Evidence map›Paper›PMID 35920793›Full record

Observational studyJapanese journal of clinical oncology2022

Real-world effectiveness of nivolumab plus ipilimumab and second-line therapy in Japanese untreated patients with metastatic renal cell carcinoma: 2-year analysis from a multicenter retrospective clinical study (J-cardinal study).

Takahiro Kojima, Renpei Kato, Tomokazu Sazuka, Hayato Yamamoto, Shohei Fukuda, Kazutoshi Yamana, Noboru Nakaigawa, Yusuke Sugino, Shuzo Hamamoto, Hiroaki Ito and 2 more

Open access · hybridAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Japanese journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study.International journal of urology : official journal of the Japanese Urological Association · 2026
    Observational
  4. Review
  5. Article
  6. Observational
  7. Observational
  8. Article
  9. Article
  10. Article
  11. 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

12 authors at 11 institutions in 1 country.

Takahiro KojimaDepartment of Urology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.ORCID 0000-0003-4150-9631
Renpei KatoDepartment of Urology, Iwate Medical University, Iwate, Japan.
Tomokazu SazukaDepartment of Urology, Chiba University Graduate School of Medicine, Chiba, Japan.
Hayato YamamotoDepartment of Urology, Hirosaki University Graduate School of Medicine, Aomori, Japan.
Shohei FukudaDepartment of Urology, Tokyo Medical and Dental University, Tokyo, Japan.
Kazutoshi YamanaDepartment of Urology, Molecular Oncology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan.
Noboru NakaigawaDepartment of Urology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan.
Yusuke SuginoDepartment of Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, Mie, Japan.
Shuzo HamamotoDepartment of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.ORCID 0000-0002-9968-7468
Hiroaki ItoOncology Medical, Bristol-Myers Squibb K.K., Tokyo, Japan.
Hiroshi MurakamiOncology Medical Affairs, Ono Pharmaceutical Co., Ltd., Tokyo, Japan.
Wataru ObaraDepartment of Urology, Iwate Medical University, Iwate, Japan.ORCID 0000-0003-2720-9640
Iwate Medical University · JPBristol-Myers Squibb (Japan) · JPChiba University · JPHirosaki University · JPMie University · JPNagoya City University · JPNiigata University · JPOno Pharmaceutical (Japan) · JPTokyo Medical and Dental University · JPUniversity of Tsukuba · JPYokohama City University · JP

Funding

ONO Pharmaceutical and Bristol-Myers Squibb
6 · The paper itself

Abstract

backgroundNivolumab plus ipilimumab combination therapy is one of the standard therapies for untreated renal cell carcinoma patients with an International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poor risk. We have previously reported the 1-year analysis results of the effectiveness and safety of nivolumab plus ipilimumab combination therapy in the real-world setting in Japan. Here, we report the effectiveness of nivolumab plus ipilimumab combination therapy and of second-line therapy, using 2-year analysis.

methodsThis retrospective observational study enrolled Japanese patients with previously untreated metastatic renal cell carcinoma who initiated nivolumab plus ipilimumab combination therapy between August 2018 and January 2019. Data were collected from patients' medical records at baseline and at 3 months, 1 year and 2 years after the last enrollment.

resultsOf the 45 patients enrolled, 10 patients (22.2%) each had non-clear cell renal cell carcinoma and Eastern Cooperative Oncology Group performance status ≥2 at baseline. Median follow-up period was 24.0 months; objective response rate was 41.5%, with 6 patients achieving complete response; median progression-free survival was 17.8 months and 24-month progression-free survival and overall survival rates were 41.6 and 59.1%, respectively. Second-line therapy achieved an objective response rate of 20%; median progression-free survival was 9.8 months. Median progression-free survival 2 was 26.4 months.

conclusionsThe effectiveness of nivolumab plus ipilimumab combination therapy at 2-year analysis in the real-world setting in Japan was comparable to that reported in CheckMate 214. The current analysis also demonstrated the effectiveness of second-line therapy after nivolumab plus ipilimumab combination therapy.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabJapanNivolumabRetrospective StudiesIpilimumabNivolumabipilimumabJapannivolumabreal-worldrenal cell carcinoma

Identifiers

PMID35920793
PMCPMC9631464
OpenAlexW4289594357

What OpenQuestion holds

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LicenceCC BY
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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.