Evidence mapPaperPMID 33455091Full record

SynthesisCancer reports (Hoboken, N.J.)2021

Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancer.

Hideki Maeda, Kentaro Takeda, Hisashi Urushihara, Tatsuo Kurokawa

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Cancer reports (Hoboken, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 24% 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

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
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 3 institutions in 2 countries.

Hideki MaedaDepartment of Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, Kiyose-city, Tokyo, Japan.ORCID 0000-0002-0117-3961
Kentaro TakedaBiostatistics Group, Data Science Department, Astellas Pharma Global Development, Inc, Northbrook, Illinois, USA.
Hisashi UrushiharaDivision of Drug Development & Regulatory Science, Faculty of Pharmacy, Keio University, Minato-ku, Tokyo, Japan.
Tatsuo KurokawaDivision of Drug Development & Regulatory Science, Faculty of Pharmacy, Keio University, Minato-ku, Tokyo, Japan.
Keio University · JPCenter for Global Development · USMeiji Pharmaceutical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this study was to investigate the correlation between overall survival (OS) and other clinical outcomes in patients with prostate cancer. Further, we conducted subgroup analysis in the correlation of OS.

aimThis study intended to investigate potential surrogate endpoints of OS for prostate cancer by examining the correlation between OS and the other endpoints.

methodsWe performed a systematic review through a literature search by computer-based searches of the Medline database (January 1965 and May 2014).

resultsThe contents of 115 studies with endpoint as OS were analyzed in our study. Our results showed that 47.8% (55/115) of the studies used progression-free survival as an endpoint besides OS, followed by time to progression (43.5% [50/115]) and PSA response (40.9% [47/115]). Also, the relationship between OS and each surrogate endpoint was examined using the hazard ratio (HR) by a Bayesian hybrid model for random effect multivariate meta-analysis. Our results showed that the endpoint that had the highest correlation with OS was progression-free survival (PFS) with an estimated marginal correlation of 0.939 (95%CI: 0.900, 0.967). Furthermore, our stratified analysis identified PFS in castration-resistant prostate cancer patients (0.937), in sensitive patients (0.932), in none of chemotherapy patients (0.929), in first line of the chemotherapy (0.948), in patients who received no Docetaxel previously (0.942), in both symptomatic and asymptomatic patients (0.950), in patients who received only chemotherapy (0.956), and in phase III (0.960), time to progression (TTP) in castration-resistant prostate cancer (CRPC) patients (0.942), in metastasis patients (0.948), in both symptomatic and asymptomatic patients (0.953), in patients who received only chemotherapy (0.938), and in Phase III (0.927) as endpoints, which showed a lower limit for 95% CI of estimated marginal correlation ≥0.850 with overall survival.

conclusionsOur study suggests that PFS is a potential surrogate endpoint of OS in clinical trials for patients with prostate cancer. It also suggests potential surrogate endpoints for CRPC and locally advanced prostate cancer.

Indexed as

Progression-Free SurvivalAntineoplastic Combined Chemotherapy ProtocolsDisease ProgressionDocetaxelHumansMaleProstatic NeoplasmsRandomized Controlled Trials as TopicResearch DesignDocetaxelclinical trialprostate cancersurrogate endpointsurvival

Identifiers

PMID33455091
PMCPMC8222553
OpenAlexW3122245675

What Socratic 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 Socratic graph.