Paclitaxel as First-Line Treatment for Metastatic Breast Cancer

ABSTRACT: When administered as a single agent inpretreated patients with advanced breast cancer, paclitaxel (Taxol) exhibitsremarkable antitumor activity. This trial was undertaken to compare paclitaxelwith standard chemotherapy as front-line therapy for this disease. Patientswith measurable or evaluable metastatic breast cancer, no prior chemotherapyfor metastatic disease, and an Eastern Cooperative Oncology Group performancestatus of 0 to 2 were randomized to receive paclitaxel 200 mg/m² intravenouslyover 3 hours for eight cycles (6 months) or standard treatment with oralcyclophosphamide (Cytoxan) 100 mg/m²/d days 1 through 14, intravenousmethotrexate 40 mg/m² days 1 and 8, intravenous 5-fluorouracil 600mg/m² days 1 and 8, and oral prednisolone 40 mg/m²/d (CMFP) days1 through 14 for six cycles (6 months). Patients whose disease progressedor relapsed were recommended to receive second-line epirubicin. Accrualhas been completed with 208 patients randomized, but a preplanned interimanalysis of the first 100 patients is reported here. Analysis of qualityof life, assessed by a linear analogue scale and overall quality of lifeindices, is ongoing. Objective response occurred in 31% (confidence interval,19% to 45%) with paclitaxel and 35% (confidence interval, 22% to 51%) withCMFP with stable disease in an additional 33% and 29%, respectively. Mediantime to progression was 5.5 months for paclitaxel-treated patients and6.4 months for those given CMFP, with median survival durations of 17.3and 11.3 months, respectively. Grades 3 and 4 neutropenia occurred in 64%of patients treated with paclitaxel and in 63% treated with CMFP. However,febrile neutropenia was the primary reason for hospitalization in 1% ofpaclitaxel courses, compared with 8% of CMFP courses. Nine percent of thepatients had major infections with CMFP, but none were seen with paclitaxel.Moderate or severe mucositis occurred in 13% of paclitaxel-treated and27% of CMFP-treated patients. Alopecia and peripheral neuropathy were morecommon with paclitaxel. Quality of life assessments in the first 100 patientssuggest better overall results on paclitaxel treatment as compared withCMFP. Preliminary analyses suggest that single-agent paclitaxel is welltolerated and provides comparable control of metastatic cancer to CMFPcombination therapy when used as front-line treatment. [ONCOLOGY 11(Suppl):19-23,1997]

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