New breast cancer drug may benefit younger women, too

December 6, 2017 by Amy Norton, Healthday Reporter

(HealthDay)—Adding a new drug to standard treatment can slow the progression of advanced breast cancer in younger women, a new clinical trial has found.

The drug, called ribociclib (Kisqali), was approved by the U.S. Food and Drug Administration in March for the treatment of postmenopausal with advanced cancer.

Now, experts say, the drug is just as effective for premenopausal women.

In the trial, the treatment typically doubled the time a woman remained free of cancer progression—from roughly one year to two years.

That benefit is "strikingly similar" to what's been seen in postmenopausal women, said Dr. Neil Iyengar, who specializes in treating breast cancer at Memorial Sloan Kettering Cancer Center in New York City.

Breast cancer occurs most often in older women, and tumors that develop before menopause tend to be more aggressive, explained Iyengar.

"This is an important study because it addresses the question of whether a treatment is as effective for premenopausal women as it is for postmenopausal women," he said. Iyengar was not involved in the research.

Kisqali is one of several new drugs called CDK4/6 inhibitors. They work by blocking two proteins that help cancer cells grow and divide.

The drug was specifically approved as a first-line treatment for postmenopausal women with advanced breast cancer that is hormone receptor-positive—which means estrogen fuels the cancer's growth.

It is meant to be used along with an , a drug that blocks estrogen production in . Aromatase inhibitors can be given to premenopausal women if they're used with medication that shuts down the ovaries' production of estrogen.

The new trial involved 672 women with , aged 25 to 58, who were premenopausal or going through menopause.

All of the women were given standard hormonal therapy—an aromatase inhibitor or the drug tamoxifen—plus ovary-suppressing medication. Half were randomly assigned to take Kisqali in addition. The other half took inactive placebo tablets.

The main focus of the trial was "progression-free survival"—how long a patient lives without the cancer getting worse.

Overall, women taking Kisqali were typically progression-free for two years, versus 13 months for women on standard treatment only.

The findings offer "clear proof" that the drug can work just as well for , said the trial's lead researcher, Dr. Debu Tripathy. He's a professor of medicine and chairman of the breast medical oncology department at the University of Texas M.D. Anderson Cancer Center, in Houston.

Tripathy cautioned, though, that Kisqali is not yet approved for .

Last month, Kisqali's maker Novartis said it would "begin discussions" with drug regulators based on these trial results.

Tripathy, who is a paid consultant to Novartis, was scheduled to present the findings Wednesday at the San Antonio Breast Cancer Symposium. Research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

Kisqali does have downsides. For instance, it's known to often cause a drop in certain white blood cells that help fight off infections.

In this study, three-quarters of the women who took Kisqali had a decline in blood cells called neutrophils, though most didn't have symptoms, according to Tripathy.

A small number of women had what's called a QT prolongation—a change in the heart's electrical activity that can trigger an abnormal heart rhythm. Novartis says that as a "precaution," Kisqali patients should have their heart activity checked before and during treatment.

The study does not answer the question of whether the ultimately extends women's lives, Tripathy said.

But, he added, that's a tough question, because once a woman's progresses, she'll typically try other treatments—like chemotherapy or newer "targeted" drugs.

Iyengar agreed. And, he said, researchers are still trying to figure out the best course of treatment once patients do have a progression.

For now, Iyengar said, "this study gives us new and convincing evidence that a lot of doctors and patients will want to consider."

Cost, and what insurance will cover, is another issue. Kisqali, like other CDK4/6 inhibitors, costs thousands of dollars for one 28-day cycle of .

Explore further: FDA OKs new Novartis drug for type of advanced breast cancer (Update)

More information: Debu Tripathy, M.D., professor of medicine and chairman, Breast Medical Oncology Department, University of Texas M.D. Anderson Cancer Center, Houston; Neil Iyengar, M.D., medical oncologist, Memorial Sloan Kettering Cancer Center, New York City; presentation, San Antonio Breast Cancer Symposium, San Antonio, Texas, Dec. 6, 2017

The U.S. Centers for Disease Control and Prevention has more on breast cancer in younger women.

Related Stories

FDA OKs new Novartis drug for type of advanced breast cancer (Update)

March 13, 2017
U.S. regulators have approved a new drug as an initial treatment for postmenopausal women with a type of advanced breast cancer.

New health guidance on breast cancer

November 21, 2017
In their draft guidance, the National Institute for Health and Care Excellence (NICE) said that postmenopausal women with a family history of breast cancer should now be offered the drug anastrozole, and not tamoxifen, to ...

Two breast cancer drugs get NHS approval

November 17, 2017
Two breast cancer drugs have been recommended for use by the NHS in England.

Breast cancer drug not recommended for use in England

September 4, 2017
The drug fulvestrant (Faslodex) has not been recommended in England to treat late stage breast cancer, in draft guidance.

Tamoxifen trial should prompt breast cancer patients to reconsider treatment options

December 6, 2012
A groundbreaking clinical trial involving the breast cancer drug tamoxifen should prompt certain breast cancer patients to reconsider their treatment options, according to Loyola University Medical Center breast cancer specialist ...

No increased risk of fatal CV events for breast cancer patients on newer hormone therapy

April 21, 2016
In a new study from Kaiser Permanente, researchers found the use of aromatase inhibitors, hormone-therapy drugs used to treat patients with breast cancer, was not associated with an increased risk of fatal cardiovascular ...

Recommended for you

Scientists discover new method of diagnosing cancer with malaria protein

August 17, 2018
In a spectacular new study, researchers from the University of Copenhagen have discovered a method of diagnosing a broad range of cancers at their early stages by utilising a particular malaria protein that sticks to cancer ...

Researchers find pathways that uncover insight into development of lung cancer

August 17, 2018
Lung cancer is the leading cause of preventable cancer death. A disease of complex origin, lung cancer is usually considered to result from effects of smoking and from multiple genetic variants. One of these genetic components, ...

Developing an on-off switch for breast cancer treatment

August 17, 2018
T-cells play an important role in the body's immune system, and one of their tasks is to find and destroy infection. However, T-cells struggle to identify solid, cancerous tumors in the body. A current cancer therapy is using ...

Pregnant? Eating broccoli sprouts may reduce child's chances of breast cancer later in life

August 16, 2018
Researchers at the University of Alabama at Birmingham have found that a plant-based diet is more effective in preventing breast cancer later in life for the child if the mother consumed broccoli while pregnant. The 2018 ...

Three scientists share $500,000 prize for work on cancer therapy

August 15, 2018
Tumors once considered untreatable have disappeared and people previously given months to live are surviving for decades thanks to new therapies emerging from the work of three scientists chosen to receive a $500,000 medical ...

PARP inhibitor improves progression-free survival in patients with advanced breast cancers

August 15, 2018
In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, the PARP inhibitor talazoparib extended progression-free survival (PFS) and improved quality-of-life measures over ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.