Evidence map›Paper›PMID 40456850›Full record

SynthesisScientific reports2025

Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.

Satoshi Hirano, Keisuke Hanada, Hideki Maeda

Erratum issuedAbstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

Satoshi HiranoRegulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan.
Keisuke HanadaGraduate School of Engineering, Osaka University, Osaka, Japan.
Hideki MaedaRegulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan. maeda@my-pharm.ac.jp.

Funding

Japan Society for the Promotion of Science JP23K11940
6 · The paper itself

Abstract

Confirming the patient benefit of progression-free survival (PFS) in B-cell non-Hodgkin lymphoma (B-NHL) and multiple myeloma (MM) has become increasingly challenging due to the improved outcomes brought by novel therapies. In parallel, the U.S. Food and Drug Administration recommends conducting randomized trials, focusing on evaluating early endpoints to compare study and control arms for accelerated approval (AA). From both the clinical and regulatory perspectives, identifying early surrogate endpoints for PFS is imperative. In principle, the complete response rate (CRR) is a potential early endpoint for granting AA. This study aimed to evaluate whether the CRR is a surrogate early endpoint for PFS in patients with B-cell malignancies. We investigated the results of randomized trials with data on CRR and PFS using a combined approach of PubMed and Clinical Trial.gov (CTG), identifying 52 trials after applying exclusion criteria. A meta-regression plot showed a significant correlation between the CRR and PFS with an R-squared of 0.822 in 13 trials of aggressive B-NHL, 0.941 in the 8 trials of indolent N-NHL and 0.492 in the 31 trials of MM. This meta-analysis suggests that the CRR can be considered an early surrogate endpoint for PFS in B-NHL and MM.

Indexed as

Hematologic NeoplasmsLymphoma, B-CellMultiple MyelomaHumansProgression-Free SurvivalRandomized Controlled Trials as TopicLymphomasMeta analysisMultiple myeloma

Identifiers

PMID40456850
PMCPMC12130302

What OpenQuestion holds

Textmetadata
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.