Evidence map›Paper›PMID 30132118›Full record

SynthesisJournal of cancer research and clinical oncology2018

Evaluation of classical clinical endpoints as surrogates for overall survival in patients treated with immune checkpoint blockers: a systematic review and meta-analysis.

Howard L Kaufman, Lawrence H Schwartz, William N William, Mario Sznol, Kyle Fahrbach, Yingxin Xu, Eric Masson, Andrea Vergara-Silva

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of cancer research and clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 6 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

20 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  17. Exploring Heterogeneity in Histology-Independent Technologies and the Implications for Cost-Effectiveness.Medical decision making : an international journal of the Society for Medical Decision Making · 2021
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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

8 authors.

Howard L KaufmanMassachusetts General Hospital, 55 Fruit St Gray 730, Boston, MA, USA. howardkaufman6@gmail.com.ORCID http://orcid.org/0000-0003-1131-004X
Lawrence H SchwartzColumbia University College of Physicians and Surgeons, New York Presbyterian Hospital, 622 W 168th St, New York, NY, USA.
William N WilliamMD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, USA.
Mario SznolYale School of Medicine, 333 Cedar St, New Haven, CT, USA.
Kyle FahrbachEvidera, 7101 Wisconsin Ave, Suite 1400, Bethesda, MD, USA.
Yingxin XuEvidera, 7101 Wisconsin Ave, Suite 1400, Bethesda, MD, USA.
Eric MassonAstraZeneca, 35 Gatehouse Dr, Waltham, MA, USA.
Andrea Vergara-SilvaAstraZeneca, One MedImmune Way, Gaithersburg, MD, USA.

Funding

AstraZeneca N/A
6 · The paper itself

Abstract

purposeClassical clinical endpoints [e.g., objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS)] may not be appropriate for immune checkpoint blockers (ICBs). We evaluated correlations between these endpoints and overall survival (OS) for surrogacy.

methodsRandomized controlled trials (RCTs) of solid tumors patients treated with ICBs published between 01/2005 and 03/2017, and congress proceedings (2014-2016) were included. Arm-level analyses measured 6-month PFS rate to predict 18-month OS rate. Comparison-level analyses measured ORR odds ratio (OR), DCR OR, and 6-month PFS hazard ratio (HR) to predict OS HR. A pooled analysis for single-agent ICBs and ICBs plus chemotherapy vs chemotherapy was conducted. Studies of single-agent ICBs vs chemotherapy were separately analyzed.

results27 RCTs involving 61 treatment arms and 10,300 patients were included. Arm-level analysis showed higher 6- or 9-month PFS rates predicted better 18-month OS rates for ICB arms and/or chemotherapy arms. ICB arms had a higher average OS rate vs chemotherapy for all PFS rates. Comparison-level analysis showed a nonsignificant/weak correlation between ORR OR (adjusted R

conclusionsPFS was an imperfect surrogate for OS. Predictive value of 6-month PFS HR for OS HR in the single-agent ICB analysis requires further exploration.

Indexed as

Antineoplastic AgentsEndpoint DeterminationHumansMolecular Targeted TherapyNeoplasmsRandomized Controlled Trials as TopicSurvival AnalysisAntineoplastic AgentsCytotoxic T-lymphocyte-associated antigen-4Immune checkpoint blockersProgrammed cell death-1Programmed cell death ligand-1Solid tumorsSurrogate endpoint

Identifiers

PMID30132118
PMCPMC11813378

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Registered trials

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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.