Abstract：
BACKGROUND: The TROPiCS-02 study (NCT03901339) demonstrated that sacituzumab govitecan (SG) has superior clinical outcomes over treatment of physician\'s choice (TPC) chemotherapy in patients with hormone receptor-positive, human epidermal growth factor 2 receptor-negative (HR+/HER2-) metastatic breast cancer (mBC). Here, we present health-related quality of life (HRQoL) patient-reported outcome (PRO) findings from this study.
METHODS: Eligible adults with HR+/HER2- mBC who previously received a taxane, endocrine-based therapy, a CDK4/6 inhibitor, and 2-4 lines of chemotherapy were randomized 1:1 to receive SG or TPC until progression or unacceptable toxicity. PROs were assessed at baseline and on day 1 of each cycle, using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 (EORTC QLQ-C30), EQ-5D-5L, and PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE).
RESULTS: Compared to TPC, overall least square mean change from baseline was significantly better for SG for physical functioning and dyspnea, but worse for diarrhea. Time to first clinically meaningful worsening or death was significantly longer for SG in global health status/quality of life, physical functioning, fatigue, emotional functioning, dyspnea, insomnia, and financial difficulties of the EORTC QLQ-C30 and the EQ-VAS, but longer for TPC in diarrhea. Few patients in both arms reported experiencing any worsening to level 3 or 4 treatment-related symptomatic events during treatment, as assessed by 16 PRO-CTCAE items, except for diarrhea frequency and amount of hair loss, which favored TPC.
CONCLUSIONS: SG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.
METHODS: Eligible adults with HR+/HER2- mBC who previously received a taxane, endocrine-based therapy, a CDK4/6 inhibitor, and 2-4 lines of chemotherapy were randomized 1:1 to receive SG or TPC until progression or unacceptable toxicity. PROs were assessed at baseline and on day 1 of each cycle, using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 (EORTC QLQ-C30), EQ-5D-5L, and PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE).
RESULTS: Compared to TPC, overall least square mean change from baseline was significantly better for SG for physical functioning and dyspnea, but worse for diarrhea. Time to first clinically meaningful worsening or death was significantly longer for SG in global health status/quality of life, physical functioning, fatigue, emotional functioning, dyspnea, insomnia, and financial difficulties of the EORTC QLQ-C30 and the EQ-VAS, but longer for TPC in diarrhea. Few patients in both arms reported experiencing any worsening to level 3 or 4 treatment-related symptomatic events during treatment, as assessed by 16 PRO-CTCAE items, except for diarrhea frequency and amount of hair loss, which favored TPC.
CONCLUSIONS: SG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.
摘要：
背景：TROPiCS-02研究（NCT03901339）表明，在激素受体阳性患者中，sacituzumabgovitecan（SG）具有优于医生选择（TPC）化疗的临床疗效，人表皮生长因子2受体阴性（HR+/HER2-）转移性乳腺癌（mBC）。这里,我们介绍了来自本研究的健康相关生活质量(HRQoL)患者报告结局(PRO)结果.
方法：先前接受过紫杉烷的HR+/HER2-mBC合格成人，内分泌治疗,CDK4/6抑制剂，和2-4行化疗以1:1的比例随机分配接受SG或TPC,直至进展或出现不可接受的毒性.在基线和每个周期的第1天评估PRO，使用欧洲癌症研究和治疗组织的生活质量核心30（EORTCQLQ-C30），EQ-5D-5L,和PRO不良事件通用术语标准(PRO-CTCAE)。
结果：与TPC相比，对于身体功能和呼吸困难，SG相对于基线的总体最小二乘平均变化明显更好，但腹泻更严重.在全球健康状况/生活质量中，SG首次出现有临床意义的恶化或死亡的时间明显更长。身体机能,疲劳,情感功能,呼吸困难,失眠,以及EORTCQLQ-C30和EQ-VAS的财务困难，但在腹泻中TPC更长。两组中很少有患者报告在治疗期间出现任何恶化至3级或4级治疗相关症状事件。根据16个PRO-CTCAE项目的评估，除了腹泻的频率和脱发的数量，这有利于TPC。
结论：SG与大多数症状和功能的HRQoL获益相关，与TPC相比。这支持SG作为具有预处理的HR+/HER2-mBC的患者的治疗选择的有利概况。
方法：先前接受过紫杉烷的HR+/HER2-mBC合格成人，内分泌治疗,CDK4/6抑制剂，和2-4行化疗以1:1的比例随机分配接受SG或TPC,直至进展或出现不可接受的毒性.在基线和每个周期的第1天评估PRO，使用欧洲癌症研究和治疗组织的生活质量核心30（EORTCQLQ-C30），EQ-5D-5L,和PRO不良事件通用术语标准(PRO-CTCAE)。
结果：与TPC相比，对于身体功能和呼吸困难，SG相对于基线的总体最小二乘平均变化明显更好，但腹泻更严重.在全球健康状况/生活质量中，SG首次出现有临床意义的恶化或死亡的时间明显更长。身体机能,疲劳,情感功能,呼吸困难,失眠,以及EORTCQLQ-C30和EQ-VAS的财务困难，但在腹泻中TPC更长。两组中很少有患者报告在治疗期间出现任何恶化至3级或4级治疗相关症状事件。根据16个PRO-CTCAE项目的评估，除了腹泻的频率和脱发的数量，这有利于TPC。
结论：SG与大多数症状和功能的HRQoL获益相关，与TPC相比。这支持SG作为具有预处理的HR+/HER2-mBC的患者的治疗选择的有利概况。
