scholarly journals POLARIS: a prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer

2020 ◽  
Vol 16 (31) ◽  
pp. 2475-2485
Author(s):  
Debasish Tripathy ◽  
Joanne L Blum ◽  
Gabrielle B Rocque ◽  
Aditya Bardia ◽  
Meghan S Karuturi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Outcomes ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Real World Data ◽  
Clinical Trial Registration ◽  
Hormone Receptor Positive ◽  
Metastatic Setting ◽  
The Usa

This report describes the rationale, purpose and design of the POLARIS study. POLARIS is an ongoing noninterventional, prospective, multicenter study. Female and male patients in the USA and Canada diagnosed with hormone receptor-positive/HER2-negative metastatic breast cancer were enrolled in the study and treated with the cyclin-dependent kinase 4/6 inhibitor palbociclib when hormone receptor-positive/HER2-negative metastatic breast cancer was deemed to be indicated by their physician. The study will provide real-world data on palbociclib prescribing and treatment patterns in routine clinical practice, associated clinical outcomes, treatment sequencing in the advanced/metastatic setting, patient quality of life and geriatric-specific assessments. The tumor genomic landscape in relation to clinical outcomes will be explored. POLARIS will identify benefits and side effects of palbociclib across multiple lines of therapy and in discrete subsets of patients. Clinical Trial Registration: NCT03280303 ( ClinicalTrials.gov ).

Real world clinical outcomes of palbociclib in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e13034-e13034 ◽  
Author(s):  
Akaolisa Samuel Eziokwu ◽  
Leticia Varella ◽  
Megan Lynn Kruse ◽  
Xuefei Jia ◽  
Halle C. F. Moore ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Outcomes ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Hormone Receptor Positive

Outcome of palbociclib based therapy in hormone receptor positive metastatic breast cancer patients after treatment with everolimus.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1054-1054 ◽  
Author(s):  
Ajay Dhakal ◽  
Christina Matthews ◽  
Fan Zhang ◽  
Ellis Glenn Levine ◽  
Stephen B. Edge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Clinical Benefit ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Hormone Receptor Positive ◽  
Metastatic Setting

1054 Background: Resistance mechanisms to CDK 4/6 inhibition are not well defined. Outcome data on hormone receptor positive (HR+) metastatic breast cancer patients (MBCP) treated with palbociclib (PA) after treatment with everolimus (EV) are lacking. The PALOMA 3 trial (P3) showing benefit of PA plus fulvestrant (FU) compared to FU in HR+ MBCP after progression on endocrine therapy excluded women previously treated with EV. The aim of our study was to investigate the outcomes of HR+ MBCP with prior EV treatment on PA based therapy. Methods: This is a retrospective, single institute review of HR+, HER 2 nonamplified MBCP from Jan 2014 - Nov 2016 treated with PA after treatment with EV. Women who received EV for < 1 month or PA < 14 days were excluded. Progression free survival (PFS) was defined as the time from the initiation of PA to the date of progression as determined by treating physician based on radiological, biochemical and/or clinical criteria. Response rates were determined based on available radiological data. Clinical benefit was defined as a complete response (CR), partial response (PR) or stable disease of at least 24 weeks. Results: 23 patients with mean age 67 years (42 to 81) were identified. 95% were postmenopausal, 81% had ECOG performance status 0 or 1, 83% had visceral metastases, 95% had > 2 lines of prior endocrine therapy (ET), 82% shown prior sensitivity to ET, 82% received prior chemotherapy, of which 84% were in metastatic setting. Kaplan Meier estimate showed median PFS of 2.9 months (95% CI 2.0-4.2); median PFS of P3 PA cohort was 9.5 months (95% CI 9.2-11.0). Fisher’s exact test comparing study cohort with P3 PA cohort showed statistically significant differences in objective response (CR or PR) rates of 0/23 (0%) vs. 66/347 (19%, p = 0.02) & clinical benefit ratio of 4/23 (17.4%) vs. 231/347 (66.5%, p = 0.00). Conclusions: Outcomes with PA in HR+ EV treated MBCP were worse when compared to the P3 PA cohort data. Treatment with EV may lead to resistance to CDK inhibition. Though limited by size, our data suggests that use of PA after EV is associated with low response & clinical benefit rates. Further studies are necessary to confirm the findings to determine sequencing of targeted therapies.

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