Evidence map›Paper›PMID 32417993›Full record

Trial reportInternational journal of clinical oncology2020

Effect of early adverse events resulting in sorafenib dose adjustments on survival outcomes of advanced hepatocellular carcinoma patients.

Warit Ruanglertboon, Michael J Sorich, Andrew Rowland, Ashley M Hopkins

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00699374 (A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

NCT00699374 phase3terminatednot on this map

A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled1,075ConditionsCarcinoma, HepatocellularArmssunitinib malate, sorafenib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

4 authors at 1 institution in 1 country.

Warit RuanglertboonDepartment of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia. warit.ruanglertboon@flinders.edu.au.ORCID http://orcid.org/0000-0003-0540-7427
Michael J SorichDepartment of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Andrew RowlandDepartment of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Ashley M HopkinsDepartment of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Flinders University · AU

Funding

Cancer Council South Australia 1127220Cancer Council South Australia 1159924National Breast Cancer Foundation (AUS) PF-17-007
6 · The paper itself

Abstract

backgroundSorafenib is a current first-line treatment option for advanced hepatocellular carcinoma (HCC). This study aimed to evaluate the impact of early adverse events (AEs) requiring sorafenib dose adjustment on survival outcomes of patients with advanced HCC.

methodsThe study was a secondary analysis of the phase III clinical trial NCT00699374. A landmark Cox proportional hazard analysis was used to evaluate the association between early AEs requiring sorafenib dose adjustment with survival outcomes. The primary outcome was overall survival (OS) with progression-free survival (PFS) as secondary.

resultsAEs requiring sorafenib dose adjustment within the first 28 days of therapy were significantly associated with OS (HR [95% CI]; dose interruption = 0.9 [0.7-1.2]; dose reduction = 0.6 [0.5-0.9]; discontinuation = 1.7 [0.9-3.4]; P = 0.005). No statistically significant association with PFS was identified (P = 0.148).

conclusionSorafenib dose interruptions and reduction due to AEs did not compromise the survival outcomes of patient with advanced HCC. Patients who required a sorafenib dose reduction were observed to have more favourable OS compared to those who did not experience an AE which required a dose adjustment.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNiacinamideProgression-Free SurvivalSorafenibYoung AdultAntineoplastic AgentsNiacinamideSorafenibAdverse eventsDose adjustmentPredictionResponseSorafenibSurvival

Identifiers

PMID32417993
OpenAlexW3024787246

What OpenQuestion holds

Textmetadata
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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.