Evidence map›Paper›PMID 23356514›Full record

ArticleBritish journal of haematology2013

A phase I study of pulse high-dose vorinostat (V) plus rituximab (R), ifosphamide, carboplatin, and etoposide (ICE) in patients with relapsed lymphoma.

Lihua E Budde, Michelle M Zhang, Andrei R Shustov, John M Pagel, Ted A Gooley, George R Oliveira, Tara L Chen, Nancy L Knudsen, Jennifer E Roden, Britt E Kammerer and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of haematology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00601718 (A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.0field-weighted citation impact, top 10% 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.

NCT00601718 phase1 / phase2completednot on this map

A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma

TypeinterventionalSponsorUniversity of WashingtonRan2007Enrolled29ConditionsAdult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Contiguous Stage II Mantle Cell LymphomaArmsvorinostat, rituximab, ifosfamide, carboplatin, etoposide
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 36 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Advances in targeted therapy for malignant lymphoma.Signal transduction and targeted therapy · 2020
    Review
  7. Review
  8. Recent Update of HDAC Inhibitors in Lymphoma.Frontiers in cell and developmental biology · 2020
    Review
  9. Article
  10. Genetic alterations and their clinical implications in DLBCL.Nature reviews. Clinical oncology · 2019
    Review
  11. Review
  12. Emerging epigenetic-modulating therapies in lymphoma.Nature reviews. Clinical oncology · 2019
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

15 authors at 6 institutions in 1 country.

Lihua E BuddeClinical Research Dvision, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Michelle M Zhang
Andrei R Shustov
John M Pagel
Ted A Gooley
George R Oliveira
Tara L Chen
Nancy L Knudsen
Jennifer E Roden
Britt E Kammerer
Shani L Frayo
Thomas A Warr
Thomas E Boyd
Oliver W Press
Ajay K Gopal
University of Washington · USFred Hutch Cancer Center · USEducational Service District 105 · USGreat Falls Clinic · USMassachusetts General Hospital · USValley Medical Center · US

Funding

TREATMENT OF B-CELL LYMPHOMAP01CA044991 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BALDWIN, JANELL · 1988 to 2015
$29.3M
NCI NIH HHS P01 CA044991NCI NIH HHS P01 CA 44991
6 · The paper itself

Abstract

Given the poor outcomes of relapsed aggressive lymphomas and preclinical data suggesting that ≥2·5 μmol/l concentrations of vorinostat synergize with both etoposide and platinums, we hypothesized that pulse high-dose vorinostat could safely augment the anti-tumour activity of (R)ICE [(rituximab), ifosphamide, carboplatin, etoposide] chemotherapy. We conducted a phase I dose escalation study using a schedule with oral vorinostat ranging from 400 mg/d to 700 mg bid for 5 d in combination with the standard (R)ICE regimen (days 3, 4 and 5). Twenty-nine patients [median age 56 years, median 2 prior therapies, 14 chemoresistant (of 27 evaluable), 2 prior transplants] were enrolled and treated. The maximally tolerated vorinostat dose was defined as 500 mg twice daily × 5 d. Common dose limiting toxicities included infection (n = 2), hypokalaemia (n = 2), and transaminitis (n = 2). Grade 3 related gastrointestinal toxicity was seen in 9 patients. The median vorinostat concentration on day 3 was 4·5 μmol/l (range 4·2-6·0 μmol/l) and in vitro data confirmed the augmented antitumour and histone acetylation activity at these levels. Responses were observed in 19 of 27 evaluable patients (70%) including 8 complete response/unconfirmed complete response. High-dose vorinostat can be delivered safely with (R)ICE, achieves potentially synergistic drug levels, and warrants further study, although adequate gastrointestinal prophylaxis is warranted.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDrug SynergismEtoposideFemaleHumansHydroxamic AcidsIfosfamideLymphomaMaleMiddle AgedRituximabVorinostatAntibodies, Monoclonal, Murine-DerivedCarboplatinEtoposideHydroxamic AcidsIfosfamideRituximabVorinostat

Identifiers

PMID23356514
PMCPMC3618618
OpenAlexW2022625652

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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.