Evidence map›Paper›PMID 24705492›Full record

Trial reportBlood2014

Eradication of bone marrow minimal residual disease may prompt early treatment discontinuation in CLL.

Paolo Strati, Michael J Keating, Susan M O'Brien, Jan Burger, Alessandra Ferrajoli, Nitin Jain, Francesco Paolo Tambaro, Zeev Estrov, Jeffrey Jorgensen, Pramoda Challagundla and 2 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00759798 (Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
9.6field-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.

NCT00759798 phase2completednot on this map

Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2008 to 2020Enrolled289ConditionsChronic Lymphocytic Leukemia, LeukemiaArmsFludarabine, Cyclophosphamide, Rituximab
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 141 citations in OpenAlex.

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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Paolo StratiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Michael J KeatingDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Susan M O'BrienDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Jan BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Francesco Paolo TambaroDipartimento di Patologia Generale, Seconda Università degli Studi di Napoli, Napoli, Italy; and.
Zeev EstrovDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
Jeffrey JorgensenDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Pramoda ChallagundlaDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Stefan H FaderlDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
William G WierdaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;
The University of Texas MD Anderson Cancer Center · USUniversity of Naples Federico II · IT

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
NCI NIH HHS P01 CA081534NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

The high complete remission rate with first-line combined fludarabine, cyclophosphamide, and rituximab (FCR) begs the question of the value of minimal residual disease (MRD)-negative status as a treatment end point. We report on 237 patients with chronic lymphocytic leukemia who received first-line FCR. MRD was prospectively assessed by 4-color flow cytometry in bone marrow after course 3 and at final response assessment. After course 3 and at final response assessment, 17% and 43% of patients were MRD negative in bone marrow, respectively. A mutated immunoglobulin heavy chain variable gene and trisomy 12 were independently associated with MRD-negative status both after 3 courses of FCR and at final response assessment in multivariable analyses (MVAs). MRD-negative status was independently associated with significantly longer progression-free survival (PFS) and overall survival (OS) in MVA (P = .03 and .02, respectively). This association was confirmed also on landmark MVA at the time of MRD assessment (P = .04 and .05, respectively). MRD-negative patients had comparable PFS and OS, independent of the number of courses received or interim staging. Early MRD eradication may be a desirable goal, prompting consideration of early discontinuation of treatment. This trial was registered at www.clinicaltrials.gov as #NCT00759798.

Indexed as

Withholding TreatmentAdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBone MarrowCyclophosphamideDisease-Free SurvivalFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm, ResidualRemission InductionAntibodies, Monoclonal, Murine-DerivedCyclophosphamidefludarabineRituximabVidarabine

Identifiers

PMID24705492
PMCPMC4067501
OpenAlexW2057432590

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.