BACKROUND: MADELINE is an observational, multicenter study of women with HR+/HER2- advanced or metastatic breast cancer (aBC/mBC) who were followed for 6 months to evaluate patient reported quality of life (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 the impact of aBC/mBC or its treatment on productivity, energy, and physical activity in patients treated with palbociclib.
MATERIALS AND METHODS: Patients indicated weekly how aBC/mBC or its treatment interfered with family/social life and limited productivity, physical activities and energy on a 5-point scales (“Not at all”, “A little bit”, “Moderately”, “Quite a bit”, “A great deal”) as well as employment status. 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. Patient demographic and clinical data including adverse events was recorded in an eCRF. The relationship between weekly productivity limitation (“not at all” or ”a little bit” vs. “moderately” to “a great deal”) and neutropenia (yes/no), pain (<2 vs ≥2), and fatigue (<2 vs ≥2) was evaluated using GLM logistic models.
RESULTS: Twenty-five sites contributed 139 patients (median [range] age 60 [34, 82]; white: 83%; ECOG 0-1: 87%). About half of patients (49%) were employed at baseline and employment status was generally stable over time when excluding missing data and early withdrawals. Most patients across the first week of all cycles indicated aBC/mBC or its treatment limited or interfered physical activity, energy or stamina, productivity, family life, and social life “Not at all” or “A little”. These findings were similar regardless of experience with neutropenia. The overall odds ratio (95% CI) for pain and fatigue severity > 2 vs. severity ≤ 2 on productivity limitation from aBC/mBC or its treatment of was 5.8 (3.3, 10.2) and 8.2 (4.8, 14.0) respectively. Evaluation of the GLM logistic model showed neutropenia had an inconsistent and insignificant effect on productivity limitation with a non-estimable overall odds ratio.
CONCLUSIONS: The majority of patients treated with palbociclib in the MADELINE study indicated aBC/mBC or its treatment limited productivity, energy, and physical activity “Not at all” or “A little”. Employment was stable across cycles for patients remaining in the study. While results suggest a low level of pain and fatigue in the study, there was a significant effect on productivity limitation with higher levels of pain and fatigue associated with higher limitations on productivity. Neutropenia was not associated with higher limitations on productivity.
