Evidence map›Paper›PMID 32071431›Full record

Trial reportLeukemia2020

Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.

Carmen D Herling, Florence Cymbalista, Carolin Groß-Ophoff-Müller, Jasmin Bahlo, Sandra Robrecht, Petra Langerbeins, Anna-Maria Fink, Othman Al-Sawaf, Raymonde Busch, Raphael Porcher and 17 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

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  5. Lymphocyte count and risk of chronic lymphocytic leukemia.Journal of the National Cancer Institute · 2026
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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

27 authors at 12 institutions in 3 countries.

Carmen D Herling *Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.
Florence Cymbalista *Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.
Carolin Groß-Ophoff-Müller *Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Jasmin BahloDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Sandra RobrechtDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Petra LangerbeinsDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Anna-Maria FinkDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Othman Al-SawafDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0001-9895-0570
Raymonde BuschInstitute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.
Raphael PorcherCenter of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.
Bruno CazinService de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.
Brigitte DreyfusService d'Hematologie, CHU Poitiers, Poitiers, France.
Stefan IbachWiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.
Stéphane LeprêtreInserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.
Kirsten FischerDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Florian KaiserDay Clinic Hematology Oncology Palliative Care, Landshut, Germany.
Barbara EichhorstDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Clemens-Martin WentnerDepartment of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.
Manuela A HoechstetterDepartment of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.
Hartmut DöhnerDepartment of Internal Medicine III, University of Ulm, Ulm, Germany.
Veronique LeblondDepartment of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.
Michael KnebaSecond Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.
Remi LetestuHopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.
Sebastian BöttcherSecond Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.
Stephan StilgenbauerDepartment of Internal Medicine III, University of Ulm, Ulm, Germany.
Michael HallekDepartment I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Vincent LevyUnite de Recherche Clinique, Hopital Avicenne, Bobigny, France.
University of Cologne · DEAssistance Publique – Hôpitaux de Paris · FRChristian-Albrechts-Universität zu Kiel · DEMünchen Klinik Schwabing · DEUniversität Ulm · DECentre Hospitalier Universitaire de Poitiers · FRHôpital Avicenne · FRHôpital Claude Huriez · FRHôtel-Dieu de Paris · FRInserm · FRSorbonne Université · FRUniversity of Applied Sciences Landshut · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care "watch and wait" for these patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm, ResidualProspective StudiesRituximabVidarabineCyclophosphamidefludarabineRituximabVidarabine

Identifiers

PMID32071431
PMCPMC7387319
OpenAlexW3008994472

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.