A brief discussing the data from the NOAH trial in which Herceptin was added to chemotherapy before surgery for HER2-positive locally advanced breast cancer.
Adding Herceptin (trastuzumab) to chemotherapy before surgery prolongs survival without recurrence in HER2-positive locally advanced breast cancer, according to data from the phase III NOAH trial.
Locally advanced breast cancer, defined as cancer that has spread beyond the breast into the skin, muscle, and lymph nodes, accounts for six to 10 percent of all new cases of breast cancer and carries a high risk of recurrence. Inflammatory breast cancer is a particularly aggressive type of locally advanced breast cancer. In order to improve outcomes for these patients, treatment before surgery is the standard of care.
Of the 327 patients enrolled in the study, 228 tested positive for HER2 and were randomly assigned to receive anthracycline- and taxane-based chemotherapy with or without Herceptin before surgery. Patients continued taking Herceptin up to one year. After median follow-up of three years, 70.1 percent of patients in the Herceptin arm were free of disease compared with 53.3 percent of women in the chemotherapy-alone arm, translating to a reduction in the relative risk of recurrence by almost half.
In addition, the tumor was completely eradicated in nearly twice as many patients in the Herceptin arm compared with the chemotherapy-alone arm—43 percent compared with 23 percent, respectively. Nineteen patients crossed over to the Herceptin arm after the data showed a clear benefit.
The 99 patients who tested negative for HER2 received the chemotherapy-alone regimen. Although not a major focus of the study, data showed 67.4 percent of HER2-negative patients were free of disease at follow-up, and 17 percent had complete eradication of the tumor.
The Herceptin regimen was well-tolerated and fewer than 2 percent of patients experienced grade 2 or 3 cardiotoxicity, a side effect associated with Herceptin.
According to the trial’s investigators, these data suggest pre-operative Herceptin plus chemotherapy should become the standard of care for women with HER2-positive locally advanced breast cancer.
Read more of CURE's coverage of the 31st annual San Antonio Breast Cancer Symposium at http://media.curetoday.com/htmlemail/sabcs.