PMID- 34388698
OWN - NLM
STAT- MEDLINE
DCOM- 20211015
LR  - 20211015
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Print)
IS  - 0960-9776 (Linking)
VI  - 59
DP  - 2021 Oct
TI  - Efficacy and safety of palbociclib in patients with estrogen 
      receptor-positive/human epidermal growth factor receptor 2-negative advanced 
      breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2.
PG  - 321-326
LID - S0960-9776(21)00425-2 [pii]
LID - 10.1016/j.breast.2021.07.017 [doi]
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).
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Gelmon, Karen
AU  - Gelmon K
AD  - British Columbia Cancer Agency, Vancouver, BC, Canada. Electronic address: 
      kgelmon@bccancer.bc.ca.
FAU - Walshe, Janice M
AU  - Walshe JM
AD  - Cancer Trials Ireland, Dublin, Ireland.
FAU - Mahtani, Reshma
AU  - Mahtani R
AD  - Sylvester Cancer Center, University of Miami, Deerfield Beach, FL, USA.
FAU - Joy, Anil A
AU  - Joy AA
AD  - Cross Cancer Institute, Edmonton, AB, Canada.
FAU - Karuturi, Meghan
AU  - Karuturi M
AD  - MD Anderson Cancer Center, Houston, TX, USA.
FAU - Neven, Patrick
AU  - Neven P
AD  - Breast Centre, UZ Leuven, Leuven, Belgium.
FAU - Lu, Dongrui Ray
AU  - Lu DR
AD  - Pfizer Inc, San Diego, CA, USA.
FAU - Kim, Sindy
AU  - Kim S
AD  - Pfizer Inc, San Diego, CA, USA.
FAU - Schnell, Patrick
AU  - Schnell P
AD  - Pfizer Inc, New York, NY, USA.
FAU - Bananis, Eustratios
AU  - Bananis E
AD  - Pfizer Inc, New York, NY, USA.
FAU - Schwartzberg, Lee
AU  - Schwartzberg L
AD  - West Cancer Center, Germantown, TN, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01740427
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210728
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Piperazines)
RN  - 0 (Pyridines)
RN  - 0 (Receptors, Estrogen)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - G9ZF61LE7G (palbociclib)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Breast Neoplasms/drug therapy
MH  - Female
MH  - Humans
MH  - Piperazines
MH  - Pyridines
MH  - Receptor, ErbB-2
MH  - *Receptors, Estrogen
PMC - PMC8361185
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - Palbociclib
OT  - Preexisting condition
OT  - Progression-free survival
OT  - Safety
COIS- Declaration of competing interest 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.
EDAT- 2021/08/14 06:00
MHDA- 2021/10/16 06:00
PMCR- 2021/07/28
CRDT- 2021/08/13 20:24
PHST- 2021/07/13 00:00 [received]
PHST- 2021/07/26 00:00 [accepted]
PHST- 2021/08/14 06:00 [pubmed]
PHST- 2021/10/16 06:00 [medline]
PHST- 2021/08/13 20:24 [entrez]
PHST- 2021/07/28 00:00 [pmc-release]
AID - S0960-9776(21)00425-2 [pii]
AID - 10.1016/j.breast.2021.07.017 [doi]
PST - ppublish
SO  - Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.