While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.
While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns. In a new study in BMC Cancer, researchers reported findings from the Rollover Protocol Study that collected safety data on long-term trastuzumab therapy (5 or more years in patients with HER2-positive breast cancer and 3 or more years in patients with gastric cancer).
In total, 19 patients with breast cancer and 6 patients with gastric cancer who had stable disease received long-term trastuzumab therapy during the study. The patients previously treated with trastuzumab continued to receive the drug at a loading dose of 4 mg/kg followed by weekly 2-mg/kg maintenance doses beginning 3 weeks after the loading dose. Therapy continued until progression, lack of treatment benefit, toxicity, patient decision, or patient death.
All patients discontinued treatment by the study’s end, due to adverse events (AEs), insufficient response, a switch to commercially available trastuzumab or subcutaneous trastuzumab outside the study context, patient decision, investigator decision, or sponsor request. The median duration of treatment in the breast cancer group was 8 years and 7 months (range, 5 years and 4 months to 13 years and 11 months). In the gastric cancer group, the median duration of treatment was 5 years and 2 months (range, 3 years and 4 months to 7 years and 4 months).
While the risk of cardiac AEs is a concern with trastuzumab treatment, in the 20 patients who had left ventricular ejection fraction (LVEF) measurements available, the cardiac status of these patients remained stable over time; no marked changes in LVEF were observed.
Of the total group, 7 patients (28.0%) reported serious AEs (SAEs), none of which were considered related to trastuzumab treatment. Reported SAEs were pain, septic arthritis, erysipelas, lung cancer, fibula fracture, urinary tract infection, and a broken leg. There were no reports of cardiac SAEs, and there were no deaths during the study period.
The authors conclude that, in patients who received long-term treatment for their HER2-positive disease, trastuzumab had an acceptable safety profile and was well tolerated. “Stable LVEF outcomes and the absence of cardiac SAEs suggest that long-term [trastuzumab] therapy is feasible and without any additional cardiac safety risk, particularly with continued patient care and monitoring according to standard practice,” write the authors.
Reference
Müller V, Clemens M, Jassem J, et al. Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018;18:295. doi: 10.1186/s12885-018-4183-2.
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.