Patients receiving sacituzumab govitecan also reported lower symptomatic impact of fatigue, pain, dyspnea, and insomnia.
New data from the phase 3 ASCENT study show that patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received sacituzumab govitecan (Trodelvy; Gilead) had significant and clinically meaningful improvements in health-related quality of life.
These findings are in addition to previously reported overall survival (OS) benefits. According to a Gilead press release, patients receiving sacituzumab govitecan had an OS of 11.8 months compared to 6.9 months among patients who received standard of care. The new trial results were presented at the European Society of Medical Oncology Congress 2021.
“In TNBC, limited treatment options and poor survival outcomes are compounded by a significant decrease in quality of life, especially in relapsed or refractory metastatic disease, where patients can undergo many rounds of chemotherapy,” said Sibylle Loibl, MD, of the Centre for Hematology and Oncology at Bethanien-Hospital Frankfurt, in the press release. “Trodelvy is not only the first treatment to extend survival in these patients, but this analysis shows it can also significantly lessen the burden of symptoms when quality time is especially important.”
TNBC is the most aggressive form of the disease and accounts for approximately 15% of all breast cancers, according to the press release. It is most commonly diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. Due to the lack of estrogen and progesterone receptors in TNBC cells, treatment options are limited compared with other types of breast cancer.
According to the press release, health-related quality of life in the trial was assessed at baseline, on day 1 of each treatment cycle, and at the end of treatment with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, which measured patients’ perceptions of their own physical, mental, and social health.
Analysis of the questionnaires found that patients receiving sacituzumab govitecan had significant and clinically meaningful improvements in health-related quality of life scores, including for global health status, physical functioning, and emotional functioning, compared with patients who received physician’s choice of chemotherapy. Furthermore, patients receiving sacituzumab govitecan also reported lower symptomatic impact of fatigue, pain, dyspnea, and insomnia.
Only diarrhea was significantly and meaningfully worse for patients taking sacituzumab govitecan (14.07 vs. -1.27; p<0.01). However, this finding did not appear to translate to an adverse effect on patients’ global health score or functioning.
The safety profile of sacituzumab govitecan was consistent with earlier reports from the ASCENT study. The press release noted that the prescribing information has a boxed warning for severe or life-threatening neutropenia and severe diarrhea.
“Many metastatic TNBC patients’ disease will quickly progress following chemotherapy, so the survival benefit with Trodelvy is highly meaningful, and the quality of that time is also very important,” said Bill Grossman, MD, PhD, senior vice president of oncology and clinical research at Gilead Sciences, in the press release. “We are committed to improving overall outcomes for patients with this aggressive disease, including more and potentially better time when it matters most.”
Trodelvy Significantly Improved Quality of Life Over Standard of Care in 2L+ Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study. News release. Gilead; September 16, 2021. Accessed September 21, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/9/trodelvy-significantly-improved-quality-of-life-over-standard-of-care-in-2l-metastatic-triplenegative-breast-cancer-in-phase-3-ascent-study