By Aristos Georgiou
Science and Health Reporter
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A novel combination of immunotherapy and chemotherapy has extended survival by up to ten months in people with an aggressive form of breast cancer according to a study published in the New England Journal of Medicine.
In the groundbreaking phase III clinical trial (those which assess the effectiveness of an intervention) involving more than 900 people, the treatment was also found to reduce the risk of death or the cancer progressing by as much as 40 percent, researchers from Queen Mary University London (QMUL) and St. Bartholomew's Hospital found.
Triple-negative breast cancer (TNBC) is an aggressive form of the disease which often affects young women with many diagnosed in their 40s or 50s. Currently, the standard treatment is chemotherapy which many patients quickly develop a resistance to. If the cancer spreads around the body, or metastasizes, survival is often only 12 to 15 months.
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The new treatment combines standard weekly chemotherapy (nab-paclitaxel) sessions with a biweekly dose of atezolizumab—a drug which boosts the body's natural defenses to fight the cancer. The chemotherapy "roughs up" the surface of the cancer enabling the body's immune system to better recognize and fight the cancer.
To assess the efficacy of the treatment, the researchers randomly assigned patients with untreated metastatic TNBC to receive either atezolizumab plus nab-paclitaxel or a placebo plus nab-paclitaxel. Patients continued the intervention until the disease progressed or an unacceptable level of toxic events occurred.
The results showed that the median overall survival was 21.3 months with atezolizumab plus nab-paclitaxel and 17.6 months with placebo plus nab-paclitaxel.
"These results are a massive step forward," Peter Schmid, Professor of Cancer Medicine at QMUL's Barts Cancer Institute, said in a statement. "We are changing how triple-negative breast cancer is treated in proving for the first time that immune therapy has a substantial survival benefit. In a combined treatment approach, we are using chemotherapy to tear away the tumor's "immune-protective cloak" to expose it, enabling people's own immune system to get at it."
"Triple-negative breast cancer is an aggressive form of breast cancer; we have been desperately looking for better treatment options," he said. "It is particularly tragic that those affected are often young, with many themselves having young families. I'm thrilled that by using a combination of immunotherapy and chemotherapy we are able to significantly extend lives compared to the standard treatment of chemotherapy alone."
Lajos Pusztai, a breast cancer expert from the Yale Cancer Center Genetics and Genomics Program, who was not involved in the research, described the latest results as "very important."
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"At one year after randomization, 16 percent of patients were without progression of their cancer with chemotherapy alone compared to 29 percent with chemotherapy plus atezolizumab," he told Newsweek. "More importantly, in the chemotherapy arm 50 percent of the patients had died by month 15, whereas the combination treatment group reached this sad landmark only by month 25, hence the median survival improvement of 10 months.
"This is unprecedented in any previous metastatic triple-negative breast cancer trial," he said. "No other drug improved survival as first line, that is initial treatment, for metastatic TNBC. This also happens to be the first positive, large immunotherapy trial in breast cancer. I think this heralds the dawn of immunotherapy in breast cancer—we are late boomers in this field."
It is important to note that 103 patients experienced serious side effects from the combination therapy and six suffered fatal reactions to the trial regimen. But with regards to this, Pusztai said that the study did not reveal anything unexpected because this class of drugs have been used extensively in other cancers.
"At the end, more people were alive among those who got the [combination therapy] than those who got the placebo and chemo, so the overall effect is a net benefit and prolongation of life for the study population," he said. "The agents can cause very unpleasant autoimmune reactions and some of these can be fatal. However, metastatic TNBC is always fetal, hence we keep looking for better therapies."
"In this study the adverse events were very similar in the two arms," he said. "There seemed to be no worsening of chemotherapy related side effects, but immunotherapy adds a few additional immune related side effects. The most common was thyroid hormone abnormalities (these can be easily managed)—17 percent versus 4 percent in the chemo alone arm. Overall, a few more patients withdrew from the study due to toxicity in the combination therapy arm, 6.4 percent versus 1.4 percent."
The authors of the study hope that the treatment could become available in the near future for the treatment of triple-negative breast cancer.
This article has been updated to include additional comments from Lajos Pusztai.
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