Abstract PD10-03: 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

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.

Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

“…As an additional limitation, QoL was not prospectively evaluated in our population, thus we were not able to confirm the reported data and the more recent follow-up updates on such a relevant issue. 15 , 51 – 53 …”

“…48 As an additional limitation, QoL was not prospectively evaluated in our population, thus we were not able to confirm the reported data and the more recent follow-up updates on such a relevant issue. 15,[51][52][53] Despite these limitations, the current study provides much needed insight into the real-world use of palbociclib plus ET in women with HR+/ HER2-negative MBC, capturing detailed clinical, treatment and outcome data through a median follow-up period of 24 months which is, to our knowledge, the longest reported to date outside of clinical trials.…”

CDK4/6 Inhibitors in HR+/HER2- Advanced/metastatic Breast Cancer: A Systematic Literature Review of Real-World Evidence Studies

“…Three studies on palbociclib in combination with AI or fulvestrant reported PROs including the Cancer Therapy Satisfaction Questionnaire (CTSQ) [71,72], Global Health Status scores and the Functional Scales and Symptom Subscale scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [73], daily mood, pain severity, fatigue [74], and the impact of therapy on mood in relation to depression status (using the Center for Epidemiologic Studies Depression scale [CES-D-10]) [75]. Nearly all patients (96%) reported that the benefits of palbociclib in combination with either an AI or fulvestrant in all lines met or exceeded their expectations according to the CTSQ [71,72].…”

“…Nearly all patients (96%) reported that the benefits of palbociclib in combination with either an AI or fulvestrant in all lines met or exceeded their expectations according to the CTSQ [71,72]. Based on changes in EORTC QLQ-C30 from baseline to 6 months, patients' QoL was stable or modestly improved (although changes were generally below the clinically meaningful threshold) for treatment with palbociclib plus letrozole, anastrozole or exemestane in all lines [73]. Patients receiving palbociclib in combination with either an AI or fulvestrant in all lines with CES-D-10 scores indicating depression reported being more negatively impacted by BC or associated treatments than did patients without depression [75].…”

CDK4/6 inhibitors in the treatment of metastatic breast cancer. Choosing optimal therapy for estrogen-receptor-positive HER2-negative metastatic breast cancer: analysis of doctors’ preferences (“Prometheus”) in Russia – first results of the survey

“…Помимо рандомизированных, про-и ретроспективные мировые наблюдательные исследования по оценке эффективности и безопасности применения ингибиторов CDK4 / 6 (в частности, палбоциклиба) в 1-2-й линиях терапии распространенного РМЖ в широкой гетерогенной популяции пациенток из ежедневной клинической практики отметили высокую частоту объективного ответа -до 59,9 %, медиану ВБП, сопоставимую с таковой в рандомизированных исследованиях, -20,0-29,4 мес, более редкую необходимость коррекции дозы и неуклонный рост доли назначения комбинированной терапии за счет повышения доверия специалистов [24][25][26][27][28]. Эти данные послужили основой для проведения опроса «Прометей».…”