Background: MADELINE is an observational, multicenter study of women in the United States with metastatic breast cancer (MBC) receiving palbociclib in combination with an aromatase inhibitor (AI) as initial endocrine therapy, or fulvestrant after progression on prior endocrine therapy. A novel mobile application is used to collect real-time patient-reported outcome (PRO) data to assess patient functioning and quality of life through daily, weekly, and monthly questionnaires for 6 months.
Methods: An interim analysis of select PRO data was conducted among completed and ongoing patients with a minimum of baseline mobile app and eCRF data as of May 1, 2019. PROs analyzed included daily assessments of seven-level mood rating (very sad to most happy), pain and fatigue severity measured using an 11-point (0 to 10 with 10 being the worst possible pain or fatigue) numeric rating scale (NRS), and pain location. Analyses were descriptive and daily data were averaged to create weekly scores.
Results: Twenty-three sites contributed 137 patients (mean [± standard deviation] age 59.7 ± 11.74; white: 84%; ECOG 0-1: 87%; initiated palbociclib plus AI at enrollment: 62%). At the start of cycle 1, the average percentage of days where patients reported a mood of “Neutral” was 44.5%, followed by “Content” with 26.5%; results were relatively stable across the study. The average daily level of pain was 2.3 (2.32) on the NRS during cycle 1, week 1 with no substantial numerical changes across the study [cycle 6, week 4: mean± standard deviation 2.0 (2.13)]. Pain was indicated throughout the body but reported more frequently in the lower body, legs and chest. The average daily fatigue severity on the NRS during the following time points were [mean ± standard deviation]: cycle 1, week 1: 2.8 (2.25); cycle 3, week 1: 2.5 (2.31); and cycle 6, week 1: 2.3 (1.91). Results were relatively similar for patients that initiated either palbociclib plus AI or palbociclib plus fulvestrant. Average daily pain and fatigue scores for week 1 by cycle are shown in the table.
Conclusions: Daily reported PRO collected in the MADELINE study suggest a low level of pain and fatigue that does not change substantially over time. The most commonly reported mood ratings among patients were neutral or content.