Evidence map›Paper›PMID 38231777›Full record

ArticleJapanese journal of clinical oncology2024

Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies.

Shunji Takahashi, Hideaki Bando, Ichiro Kinoshita, Shanu Modi, Junji Tsurutani, Yung-Jue Bang, Yuta Sato, Shunsuke Nakatani, Caleb Lee, Masahiro Sugihara and 2 more

2 registry-linked trialsOpen access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Japanese journal of clinical oncology, 2024. 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 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
10.9field-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.

NCT02564900 phase1completednot on this map

Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2015 to 2023Enrolled292ConditionsAdvanced Solid TumorsArmsDS-8201a (DP1), DS-8201a (DP2), DS-8201a (DP)
NCT03383692 phase1completednot on this map

A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2018 to 2023Enrolled40ConditionsNeoplasm MetastasisArmsDS-8201a, Ritonavir, Itraconazole
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  3. Trial
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  5. Review
  6. Article
  7. Contemporary Management of Malignancies of the Parotid Gland: A State-of-the-Art Review.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Review
  8. Article
  9. Article
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  11. Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
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  15. Article
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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 9 institutions in 3 countries.

Shunji TakahashiDivision of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0002-5031-1953
Hideaki BandoDepartment of Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Ichiro KinoshitaDepartment of Medical Oncology, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.
Shanu ModiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Yuta SatoClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Shunsuke NakataniClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Caleb LeeGlobal Oncology R&D, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Masahiro SugiharaGlobal Oncology Clinical Development, Data Intelligence, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Yasuyuki OkudaGlobal Oncology Clinical Development, Data Intelligence, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Hiroji IwataDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Daiichi-Sankyo (Japan) · JPAichi Cancer Center · JPDaiichi Sankyo (United States) · USHokkaido University Hospital · JPMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPSeoul National University · KRShowa University · JPThe Cancer Institute Hospital · JP

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Daiichi Sankyo, JapanNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundHER2-expressing salivary gland carcinoma (SGC) is associated with poor prognosis. Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies. This study aimed to present the efficacy and safety of T-DXd in patients with HER2-expressing SGC from a pooled analysis.

methodsPatients with HER2-expressing SGC were pooled from two phase I, open-label studies of T-DXd: a two-phase, multiple-dose, first-in-human study (NCT02564900) and a single-sequence crossover drug-drug interaction study (NCT03383692). Endpoints included efficacy (objective response rate [ORR], duration of response [DoR] and progression-free survival [PFS]) and safety.

resultsThis pooled analysis included 17 patients with SGC (median age: 57 years; male: 88.2%); median (range) follow-up duration was 12.0 (2.3-‍34.8) months. Among these patients, 14 had received prior HER2-targeted agents and 13 had undergone prior radiotherapy. The investigator-assessed confirmed ORR was 58.8% (95% confidence interval [CI], 32.9-‍81.6). The median (95% CI) DoR and PFS were 17.6 months (4.0 to not evaluable [NE]) and 20.5 months (11.1-NE), respectively. All 17 patients reported treatment-emergent adverse events (TEAEs); 76.5% reported TEAEs of grade ≥3. The most common TEAEs were decreased appetite (94.1%), nausea (88.2%) and neutrophil count decreased (76.5%). Of the 17 patients, five (29.4%) reported adjudicated drug-related interstitial lung disease (grade 1, n = 3; grade 2, n =1; grade 3, n = 1).

conclusionThe results of this pooled analysis provide evidence that clinical benefit is achievable with T-DXd in patients with HER2-expressing SGC. CLINICAL TRIAL INFORMATION: FIH study, NCT02564900; DDI study, NCT03383692.

Indexed as

CamptothecinCarcinomaImmunoconjugatesTrastuzumabAntibodies, Monoclonal, HumanizedErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedSalivary GlandsAntibodies, Monoclonal, HumanizedCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecanDS8201-A-A104DS8201-A-J101human epidermal growth factor receptor 2salivary gland carcinomatrastuzumab deruxtecan

Identifiers

PMID38231777
PMCPMC10999761
OpenAlexW4390939321

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.