Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy
| Autor: | EM Grischke, Sarah Shekarriz, Masakazu Toi, Joohyuk Sohn, Valerie Andre, Gregory L Price, Gebra Cuyun Carter, Peter A. Kaufman, Patrick Neven, George W. Sledge, Clemens Stoffregen |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology Quality of life Cancer Research medicine.medical_specialty Receptor ErbB-2 Population Aminopyridines Breast Neoplasms Placebo 03 medical and health sciences 0302 clinical medicine Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Breast Cancer medicine Humans Brief Pain Inventory education Fulvestrant education.field_of_study Patient-reported outcomes business.industry Hazard ratio Patient‐reported outcomes medicine.disease Abemaciclib 030104 developmental biology Tolerability Receptors Estrogen 030220 oncology & carcinogenesis Benzimidazoles Female Advanced breast cancer business medicine.drug |
| Zdroj: | The Oncologist |
| Popis: | Background In the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression‐free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor‐positive (HR+), HER2‐negative advanced breast cancer (ABC). This study assessed patient‐reported pain, global health‐related quality of life (HRQoL), functioning, and symptoms. Materials and Methods Abemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI‐sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ‐C30); and Breast Cancer Questionnaire (QLQ‐BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3–13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm. Results On‐treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n = 446) experienced a 4.9‐month delay in pain deterioration (mBPI‐sf), compared with the control arm (n = 223), and significantly greater TTSD on the mBPI‐sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59–0.98) and QLQ‐C30 pain item (hazard ratio, 0.62; 95% CI, 0.48–0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20–2.10). Conclusion HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine‐resistant HR+, HER2‐negative ABC. Implications for Practice In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor‐positive (HR+), HER2‐negative (−) advanced breast cancer (ABC). Impact on health‐related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient‐reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient‐reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2− ABC. This study assessed patient‐reported pain and global health‐related quality of life, functioning, and symptoms of patients participating in the phase III MONARCH 2 study. |
| Databáze: | OpenAIRE |
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