Evidence map›Paper›PMID 26218678›Full record

Trial reportCancer2015

Fludarabine, cyclophosphamide, and multiple-dose rituximab as frontline therapy for chronic lymphocytic leukemia.

Nicholas J Short, Michael J Keating, William G Wierda, Stefan Faderl, Alessandra Ferrajoli, Zeev Estrov, Susan C Smith, Susan M O'Brien

Open access · greenAbstract readClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Obinutuzumab for the treatment of indolent lymphoma.Future oncology (London, England) · 2016
    Review
  8. Review
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 3 institutions in 1 country.

Nicholas J ShortDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael J KeatingDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
William G WierdaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Stefan FaderlDivision of Leukemia, Hackensack University Medical Center, Hackensack, New Jersey.
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Zeev EstrovDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Susan C SmithDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Susan M O'BrienChao Family Comprehensive Cancer Center, University of California Irvine, Orange, California.
The University of Texas MD Anderson Cancer Center · USHackensack University Medical Center · USUniversity of California, Irvine · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundFludarabine, cyclophosphamide, and rituximab (FCR) result in durable responses in patients with previously untreated chronic lymphocytic leukemia (CLL). Previous reports have suggested that in patients with relapsed CLL, a dose-intensified rituximab regimen increases response rates in comparison with standard-dose rituximab. It is unknown whether rituximab intensification of the FCR regimen will result in improved response rates and patient outcomes in patients with previously untreated CLL.

methodsA single-arm study was conducted to evaluate the safety and efficacy of a modified FCR regimen with multiple-dose rituximab (FCR3) in 65 patients with previously untreated CLL. The results were compared with those for a historical cohort treated with FCR.

resultsThe overall response rate to FCR3 was 97%, with 75% of the patients achieving a complete remission. Minimal residual disease negativity was achieved for 62% of the patients according to flow cytometry. The median time to progression (TTP) was 81 months, and the median overall survival (OS) was not reached, with 58% of the patients still alive at a median survivor follow-up of 9.7 years. Grade 3 or 4 neutropenia, grade 3 or 4 thrombocytopenia, and major infections were observed with 45%, 5%, and 1.9% of the FCR3 courses, respectively. Therapy-related myelodysplastic syndrome (t-MDS) or therapy-related acute myelogenous leukemia (t-AML) developed in 7 patients (11%; P < .01 vs the historical FCR cohort).

conclusionsIn patients with previously untreated CLL, FCR3 resulted in response rates, TTP, and OS similar to those of a historical cohort of patients treated with FCR. FCR3 was associated with an increased incidence of t-MDS/t-AML.

Indexed as

AdultAgedAged, 80 and overCyclophosphamideDisease ProgressionDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedRituximabSurvival RateTreatment OutcomeCyclophosphamidefludarabineRituximabVidarabineand rituximab (FCR)chemoimmunotherapychronic lymphocytic leukemiacyclophosphamidefludarabinerituximabtherapy-related acute myelogenous leukemiatherapy-related myelodysplastic syndrome

Identifiers

PMID26218678
PMCPMC4824541
OpenAlexW1834572928

What OpenQuestion holds

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Registered trials

None linked

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.