Evidence map›Paper›PMID 35997546›Full record

ArticleCancer science2022

Immune-related adverse events in urothelial cancer patients: Adjustment for immortal time bias.

Hikari Otsuka, Yuki Kita, Katsuhiro Ito, Takeshi Sano, Junichi Inokuchi, Ryotaro Tomida, Atsushi Takahashi, Kazumasa Matsumoto, Ryoma Kurahashi, Yu Ozaki and 9 more

Open access · goldAbstract read
In one paragraph

Article in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

19 authors at 13 institutions in 1 country.

Hikari OtsukaDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0002-3547-2169
Yuki KitaDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0002-6942-9695
Katsuhiro ItoDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0002-6322-9190
Takeshi SanoDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0001-5854-6258
Junichi InokuchiDepartment of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Ryotaro TomidaDepartment of Urology, Shikoku Cancer Center, Matsuyama, Japan.
Atsushi TakahashiDepartment of Urology, Hakodate Goryoukaku Hospital, Hakodate, Japan.
Kazumasa MatsumotoDepartment of Urology, Kitasato University, Sagamihara, Japan.
Ryoma KurahashiDepartment of Urology, Kumamoto University, Kumamoto, Japan.
Yu OzakiDepartment of Urology, National Hospital Organization Himeji Medical Center, Himeji, Japan.
Masayuki UegakiDepartment of Urology, Toyooka Hospital, Toyooka, Japan.
Satoru MaruyamaDepartment of Urology, Hokkaido Cancer Center, Sapporo, Japan.
Shoichiro MukaiDepartment of Urology, University of Miyazaki, Miyazaki, Japan.
Masakazu TsutsumiDepartment of Urology, Hitachi General Hospital, Hitachi, Japan.
Takashi KawaharaDepartment of Urology, University of Tsukuba, Tsukuba, Japan.ORCID https://orcid.org/0000-0001-6494-819X
Takehiko SegawaDepartment of Urology, Kyoto City Hospital, Kyoto, Japan.
Hiroshi KitamuraDepartment of Urology, University of Toyama, Toyama, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takashi KobayashiDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0003-1069-2816
Kyoto University · JPHakodate National Hospital · JPHimeji Medical Center · JPHitachi General Hospital · JPKitasato University · JPKumamoto University · JPKyoto City Hospital · JPKyushu University · JPShikoku Cancer Center · JPToyooka Hospital · JPUniversity of Miyazaki · JPUniversity of Toyama · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate the association between the onset, severity, and type of immune-related adverse events (irAEs) and the efficacy of pembrolizumab in patients with platinum-pretreated advanced urothelial carcinoma (UC), we retrospectively collected clinical datasets of 755 patients and conducted landmark analysis. Patients who survived for fewer than 3 months were excluded from the evaluation to reduce the immortal time bias. In total, 620 patients were evaluated, of whom 220 patients (35.5%) experienced grade ≥2 irAEs, including 134 patients with grade 2 irAEs and 86 with grade ≥3 irAEs. Propensity score matching extracted 198 patients with and without grade ≥2 irAEs. The onset of grade ≥2 irAEs was associated with longer median progression-free survival (PFS) (8.3 months vs. 4.5 months, p = 0.003) and overall survival (OS) (20.4 months vs. 14.3 months, p = 0.031) and a higher objective response rate (ORR) (44.8% vs. 30.2%, p = 0.004). Patients with grade 2 irAEs had significantly better oncological outcomes (PFS, OS, and ORR) than grade ≤1 and ≥3 irAEs. Patients with grade ≥3 irAEs had worse outcomes than grade 2 irAEs. Endocrine and skin irAEs were related with better survival outcomes, and the rate of severities was lower in these categories. In conclusion, the occurrence of irAEs, particularly low-grade irAEs, was predictive of pembrolizumab efficacy in patients with platinum-pretreated advanced UC.

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Transitional CellUrinary Bladder NeoplasmsHumansNivolumabPlatinumRetrospective StudiesAntineoplastic Agents, ImmunologicalNivolumabPlatinumimmortal time biasimmune-related adverse eventspembrolizumabtherapeutic efficacyurothelial carcinoma

Identifiers

PMID35997546
PMCPMC9633286
OpenAlexW4292722415

What OpenQuestion 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 OpenQuestion graph.