In a nutshell
This study aimed to investigate the combination of alpelisib (Piqray) and fulvestrant (Faslodex) in patients with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor 2 (HER2) negative, advanced breast cancer (BC).
This study concluded that this combination provided positive outcomes for these patients.
The PI3K pathway normally helps cells get the energy they need to survive. Some BCs have genetic abnormalities (mutations) that help them grow and spread. A mutation in the PIK3CA gene leads to an overactivation of the PI3K pathway. This helps cancer cells survive and grow.
Alpelisib is a type of targeted therapy that blocks the PI3K pathway. It can be used in combination with fulvestrant. Fulvestrant is a hormonal therapy that can be used to treat HR+ breast cancer. It blocks the action of the hormone estrogen that stimulated BC cells to grow in HR+ BC.
It was previously shown that alpelisib combined with fulvestrant improves the survival without cancer worsening compared to fulvestrant alone in patients with PIK3CA-mutated, HR+, HER2- advanced BC in the short-term. However, longer-term outcomes of this combination are still under investigation.
Methods & findings
This study involved 341 men and postmenopausal women with PIK3CA-mutated, HR+, HER2- advanced BC who had disease progression on or after treatment with an aromatase inhibitor (AI; a type of hormonal therapy). Patients received either alpelisib plus fulvestrant or a placebo plus fulvestrant. Patients were followed-up for an average of 42.4 months.
The average overall survival was 39.3 months for the alpelisib group compared to 31.4 months for the placebo group. In patients with cancer spread to the lungs and/or liver the average overall survival was 37.2 months for the alpelisib group compared to 22.8 months for the placebo group.
The average time until patients needed further chemotherapy was 23.3 months for the alpelisib group compared to 14.8 months for the placebo group.
Skin reactions such as rash were more common in the alpelisib group (54%) compared to the placebo group (9%).
The bottom line
This study concluded that the addition of alpelisib to fulvestrant provided better outcomes in patients with PIK3CA-mutated, HR+, HER2– advanced BC.
The fine print
This study was funded by Novartis, the manufacturer of alpelisib.
Published By :
Annals of oncology: official journal of the European Society for Medical Oncology
Nov 24, 2020
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