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Immunogenicity of Trastuzumab Intravenous and Subcutaneous Formulations in the Phase III Hannah Study
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In the HannaH study, trastuzumab pharmacokinetics and pCR rates within each treatment arm were similar regardless of trastuzumab-ADA status or treatment cycle.
“Trastuzumab pharmacokinetics and pCR rates within each treatment arm were similar regardless of trastuzumab–ADA status or treatment cycle.”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [84]
In the HannaH study, the incidence of administration-related reactions was not statistically different independent of ADA status.
“Likewise, the incidence of administration-related reactions was not statistically different independent of the ADA status [84].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [84]
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Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities
Bittner, B., Richter, W., & Schmidt, J. (2018) · BioDrugs · doi:10.1007/s40259-018-0295-0 · Cited by 447
Pivot, X., Gligorov, J., Müller, V., Curigliano, G., Knoop, A., Verma, S., Jenkins, V., Scotto, N., Osborne, S., Fallowfield, L., et al. (2014) · Annals of Oncology · doi:10.1093/annonc/mdu364 · Cited by 177
Rugo, H. S., Barve, A. J., Waller, C. F., Bronchud, M. H., Herson, J., Yuan, J., Sharma, R. K., Baczkowski, M., Kothekar, M., Loganathan, S., et al. (2016) · JAMA · doi:10.1001/jama.2016.18305 · Cited by 146
Jackisch, C., Kim, S.-B., Semiglazov, V., Melichar, B., Pivot, X., Hillenbach, C., Stroyakovskiy, D., Lum, B. L., Elliott, R., Weber, H. A., et al. (2015) · Annals of Oncology · doi:10.1093/annonc/mdu524 · Cited by 114
Self-citationPegram, M. D., Bondarenko, I., Zorzetto, M. M. C., Hingmire, S., Iwase, H., Криворотько, П. В., Lee, K. S., Li, R. K., Pikiel, J., Aggarwal, R. K., et al. (2018) · British Journal of Cancer · doi:10.1038/s41416-018-0340-2 · Cited by 62
Jackisch, C., Scappaticci, F. A., Heinzmann, D., Bisordi, F., Schreitmüller, T., von Minckwitz, G., & Cortés, J. (2014) · Future Oncology · doi:10.2217/fon.14.187 · Cited by 39
Self-citationPimentel, F. F., Morgan, G., Tiezzi, D. G., & de Andrade, J. M. (2018) · Pharmaceutical Medicine · doi:10.1007/s40290-018-0247-5 · Cited by 16
Trastuzumab immunogenicity development in patients’ sera and in laboratory animals
Kilany, L. A. A., Gaber, A. A.-S., Aboulwafa, M., & Hafez-Zedan, H. (2021) · BMC Immunology · doi:10.1186/s12865-021-00405-z · Cited by 13
Bittner, B., & Schmidt, J. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-823741-0.00002-6 · Cited by 2
Metadata
- Authors
- Hegg, R., Pienkowski, T., Chen, S., Staroslawska, E., Falcon, S., Kovalenko, N., Al-Sakaff, N., Heinzmann, D., Kolaitis, G., & Ismael, G.
- Affiliations
- Hospital da Mulher São Paulo (BR)
- Chang Gung Memorial Hospital (TW)
- Hospital Nacional Edgardo Rebagliati Martins (PE)
- Stavropol Regional Clinical Oncology Center (RU)
- F. Hoffmann-La Roche AG (CH)
- Hospital Amaral Carvalho (BR)
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2012-09
- Volume
- 23
- Pages
- ix103
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2999794381
- Cited by
- 9
- References
- 0
- Citations by year
- 2022: 1 · 2021: 1 · 2018: 3 · 2016: 1 · 2014: 3
- FWCI
- 0.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- trastuzumab, subcutaneous formulation, intravenous formulation, anti-drug antibodies, immunogenicity, HER2-positive breast cancer, pathological complete response, rHuPH20, neutralizing antibodies, infusion reactions, treatment safety, HER2-targeted therapy, non-inferiority
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