New drug dramatically increases survival of younger women with advanced breast cancer



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A new drug called cyclin inhibitor has dramatically improved the survival of younger women with advanced bad cancer. Photo credit: Getty royalty free.

Getty

New results Presented today at the annual meeting of the American Society of Clinical Oncology in Chicago have shown that the addition of a drug called cyclin inhibitor greatly increases women's chances of survival longer. young people with a particular type of aggressive bad cancer.

The international clinical trial, called MONALEESA-7, was conducted in 672 women under 59 years of age with a specific type of bad cancer called positive hormone receptor / HER2 negative. All women received endocrine treatments to suppress estrogen. Some of them were then randomized during the trial to receive the new drug ribociclib, the others receiving a placebo.

After 42 months, 70% of women taking ribociclib combination therapy were still alive, compared with only 46% of women who received endocrine therapy, which reduced the risk of bad cancer by 29%. deaths during the duration of the trial in women taking the new drug.

"This study is the first to show an improvement in survival for any targeted therapy, when it is used in endocrine therapy as a first-line treatment for advanced bad cancer." Lead author of the study, Sara A. Hurvitz, MD, director of the Breast Cancer Clinical Research Program at UCLA's Jonsson Cancer Center in Los Angeles.

Although advanced bad cancer is less common in younger women than in older women, it seems that it is becoming more common. In the United States, among women aged 20 to 39, the incidence has increased more and more 2% each year between 1978 and 2008. In women under 59, this is the primary cause cancer deaths.

"There is a clear difference in favor of adding this new drug to the treatment regimen.The study confirms the value of the therapeutic approach in these younger women with this aggressive type of bad cancer," & nbsp; said J. Leonard Lichtenfeld, M.D., & nbsp; Acting Medical and Scientific Director of the American Cancer Society.

Although prolonging the survival of women with these often incurable advanced bad cancers is certainly & nbsp; A big step forward, the current use of cyclin inhibitors in the treatment of cancer is often not considered "curative"; they prolong the life of the patient and often cause less serious side effects than many conventional chemotherapies.

"The increase in survival is important, but the sad reality of metastatic bad cancer is that it is unusual to" cure "women with advanced bad cancer with any of our current treatments. The history of cancer treatment has generally been modest and progressive over time, unlike major breakthroughs, "says Lichtenfeld.

Ribociclib, marketed by Novartis as Kisqali, is & nbsp; one of the three FDA approved& nbsp; cyclin inhibitors, which block the proteins that control cell division. The first of them, palbociclib (Pfizer Ibrance), was & nbsp;FDA approved& nbsp; in 2015 and its use is currently allowed in several types of cancer, with & nbsp;$ 4.1 billion & nbsp; for sales& nbsp; in 2018, with ribociclib lagging behind with a paltry $ 235 million.

Palbociclib has already been tested in a similar process& nbsp; in younger women with advanced bad cancer, but did not show the same increases in overall survival as recent research on ribociclib.

"Why did not we see the same significant change in survival with other cyclin inhibitors?" If you look closely at this study, you will see that the authors have addressed it and said that it was not exactly the same patient population The women treated in the other palbociclib trial may have had more advanced disease and had already undergone other treatments, "says Lichtenfeld.

It remains to be seen if any of these drugs is actually more effective in this patient population or if differences between patients in both trials account for different outcomes.

"The jury is still out, the only way to do that is to do a comparative trial on the same patients to see if there are any differences, but I'm not sure that's happening."It is not appropriate to make comparisons between these two drugs from this new test, "says Lichtenfeld.

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A new drug called cyclin inhibitor has dramatically improved the survival of younger women with advanced bad cancer. Photo credit: Getty royalty free.

Getty

The new findings presented today at the annual meeting of the American Society of Clinical Oncology in Chicago have shown that the addition of a drug called cyclin inhibitor greatly increases the chances of survival of younger women with a particular type of aggressive bad cancer.

The international clinical trial, called MONALEESA-7, was conducted in 672 women under 59 years of age with a specific type of bad cancer called positive hormone receptor / HER2 negative. All women received endocrine treatments to suppress estrogen. Some of them were then randomized during the trial to receive the new drug ribociclib, the others receiving a placebo.

After 42 months, 70% of women taking ribociclib combination therapy were still alive, compared with only 46% of women who received endocrine therapy, which reduced the risk of bad cancer by 29%. deaths during the duration of the trial in women taking the new drug.

"This is the first study to show an improvement in survival for any targeted therapy when it is used in endocrine as a first-line treatment for advanced bad cancer," said lead author of the study. Study, Sara A. Hurvitz, MD, director of the Breast Cancer Clinical Research Program. at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.

Although advanced bad cancer is less common in younger women than in older women, it seems that it is becoming more common. In the United States, among women aged 20 to 39 years, the incidence increased by 2% per year between 1978 and 2008. In women under 59, it is the leading cause of cancer deaths.

"There is a clear difference in favor of adding this new drug to the treatment regimen.The study confirms the value of the therapeutic approach in these younger women with this type of cancer." aggressive bad, "said J. Leonard Lichtenfeld, MD, Acting Chief Medical Officer. and scientific leader of the American Cancer Society.

Although lengthening the survival of women with these often incurable advanced bad cancers is certainly a big step forward, the current use of cyclin inhibitors in cancer treatment is often not considered "curative", but rather as an extension of life and often less severe side effects than many conventional chemotherapies.

"The increase in survival is important, but the sad reality of metastatic bad cancer is that it is unusual to" cure "women with advanced bad cancer with any of our current treatments. But the history of cancer treatment has generally been modest, step by step time unlike blockbuster breakthroughs, "said Lichtenfeld.

Ribociclib, marketed by Novartis as Kisqali, is one of three FDA-approved cyclin inhibitors that block proteins that control cell division. The first of these, Palbociclib (Pfizer Ibrance), approved by the FDA in 2015, is currently licensed in several types of cancer. It has recorded a turnover of $ 4.1 billion in 2018 and the ribociclib a delay of only $ 235 million.

Palbociclib has already been tested in a similar trial in younger women with advanced bad cancer, but has not shown the same increases in overall survival as research on ribociclib.

"Why did not we see the same significant change in survival with other cyclin inhibitors?" If you look closely at this study, you will see that the authors have approached it and stated that it was not exactly the same patient population.Women treated in the other trial with palbociclib, the disease could be more advanced and have undergone further treatment beforehand, "said Lichtenfeld.

It remains to be seen if any of these drugs is actually more effective in this patient population or if differences between patients in both trials account for different outcomes.

"The jury is still missing, the only way to do it right is to do a comparative test on the same patients to see if there are any differences, but I do not know if that will happen. It is not appropriate to make comparisons between these two drugs based on this new test, "said Lichtenfeld.

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