114P Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) plus chemotherapy in HER2-positive early breast cancer (EBC): Long-term efficacy and safety analysis of the randomised, open-label, multicentre phase III (neo)adjuvant FeDeriCa study Article Swipe
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· 2024
· Open Access
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· DOI: https://doi.org/10.1016/j.esmoop.2024.103102
The primary analysis of the FeDeriCa study (NCT03493854; Tan AR, et al. Lancet Oncol 2021) showed that PH FDC SC cycle 7 P and H serum trough concentrations were non-inferior to intravenous (IV) P and H, with comparable total pathological complete response rates and safety profiles when given as neoadjuvant therapy for HER2-positive EBC. Here we report long-term efficacy and safety data. Patients (pts) had HER2-positive operable, locally advanced or inflammatory stage II–IIIC BC and left ventricular ejection fraction ≥55%. They received eight cycles of neoadjuvant chemotherapy (one of two standard regimens chosen by the investigator) + P IV (840 mg loading dose then 420 mg maintenance) + H IV (8 mg/kg then 6 mg/kg) or PH FDC SC (1200 mg P/600 mg H then 600 mg each as FDC SC) every 3 weeks during cycles 5–8 in a 1:1 randomisation design. Pts continued adjuvant HER2-targeted treatment after surgery, per randomisation, to complete 18 cycles. Secondary endpoints included invasive disease-free survival (iDFS), event-free survival (EFS), distant recurrence-free interval (DRFI), overall survival (OS) and safety (focusing on cardiac adverse events). Data cut-off was 2 Jun, 2023; median follow-up was 51.4 months in the P + H IV arm and 51.2 months in the PH FDC SC arm. Long-term efficacy data are shown in the table. No new safety signals, including for cardiac safety, were observed.Table: 114PP + H IV n = 252PH FDC SC n = 248iDFSPts who underwent surgery, n239234Pts with event, n (%)23 (9.6)26 (11.1)Unstratified hazard ratio (HR)(95% confidence interval [CI])1.13 (0.64, 1.97)4-year event-free rate (95% CI)89.5 (85.4, 93.6)88.5 (84.3, 92.7)EFSPts, n252248Pts with event, n (%)29 (11.5)32 (12.9)HR (95% CI)1.20 (0.72, 1.98)4-year event-free rate (95% CI)88.5 (84.4, 92.5)86.6 (82.2, 90.9)DRFIPts, n252248Pts with event, n (%)18 (7.1)19 (7.7)HR (95% CI)1.17 (0.61, 2.24)4-year event-free rate (95% CI)92.5 (89.2, 95.8)91.9 (88.4, 95.4)OSPts, n252248Pts with event, n %12 (4.8)14 (5.6)HR (95% CI)1.26 (0.58, 2.72)4-year event-free rate (95% CI)95.5 (92.9, 98.1)94.1 (91.1, 97.1) Open table in a new tab The long-term efficacy of PH FDC SC was comparable to that of P + H IV. Safety remained similar to P + H IV and consistent with P + H + chemotherapy. Overall, these findings support the primary analysis results. PH FDC SC is established as a faster, more convenient, less invasive, pt- and healthcare professional-preferred alternative to P + H IV for pts with HER2-positive BC.
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.esmoop.2024.103102
- http://www.esmoopen.com/article/S2059702924008706/pdf
- OA Status
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- Related Works
- 10
- OpenAlex ID
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https://openalex.org/W4397007666Canonical identifier for this work in OpenAlex
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https://doi.org/10.1016/j.esmoop.2024.103102Digital Object Identifier
- Title
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114P Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) plus chemotherapy in HER2-positive early breast cancer (EBC): Long-term efficacy and safety analysis of the randomised, open-label, multicentre phase III (neo)adjuvant FeDeriCa studyWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
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2024-05-01Full publication date if available
- Authors
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Christian Jackisch, S-A. Im, André Mattar, Rámón Colomer, Daniil Stroyakovskiy, Zbigniew Nowecki, Michelino De Laurentiis, J-Y Pierga, Kyung Hae Jung, Christian Schem, Sarah Heeson, Veronica Craine, Bing Wang, Eleonora Restuccia, Antoinette R. TanList of authors in order
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https://doi.org/10.1016/j.esmoop.2024.103102Publisher landing page
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https://www.esmoopen.com/article/S2059702924008706/pdfDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://www.esmoopen.com/article/S2059702924008706/pdfDirect OA link when available
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Pertuzumab, Trastuzumab, Medicine, Oncology, Chemotherapy, Fixed-dose combination, Breast cancer, Pharmacology, Internal medicine, CancerTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.pathological | 39 |
| abstract_inverted_index.(NCT03493854; | 7 |
| abstract_inverted_index.90.9)DRFIPts, | 280 |
| abstract_inverted_index.HER2-positive | 52, 65, 390 |
| abstract_inverted_index.HER2-targeted | 145 |
| abstract_inverted_index.chemotherapy. | 356 |
| abstract_inverted_index.investigator) | 95 |
| abstract_inverted_index.randomisation | 140 |
| abstract_inverted_index.concentrations | 27 |
| abstract_inverted_index.randomisation, | 150 |
| abstract_inverted_index.observed.Table: | 223 |
| abstract_inverted_index.recurrence-free | 166 |
| abstract_inverted_index.(11.1)Unstratified | 245 |
| abstract_inverted_index.professional-preferred | 380 |
| cited_by_percentile_year | |
| countries_distinct_count | 12 |
| institutions_distinct_count | 15 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8299999833106995 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.13998414 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |