This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers. Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.
Study Type
OBSERVATIONAL
Enrollment
121
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Mean Age
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients by CDKi 4/6
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause Patients by CDKi 4/6
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Starting First-Line Therapy with CDKi 4/6
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Starting Second-Line Therapy with CDKi 4/6
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Time frame: Baseline, defined as start of treatment with CDKi
Initial Dose of CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Without Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients Without Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause Patients Without Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients with at Least One Dose Change
Time frame: Up to 6 months post-initiation of CDKi treatment
Average Number of Dose Changes Per Patient
Time frame: Up to 6 months post-initiation of CDKi treatment
Number of Palbociclib-treated Patients by Number of Dose Changes
Time frame: Up to 6 months post-initiation of CDKi treatment
Number of Ribociclib-treated Patients by Number of Dose Changes
Time frame: Up to 6 months post-initiation of CDKi treatment
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