Abstract P1-18-25: Real-world quality of life (QoL) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC) treated with palbociclib: A patient-reported outcome (PRO) analysis from POLARIS
Authors: Karuturi Meghan S. , Rocque Gabrielle B. , Cappelleri Joseph C. , Blum Joanne L. , McCune Steven L. , Telivala Bijoy , Kurian Sobha , Anderson Daniel M. , Tsai Michaela , Pluard Timothy , Migas John , Wang Yao , Montelongo Monica Z. , Tripathy Debu 
Published: March 2022

Background: POLARIS is an ongoing, prospective, real-world, noninterventional, multicenter study in patients with HR+/HER2- ABC receiving palbociclib in the United States and Canada. This report describes PRO data from a real-world setting of patients with ABC receiving palbociclib. Methods: POLARIS has a targeted enrollment of 1500 patients from ~110 sites in the United States and Canada. Key inclusion criteria included patients with HR+/HER2- ABC with evidence of metastatic disease. QoL was assessed with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30). A clinical problem threshold for 5 functioning and 9 symptom scales of the EORTC QLQ-C30 was established with anchor questions assigned for each domain to assess functional health and symptom burden. Results: As of March 16, 2021, 1240 patients were treated with palbociclib and had EORTC QLQ-C30 data collected and analyzed (at baseline, n=1240; after 6 months of palbociclib treatment, n=1076; after 12 months of palbociclib treatment, n=926). At baseline, the median age of patients was 64 years (Table 1). The majority of patients were white (82%) and 98.8% were female. Nearly 95% of patients had stage 4 metastatic disease, 5.1% had locally advanced stage (III), 68% had a recurrent disease from the earlier stage (0-III), and 27.3% had de novo stage IV disease diagnosed at enrollment. In this cohort, 98.3% of patients were estrogen receptor-positive (ER+)/progesterone receptor-positive (PR+), 94% were HER2-, with 99% of patients HER2- also ER+/PR+ at or nearest to the enrollment date. The percentages of patients with functioning scale scores (physical [baseline=54.6%; month 6=50.2%; month 12=50.4%], role [baseline=28.6%; month 6=20.1%; month 12=18.6%], social [baseline=24.2%; month 6=15%; month 12=15%], emotional [baseline=37.1%; month 6=29.6%; month 12=29.4%], and cognitive [baseline=34.2%; month 6=34.5%; month 12=31.7%]) below the clinical problem threshold remained stable over the first 12 months of palbociclib treatment (Table 2). A similar trend across time was observed with the symptom scales with the percentages of patients (fatigue, pain, nausea and vomiting, insomnia, appetite loss, constipation, dyspnea, diarrhea, and financial difficulties) above the clinical problem threshold also remaining stable over the first 12 months (Table 2). Conclusions: In this PRO analysis, palbociclib treatment did not have any significant adverse impact on QoL in patients with HR+/HER2- ABC as assessed by QLQ-C30 functioning and symptom scales. Pfizer (NCT03280303)

Table 1.Patient Demographic CharacteristicsCharacteristicTotal. (N=1240)Age at study enrollmentMedian (range), y64 (22-97)Distribution, n (%)&lt;40 y61 (4.9)40 to 50 y144 (11.6)51 to 69 y622 (50.2)70 to 74 y181 (14.6)75 to 84 y198 (16.0)≥85 y34 (2.7)Sex, n (%)Male15 (1.2)Female1225 (98.8)Race, n (%)American Indian or Alaska Nativea8 (0.6)Asian19 (1.5)Black or African Americana138 (11.1)Native Hawaiian or other Pacific Islandera5 (0.4)White1017 (82.0)Not reported due to confidentiality regulations27 (2.2)Other23 (1.9)Not reported3 (0.2)Ethnicity, n (%)Hispanic or Latinob104 (8.4)Not Hispanic or Latino1099 (88.6)Not reported due to confidentiality regulations36 (2.9)Time from ABC/mBC diagnosis date to study enrollment dateMedian (range), y1.35 (0-248)Missing, n7Distribution, n (%)≤1 mo508 (41.0)&gt;1 to 2 mo247 (19.9)&gt;2 to 3 mo71 (5.7)&gt;3 to 4 mo22 (1.8)&gt;4 to 5 mo23 (1.9)&gt;5 to 6 mo12 (1.0)&gt;6 mo350 (28.2)aMinority. bMinority among White. ABC=advanced breast cancer; mBC=metastatic breast cancer.

