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A major study showed that women with aggressive breast cancer lived longer if they received immunotherapy with chemotherapy, rather than chemotherapy alone.
The findings should change women's standards of care such as those in the clinical trial, which had an advanced case of triple negative breast cancer. This form of the disease often resists standard therapies and survival rates are low. It is twice as common among African-American women as it is among white women and more likely to occur among younger women.
The researchers said the new study was a long awaited advance for immunotherapy in breast cancer. Until now, most progress has been made in other cancers, including lung cancer and melanoma, an aggressive skin cancer.
These findings could lead to the first approval by the Food and Drug Administration of an immunotherapy drug intended to treat breast cancer. But approval would probably be limited to some type of aggressive cancer.
Although triple negative tumors occur in only about 15% of patients with invasive breast cancer in the United States (about 40,000 per year), they account for a disproportionate share of deaths, ranging from 30 at 40%.
"These women really needed a break," said Dr. Ingrid Mayer, a breast cancer specialist at Vanderbilt University, during a phone interview. "Nothing worked well."
Dr. Mayer, who was not part of the study, described the results as "very important". She said she received consulting fees from seven pharmaceutical companies, including Genentech, the maker of the research immunotherapy drug.
The term "triple negative" refers to the lack of sensitivity of tumors to estrogen hormones and progesterone and the lack of a protein called HER2, which is a treatment target.
In the study, immunotherapy consisted of atezolizumab (brand name Tecentriq), which belongs to a class of drugs called control point inhibitors; the chemotherapy was nab-paclitaxel (Abraxane).
The results were published Saturday in The New England Journal of Medicine, and was to be presented at a meeting of the European Society of Medical Oncology in Munich. The study included 902 patients treated in 246 medical centers in 41 countries. Genentech, part of Roche, has already submitted the data to F.D.A. For approval.
Checkpoint inhibitors such as atezolizumab work by helping T cells, a type of white blood cell that is part of the immune system, to recognize and attack cancer. The research that led to these drugs won the Nobel Prize for Medicine this year.
Medications generally work for less than half of patients, but can provide lasting recovery even in critically ill people. Side effects can be dangerous or even fatal, and the treatment costs more than $ 100,000 a year.
In other cancers, researchers sometimes describe tumors as "hot", which means that they tend to have many mutations – genetic abnormalities that the immune system may recognize as foreign and likely to develop. # 39; attack.
But breast cancers tend to be relatively "cold," with fewer mutations. The immune system is less likely to recognize them as invaders, which may partly explain why previous studies on checkpoint inhibitors in breast cancer have been somewhat disappointing, researchers said.
In the new study, the key to success seems to have been chemotherapy associated with immunotherapy.
"Chemotherapy removes the cloak that cancer has managed to take on," said Dr. Mayer.
Chemotherapy can help ignite the immune system, in part by killing the cancer cells, which then release substances that the T cells detect as foreign and begin to hunt.
The new study "is a big deal and has made the world the buzz of breast cancer research," said Dr. Larry Norton of the Memorial Sloan Kettering Cancer Center in an email. He did not participate in the study, although he said he performed paid consulting work in the last two years for the manufacturer of Abraxane.
Beyond the change in treatment practices, he said the research "opens the door to new approaches to using the immune system to fight breast cancer and that there's every place to stay." to wait for major advances in this country ".
He warned that the combined treatment should be further studied to evaluate the side effects.
Dr. Kevin Kalinsky, Breast Cancer Specialist at Irving Medical Center of New York-Presbyterian / Columbia University, suggested that patients like those in the study should talk to their doctor "to find out if it is possible for them to have access to the drugs then wait for the FDA approval. "
He did not participate in this study. He said he received consulting fees from a dozen pharmaceutical companies, including Genentech.
The women participating in the study had a triple-negative breast cancer that had just been diagnosed and which had become metastatic, which meant that it had begun to spread. Once this happens, the outlook is bleak, with many patients surviving 18 months or less.
Half received chemotherapy alone and half received chemotherapy plus immunotherapy.
Among those who received the combination, the median survival was 21.3 months, compared to 17.6 months for those who received chemotherapy alone. The difference was not statistically significant.
But when the researchers looked at women carrying a marker called PD-L1 on their cancer cells, the results were striking: the median survival was 25 months in the combined group, versus 15.5 months with chemotherapy alone. This finding was not statistically analyzed and patients are always followed.
Doctors say that the difference in survival is important.
"It really changes the game," said Dr. Sylvia Adams, author of the NYU Langone Health Perlmutter Cancer Center study.
Cancer patients with the PD-L1 marker tend to respond better to checkpoint inhibitors than those who do not. In this study, 41% of patients had the marker. Genentech is seeking approval for treatment in triple-negative patients with the marker.
Dr. Adams stated that some patients, after initial treatment with both types of medications, had been doing well for two or three years with immunotherapy alone.
The "million dollar question," she said, is whether they can stop immunotherapy safely if they show no signs of cancer. For the moment, they are sticking to treatment.
She noted that patients in the study had some of the expected side effects of immunotherapy, including inflammation of the lungs and pancreas.
Dr. Adams stated that she did not accept money from pharmaceutical companies, but that her medical center had received Genentech 's money to fund her research.
Maribel Ramos, 42, was treated in another hospital, which had recommended chemotherapy for her advanced triple negative breast cancer.
"I was very worried because I know that with this type of cancer, chemotherapy does not work," Ms. Ramos said. She has three daughters: a twin of 23 years old and 10 years old.
Her sister, a nurse from New York University, told her about the study and started her treatment in February 2016. She did not know it at the time, but she was randomly selected to receive the treatment. combined treatment. In a few months, his tumors began to contract. Nine months ago, for the first time, a CT scan revealed no signs of cancer. She stays on immunotherapy.
"I'm so happy that you can live longer," Ramos said. "I hope that all women who fight cancer, especially the triple negative, can get this drug. I would recommend to all women to get a second opinion, and sometimes even a third. She added, "It can save your life. "
Approximately 266,120 new cases of invasive breast cancer are expected among women in 2018 in the United States and 40,920 deaths.
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