Long-Term Follow-up Confirms Low Incidence of Cardiac Events Associated With Trastuzumab

“At a median follow-up of 8 years, patients receiving trastuzumab (Herceptin) sequentially after chemotherapy and radiotherapy in the Herceptin Adjuvant (HERA) trial had a low incidence of cardiac events and these were reversible in the vast majority of patients. This long-term assessment confirms and extends previous reports of cardiac safety.

“The three-arm HERA trial compared 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. ‘This is the first time that results of the 2-year trastuzumab arm have been reported, and the follow-up time has doubled,’ researchers reported in the Journal of Clinical Oncology.

“Eligible patients had a left-ventricular ejection fraction of at least 55% following neoadjuvant chemotherapy with or without radiotherapy and cardiac function was closely monitored. Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4% of the 1,673 patients receiving 2 years of trastuzumab and 5.2% of the 1,682 patients receiving 1 year of trastuzumab.”

Editor’s note: This story discusses the results of a study that investigated the effects of the drug trastuzumab (brand name Herceptin) on cardiac health. The study involved 5,102 patients with HER2-positive, early-stage breast cancer. All of the patients had been previously treated. Patients were given trastuzumab as an adjuvant therapy—a treatment given after the main treatment to keep cancer from returning. Researchers found a low incidence of adverse cardiac events for the patients. However, they say that each patient should still have a cardiac assessment before and while taking trastuzumab to ensure that any problems are detected early.


Continued Event-Free Survival Benefit of Neoadjuvant/Adjuvant Trastuzumab in HER2-Positive Locally Advanced Breast Cancer

The gist: A recent clinical trial found that the drug trastuzumab (Herceptin) improves survival and lowers the risk of recurrence for women with HER2-positive, locally advanced breast cancer. Patients in the trial received Herceptin as part of both neoadjuvant (before surgery) and adjuvant (after surgery) treatment. The researchers followed the patients for five years after treatment.

“As reported by Gianni et al in The Lancet Oncology, long-term follow-up of women with HER2-positive locally advanced breast cancer receiving neoadjuvant chemotherapy alone vs with neoadjuvant and adjuvant trastuzumab (Herceptin) in the phase III NOAH trial has shown continued event-free survival benefit of trastuzumab treatment and a strong association of event-free survival with pathologic complete response rate in trastuzumab recipients.

“In this open-label trial, 235 women with HER2-positive locally advanced or inflammatory breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (n = 118) or with 1 year of trastuzumab given concurrently with neoadjuvant chemotherapy and continued after surgery. (A parallel group with HER2-negative disease received neoadjuvant chemotherapy alone; outcomes in this group are not reported here.)”


FDA to Regulate Personalized Medicine

Now that medical treatment is increasingly tailored to patient subtypes (eg, lung cancer patients with mutations in the ALK gene can be treated with Xalkori), the U.S. Food and Drug Administration (FDA) has released a new report explaining how it will regulate personalized therapies and tests. The first targeted therapy used in the U.S. was trastuzumab, which is for HER2 breast cancer and was approved in 1998. Since then, the FDA has approved more than 100 treatments that target specific genetic abnormalities, including four drugs for cancer subtypes that are identified by companion test kits.


FDA to Regulate Personalized Medicine

Now that medical treatment is increasingly tailored to patient subtypes (eg, lung cancer patients with mutations in the ALK gene can be treated with Xalkori), the U.S. Food and Drug Administration (FDA) has released a new report explaining how it will regulate personalized therapies and tests. The first targeted therapy used in the U.S. was trastuzumab, which is for HER2 breast cancer and was approved in 1998. Since then, the FDA has approved more than 100 treatments that target specific genetic abnormalities, including four drugs for cancer subtypes that are identified by companion test kits.


FDA to Regulate Personalized Medicine

Now that medical treatment is increasingly tailored to patient subtypes (eg, lung cancer patients with mutations in the ALK gene can be treated with Xalkori), the U.S. Food and Drug Administration (FDA) has released a new report explaining how it will regulate personalized therapies and tests. The first targeted therapy used in the U.S. was trastuzumab, which is for HER2 breast cancer and was approved in 1998. Since then, the FDA has approved more than 100 treatments that target specific genetic abnormalities, including four drugs for cancer subtypes that are identified by companion test kits.