Evidence map›Paper›PMID 34932235›Full record

Trial reportCancer science2022

Phase 1/2 study evaluating the safety and efficacy of DSP-7888 dosing emulsion in myelodysplastic syndromes.

Yasunori Ueda, Kensuke Usuki, Jiro Fujita, Itaru Matsumura, Nobuyuki Aotsuka, Naohiro Sekiguchi, Tomonori Nakazato, Hiromi Iwasaki, Mariko Takahara-Matsubara, Saori Sugimoto and 5 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Vaccines: a promising therapy for myelodysplastic syndrome.Journal of hematology & oncology · 2024
    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

15 authors at 12 institutions in 1 country.

Yasunori UedaDepartment of Hematology/Oncology, Kurashiki Central Hospital, Okayama, Japan.ORCID https://orcid.org/0000-0002-4487-5808
Kensuke UsukiDepartment of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.
Jiro FujitaDepartment of Hematology and Oncology, Osaka University Hospital, Osaka, Japan.
Itaru MatsumuraDepartment of Hematology and Rheumatology, Kindai University Hospital, Osaka, Japan.ORCID https://orcid.org/0000-0003-2818-4270
Nobuyuki AotsukaDepartment of Hematology Oncology, Japanese Red Cross Narita Hospital, Chiba, Japan.
Naohiro SekiguchiDepartment of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9860-8257
Tomonori NakazatoDepartment of Hematology, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.
Hiromi IwasakiDepartment of Hematology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Mariko Takahara-MatsubaraSumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.
Saori SugimotoSumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.
Masashi GotoSumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.
Tomoki NaoeNational Hospital Organization Nagoya Medical Center, Aichi, Japan.
Masahiro KizakiDepartment of Hematology, Saitama Medical Center, Saitama, Japan.
Yasushi MiyazakiDepartment of Hematology, Atomic Bomb Disease and Hibakusha Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.ORCID https://orcid.org/0000-0003-3683-7147
Koichi AakashiDepartment of Medicine and Biosystemic Science Faculty of Medicine, Kyushu University, Fukuoka, Japan.
Sumitomo Dainippon Pharma (Japan) · JPNational Hospital Organization · JPJapanese Red Cross Narita Hospital · JPKindai University Hospital · JPKurashiki Central Hospital · JPKyushu University · JPNagasaki University · JPNational Kyushu Medical Center · JPNTT Medical Center · JPOsaka University Hospital · JPSocial Insurance Saitama Chuo Hospital · JPYokohama Municipal Citizen's Hospital · JP

Funding

Sumitomo Dainippon Pharma Co., Ltd.
6 · The paper itself

Abstract

DSP-7888 is an immunotherapeutic cancer vaccine derived from the Wilms' tumor gene 1 (WT1) protein. This phase 1/2 open-label study evaluated the safety and efficacy of DSP-7888 dosing emulsion in patients with myelodysplastic syndromes (MDS). DSP-7888 was administered intradermally (3.5 or 10.5 mg) every 2 weeks for 6 months and then every 2-4 weeks until lack of benefit. Twelve patients were treated in phase 1 (3.5 mg, n = 6; 10.5 mg, n = 6), with no dose-limiting toxicities reported. Thus, the 10.5 mg dose was selected as the recommended phase 2 dose, and 35 patients were treated in phase 2. Forty-seven patients received ≥1 dose of the study drug and comprised the safety analysis set. The most common adverse drug reaction (ADR) was injection site reactions (ISR; 91.5%). Grade 3 ISR were common (58.8%) in phase 1 but occurred less frequently in 2 (22.9%) following implementation of risk minimization strategies. Other common ADR were pyrexia (10.6%) and febrile neutropenia (8.5%). In the efficacy analysis set, comprising patients with higher-risk MDS after azacitidine failure in phases 1 and 2 (n = 42), the disease control rate was 19.0%, and the median overall survival (OS) was 8.6 (90% confidence interval [CI], 6.8-10.3) months. Median OS was 10.0 (90% CI, 7.6-11.4) months in patients with a WT1-specific immune response (IR; n = 33) versus 4.1 (90% CI, 2.3-8.1) months in those without a WT1-specific IR (n = 9; P = .0034). The acceptable safety and clinical activity findings observed support the continued development of DSP-7888 dosing emulsion.

Indexed as

Cancer VaccinesMyelodysplastic SyndromesAzacitidineEmulsionsHumansTreatment OutcomeVaccines, SubunitWT1 ProteinsAzacitidineCancer VaccinesEmulsionsVaccines, SubunitWT1 ProteinsDSP-7888high-risk myelodysplastic syndromemyelodysplastic syndromesWilms’ tumor gene 1WT1 peptide vaccine

Identifiers

PMID34932235
PMCPMC8990724
OpenAlexW4200261886

What OpenQuestion holds

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LicenceCC BY-NC
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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.