PMID- 38261228
OWN - NLM
STAT- Publisher
LR  - 20240123
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
DP  - 2024 Jan 23
TI  - Poziotinib treatment in patients with HER2-positive advanced breast cancer who 
      have received prior anti-HER2 regimens.
LID - 10.1007/s10549-023-07236-z [doi]
AB  - PURPOSE: Poziotinib is an irreversible pan-inhibitor of the human epidermal 
      growth factor receptor (HER) that has shown acceptable tolerability and antitumor 
      activity in phase I and II trials in patients with advanced solid tumors. In the 
      present open-label, multicenter phase II study, we demonstrate safety, 
      tolerability, and preliminary efficacy data from two different dosing schedules 
      in patients with HER2-positive advanced breast cancer. PATIENTS AND METHODS: 
      Patients who had received at least two prior HER2-directed therapy lines for 
      advanced disease, received 24 mg poziotinib on an intermittent dosing schedule 
      (cohort 1) or 16 mg poziotinib once daily on a continuous dosing schedule (cohort 
      2). The primary endpoint was overall response rate (ORR). Secondary endpoints 
      were progression-free survival (PFS), disease control rate (DCR), and time to 
      progression (TTP). Secondary endpoints additionally included safety and 
      pharmacokinetics. RESULTS: A total of 67 patients were enrolled. The ORR was 30% 
      in both groups (p = 0.98). DCR was 60% vs 78% (p = 0.15) and median PFS and TTP 
      were 4.1 vs 4.9 months (both p = 0.30) for cohorts 1 and 2, respectively. The 
      most common treatment related adverse events (AEs) of any grade included diarrhea 
      (88% vs 85%, p = 0.76), rash (88% vs 88%, p = 0.96), and stomatitis (64% vs 56%, 
      p = 0.52), with grade 3-4 diarrhea occurring in 33% vs 32% of patients (p = 0.93) 
      and grade 3-4 rash in 27% vs 35% of patients (p = 0.48) in cohort 1 vs cohort 2, 
      respectively. CONCLUSION: Poziotinib demonstrated evidence of clinical activity 
      in patients with pre-treated HER2-positive advanced breast cancer, although high 
      levels of toxicity may preclude further studies at this time.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC, part of Springer Nature.
FAU - Nasrazadani, Azadeh
AU  - Nasrazadani A
AD  - Division of Breast Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
FAU - Marti, Juan Luis Gomez
AU  - Marti JLG
AD  - Lenox Hill Hospital, New York City, NY, USA.
FAU - Lathrop, Kate
AU  - Lathrop K
AD  - The University of Texas Health Science Center at San Antonio, San Antonio, TX, 
      USA.
FAU - Restrepo, Alvaro
AU  - Restrepo A
AD  - Texas Oncology-McAllen, McAllen, TX, USA.
FAU - Leu, Szu-Yun
AU  - Leu SY
AD  - Spectrum Pharmaceuticals, Irvine, CA, USA.
FAU - Bhat, Gajanan
AU  - Bhat G
AD  - Spectrum Pharmaceuticals, Irvine, CA, USA.
FAU - Brufsky, Adam
AU  - Brufsky A
AUID- ORCID: 0000-0001-8080-7960
AD  - Magee-Womens Hospital of UPMC, 300 Halket St, Pittsbugh, PA, 15213, USA. 
      brufskyam@upmc.edu.
LA  - eng
PT  - Journal Article
DEP - 20240123
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
SB  - IM
OTO - NOTNLM
OT  - Breast cancer
OT  - HER2
OT  - Metastatic
OT  - Poziotinib
OT  - Targeted therapy
EDAT- 2024/01/23 12:43
MHDA- 2024/01/23 12:43
CRDT- 2024/01/23 11:13
PHST- 2023/05/19 00:00 [received]
PHST- 2023/11/22 00:00 [accepted]
PHST- 2024/01/23 12:43 [medline]
PHST- 2024/01/23 12:43 [pubmed]
PHST- 2024/01/23 11:13 [entrez]
AID - 10.1007/s10549-023-07236-z [pii]
AID - 10.1007/s10549-023-07236-z [doi]
PST - aheadofprint
SO  - Breast Cancer Res Treat. 2024 Jan 23. doi: 10.1007/s10549-023-07236-z.