Evidence map›Paper›PMID 23753021›Full record

Trial reportHaematologica2013

First-line treatment with rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine and followed by consolidation with 90Y-ibritumomab-tiuxetan in patients with mantle cell lymphoma. Results of a multicenter, phase 2 pilot trial from the GELTAMO group.

Reyes Arranz, Ana García-Noblejas, Carlos Grande, Jimena Cannata-Ortiz, José J Sánchez, José-Antonio García-Marco, Concepción Aláez, Javier Pérez-Calvo, Pilar Martínez-Sánchez, Blanca Sánchez-González and 7 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.3field-weighted citation impact, top 6% 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

9 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Frontline therapy and role of high-dose consolidation in mantle cell lymphoma.Hematology. American Society of Hematology. Education Program · 2016
    Review
  7. Article
  8. Article
  9. 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

17 authors at 10 institutions in 1 country.

Reyes Arranzrarranzs@telefonica.net.
Ana García-Noblejas
Carlos Grande
Jimena Cannata-Ortiz
José J Sánchez
José-Antonio García-Marco
Concepción Aláez
Javier Pérez-Calvo
Pilar Martínez-Sánchez
Blanca Sánchez-González
Miguel-Angel Canales
Eulogio Conde
Alejandro Martín
Eva Arranz
María-José Terol
Antonio Salar
Dolores Caballero
Hospital Universitario de La Princesa · ESComplejo Hospitalario de Salamanca · ESHospital Del Mar · ESClínica Rementería · ESClinica Universidad de Navarra · ESHospital Clínico Universitario de Valencia · ESHospital General Universitario Morales Meseguer · ESHospital Universitario La Paz · ESHospital Universitario Puerta de Hierro Majadahonda · ESMarqués de Valdecilla University Hospital · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe prognosis for fit patients with mantle cell lymphoma has improved with intensive strategies. Currently, the role of maintenance/consolidation approaches is being tested as relapses continue to appear. In this trial we evaluated the feasibility, safety and efficacy of rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine followed by consolidation with (90)Y-ibritumomab tiuxetan. Patients received six cycles followed by a single dose of (90)Y-ibritumomab tiuxetan. Thirty patients were enrolled; their median age was 59 years. Twenty-four patients finished the induction treatment, 23 achieved complete remission (77%, 95% confidence interval 60-93) and one patient had progressive disease (3%). Eighteen patients (60%), all in complete remission, received consolidation therapy. In the intent-to-treat population, failure-free, progression-free and overall survival rates at 4 years were 40% (95% confidence interval 20.4-59.6), 52% (95% confidence interval 32.4-71.6) and 81% (95% confidence interval 67.28-94.72), respectively. For patients who received consolidation, failure-free and overall survival rates were 55% (95% confidence interval 31.48-78.52) and 87% (95% confidence interval 70-100), respectively. Hematologic toxicity was significant during induction and responsible for one death (3.3%). After consolidation, grade 3-4 neutropenia and thrombocytopenia were observed in 72% and 83% of patients, with a median duration of 5 and 12 weeks, respectively. Six (20%) patients died, three due to secondary malignancies (myelodysplastic syndrome and bladder and rectum carcinomas). In conclusion, in our experience, rituximab-hyperCVAD alternated with rituximab-methotrexate-cytarabine and followed by consolidation with (90)Y-ibritumomab tiuxetan was efficacious although less feasible than expected. The unacceptable toxicity observed, especially secondary malignancies, advise against the use of this strategy.

trial registrationclinical.gov identifier: NCT2005-004400-37.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDisease-Free SurvivalDrug Administration ScheduleFemaleHumansLymphoma, Mantle-CellMaleMethotrexateMiddle AgedPilot ProjectsProspective StudiesAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedCytarabineibritumomab tiuxetanMethotrexateRituximab

Identifiers

PMID23753021
PMCPMC3789461
OpenAlexW2167387655

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.