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For the first time, one of the new immunotherapy drugs has shown promise against breast cancer as part of a large study combining chemotherapy to treat an aggressive form of the disease. But the benefits for most women were low, raising the question of whether the treatment is worth its high cost and its side effects.
The results were discussed Saturday at a conference on cancer in Munich and published by the New England Journal of Medicine.
Drugs called checkpoint inhibitors have transformed the treatment of many types of cancer by removing a chemical brake that prevents the immune system from killing tumor cells.
The new Tecentriq plus chemo vs chemo alone Roche study was administered to 902 women with triple negative advanced breast cancer. About 15% of cases are of this type – their growth is not fed by estrogen hormones or progesterone, nor by the gene that targets Herceptin, which makes them difficult to treat.
The women in the study who received Tecentriq plus chemotherapy went on average two more months on average without their cancer worsening, compared with those of chemo alone – a modest benefit. The combo did not significantly improve survival at first before the end of long-term follow-up.
Previous studies have shown that immunotherapies work best in patients with high levels of drug-targeted protein. The breast cancer study plan advocated analyzing how women behaved according to this factor if Tecentriq improved overall survival.
The drug failed this test, but researchers have always looked at protein results and found encouraging signs. Women with high rates who received combination therapy lived for about 25 months on average versus about 15 months for women receiving chemotherapy alone.
That's a big difference, but it will take longer to see if there is a reliable way to predict the benefits, said Jennifer Litton of the MD Anderson Cancer Center in Houston. She did not play any role in conducting the study but recruited patients and supervised 14 others who are testing immunotherapies.
Another breast cancer specialist who played no role in the study, Michael Hassett of the Boston-based Dana-Farber Cancer Institute, said he felt "excited with caution" that immunotherapy may be proving useful for some breast cancer patients.
Side effects need to be examined closely, said the two doctors. Almost all study participants had typical chemotherapy-related side effects such as nausea or low blood cell counts, but serious effects were more common with combination therapy, and twice as many women stopped treatment for this reason.
Three of the six deaths due to the side effects of the choice group were attributed to the treatment itself; only one of three deaths of this type in the chemo group was.
Cost is another concern. Tecentriq costs $ 12,500 a month. The chemotherapy used in this study was Celgene abraxane, which costs about $ 3,000 per dose, plus doctor fees for intravenous treatment. Older chemotherapy drugs cost less, but require that patients use a steroid to prevent allergic reactions that may interfere with immunotherapy. Abraxane was chosen because it avoids the use of a steroid, said Sylvia Adams, head of the study, NYU Langone Health.
The study was sponsored by Roche and many research directors consult or work for the company or own shares in their possession.
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