TY - JOUR
T1 - Efficacy and safety of palbociclib in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer with preexisting conditions
T2 - A post hoc analysis of PALOMA-2
AU - Gelmon, Karen
AU - Walshe, Janice M.
AU - Mahtani, Reshma
AU - Joy, Anil A.
AU - Karuturi, Meghan
AU - Neven, Patrick
AU - Lu, Dongrui Ray
AU - Kim, Sindy
AU - Schnell, Patrick
AU - Bananis, Eustratios
AU - Schwartzberg, Lee
N1 - Funding Information:
K Gelmon has received consulting/advisory fees from Pfizer Inc, Novartis, AstraZeneca, NanoString Technologies, and Merck. JM Walshe has received consulting/advisory fees and fees for non-CME services from Roche, Genomic Health, and Pfizer Inc. R Mahtani has received research funding from Agendia, Amgen, AstraZeneca, Biotheranostics, Daiichi, Eisai, Genentech, Immunomedics, Lilly, Merck, Novartis, Pfizer, Puma, Sanofi, and SeaGen. AA Joy has received consulting/advisory fees from Mylan, Teva, Purdue, BMX, BI, Genomic Health, PUMA, Pfizer Inc, Roche, AstraZeneca, Novartis, and Lilly. M Karuturi has received consulting/advisory fees from Pfizer Inc. DR Lu, S Kim, P Schnell, and E Bananis are employees of and own stock in Pfizer Inc.
Funding Information:
This study was funded by Pfizer Inc. Editorial support was provided by John Teiber, PhD, of ICON (North Wales, PA, USA) and was funded by Pfizer Inc.
Publisher Copyright:
© 2021
PY - 2021/10
Y1 - 2021/10
N2 - Objective: In the PALOMA-2 trial, palbociclib in combination with letrozole prolonged progression-free survival (PFS) and exhibited an acceptable safety profile in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC). This post hoc analysis of PALOMA-2 evaluated the efficacy and safety of palbociclib plus letrozole in patients with preexisting conditions grouped by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC). Methods: Postmenopausal patients without prior treatment for ABC were randomized 2:1 to receive palbociclib (125 mg/d on a 3 weeks on/1 week off schedule) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. Patients were grouped by the following MedDRA SOC preexisting conditions: gastrointestinal, musculoskeletal, metabolic, and vascular/cardiac. Median PFS was estimated by the Kaplan-Meier method, and treatment emergent adverse events (AEs) were compared between treatment arms within each preexisting condition subgroup. Results: At baseline, 276 (41.4 %) patients had preexisting gastrointestinal disorders, 390 (58.6 %) had musculoskeletal disorders, 259 (38.9 %) had metabolic disorders, and 382 (57.4 %) had vascular/cardiac disorders. Baseline characteristics were similar between subgroups and between each arm within subgroups. Regardless of baseline preexisting condition, palbociclib plus letrozole prolonged PFS compared with placebo plus letrozole. Treatment-emergent AEs associated with palbociclib plus letrozole and dose modifications due to AEs were similar across preexisting condition subgroups. Conclusion: This post hoc analysis of PALOMA-2 demonstrated a favorable effect of palbociclib on PFS and a safety profile consistent with previous observations, regardless of underlying preexisting condition. Pfizer Inc (NCT01740427).
AB - Objective: In the PALOMA-2 trial, palbociclib in combination with letrozole prolonged progression-free survival (PFS) and exhibited an acceptable safety profile in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC). This post hoc analysis of PALOMA-2 evaluated the efficacy and safety of palbociclib plus letrozole in patients with preexisting conditions grouped by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC). Methods: Postmenopausal patients without prior treatment for ABC were randomized 2:1 to receive palbociclib (125 mg/d on a 3 weeks on/1 week off schedule) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. Patients were grouped by the following MedDRA SOC preexisting conditions: gastrointestinal, musculoskeletal, metabolic, and vascular/cardiac. Median PFS was estimated by the Kaplan-Meier method, and treatment emergent adverse events (AEs) were compared between treatment arms within each preexisting condition subgroup. Results: At baseline, 276 (41.4 %) patients had preexisting gastrointestinal disorders, 390 (58.6 %) had musculoskeletal disorders, 259 (38.9 %) had metabolic disorders, and 382 (57.4 %) had vascular/cardiac disorders. Baseline characteristics were similar between subgroups and between each arm within subgroups. Regardless of baseline preexisting condition, palbociclib plus letrozole prolonged PFS compared with placebo plus letrozole. Treatment-emergent AEs associated with palbociclib plus letrozole and dose modifications due to AEs were similar across preexisting condition subgroups. Conclusion: This post hoc analysis of PALOMA-2 demonstrated a favorable effect of palbociclib on PFS and a safety profile consistent with previous observations, regardless of underlying preexisting condition. Pfizer Inc (NCT01740427).
KW - Advanced breast cancer
KW - Palbociclib
KW - Preexisting condition
KW - Progression-free survival
KW - Safety
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U2 - 10.1016/j.breast.2021.07.017
DO - 10.1016/j.breast.2021.07.017
M3 - Article
C2 - 34388698
AN - SCOPUS:85113252674
SN - 0960-9776
VL - 59
SP - 321
EP - 326
JO - Breast
JF - Breast
ER -