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The effect of neutropenia on patientreported functioning and quality of life (QOL) among palbociclib participants of the MADELINE study
Richardson, D., Zhan, L., Reynolds, M., Odom, D., Hollis, K., Mitra, D., Mcroy, L., Jones, C. F., Mahtani, R. L., & Hargis, J. B. (2020). The effect of neutropenia on patientreported functioning and quality of life (QOL) among palbociclib participants of the MADELINE study. Journal of Clinical Oncology, 38(15_suppl), 1064. https://doi.org/10.1200/JCO.2020.38.15_suppl.1064
Background: MADELINE is an observational, multicenter study of women with HR+/HER2- advanced or metastatic breast cancer who were followed for 6 months to evaluate patient reported QOL after initiating palbociclib combination therapy or other approved treatment in the US. A novel mobile application was developed to capture PROs for QOL at daily, weekly, monthly/cycle-based intervals for up to 6 months. QOL measures were evaluated to determine if palbociclib-treated patients experiencing episodes of neutropenia had associated decreases in QOL compared to patients without episodes of neutropenia. Methods: Patients completed the SF-12 and CES-D-10 at baseline and each cycle. Change from baseline was assessed using mean scores and mixed-effects models. Daily pain and fatigue severity were measured on an 11-point scale (0-10, 10 being worst possible pain/fatigue) and averaged to create weekly scores. Patients indicated weekly how breast cancer or its treatment interfered with family/social life, productivity, physical activity and energy on a 5-point scales (from not at all to a great deal). Demographic and clinical data including adverse events were recorded in an eCRF. Results: 25 sites contributed 139 patients (median [range] age 60 [34, 82]; white: 83%; ECOG 0-1: 87%). During the 6-month follow up period, 45% of patients experienced ≥1 neutropenia event (grade 1-4: 17%, 27%, 24%, 2%) and 11% had an event resulting in a dose change. Least-square (LS) mean change from baseline to end of study for the SF-12 Physical/Mental Component summaries (PCS/MCS) and the CES-D-10 showed no association between neutropenia and decreased QOL. Daily pain/fatigue was relatively stable for those with neutropenia (cycle 1, week 1: 2.8 [1.95] and 1.8 [0.95]; cycle 6, week 1: 2.4 [1.95] and 2.3 [1.59]) and those without (cycle 1, week 1: 2.2 [2.46] and 2.8 [2.39]; cycle 6, week 1: 1.6 [2.29] and 2.4 [2.22]). There was no significant change for impact of breast cancer or treatment across cycles. Conclusions: Patients with neutropenia did not experience decreased QOL compared to patients without neutropenia nor did patients as a whole experience numerically or clinically meaningful decrease in QOL throughout the follow up period. Daily PROs collected suggest a low level of pain/fatigue that did not change substantially over time.