Hungarian real-world research study confirms tolerability of palbociclib similar to registration trials in breast cancer patients.

CONTEXT:  A retrospective review of 962 Hungarian breast cancer patients published in OncoTargets and Therapy provides insights into the real-world use of palbociclib in a large patient population.  The findings confirm the good tolerability of palbociclib with similar dose reduction rates to those reported from pre-approval trials.

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1. “The following demographic and clinical parameters were examined at baseline: 1) age; 2) endocrine partner for palbociclib (AI or fulvestrant); 3) menopausal status; 4) disease stage (locally advanced or metastatic) at diagnosis and type of metastatic disease (de novo or recurrent metastatic); 5) sites of metastases; 6) prior therapy for eBC; 7) line of treatment at palbociclib initiation; 8) prior therapy for ABC before palbociclib initiation.” 

2. “Hormone receptor-positive (HR+) BC is the most common type of BC, and an estimated 60–75% of advanced BC (ABC) patients (locally advanced BC and metastatic BC) have HR+/HER2− disease.” 

3. “Once introducing new therapies in oncology, the reproducibility of RCT data in real-world populations is an increasing concern, with real-world evidence having an increasing role in health care decisions.19. Therefore, the aim of this retrospective study was to describe patient demographics, disease characteristics, and treatment patterns in a population-based sample of patients with HR+/HER2− ABC treated with palbociclib in combination with endocrine therapy in accordance with the EMA label.” 

4. “Metastatic BC was defined as follows: 1) inpatient occurrence of the ICD-10 code C78 (Secondary malignant neoplasm of respiratory and digestive organs) or C79 (Secondary malignant neoplasm of other and unspecified sites) between diagnosis and the first prescription claim for palbociclib; or 2) radiotherapy administered for metastases; or 3) initiation of bisphosphonate or denosumab treatment before or within 60 days after the initiation of palbociclib therapy.” 

5. “De novo metastatic BC was defined based on the initiation of palbociclib combination therapy within 90 days after diagnosis if the patient received no prior treatments for ABC apart from the combination partner of palbociclib (AI or fulvestrant) or, the rest of the cases were classified as “Recurrent” breast cancer.” 

Source URL: https://www.dovepress.com/demographic-characteristics-and-treatment-patterns-among-patients-rece-peer-reviewed-fulltext-article-OTT