In a groundbreaking study, a drug called Lynparza (Olaparib) wa found to reduce the risk of breast cancer recurrence in BRCA gene mutation carriers. The pill, which is classed as a PARP inhibitor, was developed by AstraZeneca and Merck.
PARP inhibitors block the cancer cell’s ability to repair its own DNA. This means if a cancer cell is damaged by a treatment like chemotherapy or radiation, it will be unable to repair itself and will die.
The clinical study, published in the New England Journal of Medicine, began in 2014 and enrolled a total of 1,836 women. All the study participants were carriers of a BRCA gene mutation and had a history of early stage HER2-negative breast cancers. All patients had undergone breast cancer surgery and chemotherapy and were also considered at high risk for breast cancer recurrence based on their tumor size or lymph node involvement.
Half of the study participants were given Lynparza daily for a year. The other half received a placebo. A little over two years after the beginning of treatment, the study found that the women taking Lynparza saw a 42% reduction in the risk of breast cancer recurrence or death. The study also reported that at 3 years after beginning treatment, 85.9% of Lynparza users were still living without evidence of a recurrence, compared to 77.1% of women who received the placebo.
As it stands today, AstraZeneca will be submitting the results of this study to regulators to request approval for use in early-stage breast cancer patients with a BRCA genetic mutation. Currently the drug is approved by the FDA to treat advanced-stage breast cancer in BRCA gene mutation carriers.
Nipple-sparing mastectomy (NSM) is the latest evolution in mastectomy technique. The procedure preserves the entire skin envelope and nipple-areola. Only the underlying breast tissue is removed. Nipple-sparing mastectomy significantly improves cosmetic results when combined with immediate breast reconstruction, and is oncologically safe when performed in appropriate candidates. It can also improve the return of sensation in some patients.
However, certain factors such as large breast size and a low nipple location can increase the risk of complications such as partial or even complete necrosis of the nipple and areola. There is some good news though for patients choosing NSM to decrease their risk of getting breast cancer (“prophylactic” or “risk-reducing” NSM)… “Staged” surgery with a breast reduction performed at least three months before the NSM significantly decreases these complications in patients with larger breasts.
According to a study published in Plastic and Reconstructive Surgery that compared the staged approach with the traditional all-in-one surgery, staged surgery patients experienced no major skin or nipple-areola necrosis. However, patients who did not reduce their breast size via a breast reduction before having their NSM and immediate reconstruction experienced major necrosis 22% of the time.
The staged approach allows surgeons to reduce the patient’s overall breast size, remove excess skin, and reposition the nipple-areola before the definitive NSM and reconstruction. By decreasing the overall size of the breast and relocating the nipple-areola to a more favorable position ahead of time, the demands on the blood supply at the time of the NSM are significantly reduced. This in turn decreases the risk of complications.
Staging does add an addition surgery and cost, along with a longer overall recovery period, but should be considered in patients who may otherwise not be good candidates for risk-reducing NSM due to large breast size or a low-lying nipple-areola. Patients with a cancer diagnosis are usually not candidates for this staged approach due to the delay it adds to treatment of the cancer.
A leader in breast cancer treatment education and shared decision-making, Breast Advocate® is excited to announce the release of our updated free app for breast cancer surgery and breast reconstruction. Thank you to our users for providing the valuable feedback that has helped make our app even better!
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The US Preventive Services Task Force (USPSTF) issued a new recommendation statement calling for more patients to receive genetic counseling and genetic testing for BRCA1 and BRCA2 gene mutations.
Often referred to as the “breast cancer gene,” mutations in BRCA1 and BRCA2 genes have been shown to increase the likelihood of an individual developing breast, ovarian, fallopian tube and peritoneal cancer.
To better predict and manage the risk of developing hereditary cancers, the USPSTF is now recommending more patients, including breast, ovarian, fallopian tube and peritoneal cancer survivors, undergo genetic counseling and genetic testing. Previously, the USPSTF only recommended those who had a family history BRCA-related cancers be tested.
The USPSTF statement, published in the JAMA Network, recommends that “primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing… The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations.”
Why are these tests important? Expanding testing will potentially help survivors determine which treatments would be best based on their current diagnosis, as well as alert them to treatments that could significantly lower their future cancer risk, such as risk-reducing mastectomy and hysterectomy. It could also be very important and possibly life-saving for some of the survivors’ family members.
While the updated recommendations are very good news, in several ways they do not go far enough: newly diagnosed patients with breast or ovarian cancer, patients with advanced cancers, and men were not included. Men who carry a BRCA gene mutation are at increased risk for breast, pancreatic and prostate cancers, and should also have counseling and testing. As in women, these mutations can be passed on to their children and beyond.
Anyone who is concerned about their future cancer risk and doesn’t fall into these guidelines should consider proactively seeking a consultation with a genetic counselor. You can find a certified genetic counselor near you via the National Society of Genetic Counselors.
Robotic nipple-sparing mastectomy was first described in 2015 and appears to be gaining traction in Europe. Slower to catch on in the US, the procedure is now also starting to raise safety concerns for some surgeons.
The da Vinci robot is not yet FDA-approved for mastectomy. There is concern amongst some medical professionals that robotic tumor removal could inadvertently cause breast cancer cells to spread by fragmenting the cancerous tissue as it is being pulled out of the small incision.
Dr Hooman Noorchashm, a Philadelphia-based surgeon turned patient advocate, has raised questions about the safety and appropriateness of using the da Vinci robot for mastectomies… “The reason why I am focused on robotic mastectomy is because I think there is a parallel [with hysterectomy via power morcellator] of selling cosmesis and convenience to women for a surgical operation. The US Food and Drug Administration (FDA) has a history of being lax in its oversight of 510K devices, which include the power morcellator and the da Vinci robot, he said. These devices can replace established standards of care without proper evidence.”
To date there have been no clinical trials to compare the safety of robotic surgery with the traditional techniques used for breast cancer surgery.
Dr Noorchashm has also referred to a recent study from MD Anderson that compared survival rates of laparoscopic hysterectomies for cervical cancer to traditional “open” surgical methods that use larger incisions. The research found that patients who underwent the minimally invasive laparoscopic surgery were four times more likely to experience recurrence than those who had the open surgery. These finding came over 10 years after laparoscopic surgery was recommended as the standard for care.
This is not to say that robotic surgery isn’t an option for some patients. Recent headlines have praised surgeons for performing robot-assisted prophylactic breast surgery and immediate implant-based breast reconstruction. Although controversial, there is no evidence to suggest robotic surgery could increase the risk of developing breast cancer in preventative mastectomy cases.
Long-term, high quality research is underway, but it could be years before there is a better understanding of the full impact and risk of robotic surgery for breast cancer patients.
Looking for more information to help you weigh your surgical options? Download the Breast Advocate app now.
Addendum 2/28/19:
FDA issues safety communication about robotic mastectomies – Caution When Using Robotically-Assisted Surgical Devices in Women’s Health including Mastectomy and Other Cancer-Related Surgeries.