New Treatment for Advanced Endometrial Cancer
- The Food and Drug Administration (FDA) has approved a new combination therapy for a specific type of advanced or recurrent endometrial cancer, providing hope for disease that had previously not had many good treatment options.
- The approval was based on new research, which shows durvalumab (brand name Imfinzi) given with chemotherapy, followed by durvalumab given as a maintenance therapy, could significantly improve progression-free survival for women with advanced or recurrent endometrial cancer who had a genetic marker known as mismatch repair deficiency.
- Durvalumab is an immunotherapy drug that powers up the body’s immune system so it can better identify and attack cancer cells.
- Among patients with mismatch repair deficient tumors, durvalumab doubled progression-free survival, or the amount of time that a patient’s cancer does not get any worse. At this time, the drug combination is only approved for patients with mismatch repair deficient tumors.
New research shows that durvalumab given with chemotherapy, followed by durvalumab given as a maintenance therapy, significantly improved progression-free survival for women with advanced endometrial cancer who had mismatch repair deficient tumors, which refers to a situation where cancer cells have mutations in genes that are involved in correcting mistakes made when DNA is copied.
Read MoreAdvanced endometrial cancer is a disease that previously had very few effective treatment options.
“For a long time, patients with early-stage endometrial cancer generally did very well with a combination of surgery, maybe some radiotherapy,” says Dr. Shannon Westin, a professor in the Department of Gynecologic Oncology and Reproductive Medicine at the University of Texas, MD Anderson Cancer Center in Houston. Dr. Westin is also an investigator on the DUO-E trial.
“However, there’s a population of patients that are diagnosed at a later stage, stage three or four, or that have their cancer come back after initial therapy. And those patients have had a really hard time,” she added.
What Did the Data Show?
In the trial, patients received either durvalumab or placebo with a standard-of-care chemotherapy regimen of carboplatin and paclitaxel, which was given every three weeks for at least six treatments. Then, following chemotherapy, patients received either durvalumab again or a placebo until their cancer was seen to be growing on surveillance imaging.
The trial investigators were most interested in a cancer outcome known as progression-free survival (PFS), or the amount of time from trial enrollment until patients’ cancer worsened.
PFS was significantly longer among the patients who received durvalumab with standard-of-care chemotherapy compared to those receiving placebo with chemotherapy, meaning that durvalumab was successful at improving outcomes.
However, the trial investigators observed that most of this benefit seen in the overall trial population was because of the effect of durvalumab on patients with mismatch repair deficient tumors, whereas patients with mismatch repair proficient tumors seemed to benefit less. Because of this, the FDA approved durvalumab only for patients with mismatch repair deficient tumors at this time.
How Effective Was the Treatment Approach?
The mismatch repair system is responsible for correcting errors in DNA that occur during cell replication. Mismatch repair deficient tumors tend to accumulate high numbers of DNA errors, which makes them more recognizable to the immune system. Previous research, in both endometrial cancer as well as in other cancer types, has shown that immunotherapy is especially effective against mismatch repair deficient tumors.
Among patients with mismatch repair deficient tumors, durvalumab doubled PFS. This is a major advance in a disease where outcomes have historically remained quite poor.
“The combination of durvalumab and chemotherapy… could redefine the standard care for advanced endometrial cancer, providing new hope for patients who previously had limited options,” Dr. Westin explains.
The trial also evaluated the addition of olaparib (brand name Lynparza), a PARP inhibitor, to the maintenance phase of treatment (i.e. after completing durvalumab with chemotherapy). Olaparib has not been approved in that setting yet, and these results will be evaluated further in future reports of the DUO-E trial with a longer follow-up time.
What are the Side Effects?
Like all cancer treatments, these therapies can also have side effects. The decision to use these treatments involves weighing the potential benefits against the risks and side effects, tailored to each patient’s situation and health condition.
Durvalumab can cause inflammation in various parts of the body, which can lead to:
- Skin rashes
- Diarrhea
- Liver inflammation
Other common side effects seen among patients who received durvalumab with chemotherapy in the DUO-E trial included:
- Peripheral neuropathy
- Musculoskeletal pain
- Nausea
- Alopecia (i.e. hair loss)
- Fatigue
- Abdominal pain
- Constipation
- Rash
- Diarrhea
- Vomiting
- Cough
To manage these side effects, your doctor will closely monitor you and may adjust your treatment plan or prescribe medications to manage specific side effects.
One other thing to keep in mind about this combination treatment: it may add to your cost of care. Be sure to discuss treatment expenses with your care team. They can help you understand your insurance coverage, out-of-pocket costs, and potential financial assistance programs.
How is This Approach Changing Treatment?
Immunotherapy is reshaping cancer care by offering improved outcomes in clinical situations where traditional treatments have fallen short. These therapies focus not just on attacking cancer broadly, but on finding and attacking the cancer’s specific weaknesses. Immunotherapies like durvalumab train the immune system to spot and destroy cancer cells more efficiently.
Dr. Westin emphasizes the significance of this shift. “We’re not just treating cancer, we’re outsmarting it by targeting its vulnerabilities. This approach marks a significant departure from one-size-fits-all treatments, offering a beacon of hope for those with advanced stages of endometrial cancer,” she says.
Watch: Nobel Prize Winner, Dr. Jim Allison discusses breakthrough cancer treatment, immunotherapy
Questions to Ask Your Doctor
- Is this new treatment a good choice for me?
- What improvements can I expect, and how will we track progress?
- What side effects can I expect, and how can we deal with them?
- How will these treatments affect my daily routine and well-being?
- What is the cost, and is financial assistance available?
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