Dataset Information

Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study.

ABSTRACT:

Background

There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer.

Methods

We conducted a cohort study of breast cancer patients initiating palbociclib and fulvestrant from February 2015 to September 2017 using the HealthCore Integrated Research Database (HIRD), a longitudinal claims database of commercial health plan members in the United States. The historical comparator cohort comprised patients initiating fulvestrant monotherapy from January 2011 to January 2015. Propensity score matching and Cox regression were used to estimate hazard ratios for various safety events. For acute liver injury (ALI), additional analyses and medical record validation were conducted.

Results

There were 2445 patients who initiated palbociclib including 566 new users of palbociclib-fulvestrant, and 2316 historical new users of fulvestrant monotherapy. Compared to these historical new users of fulvestrant monotherapy, new users of palbociclib-fulvestrant had a greater than 2-fold elevated risk for neutropenia, leukopenia, thrombocytopenia, stomatitis and mucositis, and ALI. Incidence of anemia and QT prolongation were more weakly associated, and incidences of serious infections and pulmonary embolism were similar between groups after propensity score matching. After adjustment for additional ALI risk factors, the elevated risk of ALI in new users of palbociclib-fulvestrant persisted (e.g. primary ALI algorithm hazard ratio (HR)?=?3.0, 95% confidence interval (CI)?=?1.1-8.4).

Conclusions

This real-world study found increased risks of several adverse events identified in clinical trials, including neutropenia, leukopenia, and thrombocytopenia, but no increased risk of serious infections or pulmonary embolism when comparing new users of palbociclib-fulvestrant to fulvestrant monotherapy. We observed an increased risk of ALI, extending clinical trial findings of significant imbalances in grade 3/4 elevations of alanine aminotransferase (ALT).

SUBMITTER: Beachler DC

PROVIDER: S-EPMC7831235 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study.

Beachler Daniel C DC de Luise Cynthia C Jamal-Allial Aziza A Yin Ruihua R Taylor Devon H DH Suzuki Ayako A Lewis James H JH Freston James W JW Lanes Stephan S

BMC cancer 20210125 1

<h4>Background</h4>There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer.<h4>Methods</h4>We conducted a cohort study of breast cancer patients initiating palbociclib and fulvestrant from February 2015 to September 2017 using the HealthCore Integrated Research Database (HIRD), a longitudinal claims database of commercial health plan members in the United States. The historical comparator cohort comprised patients initiating fulvestra ...[more]

PMID: 33494720

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Dataset Information

Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study.

Background

Methods

Results

Conclusions

Publications

Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study.

Similar Datasets

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