Background: MADELINE is an observational, multicenter study of women in the United States with advanced/metastatic breast cancer (ABC/MBC) receiving palbociclib in combination with either an aromatase inhibitor (AI) as initial endocrine therapy or fulvestrant after progression on prior endocrine therapy. A novel mobile application was 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: Patients completed the Center for Epidemiologic Studies Depression Scale (CES-D-10) at each cycle; total scores range from 0 to 30, where 10 or more is considered to indicate depression. Based on CES-D-10 scores patients’ depression status could vary cycle-to-cycle. Data on patient’s mood was collected using a daily seven-level mood rating (“very sad” to “most happy”) and a weekly five-level question on breast cancer or its treatment’s negative effect on mood or emotions (“not at all” to “a great deal”). A descriptive analysis examining the relationship between depression (CES-D-10), and the two mood questions was conducted among patients with a completed baseline electronic case report form and relevant mobile app data as of May 1, 2019.
Results: Twenty-three sites contributed 137 patients (median [range] age 60 [34, 82]; white: 84%; ECOG 0-1: 87%; initiated palbociclib plus AI at enrollment: 62%). At cycle 1, 48 patients were classified as without depression (score <10) and 33 patients with depression (score >10). During week 1 of cycle 1, the average percentage of days where patients without depression reported a mood of “Neutral” was 37.8%, “Content” was 34.8%, and “Happy” was 22.9% compared to patients with depression reporting 55.2% for “Neutral”, 21.6% for “Content”, and 2.6% for “Happy”. In the same reporting period, 56% (15/27), 19% (5/27), and 4% (1/27) of patients with depression indicated breast cancer or its treatment had negatively impacted their mood or emotions “moderately”, “quite a bit”, or “a great deal” respectively whereas 13% (5/38) of patients without depression indicated it negatively impacted their mood or emotions “moderately” and 0% indicated either “quite a bit” or “a great deal”. Results were relatively similar across the cycles overall and for patients that initiated either palbociclib plus AI or palbociclib plus fulvestrant.
Conclusions: The majority of patients in the MADELINE study did not report symptoms indicating depression based on the CES-D-10 at the beginning of treatment and across cycles. Results suggest that the mood and emotions of patients with depression was more negatively impacted by breast cancer or its treatment compared with patients without depression.