Evidence map›Paper›PMID 34473544›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer: Open-Label, Randomized Trial in Japan (NINJA).

Junzo Hamanishi, Nobuhiro Takeshima, Noriyuki Katsumata, Kimio Ushijima, Tadashi Kimura, Satoshi Takeuchi, Koji Matsumoto, Kimihiko Ito, Masaki Mandai, Hidekatsu Nakai and 32 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 127 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
127citing papers in PubMed, 13 pooled it
23.9field-weighted citation impact, top 1% 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

127 citing papers in PubMed, 13 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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67 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

42 authors at 20 institutions in 1 country.

Junzo HamanishiDepartment of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-7750-0623
Nobuhiro TakeshimaDepartment of Gynecology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
Noriyuki KatsumataDepartment of Medical Oncology, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.
Kimio UshijimaDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan.
Tadashi KimuraDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Japan.
Satoshi TakeuchiDepartment of Obstetrics and Gynecology, Iwate Medical University Hospital, Iwate, Japan.ORCID 0000-0001-8868-6462
Koji MatsumotoDepartment of Medical Oncology, Hyogo Cancer Center, Akashi, Japan.ORCID 0000-0003-1907-0247
Kimihiko ItoDepartment of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Japan.ORCID 0000-0002-3115-7997
Masaki MandaiDepartment of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osakasayama, Japan.
Hidekatsu NakaiDepartment of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osakasayama, Japan.ORCID 0000-0002-9994-2131
Noriaki SakuragiDepartment of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID 0000-0002-0653-8325
Hidemichi WatariDepartment of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID 0000-0002-4189-6187
Nobutaka TakahashiDivision of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.ORCID 0000-0002-4194-4388
Hidenori KatoDepartment of Gynecology, Hokkaido Cancer Center, Sapporo, Japan.
Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-1903-7001
Kan YonemoriDepartment of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-7624-7611
Mika MizunoDepartment of Obstetrics and Gynecology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0003-3151-8315
Kazuhiro TakeharaDepartment of Gynecologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.ORCID 0000-0001-8808-3338
Hitoshi NiikuraDepartment of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Takashi SawasakiDepartment of Obstetrics and Gynecology, National Hospital Organization Kure Medical Center, Kure, Japan.
Sari NakaoDepartment of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba Hospital, Tsukuba, Japan.
Toshiaki SaitoGynecology Service, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Takayuki EnomotoDepartment of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.ORCID 0000-0003-4538-5541
Satoru NagaseDepartment of Obstetrics and Gynecology, Yamagata University Hospital, Yamagata, Japan.ORCID 0000-0001-5212-1128
Nao SuzukiDepartment of Obstetrics and Gynecology, St Marianna University School of Medicine, Kawasaki, Japan.
Takashi MatsumotoDepartment of Obstetrics and Gynecology, Ehime University Hospital, Toon, Japan.ORCID 0000-0002-7873-2303
Eiji KondoDepartment of Obstetrics and Gynecology, Mie University Hospital, Tsu, Japan.ORCID 0000-0001-9773-2520
Kenzo SonodaDepartment of Obstetrics and Gynecology, Kyushu University Hospital, Fukuoka, Japan.ORCID 0000-0001-9887-3923
Satomi AiharaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Saga University Hospital, Saga, Japan.
Yoichi AokiDepartment of Obstetrics and Gynecology, University of the Ryukyus Hospital, Okinawa, Japan.ORCID 0000-0003-3545-8639
Aikou OkamotoDepartment of Obstetrics and Gynecology, The Jikei University Hospital, Tokyo, Japan.
Hirokuni TakanoDepartment of Obstetrics and Gynecology, The Jikei University Kashiwa Hospital, Kashiwa, Japan.
Hiroshi KobayashiDepartment of Obstetrics and Gynecology, Nara Medical University Hospital, Kashihara, Japan.
Hisamori KatoDepartment of Gynecology, Kanagawa Cancer Center, Yokohama, Japan.
Yoshito TeraiDepartment of Gynecologic Oncology, Osaka Medical College Hospital, Takatsuki, Japan.ORCID 0000-0002-5581-8518
Akira TakazawaData Science, Ono Pharmaceutical Co, Ltd, Osaka, Japan.ORCID 0000-0002-4755-8007
Yusuke TakahashiOncology Clinical Development Unit, Ono Pharmaceutical Co, Ltd, Osaka, Japan.
Yoshinobu NambaClinical Science, Ono Pharmaceutical Co, Ltd, Osaka, Japan.
Daisuke AokiDepartment of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0002-9596-8326
Keiichi FujiwaraDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-7388-0243
Toru SugiyamaDepartment of Obstetrics and Gynecology, Iwate Medical University Hospital, Iwate, Japan.ORCID 0000-0002-2385-9040
Ikuo KonishiNational Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Ono Pharmaceutical (Japan) · JPHokkaido University · JPIwate Medical University · JPKanagawa Prefectural Hospital Organization · JPKyoto University · JPNational Hospital Organization Kyushu Cancer Center · JPSaitama Medical University · JPEhime University Hospital · JPHyogo Prefectural Cancer Center · JPJikei University Kashiwa hospital · JPKagoshima University Hospital · JPKansai Rosai Hospital · JPKeio University · JPKindai University · JPKurume University · JPKyoto Medical Center · JPMie University Hospital · JPNara Medical University Hospital · JPNational Hospital Organization · JPNiigata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase III, multicenter, randomized, open-label study investigated the efficacy and safety of nivolumab versus chemotherapy (gemcitabine [GEM] or pegylated liposomal doxorubicin [PLD]) in patients with platinum-resistant ovarian cancer. MATERIALS AND

methodsEligible patients had platinum-resistant epithelial ovarian cancer, received ≤ 1 regimen after diagnosis of resistance, and had an Eastern Cooperative Oncology Group performance score of ≤ 1. Patients were randomly assigned 1:1 to nivolumab (240 mg once every 2 weeks [as one cycle]) or chemotherapy (GEM 1000 mg/m

resultsPatients (n = 316) were randomly assigned to nivolumab (n = 157) or GEM or PLD (n = 159) between October 2015 and December 2017. Median OS was 10.1 (95% CI, 8.3 to 14.1) and 12.1 (95% CI, 9.3 to 15.3) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.0; 95% CI, 0.8 to 1.3;

conclusionAlthough well-tolerated, nivolumab did not improve OS and showed worse PFS compared with GEM or PLD in patients with platinum-resistant ovarian cancer.

Indexed as

Drug Resistance, NeoplasmAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDoxorubicinFemaleFollow-Up StudiesGemcitabineHumansJapanLymphatic MetastasisMiddle AgedNeoplasm InvasivenessNivolumabDeoxycytidineDoxorubicinGemcitabineliposomal doxorubicinNivolumabPlatinumPolyethylene Glycols

Identifiers

PMID34473544
PMCPMC8601279
OpenAlexW3198783816

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.