Evidence map›Paper›PMID 35435967›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Alpha-Fetoprotein as a Potential Surrogate Biomarker for Atezolizumab + Bevacizumab Treatment of Hepatocellular Carcinoma.

Andrew X Zhu, Farshid Dayyani, Chia-Jui Yen, Zhenggang Ren, Yuxian Bai, Zhiqiang Meng, Hongming Pan, Paul Dillon, Shivani K Mhatre, Vincent E Gaillard and 3 more

Abstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

75 citing papers in PubMed, 1 synthesis or guideline pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Andrew X ZhuJiahui International Cancer Center, Jiahui International Hospital, Shanghai, P.R. China.ORCID 0000-0003-4873-5033
Farshid DayyaniChao Family Comprehensive Cancer Center, University of California, Irvine, Irvine, California.ORCID 0000-0002-4970-5189
Chia-Jui YenDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.
Zhenggang RenDepartment of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, P.R. China.
Yuxian BaiDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, P.R. China.
Zhiqiang MengDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China.
Hongming PanDepartment of Medical Oncology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, P.R. China.
Paul DillonPersonalized Health Care Real World Data Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0002-3422-5473
Shivani K MhatrePersonalized Health Care Real World Data Oncology, Genentech, Inc., South San Francisco, California.ORCID 0000-0002-5137-1106
Vincent E GaillardGlobal Product Development Medical Affairs, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Sairy HernandezUS Medical Affairs, Genentech, Inc., South San Francisco, California.
Robin Kate KelleyDepartment of Medicine (Hematology/Oncology), University of California San Francisco, San Francisco, California.ORCID 0000-0002-1984-2430
Bruno SangroLiver Unit, Clinica Universidad de Navarra-IDISNA and CIBEREHD, Pamplona, Spain.ORCID 0000-0002-4177-6417

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAtezolizumab + bevacizumab is the new standard of care for systemic treatment-naïve, unresectable hepatocellular carcinoma (HCC). This exploratory study investigated on-treatment alpha-fetoprotein (AFP) response as a potential surrogate biomarker of prognosis for the combination therapy. EXPERIMENTAL

designData from Group A of the phase Ib GO30140 study were used to identify the optimal time for AFP measurement and AFP cutoffs to differentiate patients by their best confirmed response per independent review facility-assessed RECIST (IRF-RECIST) version 1.1: responders from nonresponders and patients with disease control from primary progressors. We applied these cutoffs to independent data from the atezolizumab + bevacizumab arm of the phase III IMbrave150 trial to distinguish patients based on (i) overall survival (OS) and progression-free survival (PFS) per IRF-RECIST 1.1 and (ii) best confirmed response per IRF-RECIST 1.1.

resultsWe derived AFP cutoffs of ≥75% decrease and ≤10% increase from baseline at 6 weeks to identify responders and those who had disease control, respectively. These cutoffs had high sensitivity and specificity in GO30140. In IMbrave150 patients, sensitivity was 0.59 and specificity was 0.86 for the ≥75% decrease AFP cutoff; the sensitivity was 0.77 and specificity was 0.44 for the ≤10% increase AFP cutoff. Both AFP cutoffs were associated with longer OS and PFS, particularly in patients with hepatitis B virus etiology (HR < 0.5; P < 0.01).

conclusionsAFP response at 6 weeks after initiating treatment is a potential surrogate biomarker of prognosis for patients with HCC receiving atezolizumab + bevacizumab. See related commentary by Cappuyns and Llovet, p. 3405.

Indexed as

Carcinoma, HepatocellularLiver Neoplasmsalpha-FetoproteinsAntibodies, Monoclonal, HumanizedBevacizumabBiomarkersHumansRetrospective Studiesalpha-FetoproteinsAntibodies, Monoclonal, HumanizedatezolizumabBevacizumabBiomarkers

Identifiers

PMID35435967
PMCPMC9662926

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.