Table 2.Percentages of Symptoms and Functional ImprovementScaleClinical problem (threshold)Baselinea n (%)Month 6a n (%)Month 12a n (%)Functioning ScalesbPhysical functioningc&lt;83629 (54.6)365 (50.2)239 (50.4)Mean (SD)73.3 (24.8)76.9 (22.2)76.7 (21.7)Role functioningc&lt;58330 (28.6)146 (20.1)88 (18.6)Mean (SD)70.4 (32.7)76.0 (27.8)77.2 (26.6)Social functioningd&lt;58278 (24.2)109 (15.0)71 (15.0)Mean (SD)74.4 (29.8)80.7 (25.0)81.0 (25.3)Emotional functioninge&lt;71427 (37.1)215 (29.6)139 (29.4)Mean (SD)74.3 (23.1)79.6 (20.4)80.5 (21.0)Cognitive functioninge&lt;75394 (34.2)251 (34.5)150 (31.7)Mean (SD)78.9 (24.4)80.4 (21.3)80.7 (22.9)Symptom ScalesbFatiguec&gt;39421 (36.5)256 (35.2)144 (30.4)Mean (SD)36.7 (26.9)34.2 (23.0)33.0(24.4)Painc&gt;25614 (53.3)341 (46.9)221 (46.6)Mean (SD)34.8 (31.7)26.7 (26.4)26.6 (27.2)Nausea and vomitingc&gt;8423 (36.7)233 (32.0)153 (32.3)Mean (SD)12.4 (21.2)9.4 (17.4)9.7 (17.3)Insomniaf&gt;50279 (24.2)156 (21.5)89 (18.8)Mean (SD)31.7 (31.1)29.3 (28.9)26.8 (29.0)Appetite lossf&gt;50205 (17.8)72 (9.9)48 (10.1)Mean (SD)23.3 (30.2)16.9 (25.0)15.9 (25.2)Constipationc&gt;50142 (12.3)71 (9.8)46 (9.7)Mean (SD)18.9 (27.6)15.7 (23.7)15.3 (23.8)Dyspneag&gt;17547 (47.6)323 (44.5)207 (43.7)Mean (SD)23.0 (28.8)19.1 (24.8)18.5 (24.5)Diarrheah&gt;17327 (28.5)209 (28.7)120 (25.4)Mean (SD)12.9 (23.5)12.8 (22.6)10.5 (20.1)Financial Impact of Diseasei&gt;17563 (49.0)322 (44.3)198 (42.0)Mean (SD)26.9 (33.2)22.5 (30.3)20.2 (27.9)aThe number of patients eligible at a visit is based on data expected to be available through the latest date of exposure, visit date, or questionnaire date. Baseline, N=1240; Month 6, N=1076; Month 12, N=926. bPercentages for functional and symptom scales were calculated based on “n,” the number of measurements available. Values for Mean (Standard Deviation, SD) were also based on “n”. cn (missing), Baseline=1152 (88); Month 6=727 (349); Month 12=474 (452) dn (missing), Baseline=1151 (89); Month 6=726 (350); Month 12=473 (453) en (missing), Baseline=1151 (89); Month 6=727 (349); Month 12=473 (453) fn (missing), Baseline=1151 (89); Month 6=727 (349); Month 12=474 (452) gn (missing), Baseline=1149 (91); Month 6=726 (350); Month 12=474 (452) hn (missing), Baseline=1149 (91); Month 6=727 (349); Month 12=473 (453) in (missing), Baseline=1149 (91); Month 6=727 (349); Month 12=471 (455) Note: For functioning scales, scoring below the clinical problem threshold indicates a clinically important problem whereas, for the symptom scales, scores above the clinical problem threshold indicate such a problem.

Citation Format: Meghan S. Karuturi, Gabrielle B. Rocque, Joseph C. Cappelleri, Joanne L. Blum, Steven L. McCune, Bijoy Telivala, Sobha Kurian, Daniel M. Anderson, Michaela Tsai, Timothy Pluard, John Migas, Yao Wang, Monica Z. Montelongo, Debu Tripathy. Real-world quality of life (QoL) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC) treated with palbociclib: A patient-reported outcome (PRO) analysis from POLARIS [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-18-25.