TY - JOUR
T1 - Efficacy and safety of palbociclib plus endocrine therapy in North American women with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer
AU - Gelmon, Karen A.
AU - Cristofanilli, Massimo
AU - Rugo, Hope S.
AU - DeMichele, Angela M.
AU - Joy, Anil A.
AU - Castrellon, Aurelio
AU - Sleckman, Bethany
AU - Mori, Ave
AU - Theall, Kathy Puyana
AU - Lu, Dongrui R.
AU - Huang, Xin
AU - Bananis, Eustratios
AU - Finn, Richard S.
AU - Slamon, Dennis J.
N1 - Funding Information:
These analyses, and the studies included in these analyses (NCT01740427, NCT01942135), were sponsored by Pfizer Inc. Editorial support was provided by Jennifer Fetting, PhD, and Catherine Grillo of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and was funded by Pfizer. The authors thank Dr. Shailendra Verma for his contributions to the design of this work and to the acquisition of data.
Funding Information:
These analyses, and the studies included in these analyses (NCT01740427, NCT01942135), were sponsored by Pfizer Inc. Editorial support was provided by Jennifer Fetting, PhD, and Catherine Grillo of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and was funded by Pfizer. The authors thank Dr. Shailendra Verma for his contributions to the design of this work and to the acquisition of data.
Publisher Copyright:
© 2019 The Authors. The Breast Journal published by Wiley Periodicals, Inc.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in combination with endocrine therapy. We investigated the efficacy and safety of palbociclib in patients enrolled in North America during two-phase 3 trials: PALOMA-2 (n = 267, data cutoff: May 31, 2017) and PALOMA-3 (n = 240, data cutoffs: April 13, 2018, for overall survival, October 23, 2015, for all other outcomes). In PALOMA-2, treatment-naïve postmenopausal patients with advanced breast cancer were randomized 2:1 to palbociclib (125 mg/d; 3 weeks on/1 week off [3/1]) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. In PALOMA-3, patients who progressed on prior endocrine therapy were randomized 2:1 to palbociclib (125 mg/d; 3/1) plus fulvestrant (500 mg, per standard of care) or placebo plus fulvestrant; pre/perimenopausal patients received ovarian suppression with goserelin. Palbociclib plus endocrine therapy prolonged median progression-free survival vs placebo plus endocrine therapy in North American patients (PALOMA-2: 25.4 vs 13.7 months, hazard ratio, 0.54 [95% CI, 0.40–0.74], P <.0001; PALOMA-3: 9.9 vs 3.5 months, hazard ratio, 0.52 [95% CI, 0.38–0.72], P <.0001). Objective response and clinical benefit response rates were greater with palbociclib vs placebo in North American patients in both trials. While overall survival data are not yet mature for PALOMA-2, median overall survival was increased in PALOMA-3 (32.0 vs 24.7 months, hazard ratio, 0.75 [95% CI, 0.53–1.04]), though this did not reach statistical significance (P =.0869). Safety profiles in North American patients were similar to those of the overall populations; neutropenia was the most common treatment-emergent adverse event. No new safety signals were observed. In summary, palbociclib plus endocrine therapy is an effective treatment option for North American women with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer.
AB - Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in combination with endocrine therapy. We investigated the efficacy and safety of palbociclib in patients enrolled in North America during two-phase 3 trials: PALOMA-2 (n = 267, data cutoff: May 31, 2017) and PALOMA-3 (n = 240, data cutoffs: April 13, 2018, for overall survival, October 23, 2015, for all other outcomes). In PALOMA-2, treatment-naïve postmenopausal patients with advanced breast cancer were randomized 2:1 to palbociclib (125 mg/d; 3 weeks on/1 week off [3/1]) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. In PALOMA-3, patients who progressed on prior endocrine therapy were randomized 2:1 to palbociclib (125 mg/d; 3/1) plus fulvestrant (500 mg, per standard of care) or placebo plus fulvestrant; pre/perimenopausal patients received ovarian suppression with goserelin. Palbociclib plus endocrine therapy prolonged median progression-free survival vs placebo plus endocrine therapy in North American patients (PALOMA-2: 25.4 vs 13.7 months, hazard ratio, 0.54 [95% CI, 0.40–0.74], P <.0001; PALOMA-3: 9.9 vs 3.5 months, hazard ratio, 0.52 [95% CI, 0.38–0.72], P <.0001). Objective response and clinical benefit response rates were greater with palbociclib vs placebo in North American patients in both trials. While overall survival data are not yet mature for PALOMA-2, median overall survival was increased in PALOMA-3 (32.0 vs 24.7 months, hazard ratio, 0.75 [95% CI, 0.53–1.04]), though this did not reach statistical significance (P =.0869). Safety profiles in North American patients were similar to those of the overall populations; neutropenia was the most common treatment-emergent adverse event. No new safety signals were observed. In summary, palbociclib plus endocrine therapy is an effective treatment option for North American women with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer.
KW - CDK4/6 inhibitor
KW - North America
KW - metastatic breast cancer
KW - palbociclib
UR - http://www.scopus.com/inward/record.url?scp=85070995408&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070995408&partnerID=8YFLogxK
U2 - 10.1111/tbj.13516
DO - 10.1111/tbj.13516
M3 - Article
C2 - 31448513
AN - SCOPUS:85070995408
VL - 26
SP - 368
EP - 375
JO - Breast Journal
JF - Breast Journal
SN - 1075-122X
IS - 3
ER -
