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Title: New Study Supports Early Use of Taxotere in the Treatment of Operable Breast Cancer

"New Study Supports Early Use of Taxotere in the Treatment of Operable Breast Cancer"

BRIDGEWATER, NJ -- November 17, 2003 -- Study results published today in the Journal of Clinical Oncology (JCO) may provide support for the early use of Taxotere® (docetaxel) Injection Concentrate in the treatment of breast cancer. The study, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), showed improved clinical and pathological complete response rates in patients with operable breast cancer who were given Taxotere in addition to a standard anthracycline-based regimen prior to surgery, compared with those patients who only received the pre-operative (neoadjuvant) anthracycline-based regimen. A clinical complete response is defined as the complete disappearance of all clinical signs of cancer and a pathological complete response indicates that no invasive cancer is present in the breast. "While we've known for some time that neoadjuvant chemotherapy is beneficial for patients with more advanced breast cancer, this study demonstrates that patients with less advanced or operable breast cancer may also benefit from this approach," said lead investigator Harry D. Bear, M.D., Ph.D., Professor and Chairman, Division of Surgical Oncology, Virginia Commonwealth University's Medical College of Virginia and the Massey Cancer Center. "The addition of Taxotere to the pre-operative regimen significantly improved response rates. Research shows that improvement in response rates are predictive of longer survival for patients, which is why we are so encouraged by these results." In the large, Phase III study (NSABP Protocol B-27) patients were randomized to receive either four cycles of doxorubicin and cyclophosphamide (AC) followed by surgery (Group I) or four cycles of AC followed by four cycles of Taxotere, followed by surgery (Group II) or four cycles of AC followed by surgery and then four cycles of Taxotere (Group III). Among the most compelling findings was a 91 percent increase in pathologic complete response rate among patients in Group II (AC followed by Taxotere), compared with those patients given just AC (26.1 percent vs. 13.7 percent). In addition to the statistically significant increase in pathologic complete response, patients in Group II (AC followed by T) also experienced a higher clinical complete response rate than patients given AC alone (63.6 percent vs. 40.1 percent) and a higher overall response rate or tumor shrinkage (90.7 percent vs. 85.5 percent). There was also an improvement in nodal status among patients given Taxotere as part of the neoadjuvant regimen compared with those given AC alone (58.2 percent pathologically node- negative vs. 50.8 percent). In the study, 10.3 percent of patients experienced a grade 4 toxicity while receiving AC, and 23.4 percent of patients experienced a grade 4 toxicity while receiving Taxotere. The most common grade 4 event experienced by patients during treatment with Taxotere was febrile neutropenia (21.2 percent). About Taxotere Taxotere, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere promotes their assembly and blocks their disassembly, thereby preventing cancer cells from dividing and resulting in cancer cell death. Taxotere is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. The most common severe side effects associated with Taxotere include low blood cell count, fatigue, fluid retention and mouth sores. The most common non-severe side effects included hair loss, neurosensory, cutaneous, nail changes, nausea and diarrhea. These side effects are generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is not appropriate therapy for patients with significant liver impairment or a low white blood cell count. Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere, visit http://www.taxotere.com or see full prescribing information including BOXED warnings. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com. SOURCE: Aventis

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