Evidence map›Paper›PMID 36602756›Full record

Trial reportTherapeutic innovation & regulatory science2023

Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials.

Shinya Watanabe, Takahiro Nonaka, Makoto Maeda, Narushi Sugii, Koichi Hashimoto, Shingo Takano, Tomoyoshi Koyanagi, Masanobu Yamada, Yoshihiro Arakawa, Eiichi Ishikawa

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. 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

10 authors.

Shinya WatanabeDepartment of Neurosurgery, Mito Kyodo General Hospital, Tsukuba University Hospital Mito Area Medical Education Center, 3-2-7 Miyamachi, Mito, Ibaraki, 310-0015, Japan. shinya-watanabey@md.tsukuba.ac.jp.ORCID 0000-0002-9953-8665
Takahiro NonakaDepartment of Health and Medical Innovation, Graduate School of Medicine, Osaka Metropolitan University School, Osaka, Japan.
Makoto MaedaDepartment of, Pharmacy, National Cancer Center Hospital, Tokyo, Japan.
Narushi SugiiDepartment of Neurosurgery, University of Tsukuba Hospital, Tsukuba, Japan.
Koichi HashimotoTsukuba Clinical Research and Development Organization, University of Tsukuba, Tsukuba, Japan.
Shingo TakanoDepartment of Neurosurgery, University of Tsukuba Hospital, Tsukuba, Japan.
Tomoyoshi KoyanagiTsukuba Clinical Research and Development Organization, University of Tsukuba, Tsukuba, Japan.
Masanobu YamadaTsukuba Clinical Research and Development Organization, University of Tsukuba, Tsukuba, Japan.
Yoshihiro ArakawaTsukuba Clinical Research and Development Organization, University of Tsukuba, Tsukuba, Japan.
Eiichi IshikawaDepartment of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundResponse Evaluation Criteria in Solid Tumors (RECIST)-based response rates are commonly used as efficacy endpoints in phase II clinical trials for solid tumors. However, no consensus has been reached concerning adequate efficacy endpoints for phase II clinical trials targeting meningioma. Irregularity of lesions after resection, and varying degrees of dysplasia and histologic subtypes make establishing an appropriate efficacy evaluation difficult.

methodsWe analyzed primary efficacy endpoints (PEEs) and background factors from 48 trials retrieved from ClinicalTrials.gov ( https://clinicaltrials.gov/ ) using the search criteria "meningioma," "interventional," "phase II," and "study start 4/1/2001 to 3/31/2021." Primary purpose of the study was efficacy endpoint setting in overall population and three subgroups.

resultsAmong 45 PEEs set in the 39 trials included; 33 trials with single PEE, and six trials with double PEEs, 17/45 (38%) trials adopted progression-free survival (PFS) rate, 15/45 (33%) trials response rate (seven Macdonald criteria or modified, three RECIST, three volumetric estimation, one RANO criteria, one unknown), 10/45 (22%) PFS, 1/45 (2%) OS, and 2/45 (4%) other endpoints. Although 26 PEEs were time-to-event endpoints, 19 of the 26 PEEs were single-arm studies.

conclusionsTime-to-event efficacy endpoints were often compared to historical data, and two-dimensional evaluation is more suitable than one-dimensional one. Accumulation of prognostic data is essential to standardize time-to-event efficacy endpoints. Considering the difficulty of setting design for phase II clinical studies targeting meningioma, evaluation might be done with multiple efficacy endpoints.

Indexed as

Meningeal NeoplasmsMeningiomaHumansProgression-Free SurvivalBrain tumorEfficacy endpointMeningiomaPhase II clinical trialRegulatory science

Identifiers

PMID36602756

What OpenQuestion holds

Textmetadata
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.