BACKROUND: 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. Patient-reported outcome data was collected via a custom-developed mobile application at daily, weekly, and cycle-based intervals. QOL measures were evaluated to determine if palbociclib-treated patients experiencing episodes of neutropenia had associated decreases in QOL compared to those who did not.
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 and limited productivity, physical activities and energy on a 5-point scales (Not at all to A great deal). Patient demographic and clinical data including adverse events was recorded in an electronic CRF.
RESULTS: Twenty-five 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 adjustment. Evaluation of 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 in weekly item response 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 does not change substantially over time.
