Plain Language Summary
What is this summary about?
This summary describes the results from a real-world study called POLARIS and includes effectiveness results (previously published online in The Oncologist in October 2024) and patient-report outcomes (previously published online in Breast Cancer Research and Treatment in November 2024). This study assessed and followed patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) advanced breast cancer (ABC) receiving palbociclib with hormone therapy. POLARIS included patients whose breast cancer could not be cured with current treatments, including those who had advanced breast cancer that had spread beyond the breast and lymph nodes or metastatic breast cancer. Data from real-world studies, such as POLARIS, are used to confirm and complement the results of traditional clinical trials.
Patients were followed from the start of treatment and up to 3 years after treatment was stopped. The researchers wanted to see how palbociclib was used in routine clinical practice to treat patients. They checked if the treatment worked well by looking at the length of time patients lived without their cancer getting worse, and how long they lived from the start of treatment to the end of the study. They also wanted to know how patients perceived their quality of life while taking palbociclib.
What were the results?
This study showed that in routine clinical practice, most patients received palbociclib as a first-line treatment for their ABC. Aromatase inhibitors were the preferred type of hormone therapy given with palbociclib. The length of time that half of the patients lived without their cancer worsening was 18.8 months, and the length of time that half of the patients lived after starting treatment was 42.3 months. Patients who received palbociclib as a first-line treatment lived longer without their cancer worsening compared with patients receiving palbociclib as a second-line (or later) treatment. Patients also reported that their quality of life remained the same from when treatment first started up to 18 months after treatment. The greatest improvements in quality of life were seen in patients’ ability to carry out daily tasks and in their experience of pain. These data collected from the real-world setting were similar to findings reported from clinical trials of palbociclib.
What do the results mean?
This real-world study shows that treatment with palbociclib given in routine clinical practice worked well for a broad group of patients. Those receiving palbociclib as a first-line treatment generally had better outcomes than those receiving palbociclib as a second-line (or later) treatment. Patients’ quality of life remained stable over 18 months, with slight improvements in daily activities and pain. Overall, these results support findings from clinical trials and other real-world studies, showing that palbociclib plus hormone therapy is effective for treating people with HR+/HER2– ABC with little noticeable impact to patient’s quality of life.
Clinical trial number: NCT03280303
KEYWORDS: plain language summary, breast cancer, palbociclib, hormone therapy, real-world study, metastatic cancer, quality of life, survival, patient-reported outcomes
Acknowledgments
The authors would like to thank all the people who contributed to the information used in this study, as well as their co-authors who contributed to the original manuscripts.
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Disclosure statement
Debu Tripathy reports paid consultancy from Gilead (service on Data and Safety Monitoring Board), OncoDyn, and Zetagen. Joanne L. Blum has received consulting fees from Pfizer Inc. and Tempus, and has participated in speaker’s bureaus for Pfizer Inc. and Tempus. Steven McCune reports speaker’s bureau fees from BMS, and local PI nonfinancial interests (all institutional) from BMS, Merck, and Roche/Genentech. Timothy Pluard reports paid consultancy by AstraZeneca, Daiichi Sankyo, Gilead, Jazz Pharmaceuticals, and Pfizer Inc.; research funding (institution) from Arvinas, Daiichi Sankyo, DualityBio, Jazz Pharmaceuticals, Merck, Pfizer Inc., Scorpion, and Sermonix; and speaker’s bureau fees from AstraZeneca, Gilead, and Stemline. Daniel Anderson reports no conflicts of interest. Abigail Johnston served on a patient advisory panel for Pfizer Inc. during the relevant time period. Monica Z. Montelongo is an employee of ICON, which was a paid consultant to Pfizer Inc. in connection with the development of this manuscript. Zhe Zhang, Joseph C. Cappelleri, and Eric Gauthier are employees of and stockholders in Pfizer Inc. Gabrielle B. Rocque is employed with Atlas Oncology Partners, and reports research funding from Daiichi Sankyo, Genentech, and Pfizer Inc., and consulting fees from Armada, Gilead, and Pfizer Inc.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscripts apart from those disclosed.
Medical writing support was provided by Leanne M. Low, PhD, of Oxford PharmaGenesis Inc., Wilmington, DE, USA, according to Good Publication Practice guidelines (GPP2022), and was funded by Pfizer Inc.
The authors confirm that no generative AI was used in the creation of content for this publication.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
This manuscript, and the original articles, were funded by Pfizer Inc. The funder collaborated with the authors on the preparation of this plain language summary.