Postmenopausal women and men with advanced-stage hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that grew during or after hormonal therapy lived about 8 months longer when treated with the combination of Piqray (chemical name: alpelisib) and Faslodex (chemical name: fulvestrant) compared to Faslodex alone.

These latest results from the SOLAR-1 study were presented on Sept. 19, 2020, at the European Society for Medical Oncology Virtual Congress 2020. Read the abstract of Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) advanced breast cancer (ABC).

Advanced-stage breast cancer is breast cancer that has spread to tissue near the breast (locally advanced) or to parts of the body away from the breast, such as the bones or liver (metastatic).

Overall survival is how long a person lives, whether or not the cancer grows.

Piqray is a targeted therapy medicine that inhibits the PI3K pathway. The PI3K pathway helps all cells both healthy and cancer cells get the energy they need. When this pathway is overactivated because of a mutation in the PIK3CA gene, it can allow cancer cells to survive and grow. PI3K inhibitors block this pathway, with the goal of killing cancer cells.

In hormone-receptor-positive breast cancers, a PIK3CA mutation also can make the cancer resistant to hormonal therapy medicines.

About 40% of people diagnosed with hormone-receptor-positive, HER2-negative breast cancer have a PIK3CA mutation.

Piqray is a pill taken by mouth.

Faslodex is a hormonal therapy medicine called an estrogen receptor downregulator. Faslodex sits in the estrogen receptor in breast cells so the cell cant receive estrogens signals to grow and multiply. Faslodex also reduces the number of estrogen receptors and changes the shape of breast cell estrogen receptors so they dont work as well. Faslodex is a liquid that is given once a month as an injection into a muscle.

The SOLAR-1 trial included 572 people diagnosed with advanced-stage hormone-receptor-positive, HER2-negative breast cancer that had previously been treated with hormonal therapy; 341 of the cancers had a PIK3CA mutation. The people in the study were either postmenopausal women or men.

The people were randomly split into two treatment groups:

Median follow-up time was 30.8 months. This means that researchers tracked half the people for a longer time and half the people for a shorter time.

For the 341 people diagnosed with cancer with a PIK3CA mutation, overall survival was:

This difference of about 8 months was not statistically significant, which means that it could have been due to chance and not because of the difference in treatment.

Still, the researchers who did the study said the difference in overall survival was clinically meaningful and supports using Piqray to treat advanced-stage hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after hormonal therapy.

Like almost all cancer medicines, Piqray can cause side effects, some of them severe.

The most common side effects of Piqray are:

Piqray also may cause serious side effects, including:

If youre a postmenopausal woman or a man who has been diagnosed with advanced-stage hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after treatment with hormonal therapy, the latest results from the SOLAR-1 study are very encouraging.

Earlier results from the SOLAR-1 trial showed that Piqray and Faslodex led to longer progression-free survival compared to Faslodex alone. Progression-free survival is how long a person lives without the cancer growing.

These latest results showing 8 months longer overall survival for people treated with Piqray and Faslodex, while not statistically significant, offer more support for using Piqray to treat this type of breast cancer.

If youre being treated for advanced-stage hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has stopped responding to the first hormonal therapy, you and your doctor are likely considering several treatment options, including Piqray. Together, you will weigh the benefits and risks of each treatment and decide on the best treatment plan for your unique situation.

Written by: Jamie DePolo, senior editor

Published on October 16, 2020 at 11:36 AM

Visit link:
Piqray Improves Overall Survival for Advanced-Stage Hormone-Receptor-Positive, HER2-Negative Breast Cancer With PIK3CA Mutation - Breastcancer.org

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