Researchers involved in the Persephone phase 3 randomized clinical trial of 4089 women with HER2-positive early breast cancer found that 6 months of trastuzumab treatment was not inferior to the current standard.
The standard treatment for women with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer has long been 12 months of trastuzumab therapy. However, a recent clinical trial, results of which will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2018 Annual Meeting, sought to determine if a reduced treatment time of 6 months was as effective 12 months.
Researchers involved in the Persephone phase 3 randomized clinical trial of 4089 women with HER2-positive early breast cancer found that 6 months of trastuzumab treatment was not inferior to the current standard. Furthermore, the reduced treatment time was associated with fewer adverse events that are usually common with the treatment, such as headache, severe coughing, or heart problems, among other issues.
“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,” said lead study author, Helena Earl, MD, professor of clinical cancer medicine at the University of Cambridge, in a statement to the press.
Half of the women in the study were randomized to receive trastuzumab for 6 months, while the other half received the therapy for the standard period of 12 months. In addition, women also received anthracycline-based, taxane-based, or combination chemotherapy while participating in the trial.
Participants were followed for a median of 5 years. The disease-free survival rate at 4 years was 89.4% in the 6-month arm and 89.8% in the 12-month arm. Additionally, only 4% of women in the 6-month arm stopped therapy early due to cardiac problems, compared with 8% in the 12-month arm.
These results could provide women with HER2-positive breast cancer not only with the relief of fewer adverse events and shorter treatment time, but also less expensive treatment; 12-month trastuzumab costs approximately $55,000, based on Medicare estimates in 2017.
“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 American Society of Clinical Oncology’s (ASCOs) president, Bruce E. Johnson, MD, FASCO in a statement to the press.
The trial results will be presented at the ASCO’s meeting, held June 1 to 5, 2018, in Chicago, Illinois.
Reference
Earl H, Vallier AL, Dunn J, et al. Shorter trastuzumab treatment for HER2+ breast cancer can be as effective, with fewer cardiac side effects. Pesented at the American Society of Clinical Oncology’s 2018 Annual Meeting, June 1-5, 2018; Chicago, Illinois. Abstract 506. meetinglibrary.asco.org.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.