Evidence map›Paper›PMID 23227903›Full record

ArticleExperimental hematology & oncology2012

French "real life" experience of clofarabine in children with refractory or relapsed acute lymphoblastic leukaemia.

Pascale Trioche, Brigitte Nelken, Gérard Michel, Isabelle Pellier, Arnaud Petit, Yves Bertrand, Pierre Rohrlich, Claudine Schmitt, Nicolas Sirvent, Patrick Boutard and 9 more

Open access · goldAbstract read
In one paragraph

Article in Experimental hematology & oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Clofarabine experience in children with multi-relapsed acute leukemia.Turkish journal of haematology : official journal of Turkish Society of Haematology · 2014
    Article
  3. Novel agents and biomarkers for acute lymphoid leukemia.Journal of hematology & oncology · 2013
    Review
  4. Article
  5. Article
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

19 authors at 16 institutions in 1 country.

Pascale TriocheDepartment of Pediatric, APHP, Hôpital Antoine Béclère, Service de Pédiatrie, 157 rue de la porte de Trivaux, 92141 Clamart Cedex, France. pascale.trioche@abc.aphp.fr.
Brigitte Nelken
Gérard Michel
Isabelle Pellier
Arnaud Petit
Yves Bertrand
Pierre Rohrlich
Claudine Schmitt
Nicolas Sirvent
Patrick Boutard
Geneviève Margueritte
Brigitte Pautard
Stéphane Ducassou
Dominique Plantaz
Alain Robert
Caroline Thomas
Kristell Desseaux
Sylvie Chevret
André Baruchel
Assistance Publique – Hôpitaux de Paris · FRDélégation Paris 7 · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Besançon · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Caen · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Montpellier · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Nice · FRCentre Hospitalier Universitaire de Toulouse · FRHôpital Antoine-Béclère · FRHôpital de la Timone · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClofarabine alone or in combination with cyclophosphamide and etoposide has shown a good efficacy and a tolerable toxicity profile in previous studies of children with relapsed or refractory leukaemia. This report describes a retrospective study of 38 French patients who received clofarabine as a monotherapy or in combination for relapsed or refractory acute lymphoblastic leukaemia (ALL) outside of clinical trials after marketing authorization.

methodsWe retrospectively analysed data for 38 patients, up to 21 years old, attending 17 French centres. Thirty patients received clofarabine alone or in combination for a bone marrow relapse of acute lymphoblastic leukaemia (ALL) or refractory disease and eight patients for a high level of minimal residual disease (MRD). Survival and response durations were estimated by the Kaplan-Meier method.

resultsFor the 30 patients who received clofarabine for a bone marrow relapse of ALL (number of relapse, 1-3; median, 1), the overall remission rate (ORR) was 37%: eight complete remission (CR) and three complete remission without platelet recovery (CRp). Ten of the 11 responding patients subsequently underwent haematopoietic stem cell transplantation (HSCT).Only four of the eight patients who received clofarabine while in remission for a high level of MRD, showed a moderate improvement of MRD. Seven of these eight patients received HSCT and six of them were alive at the end of the study. One other patient was alive without receiving HSCT.However, clofarabine treatment was associated with a high risk of infection and hepatotoxicity. Febrile neutropenia grade ≥ 3 was reported in 79% of patients and documented infections grade ≥ 3 occurred in nine patients (24%). Hepatotoxicity grade 3 was reported in nine patients (24%). We observed four deaths related to treatment.

conclusionIn our experience, the efficacy of clofarabine is poorer than previously reported. Its toxicity is high and can be life threatening. Prospective studies on clofarabine used during earlier phases of the disease may help to define how best this new drug can be exploited for childhood and adolescent ALL.

Identifiers

PMID23227903
PMCPMC3599405
OpenAlexW2161759378

What OpenQuestion holds

Textmetadata
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.