Real-world starting dose and outcomes of palbociclib plus an aromatase inhibitor for metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13021-e13021
Author(s):  
Debra A. Patt ◽  
Xianchen Liu ◽  
Benjamin Li ◽  
Lynn McRoy ◽  
Rachel M. Layman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Practice ◽  
First Line ◽  
Starting Dose ◽  
The Us

e13021 Background: Palbociclib (PA) has been approved for HR+/HER2–advanced/metastatic breast cancer (mBC) in combination with an aromatase inhibitor (AI) or fulvestrant for more than 6 years. Regardless of the labeled recommended starting dose of 125mg/day, some patients initiate palbociclib at lower doses in routine practice. This study described real-world starting dose, patient characteristics, and effectiveness outcomes of first line PA+ AI for mBC in the US clinical setting. Methods: We conducted a retrospective analysis of Flatiron Health’s nationwide longitudinal electronic health records, which came from over 280 cancer clinics representing more than 2.2 million actively treated cancer patients in the US. Between February 2015 and September 2018, 813 HR+/HER2– mBC women initiated PA+AI as first-line therapy and had ≥ 3 months of potential follow-up. Patients were followed from start of PA+AI to December 2018, death, or last visit, whichever came first. Real-world progression-free survival (rwPFS) was defined as the time from the start of PA+AI to death or disease progression. Real-world tumor response (rwTR) was assessed based on the treating clinician’s assessment of radiologic evidence for change in burden of disease over the course of treatment. Multivariate analyses were performed to adjust for demographic and clinical characteristics. Results: Of 813 eligible patients, 68.3% were white, median age was 65.0 years, and 42.9% had visceral disease (lung and/or liver). Median duration of follow-up was 21.0 months. 805 patients had records of PA starting dose, with 125mg and 75/100mg/day being 86.5% and 13.5%, respectively. Patients who started at 75/100mg/day were more likely to be ≥75 years than those who started at 125mg/day (38.5% vs 17.1%). Other baseline and disease characteristics were generally evenly distributed. Patients who started at 125mg/day had longer median rwPFS (27.8 vs 18.6 months, adjusted HR=0.74, 95%CI=0.52-1.05) and higher rwTR (54.0% vs. 40.4%) than those patients who started 100/75mg/day (adjusted OR=1.76, 95%CI=1.13-2.74). Table presents results in detail. Conclusions: Most patients in this study initiated palbociclib at 125mg/day and dose adjustment was similar regardless of starting dose. These real-world findings may support initiation of palbociclib at a dose of 125mg/day in combination with AI for the first-line treatment of HR+/HER2- mBC. [Table: see text]

Australian real-world outcomes of ribociclib and aromatase inhibitor in hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): Results from Kisqali Access Registry for Metastatic breast cancer in Australia (KARMA) collected alongside a medicine access program.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13018-e13018
Author(s):  
Vanessa Wong ◽  
Richard de Boer ◽  
Sally E. Baron-Hay ◽  
Robert helmut Blum ◽  
Benjamin Carl Forster ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
Access Program ◽  
Dose Reductions ◽  
First Line Treatment

