Evidence map›Paper›PMID 16960145›Full record

Trial reportBlood2007

Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL).

Madeleine Duvic, Rakshandra Talpur, Xiao Ni, Chunlei Zhang, Parul Hazarika, Cecilia Kelly, Judy H Chiao, John F Reilly, Justin L Ricker, Victoria M Richon and 1 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 452 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
452citing papers in PubMed, 1 pooled it
21.9field-weighted citation impact, top 1% 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

452 citing papers in PubMed, 1 synthesis or guideline pooled it, 1,133 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review

392 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Madeleine DuvicDepartment of Dermatology, MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 434, Houston, TX 77030-4409, USA. mduvic@mdanderson.org
Rakshandra Talpur
Xiao Ni
Chunlei Zhang
Parul Hazarika
Cecilia Kelly
Judy H Chiao
John F Reilly
Justin L Ricker
Victoria M Richon
Stanley R Frankel
The University of Texas MD Anderson Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

CUTANEOUS ONCOLOGYK24CA086815 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI DUVIC, MADELEINE · 2000 to 2004
$533k
NCI NIH HHS K24 CA086815
6 · The paper itself

Abstract

The activity and safety of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid, SAHA) were evaluated in patients with refractory cutaneous T-cell lymphoma (CTCL). Group 1 received vorinostat 400 mg daily, group 2 received vorinostat 300 mg twice daily for 3 days with 4 days rest, and group 3 received vorinostat 300 mg twice daily for 14 days with 7 days rest followed by 200 mg twice daily. Treatment continued until disease progression or intolerable toxicity. The primary objective was to determine the complete and partial response (PR) rate. Time to response (TTR), time to progressive disease (TTP), response duration (DOR), pruritus relief, and safety were determined. Thirty-three patients who had received a median of 5 prior therapies were enrolled. Eight patients achieved a PR, including 7 with advanced disease and 4 with Sézary syndrome. The median TTR, DOR, and TTP for responders were 11.9, 15.1, and 30.2 weeks, respectively. Fourteen of 31 evaluable patients had pruritus relief. The most common drug-related AEs were fatigue, thrombocytopenia, diarrhea, and nausea. The most common grade 3 or 4 drug-related AEs were thrombocytopenia and dehydration. Vorinostat demonstrated activity in heavily pretreated patients with CTCL. The 400 mg daily regimen had the most favorable safety profile and is being further evaluated.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDehydrationDisease-Free SurvivalDisease ProgressionFatigueFemaleGastrointestinal DiseasesHumansHydroxamic AcidsLymphocytesLymphoma, T-Cell, CutaneousMaleMiddle AgedAntineoplastic AgentsHydroxamic AcidsVorinostat

Identifiers

PMID16960145
PMCPMC1785068
OpenAlexW2071115015

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.