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Summary of Prescibing Information
What types of patients were enrolled in the PALOMA-2 clinical trial?
PALOMA-2 included a broad patient population, including 22.1% of patients who had a DFI ≤12 months, and 40.7% of patients who had a DFI >12 months.1
PALOMA-2 Patient Baseline Characteristics1
Adapted from Finn RS, et al. 2016.1
Data cut-off date: 26 February 2016. Some percentages do not sum to 100 because of rounding.
*There were no significant differences in baseline characteristics between the 2 treatment groups except for ECOG PS (P = 0.004). Some percentages do not sum to 100 because of rounding.
†DFI was defined as the time from adjuvant or neoadjuvant therapy to recurrence. Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of DFI was not possible.1
‡Patients who received anastrozole or letrozole as a component of their adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy.1
DFI, disease-free interval; ECOG PS, Eastern Cooperative Oncology Group performance status; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; LET, letrozole; mBC, metastatic breast cancer; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer; PLA, placebo.
Reference:
Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
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