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Gemcitabine (Gemzar) has emerged from its initial clinical evaluation in patients with metastatic breast cancer as an effective antitumor agent. Its usual schedule of administration is weekly, and it is a very well-tolerated regimen. In combination with anthracyclines, the activity matches that of other commonly used multidrug regimens, including CMF (cyclophosphamide [Cytoxan, Neosar]/methotrexate/fluorouracil) or FAC (fluorouracil/doxorubicin [Adriamycin]/cyclophosphamide). When the taxanes became the most effective agents against breast cancer, two-drug and three-drug combinations with gemcitabine were initiated. This development was stimulated by the need to discover effective, non–cross-resistant regimens for patients previously exposed to anthracyclines and classical alkylating agents.

A phase I trial demonstrated that monthly docetaxel (Taxotere) and weekly gemcitabine (Gemzar) had both acceptable toxicity and encouraging antineoplastic activity in patients with previously treated advanced breast cancer. This phase II trial will determine the efficacy and toxicity of this regimen in advanced breast cancer patients who have measurable disease refractory to, or relapsed after, first-line or adjuvant chemotherapy.

Epirubicin (Ellence) is currently being studied in combination with the taxanes, such as docetaxel (Taxotere), in patients with advanced breast cancer. As a single agent, docetaxel has proven to be a very active drug in breast cancer, so the results of these combination trials are awaited with interest. Our experience has shown epirubicin/docetaxel to be a feasible and active combination in breast cancer.

The most efficacious primary chemotherapy regimens used to treat breast cancer contain anthracyclines. Unfortunately, a significant proportion of breast cancers fail to respond to such therapy. Therefore the aims of this study were (1) to determine the efficacy of primary docetaxel (Taxotere) in patients that initially fail to respond to anthracycline-based primary chemotherapy, and (2) to compare the efficacy of docetaxel with anthracycline-based primary chemotherapy in patients that are initially responsive to such therapy.

The degree of pathologic response of tumor to primary chemotherapy is of considerable prognostic importance in patients with breast cancer. The addition of docetaxel (Taxotere) to an anthracycline-based primary chemotherapy regimen has been shown to result in significantly improved pathologic breast cancer response. The identification of predictors of treatment response will permit cytotoxic regimens to be tailored to individual patient requirements and permit pathologic response rates to be improved.

The aim of this study was to assess the efficacy and toxicity of the combination of docetaxel (Taxotere) and vinorelbine (Navelbine), every 15 days, in anthracycline-pretreated metastatic breast cancer patients.

Docetaxel (Taxotere) and vinorelbine (Navelbine) are active agents in the treatment of metastatic breast cancer. Preclinical data suggest that there may be synergism between vinca alkaloids and taxane compounds. The current study evaluates the combination of docetaxel and vinorelbine with concurrent granulocyte colony-stimulating factor (G-CSF, filgrastim [Neupogen]) in anthracycline-refractory breast cancer. The objectives of this study are to determine the response rate, time to progression, survival, and toxicities of this regimen.

Weekly administration of taxanes as palliative treatment in metastatic breast cancer has been reported with significantly reduced hematologic toxicity and comparable efficacy to standard every-3-week protocols. This study update provides mature results with weekly docetaxel (Taxotere) in a larger patient population.

From March 1996 to March 1998, 106 patients with untreated metastatic breast cancer (MBC) were treated with docetaxel (Taxotere) (100 mg/m²) and doxorubicin (75 mg/m²) on an alternating cycle-by-cycle (doxorubicin, docetaxel, doxorubicin, etc) or sequential (four cycles of docetaxel, then four cycles of doxorubicin) basis, every 3 weeks, for a maximum of eight cycles.

Results of the GEPARDO Trial: A Phase IIB Study Comparing the Combination of Dose-Intensified Doxorubicin and Docetaxel With or Without Tamoxifen in Patients With Operable Breast Cancer

MIAMI, Florida-Results of a recent study suggest that Herceptin (trastuzumab) may be effective as single-agent therapy in chemotherapy-naïve women with metastatic breast cancer, said lead investigator Charles Vogel, MD, clinical professor of medicine, University of Miami School of Medicine.

PITTSBURGH-Four cycles of doxorubicin (Adriamycin) and cyclophosphamide (AC) over 63 days are as effective as six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) over 6 months in node-negative, early- stage breast cancer, Bernard Fisher, MD, reported at the ASCO annual meeting.

NEW YORK-“Survival rates could be improved if all women understood the benefits of early detection and could utilize high-quality breast cancer screening services in their communities, regardless of their ability to pay,” said Wanda K. Jones, DrPh, leadoff speaker at the National Alliance of Breast Cancer Organizations’ (NABCO) Celebration 2000 fund-raising luncheon.

This book is the 17th volume in the Basic and Clinical Oncology series edited by Bruce D. Cheson, MD. Like other volumes in this series, Expert Consultations in Breast Cancer follows a unique format and seeks to integrate advances in the basic understanding of breast cancer with promising new therapies and changing health- care economics. The integration of these different perspectives provides both a conceptual and pragmatic framework for clinical decision-making.

NEW ORLEANS-Epirubicin (Ellence) may be an effective single agent for primary treatment of operable breast cancer, according to results of a cooperative group study from the National Tumor Institute, Milan, Italy, presented at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).