of response were well differentiated by both conventional radiology response criteria [CR/CRu versus partial response (PR), P = 0.0001] and PET status (negative versus positive, P < 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively, P = 0.6427). When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923).

conclusionsRoutine use of FDG-PET does not obviate conventional staging, but may aid in determining prognosis and refine response assessments for patients with PTCL, particularly for those who do not achieve CR/CRu by conventional staging. The optimal way to incorporate FDG-PET scans for patients with PTCL remains to be determined.

trial registrationNCT00426764.

Indexed as

Antibiotics, AntineoplasticDepsipeptidesDrug Resistance, NeoplasmFluorodeoxyglucose F18Follow-Up StudiesHumansLymphoma, T-Cell, PeripheralNeoplasm StagingPositron-Emission TomographyPrognosisProspective StudiesRadiopharmaceuticalsRemission InductionSurvival RateTissue DistributionAntibiotics, AntineoplasticDepsipeptidesFluorodeoxyglucose F18Radiopharmaceuticalsromidepsinhistone deacetylase inhibitorperipheral T-cell lymphomapositron emission tomographyradiologyromidepsin

Identifiers

PMID25605745
PMCPMC4374388

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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.