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The researchers found that "the risk of progression or death was 65% lower and the risk of death was 83% lower with ibrutinib-rituximab than with chemo-immunotherapy." After three years of follow-up, progression-free survival was 89.4% in patients treated with ibrutinib-rituximab, compared to 72.9% for those treated with chemo-immunotherapy. The three-year overall survival was 98.8% versus 91.5%, respectively.
The author of the study, Dr. Tait Shanafelt, a professor of medicine at Stanford University's School of Medicine, said that the data security oversight committee of the University of Stanford said that The study had asked that the results "be immediately shared with the world because they were so dramatic and that they immediately changed their practice."
"For this to happen so early against what was traditionally a very effective treatment – just one that had high side effects – I think it was a surprise."
Still, chemoimmunotherapy, a combination of three drugs including rituximab, "led to a higher frequency of complete response" and showed less residual cancer, according to the study.
"This historic approach is actually a very effective treatment," said Shanafelt. "It's just that it's also very toxic and that many CLL patients can not tolerate it because it's so intense."
Since chemotherapy affects healthy cells in addition to cancer cells, people taking these medications may experience a variety of symptoms, including hair loss, fatigue, appetite changes, nausea, and vomiting.
The segment of patients who experienced a serious adverse event was similar in both groups – but the types of events differed.
Chemotherapy drugs, as well as leukemia itself, carry a risk of serious infections because of the way they suppress the immune system, explained Shanafelt. At the same time, ibrutinib was badociated with cardiovascular adverse events, including high blood pressure and irregular heartbeat.
The ibrutinib-rituximab, he said, presents "a more favorable overall side-effect profile".
What is the LLC?
Chronic lymphocytic leukemia, or CLL, is a slow growing cancer in which immature white blood cells multiply in the bone marrow and spread throughout the body.
Many people do not even have symptoms at the time of diagnosis because they can be detected in routine blood tests or not. But while cancer invades the bone marrow and replaces healthy cells, patients may develop anemia, be more susceptible to infections, and easily bleed or bruise.
Ibrutinib, which comes in tablet form, has sometimes been used in patients with CLL, whose cancer develops a high-risk genetic mutation that makes it less sensitive to treatment. However, the new study did not include them and thus showed benefits for a wider set of CLL patients.
"We already know in this group that traditional approaches are not as effective, so if we include these [patients in the study]it is easier for the ibrutinib to win, "explained Shanafelt.
But there is a "trap"
"The impact on overall survival is still remarkable," said Dr. Nelson Chao, chief of the Division of Hematologic Malignancies and Cell Therapy at Duke University School of Medicine. He is not involved in research.
The problem, says Chao, is that chemo-immunotherapy begins and ends; Ibrutinib should be taken indefinitely or until the patient relapses.
"There is clearly a survival advantage … but we do not really know what will be the impact of keeping people under ibrutinib," said Chao. Not to mention how to extrapolate the effects of the drug on people over 70 years old, the maximum age at which the study recruited patients.
Shanafelt asks about the same obstacles: "Is it economically feasible and accessible to all who need it, in the United States and around the world?"
Another potential disadvantage of indefinite treatment, according to the research: It is possible that drug resistance manifests itself if the cancer cells accumulate mutations that make the ibrutinib less effective. Shanafelt said such mutations have been identified in patients taking the drug, although this is rare.
For this reason, doctors are eagerly awaiting trials that could pit these drugs against each other, either alone or in combination. The researchers could not only find the best badtail, but Shanafelt hopes a solution without chemotherapy and does not require that patients take ibrutinib indefinitely.
"If we could get an badociation with the ibrutinib that we could perhaps use for a short time and get even more control while eliminating that need for chronic treatment," he said, "we would perhaps reduce the probability of selecting these genetic abnormalities that breed resistance. "
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