Results from the DECT trial indicate that a combination of epirubicin and trastuzumab improved outcomes in patients with HER2-positive breast cancer. The DECT trial is a phase II clinical trial of patients with locally advanced or operable HER-2 breast cancer treated with taxanes and concurrent anthracyclines and trastuzumab.1
Trastuzumab is a monoclonal antibody that inhibits HER2, . and It it is primarily used in the treatment of HER2-positive breast cancer. HER2 is the Human Epidermal Growth Factor Receptor 2. Its HER2 overexpression occurs in about approximately 15-% to 30% of all cases of breast cancer.
“The use of trastuzumab, a monoclonal antibody targeting the HER2 receptor, has dramatically improved the prognosis of the subgroup of breast cancer patients whose tumors overexpress this specific receptor,” explained Antonio Giordano, MD, PhD, director of the Sbarro Institute for Cancer Research at Temple University, Philadelphia, Pennsylvania.
“One of the greatest challenges in these patients has been combining trastuzumab with extremely effective drugs such as anthracyclines at the cost of an acceptable toxicity. Initial evidence seemed to discourage this approach due to the high-rate of cardiotoxicity.”
Eligible patients were age 18 to 75 years with ECOG ≤1 or lower, normal organ functions, and stage IIA to IIIB disease. Patients received 4 cycles of neoadjuvant docetaxel at 100 mg/m2 intravenously, plus trastuzumab at 6 mg/kg every 3 weeks. This was followed by 4 four 3-weekly cycles of epirubicin at 120 mg/m2 and cyclophosphamide and 600 mg/m2, plus trastuzumab.
This study enrolled 45 patients, with all but 6 (13%) completing chemotherapy. All patients underwent surgery.
Pathologic complete recovery occurred in 28 patients (62.2%) overall and in 6 (66.7%) from an inflammatory subgroup.
Patients with a Body body Mass mass Index index (BMI) ≥25 or higher and hormone responsive disease experienced 100% pathologic complete recovery. Median follow-up was 48 months, and 4-year recurrence-free survival was 74.7% [(95% CI, 58.2-91.2]. ). Over More than 15% of patients (n = 7) recurred, and 1 patient died.
Limiting toxicity was neutropenia, and treatment was well tolerated. No clinical cardiotoxicity was observed. Results on BMI merit further study and analysis.
The results indicated that the use of the anthracycline epirubicin reduced cardiotoxicity over other, more cardiotoxic antracyclines.
“Although current guidelines discourage from the concurrent use of trastuzumab and anthracyclines in HER2-positive breast cancer, we challenged once more the available evidence by administering a less cardiotoxic anthracycline,” concluded Giordano.
“The results obtained were remarkable in terms of efficacy and absolutely encouraging in terms of toxicity.”
1. Pizzuti L, Barba M, Giannarelli D, et al. Neoadjuvant sequential docetaxel followed by high-dose epirubicin in combination with cyclophosphamide administered concurrently with trastuzumab: The the DECT trial. [Published published online May 17, 2016]. J Cell Physiol. doi:10.1002/jcp.25432.