The study evaluated the addition of Gemzar to the current standard-of-care of epirubicin and cyclophosphamide followed by Taxol (paclitaxel) in patients with stage II-III breast cancer. The treatment schedule was a dose-dense sequential neoadjuvant (pre-surgical) chemotherapy combination, meaning that the combination was administered at shorter intervals between treatments.
Results showed a promising regimen in terms of pathologic complete response (pCR-the absence of invasive tumor in the breast). In addition, patients who tested positive for the HER-2 gene also were given Genentech’s Herceptin (trastuzumab) and demonstrated additional response.
Patients received a first sequence of epirubicin and cyclophosphamide (90/600 mg/m squared) for three cycles followed by a second sequence of paclitaxel and Gemzar (150/2500 mg/m squared) for six cycles. Treatment was administered on day one, every two weeks, with growth factor support. HER-2 positive patients (20 patients, 27.3%), were given trastuzumab (2mg/kg with a loading dose 4 mg/kg) concomitantly. Afterward, the patients underwent surgery, radiotherapy and adjuvant hormonal therapy according to institutional practice.
All patients from the study showed response to the regimen. Of the entire study group, 36.9% achieved a pCR (absence of invasive tumor in the breast), with 50% representation from the HER-2 positive patients who also were given trastuzumab.
“The data released today reflects our ongoing, aggressive research plan involving Gemzar as a key therapeutic foundation for the treatment of breast cancer,” said Allen Melemed, medical director of global oncology at Lilly. “We are encouraged with the activity Gemzar has shown in this breast cancer study.”