GEMZAR? (gemcitabine HCl for injection), approved in combination with paclitaxel (Taxol?) in the first-line, post-surgical treatment of metastatic breast cancer, was the subject of a study presented with encouraging results in the pre-surgical treatment of breast cancer.
The study was presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
Results showed that adding GEMZAR to the current standard-of-care treatment was a promising regimen for patients with stage II-III breast cancer. Eli Lilly and Company, the manufacturer and marketer of GEMZAR, also cited five completed or ongoing Phase III trials which will further study GEMZAR as a chemotherapeutic foundation for the treatment of early-stage breast cancer.
Today?s Phase II study evaluated the addition of GEMZAR to the current standard-of-care of epirubicin and cyclophosphamide followed by 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 trastuzumab (Herceptin?) and demonstrated additional response.
?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, M.D., medical director, global oncology at Lilly. ?We are encouraged with the activity GEMZAR has shown in this breast cancer study.?
Enrollment has been completed in one trial, and is ongoing in an additional four, Phase III early-stage breast cancer studies evaluating the addition of GEMZAR to commonly-used treatment regimens. Two adjuvant (post-surgical) therapy trials, NSABP B-38 (4,400 patients) and TANGO (3,000 patients), will compare the addition of GEMZAR to the paclitaxel arm of each study. A third adjuvant trial, SUCCESS (3,600 patients), will compare the addition of GEMZAR to a docetaxel-based regimen. Two additional trials, which are neoadjuvant specific, NSABP B-40 (1,200 patients) and Neo-TANGO (800 patients), will evaluate the addition of GEMZAR to the paclitaxel or docetaxel arm of the treatment regimen.