Evidence map›Paper›PMID 32458996›Full record

Observational studyJapanese journal of clinical oncology2020

Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study.

Shigeru Sugiyama, Kazuo Sato, Yoshiyuki Shibasaki, Yutaka Endo, Taku Uryu, Yasuharu Toyoshima, Mototsugu Oya, Naoto Miyanaga, Nagahiro Saijo, Akihiko Gemma and 1 more

2 registry-linked trialsOpen access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Japanese journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

NCT01210482 completednot on this map

Safety and effectiveness of temsirolimus in japanese patients with unresectable or metastatic renal cell carcinoma: a post-marketing, all-case surveillance study including b1771016 study - survey on long-term use -

TypeobservationalSponsorPfizerRan2010 to 2018Enrolled1,050ConditionsRenal Cell CarcinomaArmsTemsirolimus
NCT01420601 no registry record found
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. 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

11 authors at 6 institutions in 1 country.

Shigeru SugiyamaPfizer Japan Inc., Tokyo, Japan.
Kazuo SatoPfizer Japan Inc., Tokyo, Japan.
Yoshiyuki ShibasakiPfizer Japan Inc., Tokyo, Japan.
Yutaka EndoPfizer R&D G.K., Tokyo, Japan.
Taku UryuPfizer R&D G.K., Tokyo, Japan.
Yasuharu ToyoshimaPfizer R&D G.K., Tokyo, Japan.
Mototsugu OyaDepartment of Urology, Keio University Hospital, Tokyo, Japan.
Naoto MiyanagaDepartment of Urology, Mito Saiseikai General Hospital, Ibaraki, Japan.
Nagahiro SaijoJapanese Society of Medical Oncology, Tokyo, Japan.
Akihiko GemmaDepartment of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Hideyuki AkazaInterfaculty Initiative in Information Studies, Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.
Pfizer (Japan) · JPJapanese Society of Medical Oncology · JPKeio University Hospital · JPMito Saiseikai General Hospital · JPNippon Medical School · JPTokyo University of Information Sciences · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA prospective, observational, post-marketing surveillance was conducted to assess the safety and effectiveness of temsirolimus in patients with renal cell carcinoma in Japan.

methodsPatients prescribed temsirolimus for advanced renal cell carcinoma were registered and received temsirolimus (25 mg weekly, intravenous infusion for 30-60 minutes) in routine clinical settings (observation period: 96 weeks).

resultsAmong 1001 patients included in the safety analysis data set (median age, 65.0 years; men, 74.8%; Eastern Cooperative Oncology Group performance status 0 or 1, 69.6%), 778 (77.7%) reported adverse drug reactions. The most common (≥10%) all-grade adverse drug reactions were stomatitis (26.7%), interstitial lung disease (17.3%) and platelet count decreased (11.1%). The incidence rate of grade ≥3 interstitial lung disease was 4.5%. The onset of interstitial lung disease was more frequent after 4-8 weeks of treatment or in patients with lower Eastern Cooperative Oncology Group performance status (21.6% for score 0 vs 8.3% for score 4, P < 0.001). Among 654 patients in the effectiveness analysis data set, the response and clinical benefit rates were 6.7% (95% confidence interval 4.9-8.9) and 53.2% (95% confidence interval 49.3-57.1), respectively. The median progression-free survival was 18.3 weeks (95% confidence interval 16.9-21.1).

conclusionsThe safety and effectiveness profile of temsirolimus observed in this study was similar to that observed in the multinational phase 3 study. The results are generalizable to the real-world scenario at the time of this research, and safety and effectiveness of temsirolimus as a subsequent anticancer therapy for renal cell carcinoma warrants further investigation. (ClinicalTrials.gov identifier NCT01210482, NCT01420601).

Indexed as

Asian PeopleProduct Surveillance, PostmarketingAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellDisease-Free SurvivalFemaleHumansJapanKidney NeoplasmsLung Diseases, InterstitialMaleMiddle AgedProspective StudiesAntineoplastic AgentsSirolimustemsirolimuscarcinoma renal cellJapanproduct surveillance postmarketingsafetytemsirolimus

Identifiers

PMID32458996
PMCPMC7401718
OpenAlexW3029665128

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.