Evidence map›Paper›PMID 10942230›Full record

Trial reportLeukemia2000

Double induction strategy including high dose cytarabine in combination with all-trans retinoic acid: effects in patients with newly diagnosed acute promyelocytic leukemia. German AML Cooperative Group.

E Lengfelder, A Reichert, C Schoch, D Haase, T Haferlach, H Löffler, P Staib, A Heyll, W Seifarth, S Saussele and 12 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00408278 (Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00408278 phase4completednot on this mapstarted 2005, after this paper: background citation

Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005): Remission Induction With ATRA + Idarubicin. Risk-adapted Consolidation With ATRA and Anthracycline-based Chemotherapy (Idarubicin/Mitoxantrone) With Addition of Ara-C for High-risk Patients. Maintenance Therapy With ATRA + Low Dose Chemotherapy (Methotrexate + Mercaptopurine).

TypeinterventionalSponsorPETHEMA FoundationRan2005 to 2013Enrolled300ConditionsAcute Promyelocytic LeukemiaArmsATRA, Idarubicina, Mitoxantrone, ARA-C
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. History of Acute Promyelocytic Leukemia.Clinical hematology international · 2021
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Central nervous system relapse in CD56+, FLT3/ITD+ promyelocytic leukemia.Medical oncology (Northwood, London, England) · 2012
    Article
  18. Article
  19. Curing all patients with acute promyelocytic leukemia: are we there yet?Hematology/oncology clinics of North America · 2011
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

E LengfelderIII. Medizinische Klinik Mannheim, University of Heidelberg, Germany.
A Reichert
C Schoch
D Haase
T Haferlach
H Löffler
P Staib
A Heyll
W Seifarth
S Saussele
C Fonatsch
W Gassmann
W D Ludwig
A Hochhaus
D Beelen
C Aul
M C Sauerland
A Heinecke
R Hehlmann
B Wörmann
W Hiddemann
T Büchner

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A prospective multicenter study was performed to investigate the clinical and molecular results of intensified double induction therapy including high-dose cytarabine (ara-C) in combination with ATRA in newly diagnosed acute promyelocytic leukemia (APL), followed by consolidation and 3 years maintenance therapy. Fifty-one patients, diagnosed and monitored from December 1994 to June 1999, were evaluated. The median age was 43 (16-60) years. The morphologic diagnosis was M3 in 40 (78%) and M3v in 11 (22%) patients. In 15 (30%) patients the initial white blood cell counts were > or =5 x 10(9)/l. The cytogenetic or molecular proof of the translocation t(15;17) was a mandatory prerequisite for eligibility. The diagnosis was confirmed by karyotyping in 46 and by RT-PCR of the PML/RARalpha transcript in 45 cases. The rate of complete hematological remission was 92% and the early death rate 8%. Monitoring of minimal residual disease by RT-PCR of PML/RARalpha (sensitivity 10(-4)) showed negativity in 29 of 32 (91%) evaluable cases after induction, in 23 of 25 (92%) after consolidation, and in 27 of 30 (90%) during maintenance, after a median time of 2, 4 and of 18 months after diagnosis, respectively. After a median follow-up of 27 months, the estimated actuarial 2 years overall and event-free survival were both 88% (79, 97), and the 2 years relapse-free survival 96% (90, 100). The high antileukemic efficacy of this treatment strategy is demonstrated by a rapid and extensive reduction of the malignant clone and by a low relapse rate. The results suggest that the intensity of the induction chemotherapy combined with ATRA is one of the factors which may have a critical influence on the outcome of APL. A randomized trial should assess the value of an induction therapy including ATRA and high-dose ara-C in comparison to standard-dose ara-C.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBase SequenceCytarabineDNA PrimersFemaleHumansLeukemia, Promyelocytic, AcuteMaleMiddle AgedTretinoinCytarabineDNA PrimersTretinoin

Identifiers

PMID10942230

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.