7 research outputs found
Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first‑line treatment of ER+/HER2− advanced breast cancer (PALOMA‑1, TRIO‑18)
Purpose Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy
for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole
signifcantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748;
P=0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive
(ER+)/HER2− ABC. Here, we present the fnal overall survival (OS) and updated safety results.
Methods Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day,
3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was
investigator-assessed PFS; secondary endpoints included OS and safety.
Results A total of 165 patients were randomized. At the data cutof date of December 30, 2016 (median duration of follow-up,
64.7 months), the stratifed hazard ratio for OS was 0.897 (95% CI 0.623–1.294; P=0.281); median OS in the palbociclib
plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to
frst subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months,
respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade,
75%; grade 3 or 4, 59%).
Conclusions Palbociclib plus letrozole treatment led to a numerical but not statistically signifcant improvement in median
OS.
Pfzer Inc (NCT00721409
Clinical efficacy and safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment in patients (pts) with ER+ and HER2- advanced breast cancer (ABC) who have not received any systemic treatment (ST): A subgroup analysis of PALOMA-1/TRIO-18.
The effect of palbociclib (P) in combination with letrozole (L) on bone metastases in women with ER+/ HER2- metastatic breast cancer (MBC): Subanalysis from a randomized phase II study.
Long-term safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment for postmenopausal patients with ER+ and HER2- advanced breast cancer (ABC) (PALOMA-1/TRIO-18).
Overall survival results from the randomized phase II study of palbociclib (P) in combination with letrozole (L) vs letrozole alone for frontline treatment of ER+/HER2–advanced breast cancer (PALOMA-1; TRIO-18)
Background: Preclinical data identified a synergistic role for P and hormone blockade in blocking growth of ER+ breast cancer (BC) cell lines. PALOMA-1 was an open-label phase II trial comparing progression-free survival (PFS) in patients (pts) with advanced ER+/HER2–BC treated with P+ L or L alone. Median PFS increased with addition of P to L to 20.2 mos (vs 10.2 mos with L alone; HR= 0.488), with an acceptable safety profile, leading to accelerated approval by the US FDA. These results were confirmed in the phase 3 ..