Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer
In TROPiCS-02, sacituzumab govitecan (SG) demonstrated significantly longer overall survival and progression-free survival with improved quality of life vs. chemotherapy treatment of physician’s choice (TPC) in patients with HR+/HER2− metastatic breast cancer (mBC). The safety profile was consistent...
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MDPI AG
2025-03-01
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| Series: | Current Oncology |
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| Online Access: | https://www.mdpi.com/1718-7729/32/3/169 |
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| author | Hope S. Rugo Aditya Bardia Peter Schmid Sara M. Tolaney Anandaroop Dasgupta Ankita Kaushik Wendy Verret Marine Gosset Adam Brufsky Javier Cortés Frederik Marmé |
| author_facet | Hope S. Rugo Aditya Bardia Peter Schmid Sara M. Tolaney Anandaroop Dasgupta Ankita Kaushik Wendy Verret Marine Gosset Adam Brufsky Javier Cortés Frederik Marmé |
| author_sort | Hope S. Rugo |
| collection | DOAJ |
| description | In TROPiCS-02, sacituzumab govitecan (SG) demonstrated significantly longer overall survival and progression-free survival with improved quality of life vs. chemotherapy treatment of physician’s choice (TPC) in patients with HR+/HER2− metastatic breast cancer (mBC). The safety profile was consistent with previous studies of SG. We assessed the benefit-–risk profile of SG vs. TPC by integrating patient preferences with clinical benefits using Quality-adjusted Time Without Symptoms of disease progression or Toxicity of treatment (Q-TWiST) analysis in this study population. Survival time was partitioned into three health states: TOX (grade ≥3 treatment-emergent adverse events [TEAEs] after randomization/before disease progression), REL (disease progression until death or end of follow-up), and TWiST (time without progression or grade ≥3 TEAEs). Health state utility weights were obtained from the published literature. The established threshold for clinically important Q-TWiST gain is 10%. SG demonstrated significantly improved Q-TWiST vs. TPC (mean 9.7 vs. 8.1 months; difference 1.6 months; 95% CI, 0.5–2.7; <i>p</i> = 0.0067), which increased with longer follow-up. Relative Q-TWiST improvement met the threshold for clinical importance at 10.8%. Time in TOX was numerically higher with SG than TPC, and the difference stabilized over time. Q-TWiST supports a positive benefit–risk profile for SG over TPC in patients with pretreated HR+/HER2− mBC. |
| format | Article |
| id | doaj-art-3a733f1d326a4f048696b274fc776cbc |
| institution | DOAJ |
| issn | 1198-0052 1718-7729 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj-art-3a733f1d326a4f048696b274fc776cbc2025-08-20T02:42:46ZengMDPI AGCurrent Oncology1198-00521718-77292025-03-0132316910.3390/curroncol32030169Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast CancerHope S. Rugo0Aditya Bardia1Peter Schmid2Sara M. Tolaney3Anandaroop Dasgupta4Ankita Kaushik5Wendy Verret6Marine Gosset7Adam Brufsky8Javier Cortés9Frederik Marmé10Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA 94115, USAJonsson Comprehensive Cancer Center, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USACentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London EC1M 6BQ, UKDana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USAGilead Sciences, Inc., Foster City, CA 94404, USAGilead Sciences, Inc., Foster City, CA 94404, USAGilead Sciences, Inc., Foster City, CA 94404, USAEvidera, 94853 Paris, FranceMagee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USAQuirónsalud Group, Pangaea Oncology, International Breast Cancer Center (IBCC), 08028 Barcelona, SpainMedical Faculty Mannheim, Heidelberg University, 68167 Mannheim, GermanyIn TROPiCS-02, sacituzumab govitecan (SG) demonstrated significantly longer overall survival and progression-free survival with improved quality of life vs. chemotherapy treatment of physician’s choice (TPC) in patients with HR+/HER2− metastatic breast cancer (mBC). The safety profile was consistent with previous studies of SG. We assessed the benefit-–risk profile of SG vs. TPC by integrating patient preferences with clinical benefits using Quality-adjusted Time Without Symptoms of disease progression or Toxicity of treatment (Q-TWiST) analysis in this study population. Survival time was partitioned into three health states: TOX (grade ≥3 treatment-emergent adverse events [TEAEs] after randomization/before disease progression), REL (disease progression until death or end of follow-up), and TWiST (time without progression or grade ≥3 TEAEs). Health state utility weights were obtained from the published literature. The established threshold for clinically important Q-TWiST gain is 10%. SG demonstrated significantly improved Q-TWiST vs. TPC (mean 9.7 vs. 8.1 months; difference 1.6 months; 95% CI, 0.5–2.7; <i>p</i> = 0.0067), which increased with longer follow-up. Relative Q-TWiST improvement met the threshold for clinical importance at 10.8%. Time in TOX was numerically higher with SG than TPC, and the difference stabilized over time. Q-TWiST supports a positive benefit–risk profile for SG over TPC in patients with pretreated HR+/HER2− mBC.https://www.mdpi.com/1718-7729/32/3/169quality of lifeQ-TWiSTbreast cancerHR+/HER2−antibody-drug conjugatesacituzumab govitecan |
| spellingShingle | Hope S. Rugo Aditya Bardia Peter Schmid Sara M. Tolaney Anandaroop Dasgupta Ankita Kaushik Wendy Verret Marine Gosset Adam Brufsky Javier Cortés Frederik Marmé Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer Current Oncology quality of life Q-TWiST breast cancer HR+/HER2− antibody-drug conjugate sacituzumab govitecan |
| title | Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer |
| title_full | Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer |
| title_fullStr | Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer |
| title_full_unstemmed | Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer |
| title_short | Q-TWiST Analysis of Sacituzumab Govitecan vs. Chemotherapy in Previously Treated Patients with HR+/HER2− Metastatic Breast Cancer |
| title_sort | q twist analysis of sacituzumab govitecan vs chemotherapy in previously treated patients with hr her2 metastatic breast cancer |
| topic | quality of life Q-TWiST breast cancer HR+/HER2− antibody-drug conjugate sacituzumab govitecan |
| url | https://www.mdpi.com/1718-7729/32/3/169 |
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