Evidence map›Paper›PMID 24442244›Full record

Trial reportBone marrow transplantation2014

Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis.

M Magni, M Di Nicola, C Patti, R Scimè, A Mulè, A Rambaldi, T Intermesoli, P Viero, C Tarella, A Gueli and 19 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. 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

29 authors at 13 institutions in 1 country.

M MagniDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
M Di NicolaDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
C PattiDepartment of Hematology I, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
R ScimèDepartment of Hematology I, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
A MulèDepartment of Hematology I, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
A RambaldiUnit of Hematology, Ospedali Riuniti di Bergamo, Bergamo, Italy.
T IntermesoliUnit of Hematology, Ospedali Riuniti di Bergamo, Bergamo, Italy.
P VieroUnit of Hematology, Ospedali Riuniti di Bergamo, Bergamo, Italy.
C TarellaS.C.D.U. Hematology and Cellular Therapy, A.O. Ord. Mauriziano-Umberto I, Turin, Italy.
A GueliS.C.D.U. Hematology and Cellular Therapy, A.O. Ord. Mauriziano-Umberto I, Turin, Italy.
L BerguiDepartment of Hematology, A.O. S. Giovanni Battista Molinette, Turin, Italy.
L TrentinDepartment of Medicine, Hematology and Clinical Immunology Branch, Padua University School of Medicine, Padua, Italy.
A BarzanDepartment of Medicine, Hematology and Clinical Immunology Branch, Padua University School of Medicine, Padua, Italy.
F BenedettiDepartment of Hematology, Policlinico GB Rossi, Verona, Italy.
A AmbrosettiDepartment of Hematology, Policlinico GB Rossi, Verona, Italy.
F Di RaimondoDivision of Hematology, Ospedale Ferrarotto, AOU Policlinico-OVE, University of Catania, Catania, Italy.
A ChiarenzaDivision of Hematology, Ospedale Ferrarotto, AOU Policlinico-OVE, University of Catania, Catania, Italy.
G ParvisDivision of Internal Medicine and Haematology, Department of Clinical and Biological Sciences, University of Turin, Orbassano, Italy.
A BillioHematology Department, San Maurizio Regional Hospital, Bolzano, Italy.
I AttolicoDivision of Haematology, Ospedale San Carlo, Potenza, Italy.
A OlivieriDivision of Haematology, Ospedale San Carlo, Potenza, Italy.
M MontanariDivision of Haematology, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.
C Carlo-Stella1] Medical Oncology and Hematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano, Milan, Italy [2] Chair of Oncology, University of Milan, Milan, Italy.ORCID 0000000331440124
P MatteucciDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
L DevizziDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
A GuidettiDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
S VivianiDivision of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
P ValagussaFondazione Michelangelo, Milan, Italy.
A M Gianni1] Division of Medical Oncology, Bone Marrow Transplantation Unit, Fondazione IRCCS, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy [2] Chair of Oncology, University of Milan, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITOspedale Vincenzo Cervello · ITUniversity of Bergamo · ITOspedale San Carlo · ITUniversity of Catania · ITUniversity of Padua · ITAzienda Ospedaliero Universitaria San Giovanni Battista · ITFondazione Michelangelo · ITHumanitas University · ITOspedale di Bolzano · ITOspedali Riuniti di Ancona · ITUniversity of Milan · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The importance of early therapy intensification in B-cell CLL (B-CLL) patients remains to be defined. Even though several studies have been published, no randomized trials comparing directly autologous stem cell transplant (ASCT) and the accepted conventional therapy (that is, rituximab, fludarabine and CY; R-FC) have been reported so far. To assess the benefit of a first-line aggressive therapy, we designed a multicenter, randomized, phase 3 trial comparing R-FC and high-dose chemotherapy supported by ASCT in patients under 65 years of age, with stage B(II) or C B-CLL. Primary end point was CR: 96 patients were enrolled (48 in each arm). On an intent-to-treat basis, the CR rates in the ASCT and R-FC arms were 62.5% and 58%, respectively. After 5 years of follow-up, PFS was 60.4% in the ASCT arm and 65.1% in the R-FC arm, time to progression 65.8 and 70.5%, and overall survival 88% vs 88.1%, respectively. Our trial demonstrates, for the first time in a randomized manner, that frontline ASCT does not translate into a survival advantage when compared with benchmark chemoimmunotherapy in B-CLL patients; the possibility of its clinical benefit in certain subgroups remains uncertain.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideCytarabineDoxorubicinFemaleHematopoietic Stem Cell MobilizationHematopoietic Stem Cell TransplantationHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMelphalanMiddle AgedPrednisoneAntibodies, Monoclonal, Murine-DerivedCyclophosphamideCytarabineDoxorubicinfludarabineMelphalanPrednisoneRituximabVidarabineVincristine

Identifiers

PMID24442244
OpenAlexW1992853863

What OpenQuestion holds

Textmetadata
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.