‘A Real Milestone’: FDA Approves New After Surgery Treatment for High-Risk Early Breast Cancer

(If you do not know the genetic make-up of your cancer, please ask your doctor. BRCA mutations make cells more likely to divide and change rapidly, which can lead to cancer. When a breast cancer is HER2-negative, it means that the cancerous cells do not contain high levels of the protein HER2. This can mean the cancer may grow more slowly.)

Olaparib is already FDA-approved for the treatment of advanced breast cancer (metastatic disease). The approval for early stage use stems from impressive findings from the OlympiA trial, which demonstrated that the drug reduced the risk of death by 32 percent when used after surgery.

Dr. Pamela Munster, co-leader of the Center for BRCA Research at the University of California, San Francisco's Helen Diller Family Comprehensive Cancer Center, tells SurvivorNet the approval of olaparib for patients with BRCA mutations is especially noteworthy, since an estimated 70 percent of people with that genetic mutation go on to develop breast cancer. "Having the ability to provide better treatment for this group is a real milestone," Dr. Munster says.

About 5-10% of breast cancer patients have BRCA mutations, while HER-2 negative breast cancer represents about 75-80 percent of all breast cancers.

What Did The Breast Cancer Study Find?

Dr. Charles E. Geyer, a medical oncologist, breast cancer specialist and chief scientific officer with the National Surgical Adjuvant Breast and Bowel Project (NSABP), co-chaired the trial. Here are more details on the trial:

• It involved 1,800 patients at 420 centers in 23 countries.
• Study participants took an oral 300-milligram (mg) dose twice a day for a year after completing the standard of care, which usually means some combination of surgery, chemotherapy, and radiation therapy.
• Olaparib boosted the three-year survival rate to 92.8 percent, compared to 89.1 percent for patients on placebo.

"Seeing statistically significant overall survival improvement in just three years is very impressive," Dr. Geyer says. "It's providing substantial benefit for these high-risk patients."

Dr. Geyer says he's looking forward to seeing the difference olaparib makes over the next 10 years and whether this medication can possibly shift the treatment approach oncologists take with this type of inherited breast cancer. Olaparib is part of a class of drugs known as PARP (poly adenosine diphosphate-ribose polymerase) inhibitors.

Individuals with a BRCA gene mutation lose the ability to produce proteins that repair damaged DNA. Cells without these proteins can grow abnormally and become cancerous. Dr. Geyer explains that PARP, an enzyme that helps repair DNA damage in cells, allows cancer cells to repair themselves. A PARP inhibitor such as olaparib interferes with that process, effectively limiting the ability of cancer cells to repair properly and multiply.

"One thing we can look for this subset of breast cancers is whether PARP inhibitors might be the core part of treatment and then determine how chemo and radiation might be adjusted accordingly," Dr. Geyer says.

Olaparib has been used for several years to treat other types of cancer, including ovarian cancer. It's the first PARP inhibitor to demonstrate overall survival benefit in early breast cancer.

Remarkable breast cancer survivors

What Are The Side Effects?

• The main side effects of olaparib are nausea, though Dr. Geyer notes that for many people the effects were mild and became less of a problem over time. Having a small meal when taking the medication often helped.
• One other concern with olaparib is that it can elevate the risk of anemia (feeling tired due to a low red blood cell count). Dr. Geyer says that's very important that individuals taking the medication have their blood counts checked regularly. If hemoglobin levels drop, the dosage of olaparib may need to be adjusted, he explains.

Olaparib For Breast Cancer and Genetic Testing

Dr. Munster says that because an improved treatment modality now exists for this specific type of patient, it might prompt more women to get germline BRCA testing soon after a breast cancer diagnosis to determine if they are candidates for olaparib.

"It could prompt more testing for daughters, sisters, families," Dr. Munster says. "From a public health impact, that's almost as important as the approval itself. It's my personal opinion that every woman with breast cancer should get BRCA tested."

What to Ask Your Doctor

• If you have breast cancer and have not had germline BRCA testing, please ask your doctor.
• If you have breast cancer and don’t already know your breast cancer's HER2 status — together with its hormone receptor status – please ask your doctor.
• If your breast cancer is HER-2 negative, ask if you are a candidate to use olaparib
• How does olaparib work?
• What are the side effects?
• How do we measure if olaparib is working for me?

The importance of genetic testing for breast cancer

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