Evidence map›Paper›PMID 41330717›Full record

ArticleThe oncologist2025

Characterization of the safety profile of trastuzumab deruxtecan by dose: a pooled analysis across DESTINY studies.

Yeon Hee Park, Javier Cortes, Shanu Modi, Sara A Hurvitz, Giampaolo Bianchini, Hiroji Iwata, Kohei Shitara, Salvatore Siena, Yasushi Goto, Geoffrey Y Ku and 11 more

Abstract read
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
  5. 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

21 authors.

Yeon Hee ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-4156-9212
Javier CortesOncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.
Shanu ModiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States.
Sara A HurvitzDivision of Hematology and Oncology and Clinical Research Division, Department of Medicine, UW Medicine, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Giampaolo BianchiniDepartment of Medical Oncology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.ORCID 0000-0002-6790-6267
Hiroji IwataBreast Oncology Department, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-0242-4718
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Salvatore SienaDepartment of Oncology and Hemato-Oncology, Università degli Studi di Milano, Department of Hematology, Oncology, and Molecular Medicine, Niguarda Cancer Center, and Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Yasushi GotoDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Geoffrey Y KuDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States.
Charles A PowellDivision of Pulmonary, Critical Care and Sleep Medicine, Tisch Cancer Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Sandra M SwainGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center and Genetic Medicine, MedStar Health, Washington DC, United States.ORCID 0000-0002-1320-3830
Meena ArunachalamDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Martin JanekDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Yingkai ChengDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Changan ChuDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Purnima VermaDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Nataliya Kuptsova-ClarksonPatient Safety, Oncology, AstraZeneca, Gaithersburg, MD, United States.
Elton MathiasDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Erin GoodmanDaiichi Sankyo, Inc., Basking Ridge, NJ, United States.
Hope S RugoDepartment of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States.

Funding

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

Abstract

backgroundTrastuzumab deruxtecan (T-DXd), an approved human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate, may cause treatment-emergent adverse events (TEAEs), most commonly gastrointestinal and hematologic TEAEs. This pooled analysis evaluated TEAEs across 2 doses of T-DXd in patients with different cancers to support safe and effective real-world use. PATIENTS AND

methodsData were pooled from 9 phase I-III clinical trials (DS8201-A-J101; DESTINY-Breast01/02/03/04; DESTINY-Lung01/02; DESTINY-Gastric01/02) of T-DXd 5.4 or 6.4 mg/kg every 3 weeks in patients (N = 1678) with metastatic breast, gastric, or lung cancer with varying HER2 expression or HER2 mutation status. Nausea, vomiting, neutropenia, fatigue, and interstitial lung disease (ILD) were evaluated for time to onset and dose-related outcomes. Antiemetic analysis was limited before a 2020 protocol change recommending prophylaxis.

resultsCommon TEAEs (in ≥20%) were fatigue, nausea, vomiting, neutropenia, anemia, and thrombocytopenia; mostly grade 1 or 2. TEAEs leading to dose reduction, drug interruption, and discontinuation with T-DXd were 22.6%, 42.8%, and 17.7% (5.4 mg/kg), and 29.7%, 47.6%, and 16.6% (6.4 mg/kg), respectively. Neutropenia, nausea, and fatigue occurred in 34.6%, 74.6%, and 56.5% of patients (5.4 mg/kg) and 49.3%, 65.5%, and 52.8% (6.4 mg/kg). Adjudicated drug-related ILD occurred in 12.0% and 10.9%, respectively.

conclusionGastrointestinal and hematologic TEAEs were most common, with nausea, neutropenia, and fatigue most commonly reported. ILD/pneumonitis occurred in ∼11%-12% of patients, with severe cases infrequent. Most TEAEs were low grade, though dose modifications highlight the need for proactive TEAE management, particularly in older patients and those with renal impairment.

Indexed as

Antineoplastic Agents, ImmunologicalBreast NeoplasmsCamptothecinImmunoconjugatesNeoplasmsTrastuzumabAdultAgedErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedNauseaAntineoplastic Agents, ImmunologicalCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecanbreast cancergastric cancerlung cancersafetyT-DXdtrastuzumab deruxtecan

Identifiers

PMID41330717
PMCPMC12743619

What OpenQuestion holds

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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.