FORCE’s eXamining the Relevance of Articles for Young Survivors (XRAYS) program is a reliable resource for breast cancer research-related news and information. XRAYS reviews new breast cancer research, provides plain-language summaries, and rates how the media covered the topic. XRAYS is funded by the CDC.
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approval of the immunotherapy drug Tecentriq for treatment of some advanced triple-negative breast cancers.
On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval of atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for advanced triple-negative breast cancer. Tecentriq is the first drug known as an "immune checkpoint inhibitor" approved for breast cancer.
Atezolizumab (Tecentriq) is a type of immunotherapy and nab-paclitaxiel (Abraxane) is a type of chemotherapy. The FDA approved the combination of these two drugs as a first line treatment for locally advanced or metastatic triple-negative breast cancer.
Tecentriq is approved for people whose breast cancers express “programmed death-ligand 1” (PD-L1), a protein that may help cancers avoid detection by the immune system. At the same time, the FDA also approved a tumor test, a companion diagnostic test called VENTANA PD-L1 (SP142). This test looks for expression of PD-L1 in cancers and is used to predict which tumors will respond to Tecentriq.
In the clinical trial, patients who received Tecentriq and Abraxane had progression free survival of 7.5 months compared to 5.5 months among patients who received Abraxane without Tecentriq.
Among patients with PD-LI-positive tumors, the median progression free survival was 7.5 months and 5.0 months respectively. Patients who had PD-L1 positive tumors and who received Tecentriq and Abraxane survived about 10 months longer than patients who did not receive Tecentriq.
As with most cancer medicines, the combination of Tecentriq and Abraxane may cause side effects.
The most common side effects were:
35% of the breast cancer patients treated with Tecentriq and Abraxane had severe side effects compared to 30% who had only Abraxane. Severe side effects include inflammation of the lung and liver (13%).
If you’ve been diagnosed with locally advanced or metastatic triple-negative breast cancer, you may want to talk to your doctor about PD-L1 testing of your breast cancer and whether the Tecentriq plus Abraxane treatment combination is right for you.
It’s important to know that Tecentriq did not work for all patients with advanced breast cancer. On average, patients who received Tecentriq had 2 ½ months longer “progression-free survival” than patients who did not receive Tecentriq. On average, patients who received Tecentriq survived 10 months longer than patients who did not receive Tecentriq. Patients who received Tecentriq were more likely to have serious side effects.
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Triple-negative breast cancer (TNBC) accounts for approximately 15–20% of all breast cancers. TNBC is associated with earlier age of onset, aggressive clinical treatments, and a poorer prognosis compared to hormone receptor- and HER2-positive breast cancers. Given the lack of effective treatments for TNBC, researchers have focused on increasing the therapeutic options for TNBC patients.
The immune system has a key influences on the course of TNBC. Clinical trials have sought to better understand and define the role of immune checkpoint inhibitors as a treatment for TNBC. (Immune system checkpoint inhibitors are drugs that prevent malignant cells from evading the immune system). The culmination of these studies was the phase III IMpassion 130 trial. The iMpassion 130 trial showed an overall survival benefit in patients with advanced TNBC who were treated with the immune checkpoint inhibitor atezolizumab in combination with chemotherapy compared to chemotherapy alone.
This XRAYS review provides an update on research that we first covered in 2017.
Whether the combination of the PD-L1 inhibitor atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) compared to nab-paclitaxel alone increased progression-free survival in patients with locally advanced or metastatic TNBC. Progression-free survival is the period when a cancer doesn’t grow.
Patients with untreated metastatic TNBC who participated in the IMpassion130 trial were randomly assigned to receive atezolizumab plus nab-paclitaxel (451 patients) or placebo plus nab-paclitaxel (452 patients). Patients continued their treatment regimens until their disease progressed or an unacceptable level of side effects occurred. Median follow-up timewas 12.9 months.
The two primary trial goals were to determine progression-free survival (the time before tumors grew) in the population treated with atezolizumab and PD-L1-positive subgroup, and overall survival (the time before death) in the population treated with atezolizumab. If the findings related to overall survival were significant, they would then look at the impact of this treatment on the overall survival in the PD-L1-positive subgroup.
Patients who received the combination therapy showed a clinically meaningful median PFS of 7.2 months compared to 5.5 months with chemotherapy alone. One-year progression-free survival rates were 29% and 16% respectively. Among patients with PD-LI-positive tumors, median progression-free survival was 7.5 months and 5.0 months respectively.
Median overall survival was 21.3 months with combination therapy and 17.6 months with nab-paclitaxel alone. A positive overall survival outcome was achieved only in PD-L1-positve TNBC patients. In these patients, median overall survival was 25.0 months compared to 15.5 months for patients with PD-L1-negative tumors.
Almost 16% of patients who received the combination therapy had to stop treatment due to adverse effects, compared to 8.2% of those receiving nab-paclitaxel alone.
The results of IMpassion130 offer hope for immunotherapy as effective treatment of metastatic TNBC. However, researchers raised a number of questions including which tumors should be tested for PD-L1 expression, whether nab-paclitaxel is the best chemotherapy to be used with atezolizumab, and whether atezolizumab alone may be best for some patients.
Treatment with atezolizumab plus nab-paclitaxel increased progression-free survival in patients with metastatic TNBC whose tumors were PD-L1-positive.
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FORCE Information: Immune checkpoint inhibitors
FORCE Information: Metastatic breast cancer portal
FORCE Information: Tumor testing
FORCE Information: Companion diagnostic testing
FORCE Research Study Search Tool: Stage 4 breast cancer studies
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