Evidence map›Paper›PMID 20839030›Full record

Trial reportInvestigational new drugs2012

An international, multicenter phase II trial of bortezomib in patients with hepatocellular carcinoma.

George P Kim, Michelle R Mahoney, Daniel Szydlo, Tony S K Mok, Robert Marshke, Kyle Holen, Joel Picus, Michael Boyer, Henry C Pitot, Joseph Rubin and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. The proteasome regulates body weight and systemic nutrient metabolism during fasting.American journal of physiology. Endocrinology and metabolism · 2023
    Article
  10. Article
  11. Review
  12. Article
  13. TRIM proteins in hepatocellular carcinoma.Journal of biomedical science · 2022
    Review
  14. Article
  15. Review
  16. The roles of E3 ligases in Hepatocellular carcinoma.American journal of cancer research · 2022
    Review
  17. Article
  18. ADRM1 as a therapeutic target in hepatocellular carcinoma.The Kaohsiung journal of medical sciences · 2021
    Article
  19. Article
  20. Article
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

14 authors at 10 institutions in 3 countries.

George P KimMayo Clinic Florida, Jacksonville, FL, USA. kim.george@mayo.edu
Michelle R Mahoney
Daniel Szydlo
Tony S K Mok
Robert Marshke
Kyle Holen
Joel Picus
Michael Boyer
Henry C Pitot
Joseph Rubin
Philip A Philip
Anna Nowak
John J Wright
Charles Erlichman
WinnMed · USMayo Clinic · USMayo Clinic in Arizona · USNational Institutes of Health · USNational University Hospital · SGRoyal Prince Alfred Hospital · AUSir Charles Gairdner Hospital · AUUniversity of Wisconsin–Madison · USWashington University in St. Louis · USWayne State University · US

Funding

NCI NIH HHS N01 CM062205NCI NIH HHS N01 CM17104
6 · The paper itself

Abstract

background and rationaleBortezomib (PS-341, VELCADE®) is a selective inhibitor of the 26S proteasome, an integral component of the ubiquitin-proteasome pathway. This phase II study evaluated the activity and tolerability of bortezomib in unresectable hepatocellular carcinoma (HCC) patients.

methodsThe primary endpoint was confirmed tumor response rate (RR) with secondary endpoints including duration of response, time to disease progression, survival and toxicity. Treatment consisted of bortezomib, 1.3 mg/m2 IV bolus on days 1, 4, 8, and 11 of each 21-day treatment cycle. Eligibility included: no prior systemic chemotherapy, ECOG PS 0-2, Child-Pugh A or B, preserved hematologic, hepatic and neurologic function; prior liver-directed therapy was permitted.

resultsThirty-five patients enrolled and received a median of 2 cycles of treatment (range 1-12). Overall, 24 and 4 patients had a maximum severity of grade 3 and 4 adverse events (AEs), respectively. No treatment related deaths occurred. Only thrombocytopenia (11%) was seen in greater than 10% of patients. One patient achieved a partial response, lasting 13 weeks during treatment and progressed 11.6 months later; two patients received treatment for greater than 6 months. Median time-to-progression was 1.6 months and median survival was 6.0 months.

conclusionsThis international, multicenter trial evaluated bortezomib as monotherapy in unresectable HCC patients. And, despite the lack of significant activity, this report serves as a baseline clinical experience for the development of future dual biologic approaches including bortezomib.

Indexed as

Proteasome InhibitorsAdultAgedAntineoplastic AgentsAsiaBoronic AcidsBortezomibCarcinoma, HepatocellularDisease-Free SurvivalDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedAntineoplastic AgentsATP dependent 26S proteaseBoronic AcidsBortezomibProtease InhibitorsProteasome Endopeptidase ComplexProteasome InhibitorsPyrazines

Identifiers

PMID20839030
PMCPMC3896232
OpenAlexW2124426490

What OpenQuestion holds

Textmetadata
LicenceTDM
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.