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A new trial found that adding a new drug to standard hormone therapy lengthens the lives of younger women with advanced breast cancer.
The drug, called Kisqali (ribociclib), is already approved to treat such patients – based on previous results showing that it can delay the progression of their cancer.
This is the first evidence that this can also extend their life, said lead researcher Dr. Debu Tripathy, director of the Department of Breast Medical Oncology at the Dr. Anderson Cancer Center in Houston.
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After 3.5 years, 70% of patients receiving hormone therapy associated with Kisqali were still alive. This compared to 46% of those who received hormone treatment alone.
Tripathy said this evidence of a survival advantage was "a pretty big step".
And, he added, he pleads in favor of administering the drug to these patients as a "first- or second-line treatment".
The results were to be presented Tuesday at the annual meeting of the American Society of Clinical Oncology, in Chicago, and they will also be published in the New England Journal of Medicine.
Kisqali is one of three new drugs on the market called CDK4 / 6 inhibitors; the others are Verzenio (abemaciclib) and Ibrance (palbociclib). They work by blocking two proteins that help cancer cells to grow and divide.
Kisqali, taken in tablet form, was initially approved as a first-line treatment for postmenopausal women with hormone receptor-positive advanced breast cancer, which means that estrogen fuels cancer growth . Most breast cancers fall into this category.
Last year, the US Food and Drug Administration extended this approval to younger, non-menopausal women. This analysis was based on previous results of the current trial, which showed that Kisqali generally doubled the time during which patients showed no progression from one year to two years.
The new evidence of longer survival is exciting, said Dr. Larry Norton, medical director of the Lauder Breast Cancer Center at the Memorial Sloan Kettering Cancer Center in New York.
"My expectation is that, faced with this data, it will be difficult for physicians to not include this in standard care," said Norton, who did not participate in the trial.
But, he added, the results also raise "a lot of interesting questions".
One is to determine if the other two inhibitors of CDK4 / 6 could have the same benefits. "Is it a drug effect or a class effect of drugs?" Norton said.
According to Tripathy, "We do not yet know the answer to this question". Tripathy was a consultant for the Kisqali Novartis maker – who funded the lawsuit.
"There are certain biochemical differences between drugs," he noted. For their part, Tripathy found that the number of times that patients have not progressed is about twice as long.
Norton pointed out another related question: once a woman under Kisqali has seen her cancer progress, can she benefit from another CDK4 / 6 drug?
Once again, the answer is unknown, said Tripathy. But in the "real world", some doctors will probably try this strategy, he noted.
The latest discoveries are based on 672 women with advanced breast cancer, aged 25 to 58, who were pre-menopausal or menopausal. All had hormone receptor positive cancer, but negative for a protein called HER2 – a common scenario in breast cancer.
All women received standard hormone therapy – an aromatase or tamoxifen inhibitor – as well as a drug that stops the production of estrogen by the ovaries. Half were randomly assigned to also take Kisqali. The other half took inactive placebo tablets.
Kisqali is taken in cycles of three weeks and a week off.
Norton said it was "relatively nontoxic" compared to chemotherapy.
Possible side effects are fatigue, nausea, diarrhea and constipation, as well as the drop of some white blood cells that help fight infections.
A small number of women develop what is called a QT prolongation – a change in the electrical activity of the heart that can trigger an abnormal heart rhythm. Novartis says that as a precaution, cardiac activity in Kisqali patients should be monitored before and during treatment.
There is also a high cost. CDK4 / 6 inhibitors work several thousand dollars per treatment cycle. Tripathy said that insurance generally covered treatment, but some women sometimes had trouble paying for co-payments. Pharmaceutical companies have financial assistance programs, he noted.
Even though the drugs are a breakthrough, there is still a lot of work to be done, said Tripathy.
"Ultimately, these patients are progressing," he said. "We must continue to develop new treatments."
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