Evidence map›Paper›PMID 33934570›Full record

Trial reportCancer reports (Hoboken, N.J.)2021

Effectiveness and safety profile of pembrolizumab for metastatic urothelial cancer: A retrospective single-center analysis in Japan.

Motohiro Fujiwara, Takeshi Yuasa, Tetsuya Urasaki, Yoshinobu Komai, Ryo Fujiwara, Noboru Numao, Shinya Yamamoto, Junji Yonese

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

Trial report 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 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Observational
  8. Review
  9. Article
  10. 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

8 authors.

Motohiro FujiwaraDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0001-9454-3345
Takeshi YuasaDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0002-8924-6730
Tetsuya UrasakiDepartment of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Yoshinobu KomaiDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0003-0353-9303
Ryo FujiwaraDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0001-6566-1430
Noboru NumaoDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Shinya YamamotoDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Junji YoneseDepartment of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.

Funding

Smoking Research Foundation 16K11035
6 · The paper itself

Abstract

backgroundThe paradigm of medical treatment for metastatic urothelial carcinoma is dramatically changing through the introduction of pembrolizumab.

aimWe investigated the treatment effectiveness, the safety profile, and the prognostic factors of pembrolizumab in Japanese real-world clinical practice. METHODS AND

resultsThe medical records of 74 consecutive Japanese patients with metastatic urothelial cancer (UC), who started pembrolizumab as a second- or later-line treatment at our institution between January 2018 and March 2020, were reviewed and statistically analyzed. The median follow-up period after initiation of pembrolizumab was 8.5 (interquartile range: 3.5-15.7) months. The objective response rate was 30.2%, the median progression-free survival period was 4.9 months, and the median overall survival (OS) period was 13.3 months. Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), among whom eight patients (10.9%) had severe AEs (grade 3 or more), including grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the presence of liver metastasis, worse performance status (≥2), elevated serum lactate dehydrogenase, and increased C-reactive protein were predictive of shorter OS.

conclusionWe studied the effectiveness and safety profile of pembrolizumab therapy in Japanese UC patients. We believe that the data presented here will be useful for clinical physicians.

Indexed as

AgedAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellFemaleFollow-Up StudiesHumansImmune Checkpoint InhibitorsLiver NeoplasmsLymphatic MetastasisMaleMiddle AgedPrognosisRetrospective StudiesSurvival RateUrinary Bladder NeoplasmsAntibodies, Monoclonal, HumanizedImmune Checkpoint Inhibitorspembrolizumabimmune checkpoint inhibitorimmune-related adverse eventspembrolizumabprognostic factorurothelial carcinoma

Identifiers

PMID33934570
PMCPMC8714548

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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.