Evidence map›Paper›PMID 21707585›Full record

Trial reportBritish journal of haematology2011

Biweekly rituximab, cyclophosphamide, vincristine, non-pegylated liposome-encapsulated doxorubicin and prednisone (R-COMP-14) in elderly patients with poor-risk diffuse large B-cell lymphoma and moderate to high 'life threat' impact cardiopathy.

Gaetano Corazzelli, Ferdinando Frigeri, Manuela Arcamone, Anna Lucania, Maria Rosariavilla, Emanuela Morelli, Alfonso Amore, Gaetana Capobianco, Antonietta Caronna, Cristina Becchimanzi and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of haematology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02428751 (Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 7% 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.

NCT02428751 phase3unknown statusnot on this mapstarted 2015, after this paper: background citation

Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study

TypeinterventionalSponsorWenqi JiangRan2015 to 2020Enrolled216ConditionsLymphoma, Large B-Cell, DiffuseArmsPegylated liposomal doxorubicin, Doxorubicin, Rituximab, Cyclophophamide, Vincristine
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

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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

16 authors at 2 institutions in 2 countries.

Gaetano CorazzelliHaematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione G. Pascale, IRCCS, Naples, Italy. g.corazzelli@istitutotumori.na.it
Ferdinando Frigeri
Manuela Arcamone
Anna Lucania
Maria Rosariavilla
Emanuela Morelli
Alfonso Amore
Gaetana Capobianco
Antonietta Caronna
Cristina Becchimanzi
Francesco Volzone
Gianpaolo Marcacci
Filippo Russo
Rosaria De Filippi
Lucia Mastrullo
Antonio Pinto
Cancer Institute (WIA) · INOspedale S.Gennaro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This Phase II study assessed feasibility and efficacy of a biweekly R-COMP-14 regimen (rituximab, cyclophosphamide, non-pegylated liposome-encapsulated doxorubicin, vincristine and prednisone) in untreated elderly patients with poor-risk diffuse large B-cell lymphoma (DLBCL) and moderate to high 'life threat' impact NIA/NCI cardiac comorbidity. A total of 208 courses were delivered, with close cardiac monitoring, to 41 patients (median age: 73years, range: 62-82; 37% >75years) at a median interval of 15·6 (range, 13-29) days; 67% completed all six scheduled courses. Response rate was 73%, with 68% complete responses (CR); 4-year disease-free survival (DFS) and time to treatment failure (TTF) were 72% and 49%, respectively. Failures were due to early death (n=3), therapy discontinuations (no-response n=2; toxicity n=6), relapse (n=6) and death in CR (n=3). Incidence of cardiac grade 3-5 adverse events was 7/41 (17%; 95% confidence interval: 8-31%). Time to progression and overall survival at 4-years were 77% and 67%, respectively. The Age-adjusted Charlson Comorbidity Index (aaCCI) correlated with failures (P=0·007) with patients scoring ≤7 having a longer TTF (66% vs. 29%; P=0·009). R-COMP-14 is feasible and ensures a substantial DFS to poor-risk DLBCL patients who would have been denied anthracycline-based treatment due to cardiac morbidity. The aaCCI predicted both treatment discontinuation rate and TTF.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsComorbidityCyclophosphamideDoxorubicinFemaleHeart DiseasesHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPolyethylene GlycolsPrednisonePrognosisAntibodies, Monoclonal, Murine-DerivedCyclophosphamideDoxorubicinliposomal doxorubicinPolyethylene GlycolsPrednisoneRituximabVincristine

Identifiers

PMID21707585
PMCPMC3258483
OpenAlexW1813126099

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.