e13018 Background: International guidelines recommend a combination of CDK4/6 inhibitor and endocrine therapy (ET) as first line treatment for HR+, HER2- MBC. Results from MONALEESA-2 demonstrate improved progression free survival (PFS) with ribociclib (CDK4/6 inhibitor) and ET as compared to ET alone. Prior to Australia’s Pharmaceutical Benefits Scheme funding, ̃800 patients participated in the ribociclib Medicine Access Program (MAP) from May 2017 to June 2018. Methods: KARMA is a secondary data use, non-interventional study of Australian patients who received first line treatment with ribociclib and aromatase inhibitor (AI), obtained via a MAP, for HR+, HER2- MBC. The aim was to capture comprehensive patient and treatment data to reflect real world practice and outcomes. Direct comparisons were made with the ribociclib/letrozole cohort in MONALEESA-2 given that the eligibility criteria were similar for both studies. Results: Data from 160 patients at 17 sites was analysed with a median follow up of 36.5 months. Baseline characteristics are shown in the table. 63 of 160 (39%) patients remain on ribociclib/AI at time of analysis. 58% of patients had at least 1 dose reduction, with the majority (77%) requiring only a single dose reduction. The most common reasons for dose reductions were neutropenia (68%) and abnormal liver enzymes (17%). 16 of 160 (10%) discontinued treatment due to toxicity, including 1 patient with QTc prolongation > 600ms. There were no deaths due to toxicity. Median duration of treatment and PFS were 24.5 (95% CI 17.8-33.3) and 36.3 months (95% CI 29.9- NR) respectively, compared to 20.2 and 25.3 months in MONALEESA-2. Landmark PFS was 76% at 12 months, 67% at 18 months and 64% at 24 months. Conclusions: This is the first real world study of ribociclib and AI developed alongside a MAP. The combination treatment was well tolerated with similar rates of dose reductions (58% in both) and treatment discontinuation due to toxicity (10% vs 8%) when compared to MONALEESA-2. This real-world cohort achieved a superior PFS, potentially explained in part by a younger population with more favourable baseline disease characteristics, including fewer disease sites and higher rates of bone only metastases. It is encouraging to see drug tolerability and efficacy replicated in real world patients.[Table: see text]

scholarly journals Real-world effectiveness of first-line palbociclib + letrozole for metastatic breast cancer 4 years post approval in the US

2019 ◽  
Vol 30 ◽  
pp. v120-v121
Author(s):  
J. Kish ◽  
J. Trocio ◽  
T. Miller ◽  
D. Nero ◽  
D. Liassou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Metastatic Breast ◽  
First Line ◽  
The Us

scholarly journals Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2− metastatic breast cancer in US real-world clinical practice

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Angela DeMichele ◽  
Massimo Cristofanilli ◽  
Adam Brufsky ◽  
Xianchen Liu ◽  
Jack Mardekian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Practice ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Survival Outcomes ◽  
First Line ◽  
Line Setting

Abstract Background Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor–negative (HER2−) metastatic breast cancer (MBC) treated in routine clinical practice in the USA. Patients and methods This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed. Results After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2–34.9) in the palbociclib group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49–0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53–0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results. Conclusions In this “real-world” population of patients with HR+/HER2− MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting. Trial registration Clinicaltrials.gov; NCT04176354

Real-world effectiveness of palbociclib in combination with an aromatase inhibitor as first-line therapy in metastatic breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12541-e12541
Author(s):  
Xianchen Liu ◽  
Jack Mardekian ◽  
Lynn McRoy
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Small Sample ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

e12541 Background: Palbociclib in combination with an aromatase inhibitor (AI) was approved as initial endocrine therapy for patients with HR+/HER2– metastatic/advanced breast cancer (mBC) in February 2015. Evidence of real world outcomes for the combination to date has been limited by small sample size and short follow-up. This study describes patient characteristics and effectiveness of palbociclib + AI as first-line therapy in a large cohort of mBC patients in US clinical practice. Methods: Utilizing Flatiron Health’s longitudinal database, a retrospective cohort study was conducted to evaluate patients with HR+/HER2– mBC who started palbociclib + AI as first-line therapy between February 3, 2015 and August, 31, 2018. Patients were evaluated retrospectively from start of palbociclib + AI therapy on or after February 3, 2015 to November 30, 2018, death, or last visit in the database, whichever came first. Real-world progression free survival (rwPFS) was defined as months from start of palbociclib + AI therapy to death or disease progression based on clinical assessment or evidence by radiographic scan/tissue biopsy. Kaplan-Meier methods were used to estimate survival proportions in overall survival (OS) and rwPFS. Results: Of 878 who met the criteria, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement), and 94% were treated in community practice. Patients were followed up to 46 months. Median rwPFS was 21.9 months (95% CI = 20.1 – 28.2). At 3 years of follow-up, OS rate was 91.9%. For additional outcomes, see Table. Conclusions: These findings from the largest cohort yet evaluated for real world effectiveness confirm the effectiveness of palbociclib + AI in routine clinical practice as a standard of care for first line treatment of HR+/HER2- mBC. [Table: see text]

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