PMID- 36338738
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221108
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 12
DP  - 2022
TI  - Real world outcomes with alpelisib in metastatic hormone receptor-positive breast 
      cancer patients: A single institution experience.
PG  - 1012391
LID - 10.3389/fonc.2022.1012391 [doi]
LID - 1012391
AB  - BACKGROUND: It is critically important to study the real-world data of 
      FDA-approved medications to understand the response rates and toxicities observed 
      in the real-world population not represented in the clinical trials. METHODS: We 
      reviewed charts of patients diagnosed with metastatic, hormone receptor-positive, 
      human epidermal growth factor receptor 2 negative, PIK3CA-mutated breast cancer 
      treated with alpelisib from May 2019 to January 2022. Clinical characteristics 
      and treatment outcomes were collected. The association of clinical 
      characteristics with responses and adverse events (AEs) was evaluated using the 
      logistic regression model. RESULTS: 27 patients were included. Median age at 
      alpelisib initiation 67 years (range: 44, 77 years). Majority of patients had 
      excellent performance status at time of alpelisib initiation. Most patients had 
      chronic comorbidities, notably; 2 patients had controlled type 2 diabetes 
      mellitus at time of alpelisib initiation. Majority had a median of three lines of 
      therapy (range: 1, 7) before alpelisib. Clinical responses were determined using 
      RECIST v1.1. 3/27 (11.11%) patients discontinued therapy before response 
      assessment due to grade 3 AEs. Overall response rate was 12.5% (3/24), with all 
      partial responses (PR). The median duration of response was 5.77 months (range: 
      5.54, 8.98). 14/27 (51.9%) of patients required dose interruption/reduction. 
      Overall, 23/27 (85.19%) patients discontinued alpelisib of which 11 (47.83%) 
      discontinued alpelisib due to AEs. Median duration of treatment was 2 months in 
      patients who had grade 3 AEs (range: <1.00, 8.30) and 6.28 (1.15, 10.43) in those 
      who did not. Any grade AEs were reported in 24/27 (88.9%) patients, namely, 
      hyperglycemia 16/27 (59.3%), nausea 11/27 (40.7%), diarrhea 10/27 (37.0%), 
      fatigue 7/27 (25.9%) and rash 6/27 (22.2%). Grade 3 AEs were reported in 13/27 
      patients (50%), namely, hyperglycemia in 7/27 (53.8%) patients followed by skin 
      rash 4/27 (30.8%), GI side effects 3/27 (23.1%). Those with progressive disease 
      as best response to alpelisib, had more non-metabolic comorbidities, higher 
      number of liver metastases, PIK3CA E545K mutations, and shorter duration on 
      therapy compared to those with PR and stable disease. CONCLUSION: Patients should 
      be counseled about the toxicity and modest benefit observed with alpelisib in 
      real-world clinical practice when used in later lines of therapy.
CI  - Copyright (c) 2022 Alaklabi, Roy, Attwood, George, O'Connor, Early, Levine and 
      Gandhi.
FAU - Alaklabi, Sabah
AU  - Alaklabi S
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
FAU - Roy, Arya Mariam
AU  - Roy AM
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
FAU - Attwood, Kristopher
AU  - Attwood K
AD  - Department of Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer 
      Center, Buffalo, NY, United States.
FAU - George, Anthony
AU  - George A
AD  - Department of Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer 
      Center, Buffalo, NY, United States.
FAU - O'Connor, Tracey
AU  - O'Connor T
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
FAU - Early, Amy
AU  - Early A
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
FAU - Levine, Ellis G
AU  - Levine EG
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
FAU - Gandhi, Shipra
AU  - Gandhi S
AD  - Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
AD  - Department of Immunology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 
      United States.
LA  - eng
PT  - Journal Article
DEP - 20221020
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC9631302
OTO - NOTNLM
OT  - PIK3CA
OT  - adverse events
OT  - alpelisib
OT  - breast cancer
OT  - effectiveness
OT  - piqray
OT  - real-world
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/11/08 06:00
MHDA- 2022/11/08 06:01
PMCR- 2022/01/01
CRDT- 2022/11/07 04:33
PHST- 2022/08/08 00:00 [received]
PHST- 2022/10/10 00:00 [accepted]
PHST- 2022/11/07 04:33 [entrez]
PHST- 2022/11/08 06:00 [pubmed]
PHST- 2022/11/08 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2022.1012391 [doi]
PST - epublish
SO  - Front Oncol. 2022 Oct 20;12:1012391. doi: 10.3389/fonc.2022.1012391. eCollection 
      2022.