Evidence map›Paper›PMID 25445468›Full record

Trial reportClinical lymphoma, myeloma & leukemia2015

Pegylated liposomal doxorubicin replacing conventional doxorubicin in standard R-CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma: an open label, single arm, phase II trial.

Yasuhiro Oki, Michael S Ewer, Daniel J Lenihan, Michael J Fisch, Fredrick B Hagemeister, Michelle Fanale, Jorge Romaguera, Barbara Pro, Nathan Fowler, Anas Younes and 10 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  8. Review
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  12. Cardio-oncology in the older adult.Journal of geriatric oncology · 2017
    Review
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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

20 authors at 3 institutions in 1 country.

Yasuhiro OkiDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: yoki@mdanderson.org.
Michael S EwerDepartment of Cardiology, University of Texas MD Anderson Cancer Center, Houston, TX.
Daniel J LenihanDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TN.
Michael J FischDepartment of General Oncology, University of Texas MD Anderson Cancer Center, Houston, TX.
Fredrick B HagemeisterDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Michelle FanaleDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Jorge RomagueraDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Barbara ProDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Nathan FowlerDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Anas YounesDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Alan B AstrowDivision of Hematology/Oncology, Department of Medicine, Maimonides Medical Center, Brooklyn, NY.
Xuelin HuangDepartment of Biomathematics, University of Texas MD Anderson Cancer Center, Houston, TX.
Larry W KwakDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Felipe SamaniegoDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Peter McLaughlinDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Sattva S NeelapuDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Michael WangDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Luis E FayadDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
Jean-Bernard DurandDepartment of Cardiology, University of Texas MD Anderson Cancer Center, Houston, TX.
M Alma RodriguezDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
The University of Texas MD Anderson Cancer Center · USMaimonides Medical Center · USVanderbilt University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KONOPLEVA, MARINA Y · 2003 to 2023
$43.7M
UT MD Anderson Research Base - Foreign AccrualU10CA045809 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI WOLFF, ROBERT · 1987 to 2013
$21.3M
NCI NIH HHS CA045809NCI NIH HHS CA16672NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632NCI NIH HHS U10 CA045809
6 · The paper itself

Abstract

backgroundThe present multicenter phase II trial evaluated the safety and efficacy of pegylated liposomal doxorubicin (PLD) instead of conventional doxorubicin in standard R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine [Oncovin], and prednisone) therapy for elderly patients with diffuse large B-cell lymphoma. MATERIALS AND

methodsPatients aged > 60 years who had stage II to IV disease were included. Treatment consisted of rituximab 375 mg/m(2) intravenously (I.V.); cyclophosphamide 750 mg/m(2) IV; PLD 40 mg/m(2) (maximum, 90 mg) I.V. over 1 hour; and vincristine 2.0 mg I.V., all on day 1. Additionally prednisone, 40 mg/m(2), was given orally on days 1 to 1 to 5 (DRCOP [rituximab, cyclophosphamide, PLD, vincristine, and prednisone]). The cycles were repeated every 3 weeks for 6 to 8 cycles.

resultsEighty patients were enrolled and were evaluable for toxicity. The median age was 69 years. All except 1 had additional cardiac risk factors for anthracycline-induced cardiac toxicity beyond advanced age. From the intent-to-treat analysis of 79 eligible patients, the overall response rate was 86%, and the complete response rate was 78%. Cardiac events greater than grade 3 were identified in 3 patients (4%); grade 1 to 2 events, mostly asymptomatic declines in ejection fraction, were noted in another 16 patients. One death was attributed to cardiac failure. The estimated 5-year event-free and overall survival rate was 52% and 70%, respectively.

conclusionDRCOP represents an effective strategy for potentially mitigating cardiotoxicity in elderly patients with aggressive B-cell lymphoma. Future studies incorporating baseline cardiac risk assessments, long-term follow-up data, and biospecimen collection for correlative science should be undertaken.

Indexed as

AgedAged, 80 and overAge FactorsAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsComorbidityCyclophosphamideDisease ProgressionDoxorubicinDrug SubstitutionFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymphoma, Large B-Cell, DiffuseMaleAntibodies, Monoclonal, Murine-DerivedCyclophosphamideDoxorubicinliposomal doxorubicinPolyethylene GlycolsPrednisoneR-CHOP protocolRituximabVincristineAnthracyclineCardiac toxicityDiffuse large B-cell lymphomaElderly patientsPegylated liposomal doxorubicin

Identifiers

PMID25445468
PMCPMC4344896
OpenAlexW2033242559

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Registered trials

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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.