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Study: Immunotherapy may lead to long-term remission of metastatic breast cancer

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Contents

At a glance Media coverage
Findings     In-depth               
Clinical trials Limitation
Questions for your doctor             Resources                              

 

STUDY AT A GLANCE

This study is about:

Adoptive cell therapy (ACT), a new treatment for breast cancer that resulted in complete tumor regression in 1 patient.

Why is this study important?

breast cancer is breast cancer that has spread beyond the breast and to other places in the body. 

breast cancer can be difficult to treat when cancer cells have spread to many parts of the body. treatment like the one in this study boost the patient’s own immune system to better fight cancer.

This study is important because it is an example of a new, personalized treatment approach that resulted in complete shrinking of one woman's breast cancer—an unusual occurrence.

Study findings: 

This research is a case study of one woman with breast cancer that responsed very well to this treatment.

Before treatment, the 49-year old patient had advanced ER-positive, HER2-negatve breast cancer, with tumors in her breast, chest wall and . Several standard treatments, including different chemotherapies, were unsuccessful in treating her cancer.

In an ongoing clinical trial, the woman was given an experimental treatment called "adoptive cell therapy" (ACT).  Researchers used the patient's own immune cells—specifically ones that could recognize and attack her tumor cells. These immune cells (called tumor-infiltrating lymphocytes, or TILs) were grown in the lab; and then injected back into the patient.

The result was surprisingly effective. At 22 months after treatment, none of the tumors that were present before treatment were detected.

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Update

Read an update from the patient Judy Perkins, whose 4 cancer is still in remission as of March 2019 after treatment with T-cell therapy. 

What does this mean for me?

If you have breast cancer, you will likely first receive a standard of care treatment. The study in this review is very early research. The safety and effectiveness of this treatment for a larger number of patients is not yet known. While this woman responded well and is now living with no evidence of disease (NED), researchers do not know whether her response will be typical, if it will vary between patients, if it was a fluke, or if unintended side effects might occur. It may be some time before we understand who will respond best to this treatment.

This woman was part of an ongoing clinical trial to test this treatment. This trial is enrolling participants who have  breast, ovarian, endometrial or other types of cancer. Patients in this study must have a tumor that can be safely removed. Patients must have tumors that are resistant to standard treatment. If this fits your situation, you may want to consider participating in this trial or in a related study. More information on eligibility for this trial can be found here, or for other trials for breast cancer at the following link. You can search for open trials with our clinical trial research tool or through ClinicalTrials.gov.

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References

Zacharakis N, Chinnasamy H, Black M, et al. "Immune recognition of leading to complete durable regression in breast cancer." Nature Medicine. 2018;24:724-730.

Mariotto AB, Etzioni R, Hurlbert M, et al. "Estimation of the Number of Women Living with Breast Cancer in the United States." Cancer, Epidemiology, Biomarkers and Prevention. 2017;26(6):809-815. DOI:10.1158/1055-9965.EPI-16-0889

National Cancer Institute: "Study estimates number of U.S. women living with breast cancer." Posted May 18, 2017.
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People with advanced cancers

This article is also relevant for:

Men with breast cancer

Triple negative breast cancer

ER/PR +

Her2+ breast cancer

People with a genetic mutation linked to cancer risk

Women under 45

Women over 45

Metastatic cancer

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IN-DEPTH REVIEW OF RESEARCH

Study background:

breast cancer is defined as breast cancer that has spread and formed tumors at distant places in the body. It may be a woman’s initial diagnosis (at 4) or develop as a recurrence after a 1, 2 or 3 breast cancer metastasizes.

Data from a 2017 study (Mariotto, et al.) indicated that over 170,000 women in the U.S. are living with breast cancer (and there are also several hundred men with breast cancer). Five-year survival rates for breast cancer patients have increased. For ages 18-49, that rate rose from 18% between 1992-1994 to 36% between 2005-2012. During the same time, average survival for women ages 15-49 whose first diagnosis was breast cancer increased from 22.3 months to 38.7 months. Average survival time for women ages 50-64 whose first diagnosis was breast cancer increased from 19.1 months to 29.7 months.  

Despite longer life spans after diagnosis, many deaths due to breast cancer still occur annually. Based on Mariotto’s study, only about 17% of women with living with breast cancer have survived more than 10 years. breast cancer can be difficult to treat because cancer cells spread to many parts of the body and often resist standard treatment. Finding new approaches or treatments to slow, halt or reverse cancer growth continues to be an active area of research.

One promising technique for treating cancer is adoptive cell therapy (ACT), also known as adoptive transfer. Researchers extract a patient’s own tumor-infiltrating lymphocytes (TILs); these are unique immune cells that can recognize and attack her tumor cells. These TILs are then grown to vastly larger numbers in the lab and then they are reintroduced into the patient. 

Adoptive cell transfer has been used successfully with melanoma and colorectal cancer. Approximately 50% of patients with melanoma who were treated with ACT have shown complete remission. Some types of ACT involve genetically modifying immune cells to boost their effectiveness against cancer cells. In this study, however, the patient’s cells were selected and allowed to multiple in the lab, but they were not genetically modified.

This study is very important because it is the first successful application of T-cell for breast cancer. It holds hope of a new treatment approach that resulted in complete remission of one woman's breast cancer. Such a complete positive result is highly unusual.

Researchers of this study wanted to know: If treatment with a patient's own immune cells would lead to tumor remission.

