Nav: Home

Shorter trastuzumab treatment for HER2+ breast cancer can be as effective, with fewer cardiac side-effects

May 16, 2018

ASCO Perspective

"The use of trastuzumab has been a major advance for women with HER2-positive breast cancer by increasing the cure rate, but no treatment is free of side effects, and heart damage has always been a concern with this treatment. This new trial shows that a shorter length of treatment can benefit patients just as much as a longer treatment, with less risk of cardiac side effects. This is a win-win for patients with breast cancer who are receiving this common treatment," said ASCO President Bruce E. Johnson, MD, FASCO.

ALEXANDRIA, Va. - A phase III randomized clinical trial of 4,088 women with HER2-positive, early-stage breast cancer found that taking trastuzumab (Herceptin) for 6 months was non-inferior to the current standard of 12 months. The disease-free survival rate at four years was 89.4% with 6 months of therapy and 89.8% with 12 months of therapy. In addition, only 4% of women in the 6-month arm stopped trastuzumab early because of cardiac problems, compared with 8% in the 12-month arm.

"The Persephone trial's researchers worked closely with patient advocates. Everyone involved in this study is very excited by these results," said lead study author Helena Earl, MD, Professor of Clinical Cancer Medicine at the University of Cambridge in the United Kingdom. "We are confident that this will mark the first steps towards a reduction of the duration of trastuzumab treatment to 6 months in many women with HER2-positive breast cancer."

This is the largest trial to date examining the impact of shortening the duration of trastuzumab treatment, according to the authors. The results of the trial, Persephone, will be presented at the upcoming 2018 ASCO Annual Meeting in Chicago.

About the Study

Trastuzumab was granted FDA approval based on the results of three major trials reported in 2005. In these trials, the length of trastuzumab treatment was 12 months, and this treatment length quickly became the standard of care. Shortly thereafter, a small trial in Finland (FinHer) reported similar benefit from as little as 9 weeks of trastuzumab, prompting research interest in shortening treatment length to reduce side effects and costs.

In Persephone, half of the women took trastuzumab for 6 months and the other half for 12 months. Women also received chemotherapy (anthracycline-based, taxane-based, or a combination of both) while enrolled in the trial. The non-inferiority design allowed the trial to help determine whether reduced duration of treatment can be as good as the standard treatment within pre-specified limits, which are set before the trial starts.

Key Findings

The women in the trial were followed for a median of over five years. Researchers found that 89.4% of women in the 6-month arm and 89.8% in the12-month arm were alive and free of breast cancer at four years. The trial demonstrated that 6 months of trastuzumab treatment was non-inferior to 12 months.

Only 4% of women who received trastuzumab for 6 months stopped treatment early due to heart problems, compared to 8% of those who took trastuzumab for 12 months.

Next Steps

The researchers are currently analyzing their results to determine the impact of treatment length on quality of life, with qualitative feedback from trial participants. A detailed cost-effectiveness analysis is also underway.

Professor Earl stated that more research needs to be done to define the particular patients for whom treatment duration can be safely reduced. The researchers plan to analyze blood and tissue samples collected within the trial to look for biomarkers to identify different risk groups.
-end-
This study was funded by the National Institute for Health Research (NIHR) in the UK.

ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.

About ASCO:

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world's leading organization of its kind, ASCO represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at http://www.ASCO.org, explore patient education resources at http://www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube.

American Society of Clinical Oncology

Related Breast Cancer Articles:

Does MRI plus mammography improve detection of new breast cancer after breast conservation therapy?
A new article published by JAMA Oncology compares outcomes for combined mammography and MRI or ultrasonography screenings for new breast cancers in women who have previously undergone breast conservation surgery and radiotherapy for breast cancer initially diagnosed at 50 or younger.
Blood test offers improved breast cancer detection tool to reduce use of breast biopsy
A Clinical Breast Cancer study demonstrates Videssa Breast can inform better next steps after abnormal mammogram results and potentially reduce biopsies up to 67 percent.
Surgery to remove unaffected breast in early breast cancer increases
The proportion of women in the United States undergoing surgery for early-stage breast cancer who have preventive mastectomy to remove the unaffected breast increased significantly in recent years, particularly among younger women, and varied substantially across states.
Breast cancer patients with dense breast tissue more likely to develop contralateral disease
Breast cancer patients with dense breast tissue have almost a two-fold increased risk of developing disease in the contralateral breast, according to new research from The University of Texas MD Anderson Cancer.
Some early breast cancer patients benefit more from breast conservation than from mastectomy
Breast conserving therapy (BCT) is better than mastectomy for patients with some types of early breast cancer, according to results from the largest study to date, presented at ECC2017.
One-third of breast cancer patients not getting appropriate breast imaging follow-up exam
An annual mammogram is recommended after treatment for breast cancer, but nearly one-third of women diagnosed with breast cancer aren't receiving this follow-up exam, according to new findings presented at the 2016 Annual Clinical Congress of the American College of Surgeons.
Low breast density worsens prognosis in breast cancer
Even though dense breast tissue is a risk factor for breast cancer, very low mammographic breast density is associated with a worse prognosis in breast cancer patients.
Is breast conserving therapy or mastectomy better for early breast cancer?
Young women with early breast cancer face a difficult choice about whether to opt for a mastectomy or breast conserving therapy (BCT).
Breast density and outcomes of supplemental breast cancer screening
In a study appearing in the April 26 issue of JAMA, Elizabeth A.
Full dose radiotherapy to whole breast may not be needed in early breast cancer
Five years after breast-conserving surgery, radiotherapy focused around the tumor bed is as good at preventing recurrence as irradiating the whole breast, with fewer side effects, researchers from the UK have found in the large IMPORT LOW trial.

Related Breast Cancer Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Setbacks
Failure can feel lonely and final. But can we learn from failure, even reframe it, to feel more like a temporary setback? This hour, TED speakers on changing a crushing defeat into a stepping stone. Guests include entrepreneur Leticia Gasca, psychology professor Alison Ledgerwood, astronomer Phil Plait, former professional athlete Charly Haversat, and UPS training manager Jon Bowers.
Now Playing: Science for the People

#524 The Human Network
What does a network of humans look like and how does it work? How does information spread? How do decisions and opinions spread? What gets distorted as it moves through the network and why? This week we dig into the ins and outs of human networks with Matthew Jackson, Professor of Economics at Stanford University and author of the book "The Human Network: How Your Social Position Determines Your Power, Beliefs, and Behaviours".