Evidence map›Paper›PMID 26449224›Full record

Trial reportCancer chemotherapy and pharmacology2015

Phase II study of temozolomide and veliparib combination therapy for sorafenib-refractory advanced hepatocellular carcinoma.

Andrew Gabrielson, Anteneh A Tesfaye, John L Marshall, Michael J Pishvaian, Brandon Smaglo, Reena Jha, Karen Dorsch-Vogel, Hongkun Wang, Aiwu Ruth He

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01205828 (Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% 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.

NCT01205828 phase2terminatednot on this map

Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib

TypeinterventionalSponsorGeorgetown UniversityRan2010 to 2014Enrolled16ConditionsHepatocellular CarcinomaArmsTemozolomide, ABT-888
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Recent progress in treatment of hepatocellular carcinoma.American journal of cancer research · 2020
    Review
  16. Review
  17. Article
  18. Article
  19. Advances and perspectives of PARP inhibitors.Experimental hematology & oncology · 2019
    Review
  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

9 authors at 3 institutions in 2 countries.

Andrew GabrielsonDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Anteneh A TesfayeDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
John L MarshallDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Michael J PishvaianDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Brandon SmagloDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Reena JhaDepartment of Radiology, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, USA.
Karen Dorsch-VogelDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Hongkun WangDepartment of Biostatistics and Bioinformatics, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
Aiwu Ruth HeDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA. aiwu.r.he@gunet.georgetown.edu.
Georgetown University · USGeorgetown Hospital · CAGeorgetown University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine the antitumor efficacy and tolerability of combination temozolomide (TMZ) and veliparib (ABT-888) in patients with advanced, sorafenib-refractory hepatocellular carcinoma (HCC).

methodsThis single-arm phase II trial enrolled patients with pathologically confirmed, sorafenib-refractory HCC. All patients received 40 mg ABT-888 PO daily on days 1-7 and 150 mg/m(2) TMZ PO daily on days 1-5 of a 28-day cycle. The primary endpoint was objective response rate (ORR) at 2 months. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and toxicity profile. Tumor response was assessed every 2 cycles using RECIST criteria, and toxicities were assessed using CTCAE v4.03.

resultsWe enrolled 16 patients in the first phase of the trial, but the study was discontinued due to a poor ORR; only four patients (25 %) had SD after 2 cycles. Twelve patients (75 %) were taken off study after 2 months of treatment; 10 of these had disease progression. Two patients (13 %) were taken off study due to severe toxicity, and one patient (6 %) died from non-treatment-related liver failure. One patient had SD for 16 months, receiving 11 cycles of therapy before being taken off study. The most common grade 3 treatment-related toxicities included vomiting (n = 2), thrombocytopenia (n = 2), nausea (n = 1), and anemia (n = 1). The median PFS was 1.9 months, and median OS was 13.1 months.

conclusionThe combination of TMZ and ABT-888 is well tolerated in patients with advanced HCC. However, the regimen failed to show survival benefit. CLINICALTRIALS. GOV IDENTIFIER: NCT01205828.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarcinoma, HepatocellularDacarbazineDisease-Free SurvivalDNA MethylationDNA, NeoplasmDNA RepairDrug Resistance, NeoplasmFatigueFemaleGenes, BRCA1Genes, BRCA2HumansBenzimidazolesDacarbazineDNA, NeoplasmNiacinamidePhenylurea CompoundsPoly(ADP-ribose) Polymerase InhibitorsSorafenibTemozolomideveliparibHepatocellular carcinomaRefractoryTemozolomideVeliparib

Identifiers

PMID26449224
PMCPMC4612326
OpenAlexW1940434397

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LicenceCC BY
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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.