Evidence map›Paper›PMID 36534262›Full record

Trial reportInternational journal of clinical oncology2023

Veliparib with frontline chemotherapy and as maintenance in Japanese women with ovarian cancer: a subanalysis of efficacy, safety, and antiemetic use in the phase 3 VELIA trial.

Mika Mizuno, Kimihiko Ito, Hidekatsu Nakai, Hidenori Kato, Shoji Kamiura, Kimio Ushijima, Shoji Nagao, Hirokuni Takano, Masao Okadome, Munetaka Takekuma and 11 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Review
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

21 authors at 19 institutions in 2 countries.

Mika MizunoDepartment of Gynecology, Aichi Cancer Center Hospital, Nagoya-Shi, Aichi, 464-8681, Japan. mizunomizuno@kufm.kagoshima-u.ac.jp.ORCID http://orcid.org/0000-0003-3151-8315
Kimihiko ItoDepartment of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki-Shi, Hyogo, 660-8511, Japan.
Hidekatsu NakaiDepartment of Obstetrics and Gynecology, Kindai University, Faculty of Medicine, Osakasayama-Shi, Osaka, 589-8511, Japan.
Hidenori KatoDivision of Gynecologic Oncology, Hokkaido Cancer Center, Sapporo-Shi, Hokkaido, 003-0804, Japan.
Shoji KamiuraDepartment of Gynecology, Osaka International Cancer Institute, Osaka-Shi, Osaka, 541-8567, Japan.
Kimio UshijimaDepartment of Obstetrics and Gynecology, Kurume University Hospital, Kurume-Shi, Fukuoka, 830-0011, Japan.
Shoji NagaoDepartment of Gynecologic Oncology, Hyogo Cancer Center, Akashi-Shi, Hyogo, 673-8558, Japan.
Hirokuni TakanoDepartment of Obstetrics and Gynecology, Jikei University Kashiwa Hospital, Kashiwa-Shi, Chiba, 277-0004, Japan.
Masao OkadomeGynecology Service, National Hospital Organization (NHO) Kyushu Cancer Center, Fukuoka-Shi, Fukuoka, 811-1395, Japan.
Munetaka TakekumaDepartment of Gynecology, Shizuoka Cancer Center, Sunto-Gun, Shizuoka, 411-8777, Japan.
Hideki TokunagaDepartment of Gynecology, Tohoku University Hospital, Sendai-Shi, Miyagi, 980-8574, Japan.
Satoru NagaseDepartment of Obstetrics Gynecology, Yamagata University, Faculty of Medicine, Yamagata-Shi, Yamagata, 990-9585, Japan.
Daisuke AokiDepartment of Obstetrics and Gynecology, Keio University School of Medicine, Shinjuku-Ku, Tokyo, 160-8582, Japan.
Robert L ColemanDepartment of Gynecologic Oncology, US Oncology Research, The Woodlands, TX, USA.
Yasuko NishimuraAbbVie GK, Minato-Ku, Tokyo, 108-0023, Japan.
Christine K RatajczakAbbVie Inc., North Chicago, IL, USA.
Hideyuki HashibaAbbVie GK, Minato-Ku, Tokyo, 108-0023, Japan.
Hao XiongAbbVie Inc., North Chicago, IL, USA.
Noriyuki KatsumataDepartment of Medical Oncology, Nippon Medical School Musashikosugi Hospital, Kawasaki-Shi, Kanagawa, 211-8533, Japan.
Takayuki EnomotoJapanese Gynecologic Oncology Group, Shinjuku-Ku, Tokyo, 162-0825, Japan.
Aikou OkamotoDepartment of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-Ku, Tokyo, 105-8461, Japan.
ABB (Japan) · JPAbbVie (United States) · USGynecologic Oncology Group · USHyogo Prefectural Cancer Center · JPJikei University Kashiwa hospital · JPJikei University School of Medicine · JPKagoshima University · JPKansai Rosai Hospital · JPKeio University · JPKindai University · JPKurume University Hospital · JPNational Hospital Organization Hokkaido Medical Center · JPNational Hospital Organization Kyushu Cancer Center · JPNippon Medical School · JPOsaka International Cancer Institute · JPShizuoka Cancer Center · JPThe US Oncology Network · USTohoku University Hospital · JPYamagata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase 3 VELIA trial evaluated veliparib with carboplatin/paclitaxel and as maintenance in patients with high-grade serous ovarian carcinoma.

methodsPatients with previously untreated stage III-IV high-grade serous ovarian carcinoma were randomized 1:1:1 to control (placebo with carboplatin/paclitaxel and placebo maintenance), veliparib-combination-only (veliparib with carboplatin/paclitaxel and placebo maintenance), or veliparib-throughout (veliparib with carboplatin/paclitaxel and veliparib maintenance). Randomization stratification factors included geographic region (Japan versus North America or rest of the world). Primary end point was investigator-assessed median progression-free survival. Efficacy, safety, and pharmacokinetics were evaluated in a subgroup of Japanese patients.

resultsSeventy-eight Japanese patients were randomized to control (n = 23), veliparib-combination-only (n = 30), and veliparib-throughout (n = 25) arms. In the Japanese subgroup, median progression-free survival for veliparib-throughout versus control was 27.4 and 19.1 months (hazard ratio, 0.46; 95% confidence interval, 0.18-1.16; p = 0.1 [not significant]). In the veliparib-throughout arm, grade 3/4 leukopenia, neutropenia, and thrombocytopenia rates were higher for Japanese (32%/88%/32%) versus non-Japanese (17%/56%/28%) patients. Grade 3/4 anemia rates were higher in non-Japanese (65%) versus Japanese (48%) patients. Early introduction of olanzapine during veliparib monotherapy maintenance phase may help prevent premature discontinuation of veliparib, via its potent antiemetic efficacy.

conclusionsMedian progression-free survival was numerically longer in Japanese patients in the veliparib-throughout versus control arm, consistent with results in the overall study population. Pharmacokinetics were comparable between Japanese and non-Japanese patients. Data for the subgroup of Japanese patients were not powered to show statistical significance but to guide further investigation.

Indexed as

AnemiaAntiemeticsOvarian NeoplasmsThrombocytopeniaAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarboplatinFemaleHumansPaclitaxelAntiemeticsBenzimidazolesCarboplatinPaclitaxelveliparibAntiemeticsJapaneseOvarian cancerPARP inhibitorVELIAVeliparib

Identifiers

PMID36534262
PMCPMC9823063
OpenAlexW4311934109

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LicenceCC BY
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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.