To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: BREAST CANCER: Chemotherapy More Effective When Combined With Taxotere URL: http://www.pslgroup.com/dg/14F97E.htm Doctor's Guide December 10, 1999
SAN ANTONIO, TX - December 10, 1999-- Patients with locally advanced breast cancer or large primary tumors benefit more when the chemotherapeutic agent Taxotere(R) (docetaxel) is added to their conventional chemotherapy regimen before surgery than when they are treated with conventional chemotherapy alone, according to data from a Phase III trial reported by researchers here at the 22nd Annual San Antonio Breast Cancer Symposium. Chemotherapy administered before surgery is known as neoadjuvant therapy. A complete clinical response is defined as a complete disappearance of clinical signs of the tumor, while a partial response refers to a 50-percent or greater decrease in tumor size. "Patients with locally advanced breast cancer have a poor prognosis and there is clearly a need to improve the responses obtained after chemotherapy in these patients, as responses often reflect long-term survival," said Professor Oleg Eremin on behalf of Grampian University Hospitals NHS Trust, Aberdeen, Scotland. "Likewise, patients with large primary breast cancers have a grim outlook, since the larger the tumor, the more likely it is that it has spread to the lymph nodes and even to other parts of the body." The trial has enrolled 163 patients, of whom 150 have completed the treatment. The patients were 18 years of age or older, with large primary breast cancers or locally advanced breast cancer who were previously untreated. Large primary breast cancer was defined as tumors that were greater than 3 cm in size, and locally advanced cancers referred to stages T3, T4, and N2, types of classification used to stage breast cancer according to the size of the primary tumor (T) and the involvement of the lymph nodes (glands in armpit) draining the affected breast (N). Locally advanced breast cancer is defined as those tumors greater than 5 cm in diameter and tumor fixation to the chest wall or overlying skin with lymph node involvement. Those who had undergone prior treatment with chemotherapy or radiation therapy and women with apparent metastatic (disseminated) disease were not eligible for enrollment. All women received four cycles of cyclophosphamide, 1000 mg/m(2), doxorubicin, 50 mg/m(2), vincristine, 1.5 mg/m(2), and prednisone, 40 mg for 5 days, a regimen referred to as CVAP. Each cycle was repeated every three weeks. Patients who demonstrated a partial or complete response were then randomized to receive four additional cycles of the regimen or four cycles of docetaxel, 100 mg/m(2), administered as a one-hour infusion, at three-week intervals. Patients who were found to have stable or progressive disease received docetaxel treatment. At four to six weeks after the completion of chemotherapy, patients underwent surgery -- either breast-conserving surgery or mastectomy. Patients having breast conservation surgery also underwent radiotherapy. All patients in the study were treated with the hormonal agent tamoxifen postoperatively for five years, provided the agent was well-tolerated and there was no evidence of disease progression. To date, 150 patients have completed eight cycles of primary chemotherapy. In the 101 patients who were suitable for randomization after four cycles of standard therapy, 49 patients received docetaxel with an overall, significantly increased clinical response rate from 66 to 94 percent. Fifty-two women continued on standard therapy alone, but had no alteration in overall response rate (67 percent). A third group of 49 patients, who did not respond to the first four cycles of CVAP, were treated with docetaxel alone. In these 49 nonrandomized non-responders, the subsequent response rate was 47 percent. "Because there is presently no consensus on the standard chemotherapy for patients with either locally advanced breast cancer or large primary tumors, it is extremely important to define the role of new agents, such as docetaxel, that have shown high activity in previously untreated and pretreated patients with metastatic breast cancer," said Professor Eremin. "Our results suggest that docetaxel should be strongly considered in the management of patients receiving neoadjuvant chemotherapy for breast cancers." Quality of life (QOL) was evaluated through the use of standardized tests that measured factors such as mood, daily life functioning and side effects. Patients were assessed before each cycle of chemotherapy and after the end of each treatment cycle. "Quality of life scores of patients randomized to either CVAP or docetaxel showed that, even with the improved responses rates, quality of life was not compromised among the docetaxel-treated patients," said Professor Leslie G. Walker, of the University of Hull, England, who was responsible for evaluating quality of life data. "An added benefit was that women receiving docetaxel experienced significantly less nausea," he added. Patients treated with eight cycles of CVAP experienced a higher incidence of significant reduction (grades 3, 4) in blood cell counts than those treated with CVAP plus docetaxel. Other side effects, however, such as nail changes, diarrhea and indigestion, occurred more frequently among patients treated with docetaxel. Breast cancer is an abnormal cell growth originating in breast tissue. If not diagnosed and treated early, these cells can invade surrounding tissue and spread through the blood and lymph node system. Common sites of breast cancer metastases include the bone, lungs, liver, brain, and lymph nodes. The incidence of breast cancer has been increasing steadily since the 1930s. It is the most common malignancy affecting women, accounting for 20 percent of all female cancers in industrialized countries, and over 780,000 new cases are reported each year worldwide. 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