Background: Palbociclib in combination with endocrine therapy (ie, an aromatase inhibitor [AI] or fulvestrant) is a current standard of care for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer (ABC/mBC). Findings from the PALOMA clinical trials have shown that patients receiving palbociclib with AI or fulvestrant maintained stable quality of life (QoL). However, no data are currently available from real-world settings regarding patients’ QoL experiences while receiving palbociclib. Methods: This noninterventional, prospective, multicenter study evaluated female and male patients diagnosed with HR+/HER2- ABC/mBC and treated with palbociclib as indicated by the attending physician in the routine course of care. QoL was assessed using the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was collected at enrollment prior to receiving palbociclib (baseline), monthly for the first 3 months of treatment with palbociclib, and then every 3 months until the end of treatment or patient withdrawal or death. The EORTC QLQ-C30 could be completed using an interactive Web response system or a paper questionnaire. Here we report demographic characteristics and interim analysis of QoL assessments as measured by EORTC QLQ-C30 at baseline and at 3 and 6 months postbaseline. Descriptive analyses are presented for subscales of the EORTC QLQ-C30. Results: 522 patients who completed ≥6 months of palbociclib treatment as of May 20, 2019, were included in this interim analysis; 394 were prescribed palbociclib as first-line treatment. The remaining 128 patients initiated palbociclib in second and later lines. Median age at enrollment was 64 years, 98% of patients were female, and 83% were white. More than half of all patients (n=285) received palbociclib in combination with letrozole or anastrozole; of the remaining patients, 218 received palbociclib plus fulvestrant and 19 received palbociclib plus exemestane. Mean (SD) EORTC QLQ-C30 scores remained similar over the first 6 months of treatment: 66.2 (22.6) at baseline, 68.3 (19.7) at 3 months, and 70.2 (21.3) at 6 months. In addition, the mean scores for each functional scale and symptom scale on the EORTC QLQ-C30 also remained stable over the first 6 months (Table). With the exception of pain scores (which declined by 7 points), the change from baseline at 6 months generally was less than 5 points across the different subscales of EORTC QLQ-C30. Conclusions: The 522 patients examined in this interim analysis experienced stable to modestly improved QoL from baseline to 6 months after starting palbociclib. Changes from baseline in EORTC QLQ-C30 scores generally were below the 10-point threshold regarded as clinically meaningful. These early findings indicate that patients enrolled in the study have maintained their baseline QoL while being treated with palbociclib. Funding: Pfizer (NCT03280303) EORTC QLQ-C30Baseline3 Months6 MonthsGlobal Health/Quality of Life*n (missing)474 (48)292 (230)409 (113)Mean (SD) score66.2 (22.6)68.3 (19.7)70.2 (21.3)Functional scales score, mean (SD)*Physical functioning75.6 (23.3)75.8 (21.9)77.2 (21.4)Role functioning72.5 (31.9)76.7 (26.1)77.1 (26.8)Emotional functioning74.8 (22.8)77.7 (22.3)79.7 (20.5)Cognitive functioning78.8 (24.6)82.7 (20.6)80.1 (22.0)Social functioning76.4 (28.3)79.5 (25.5)81.5 (24.7)Symptom scales score, mean (SD)†Fatigue34.3 (25.7)35.0 (23.6)33.7 (22.2)Nausea and vomiting11.3 (20.2)10.4 (16.4)10.6 (19.3)Pain33.5 (30.0)27.3 (27.2)26.5 (26.9)Dyspnea22.2 (28.3)18.7 (22.5)18.8 (24.1)Insomnia29.3 (30.1)27.5 (31.7)27.4 (27.9)Appetite loss21.1 (27.9)19.4 (26.4)17.9 (26.5)Constipation18.4 (26.6)15.2 (23.8)16.0 (23.8)Diarrhea12.3 (22.1)12.0 (20.8)12.6 (22.0)Financial difficulties25.0 (32.4)23.9 (30.4)22.1 (29.5)*Higher scores indicate a better level of functioning. †Higher scores indicate more severe symptoms. Citation Format: Gabrielle Rocque, Joanne L Blum, Aldemar Montero, Ibrahim Nakhoul, Sobha Kurian, Richard C Frank, Bijoy Telivala, Mayank Ajmera, David Coblentz, Joseph C Cappelleri, Yao Wang, Debu Tripathy. Quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer treated with palbociclib in real-world practice settings [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD10-03.
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 (%)<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)>1 to 2 mo247 (19.9)>2 to 3 mo71 (5.7)>3 to 4 mo22 (1.8)>4 to 5 mo23 (1.9)>5 to 6 mo12 (1.0)>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<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<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<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<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<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>39421 (36.5)256 (35.2)144 (30.4)Mean (SD)36.7 (26.9)34.2 (23.0)33.0(24.4)Painc>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>8423 (36.7)233 (32.0)153 (32.3)Mean (SD)12.4 (21.2)9.4 (17.4)9.7 (17.3)Insomniaf>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>50205 (17.8)72 (9.9)48 (10.1)Mean (SD)23.3 (30.2)16.9 (25.0)15.9 (25.2)Constipationc>50142 (12.3)71 (9.8)46 (9.7)Mean (SD)18.9 (27.6)15.7 (23.7)15.3 (23.8)Dyspneag>17547 (47.6)323 (44.5)207 (43.7)Mean (SD)23.0 (28.8)19.1 (24.8)18.5 (24.5)Diarrheah>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>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.
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