Evidence map›Paper›PMID 25737247›Full record

Trial reportAmerican journal of hematology2015

Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma.

Peter J Hosein, Jose D Sandoval-Sus, Deborah Goodman, Alexandra Gomez Arteaga, Isildinha Reis, James Hoffman, Alexandra Stefanovic, Joseph D Rosenblatt, Izidore S Lossos

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

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

  1. Pooled it
  2. Review
  3. 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

9 authors.

Peter J HoseinDepartment of Medicine, Markey Cancer Center, University of Kentucky, Lexington, Kentucky.
Jose D Sandoval-SusDivision of Hematological Malignancies, H. Lee Moffitt Cancer Center, Tampa, Florida.
Deborah GoodmanDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
Alexandra Gomez ArteagaDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
Isildinha ReisDepartment of Public Health Sciences, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
James HoffmanDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
Alexandra StefanovicDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
Joseph D RosenblattDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.
Izidore S LossosDepartment of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.

Funding

Significance and Function of HGAL in LymphomaR01CA109335 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI LOSSOS, IZIDORE S · 2005 to 2013
$2.1M
NCI NIH HHS CA109335NCI NIH HHS R01 CA109335
6 · The paper itself

Abstract

A phase II trial of R-MACLO-IVAM followed by thalidomide maintenance for mantle cell lymphoma (MCL) demonstrated promising progression-free survival (PFS) and overall survival (OS) rates. Thalidomide maintenance was associated with significant toxicity and was subsequently modified to rituximab maintenance. Herein, we present updated results and follow-up. Two sequential phase II trials included chemotherapy-naïve patients with MCL up to 75 years old. Four cycles of R-MACLO-IVAM chemotherapy were delivered as previously described. Patients who achieved complete responses (CR) were eligible for thalidomide or rituximab maintenance therapy. Among 36 patients enrolled, the MCL International Prognostic Index (MIPI) was low in 53%, intermediate in 36% and high in 11%. Thirty-five patients completed at least 2 cycles of chemotherapy; 34 (94%) achieved a CR. After a median follow-up of 74.4 months, the 5-year PFS was 51% (95% CI 33-68%) and the 5-year OS was 85% (95% CI 73-97%). Two deaths occurred during the chemotherapy phase due to disease progression and neutropenic sepsis, respectively. One patient developed secondary acute myeloid leukemia after 7 years. R-MACLO-IVAM chemotherapy is effective for patients with newly diagnosed MCL.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleFollow-Up StudiesHumansLymphoma, Mantle-CellMaleMiddle AgedProspective StudiesRituximabSurvival AnalysisSurvival RateThalidomideAntibodies, Monoclonal, Murine-DerivedRituximabThalidomide

Identifiers

PMID25737247
PMCPMC4439262

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Registered trials

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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.