The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial
Open accessAbstract
PURPOSE: Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor 2 (HER2)–directed antibody-drug conjugate approved in HER2-expressing breast and gastric cancers and HER2-mutant non–small-cell lung cancer. Treatments are limited for other HER2-expressing solid tumors. METHODS: This open-label phase II study evaluated T-DXd (5.4 mg/kg once every 3 weeks) for HER2-expressing (immunohistochemistry [IHC] 3+/2+ by local or central testing) locally advanced or metastatic disease after ≥1 systemic treatment or without alternative treatments. The primary end point was investigator-assessed confirmed objective response rate (ORR). Secondary end points included safety, duration of response, progression-free survival (PFS), and overall survival (OS). RESULTS: At primary analysis, 267 patients received treatment across seven tumor cohorts: endometrial, cervical, ovarian, bladder, biliary tract, pancreatic, and other. The median follow-up was 12.75 months. In all patients, the ORR was 37.1% (n = 99; [95% CI, 31.3 to 43.2]), with responses in all cohorts; the median DOR was 11.3 months (95% CI, 9.6 to 17.8); the median PFS was 6.9 months (95% CI, 5.6 to 8.0); and the median OS was 13.4 months (95% CI, 11.9 to 15.5). In patients with central HER2 IHC 3+ expression (n = 75), the ORR was 61.3% (95% CI, 49.4 to 72.4), the median DOR was 22.1 months (95% CI, 9.6 to not reached), the median PFS was 11.9 months (95% CI, 8.2 to 13.0), and the median OS was 21.1 months (95% CI, 15.3 to 29.6). Grade ≥3 drug-related adverse events were observed in 40.8% of patients; 10.5% experienced adjudicated drug-related interstitial lung disease (ILD), with three deaths. CONCLUSION: Our study demonstrates durable clinical benefit, meaningful survival outcomes, and safety consistent with the known profile (including ILD) in pretreated patients with HER2-expressing tumors receiving T-DXd. Greatest benefit was observed for the IHC 3+ population. These data support the potential role of T-DXd as a tumor-agnostic therapy for patients with HER2-expressing solid tumors.
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Toxicity and response criteria of the Eastern Cooperative Oncology Group
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RECIST 1.1—Update and clarification: From the RECIST committee
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HER2-targeted therapies — a role beyond breast cancer
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Self-citationLamarca, A., Palmer, D. H., Wasan, H. S., Ross, P. J., Ma, Y. T., Arora, A., Falk, S., Gillmore, R., Wadsley, J., Patel, K., et al. (2021) · The Lancet Oncology · doi:10.1016/s1470-2045(21)00027-9 · Cited by 769
Self-citationHER2 expression status in diverse cancers: review of results from 37,992 patients
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NCCN Guidelines® Insights: Cervical Cancer, Version 1.2024: Featured Updates to the NCCN Guidelines
Abu-Rustum, N. R., Yashar, C. M., Arend, R., Barber, E., Bradley, K., Brooks, R., Campos, S. M., Chino, J., Chon, H. S., Crispens, M. A., et al. (2023) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2023.0062 · Cited by 384
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Trastuzumab Deruxtecan Resistance via Loss of HER2 Expression and Binding
Chen, W., Gupta, A., Mai, N., Nag, S., Lau, J. S., Singh, S., Chodera, J. D., Liu, B., de Stanchina, E., Pareja, F., et al. (2026) · Cancer Discovery · doi:10.1158/2159-8290.cd-25-0647 · Cited by 50
Babkoff, A., Zick, A., Hubert, A., Tarantino, P., & Grinshpun, A. (2024) · ESMO Gastrointestinal Oncology · doi:10.1016/j.esmogo.2023.100032 · Cited by 14
Lap, C. J., Rajendran, R., Martin, J. M., Uppal, M., Escobar, A., Heiraty, A. M., Estephan, F., Hahn, W., Subrahmanyam, R., Nava, V. E., et al. (2024) · Annals of Internal Medicine · doi:10.7326/annals-24-01409 · Cited by 5
Metadata
- Authors
- Meric-Bernstam, F., Makker, V., Oaknin, A., Oh, D.-Y., Banerjee, S., González-Martín, A., Jung, K. H., Ługowska, I., Manso, L., Manzano, A., Melichar, B., Siena, S., Stroyakovskiy, D., Fielding, A., Ma, Y., Puvvada, S., Shire, N., & Lee, J.-Y.
- Venue
- Journal of Clinical Oncology
- Published
- 2024-01-01
- Volume
- 42
- Issue
- 1
- Pages
- 47-58
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4387865238
- Cited by
- 1,069
- References
- 27
- FWCI
- 110.47
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Meric-Bernstam, F., Makker, V., Oaknin, A., Oh, D.-Y., Banerjee, S., González-Martín, A., Jung, K. H., Ługowska, I., Manso, L., Manzano, A., Melichar, B., Siena, S., Stroyakovskiy, D., Fielding, A., Ma, Y., Puvvada, S., Shire, N., & Lee, J.-Y. (2024). Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.23.02005
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.