Evidence map›Paper›PMID 19344412›Full record

Trial reportBritish journal of haematology2009

A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas.

Jennifer R Brown, Jonathan W Friedberg, Yang Feng, Sarah Scofield, Kimberly Phillips, Paola Dal Cin, Robin Joyce, Ronald W Takvorian, David C Fisher, Richard I Fisher and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00117156 (A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.5field-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.

NCT00117156 phase2completednot on this map

A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2003 to 2012Enrolled26ConditionsLymphoma, Non-Hodgkin, MALT LymphomaArmsFludarabine, Rituximab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. IgM monoclonal gammopathy in gastric MALToma.Journal of gastrointestinal cancer · 2014
    Article
  14. Comparative outcomes of oncologic therapy in gastric extranodal marginal zone (MALT) lymphoma: analysis of the SEER-Medicare database.Annals of oncology : official journal of the European Society for Medical Oncology · 2013
    Article
  15. Splenic marginal zone lymphoma masquerading as cirrhotic hypersplenism for seven years.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2012
    Article
  16. Article
  17. Article
  18. Rituximab in indolent lymphomas.Seminars in hematology · 2010
    Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Jennifer R BrownMedical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. jbrown2@partners.org
Jonathan W Friedberg
Yang Feng
Sarah Scofield
Kimberly Phillips
Paola Dal Cin
Robin Joyce
Ronald W Takvorian
David C Fisher
Richard I Fisher
Jane Liesveld
Diana Marquis
Donna Neuberg
Arnold S Freedman
Dana-Farber Cancer Institute · USUniversity of Rochester · USBrigham and Women's Hospital · USHarvard University · USMassachusetts General Hospital · US

Funding

The Role of BCL-6 in Berminal Center FormationP01CA092625 · NCI · DANA-FARBER CANCER INSTITUTE · PI SHIPP, MARGARET A · 2001 to 2011
$32.9M
SPORE in LymphomaP50CA130805 · NCI · UNIVERSITY OF ROCHESTER · PI FISHER, RICHARD I · 2008 to 2012
$11.7M
Genetic Alterations in Families with Multiple LymphomasK23CA115682 · NCI · DANA-FARBER CANCER INSTITUTE · PI BROWN, JENNIFER R · 2005 to 2009
$754k
CpG Plus Rituximab Therapy in Follicular LymphomaR21CA103244 · NCI · DANA-FARBER CANCER INSTITUTE · PI FREEDMAN, ARNOLD S. · 2004 to 2005
$567k
NCI NIH HHS 2P01CA092625NCI NIH HHS CA-103244NCI NIH HHS K23 CA115682NCI NIH HHS P01 CA092625NCI NIH HHS P50 CA130805NCI NIH HHS P50CA130805NCI NIH HHS R21 CA103244
6 · The paper itself

Abstract

The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa-associated lymphoid tissue (MALT) lymphoma has been largely limited to retrospective case series. This prospective phase 2 study of fludarabine and rituximab for the treatment of marginal zone lymphomas enrolled 26 patients, 14 with nodal MZL, eight with MALT lymphomas and four with splenic MZL; 81% were receiving initial systemic therapy. Only 58% [95% confidence interval (CI) 37-77%] of patients completed the planned six cycles, due to significant haematological, infectious and allergic toxicity. Four late toxic deaths occurred due to infections [15% (95% CI 4.3-35%)], two related to delayed bone marrow aplasia and two related to myelodysplastic syndrome. Nonetheless, the overall response rate was 85% (95% CI 65-96%), with 54% complete responses. The progression-free survival at 3.1 years of follow-up is 79.5% (95% CI 63-96%). We conclude that, although concurrent fludarabine and rituximab given at this dose and schedule is a highly effective regimen in the treatment of MZLs, the significant haematological and infectious toxicity observed both during and after therapy is prohibitive in this patient population, emphasizing the need to study MZLs as a separate entity.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleFollow-Up StudiesHumansLymphomaLymphoma, B-Cell, Marginal ZoneLymphoproliferative DisordersMaleMiddle AgedProspective StudiesAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedfludarabineRituximabVidarabine

Identifiers

PMID19344412
PMCPMC2752822
OpenAlexW2021363101

What OpenQuestion holds

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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.