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Population(s) looked at in the study:

This research is a case study of a 49-year-old woman with advanced breast cancer and an exceptionally effective treatment. Originally diagnosed at age 39 with in her left breast, she then had a modified radical mastectomy. She was in remission for 10 years before being diagnosed again with ER+, HER2- breast cancer with tumors in multiple locations, including several , her right breast and left chest wall. She then had several types of chemotherapy and endocrine therapies to treat her cancer that did not halt growth of her tumors.

Study findings:  

This study approach is based on —stimulating the body's own defense system to attack tumor cells. This happens naturally to some extent, but as cancer grows, a person’s immune system becomes overwhelmed and is less able to respond.

In this study, researchers collected two types of cells from the patient: tumor cells from a in the right breast and immune cells from the patient's blood. First, they identified unique proteins on the surface of the tumor cells. (These are different from the proteins of normal cells.) Because not all immune cells are alike, they then looked at the patient’s immune cells to identify the ones that could specifically target the tumor proteins. These selected tumor infiltrating lymphocytes, or TILs, were grown in large numbers in the lab and injected back into the patient, greatly strengthening her own body’s defense against her cancer.

The result was surprisingly effective: 6 weeks after treatment her tumors were reduced in size by 51%, and by 22 months after treatment, the masses in the woman's chest wall, right breast and were undetectable.

Limitations:

The largest limitation of this study is number of participants—it is a case study of just one patient. Melanoma treated by ACT is effective for 50% of patients treated; however, it is unclear what proportion of breast cancer patients would respond to this therapy. While this woman responded well and is living without detectable cancer, researchers cannot be sure if her response will be typical, whether it will vary, or if it is a fluke. This is part of an ongoing clinical trial and data from additional participants may be available in the near future.

Whether or not ACT is safe and effective is still unknown. Patients with other cancers who have been treated with ACT have experienced side effects. This patient experienced low blood phosphate levels, a high fever (associated with immune cell depletion), and other treatable major side effects during ACT. But the ACT did not appear to adversely affect her normal tissue. It is too early to know if other unintended side effects would occur when more patients are treated using this technique.

Another limitation of this study is that as part of the procedure, the patient was also treated briefly with the agent pembrolizumab once before ACT and three times after ACT. Pembrolizumab is considered a checkpoint block that can halt cancer cell growth to allow the immune system to attack the cancer more effectively. It is possible that the positive effects observed are due to this drug rather than the ACT treatment. However, historically, pembrolizumab does not have a significant effect on ER+ tumors like those in this patient. Furthermore, when researchers examined the tumor cells of this particular patient, the protein recognized by pembrolizumab was not present. Therefore, it seems unlikely that this drug accounts for the remission observed (although it may aid ACT effectiveness). Further ACT testing without this drug is needed to clarify this issue.

The patient treated is a younger woman (age 49) who does not have a hereditary mutation in a breast cancer predisposition gene. Whether or not her result will apply to women with hereditary mutations is unclear.

Conclusions:

This is an exciting and promising new technique. Much more data is needed to determine its safety and effectiveness and its potential limitations or side effects.

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Posted 8/16/18

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) brings together national expert panels that create guidelines for cancer treatment. NCCN guidelines for treatment of advanced or ER-positive breast cancer include the following:

  • Genetic testing:
    • All people diagnosed with breast cancer meet guidelines for genetic counseling and testing. 

NCCN lists the following as preferred treatments for ER-positive and breast cancer:

  • for people with or mutations:
    • NCCN lists Olaparib (Lynparza) or () for people with an inherited or mutation. 
  • First line therapy
    • NCCN lists as preferred treatment combination of hormonal therapy (aromatase inhibitor or Fulvestrant) + with a CDK4/6 inhibitor:
      •  abemaciclib (Verzenio), palbocicib (Ibrance) or ribociclib (Kisqali). 
  • For second, third or later lines of therapy, NCCN  lists the following targeted therapies or combinations as preferred treatments:
    • a combinational of hormonal therapy (aromatase inhibitor or Fulvestrant) + with a CDK4/6 inhibitor for people who have not previously received a CDK4/6 inhibitor.
    • trastuzumab deruxtecan (Enhertu) for people whose tumors are HER2-low ( 1+ or 2+) who received chemotherapy in the setting and whose cancer no longer responds to hormonal therapy. 
    • for cancers that test positive for a PIK3CA-mutation, apelisib (Piqray).
    • a combination of everolimus (Affinitor) and hormonal therapy.
    • hormonal therapy alone.
    • sacituzumab govitecan-hziy (trodelvy) for  after at least two prior therapies, with at least one line for  disease. or for HR-positive, cancers after prior treatment including hormone therapy, a CDK4/6 inhibitor and at least two lines of chemotherapy (including a taxane).

Updated: 01/04/2023

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • What is the best treatment approach for my type of cancer?
  • Am I eligible for the clinical trial covered in this review?
  • Am I eligible for any other clinical trials?
  • should I have my tumor tested for biomarkers?
  • What are the risks and potential benefits of participating in a clinical trial?

 

Open Clinical Trials
Open Clinical Trials

The following are studies looking at treatment for people with ER-positive breast cancer.  

A number of other clinical trials for people with breast cancer can be found here.

Updated: 01/04/2023

Peer Support
Peer Support

The following organizations offer peer support services for people with, or at high risk for breast cancer:

Updated: 11/29/2022

Who covered this study?

U.S. News & World Report

Breakthrough therapy seems to rid woman of advanced breast cancer This article rates 4.5 out of 5 stars

PBS

New Breast Cancer Therapy is a "Win for Society" This article rates 3.5 out of 5 stars

Fox News

Florida woman beats terminal breast cancer with new therapy This article rates 3.5 out of 5 stars

How we rated the media

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