Evidence map›Paper›PMID 32636319›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma.

Robin Kate Kelley, Tim Meyer, Lorenza Rimassa, Philippe Merle, Joong-Won Park, Thomas Yau, Stephen L Chan, Jean-Frederic Blanc, Vincent C Tam, Albert Tran and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% 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

51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
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  3. Alpha-Fetoprotein as a Potential Surrogate Biomarker for Atezolizumab + Bevacizumab Treatment of Hepatocellular Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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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

16 authors at 15 institutions in 9 countries.

Robin Kate KelleyUCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California. katie.kelley@ucsf.edu.
Tim MeyerRoyal Free Hospital and UCL Cancer Institute, London, United Kingdom.ORCID 0000-0003-0782-8647
Lorenza RimassaHumanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.ORCID 0000-0001-9957-3615
Philippe MerleGroupement Hospitalier Lyon Nord, Lyon, France.
Joong-Won ParkNational Cancer Center, Goyang, Republic of Korea.ORCID 0000-0001-9972-0494
Thomas YauQueen Mary Hospital, Hong Kong, China.
Stephen L ChanThe Chinese University of Hong Kong, Shatin, Hong Kong, China.
Jean-Frederic BlancHôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.
Vincent C TamTom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0001-8732-0530
Albert TranGroupe Hospitalier L'Archet, Nice, France.
Vincenzo DadduzioMedical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padova, Italy.
David W MarkbyExelixis, Inc., Alameda, California.
Rajesh Kaldate *Exelixis, Inc., Alameda, California.
Ann-Lii ChengNational Taiwan University Cancer Center, Taipei, Taiwan.
Anthony B El-KhoueiryUSC Norris Comprehensive Cancer Center, Los Angeles, California.
Ghassan K Abou-AlfaMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-1522-8054
Exelixis (United States) · USChinese University of Hong Kong · HKHôpital Cardiologique du Haut-Lévêque · FRHôpital l'Archet · FRHôpital Nord · FRHumanitas University · ITIstituto Oncologico Veneto · ITMemorial Sloan Kettering Cancer Center · USNational Cancer Center · KRNational Taiwan University · TWQueen Mary Hospital · CNThe Royal Free Hospital · GBUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Calgary · CAUSC Norris Comprehensive Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
Cancer Research UK 26813NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

purposeThe phase III CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes. PATIENTS AND

methodsSerum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics.

resultsMedian OS for cabozantinib versus placebo was 13.9 versus 10.3 months [HR, 0.81; 95% confidence interval (CI), 0.62-1.04] for patients with baseline AFP <400 ng/mL, and 8.5 versus 5.2 months (HR, 0.71; 95% CI, 0.54-0.94) for patients with baseline AFP ≥400 ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo. In the cabozantinib arm, median OS for patients with and without AFP response was 16.1 versus 9.1 months (HR, 0.61; 95% CI, 0.45-0.84). AFP response was independently associated with longer OS. The optimal cutoff for association with OS in the cabozantinib arm was ≤0% change in AFP at Week 8 [AFP control; HR 0.50 (95% CI, 0.35-0.71)]. HRs for PFS were consistent with those for OS.

conclusionsCabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.

Indexed as

AdultAgedAged, 80 and overalpha-FetoproteinsAnilidesCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNeoplasm StagingPlacebosPrognosisProgression-Free SurvivalProtein Kinase InhibitorsAFP protein, humanalpha-FetoproteinsAnilidescabozantinibPlacebosProtein Kinase InhibitorsPyridines

Identifiers

PMID32636319
PMCPMC7779341
OpenAlexW3040096066

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.