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Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer

PURPOSE - - Hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) endocrine-resistant metastatic breast cancer is treated with sequential single-agent chemotherapy with poor outcomes. Sacituzumab govitecan (SG) is a first-in-class antibody-drug conjugate with an...

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Main Authors: Rugo, Hope S. (Author) , Bardia, Aditya (Author) , Marmé, Frederik (Author) , Cortes, Javier (Author) , Schmid, Peter (Author) , Loirat, Delphine (Author) , Trédan, Olivier (Author) , Ciruelos, Eva (Author) , Dalenc, Florence (Author) , Pardo, Patricia Gómez (Author) , Jhaveri, Komal L. (Author) , Delaney, Rosemary (Author) , Fu, Olivia (Author) , Lin, Lanjia (Author) , Verret, Wendy (Author) , Tolaney, Sara M. (Author)
Format: Article (Journal)
Language:English
Published: [2022]
In: Journal of clinical oncology
Year: 2022, Volume: 40, Issue: 29, Pages: 3365-3376
ISSN:1527-7755
DOI:10.1200/JCO.22.01002
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.22.01002
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.22.01002
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Author Notes:Hope S. Rugo, Aditya Bardia, Frederik Marmé, Javier Cortes, Peter Schmid, Delphine Loirat, Olivier Trédan, Eva Ciruelos, Florence Dalenc, Patricia Gómez Pardo, Komal L. Jhaveri, Rosemary Delaney, Olivia Fu, Lanjia Lin, Wendy Verret, and Sara M. Tolaney, on behalf of the TROPiCS-02 study investigators
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Summary:PURPOSE - - Hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) endocrine-resistant metastatic breast cancer is treated with sequential single-agent chemotherapy with poor outcomes. Sacituzumab govitecan (SG) is a first-in-class antibody-drug conjugate with an SN-38 payload targeting trophoblast cell-surface antigen 2, an epithelial antigen expressed in breast cancer. - - METHODS - - In this global, randomized, phase III study, SG was compared with physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in endocrine-resistant, chemotherapy-treated HR+/HER2- locally recurrent inoperable or metastatic breast cancer. The primary end point was progression-free survival (PFS) by blinded independent central review. - - RESULTS - - Patients were randomly assigned to receive SG (n = 272) or chemotherapy (n = 271). The median age was 56 years, 95% had visceral metastases, and 99% had a prior cyclin-dependent kinase 4/6 inhibitor, with three median lines of chemotherapy for advanced disease. Primary end point was met with a 34% reduction in risk of progression or death (hazard ratio, 0.66 [95% CI, 0.53 to 0.83; P = .0003]). The median PFS was 5.5 months (95% CI, 4.2 to 7.0) with SG and 4.0 months (95% CI, 3.1 to 4.4) with chemotherapy; the PFS at 6 and 12 months was 46% (95% CI, 39 to 53) v 30% (95% CI, 24 to 37) and 21% (95% CI, 15 to 28) v 7% (95% CI, 3 to 14), respectively. Median overall survival (first planned interim analysis) was not yet mature (hazard ratio, 0.84; P = .14). Key grade ≥ 3 treatment-related adverse events (SG v chemotherapy) were neutropenia (51% v 38%) and diarrhea (9% v 1%). - - CONCLUSION - - SG demonstrated statistically significant PFS benefit over chemotherapy, with a manageable safety profile in patients with heavily pretreated, endocrine-resistant HR+/HER2- advanced breast cancer and limited treatment options.
Item Description:Gesehen am 01.02.2023
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.22.01002

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