Paclitaxel and Carboplatin as First-Line Chemotherapy for Advanced Breast Cancer

ABSTRACT: In a phase II study, 66 patients with advanced breast cancer (median age 56 years; range, 28 to 75 years) were treated with paclitaxel (Taxol), 175 mg/m² infused over 3 hours, and carboplatin (Paraplatin), dosed to attain an area under the concentration-time curve (AUC) of 6 mg ´ min/mL; treatment was repeated every 3 weeks. A total of 38 (58%) patients had received prior adjuvant chemotherapy, 21 with a regimen containing an anthracycline or mitoxantrone (Novantrone). As of May 1997, 295 cycles of paclitaxel-carboplatin have been administered, 248 (84%) at full dose. The relative dose intensity of paclitaxel is 0.9 (range, 0.5 to 1.2). Of the 66 patients, 8 (12%) have achieved a complete response and 27 (41%) a partial response, for a total response rate of 53%. Grade 3 to 4 toxicities have included anemia (5%), leukopenia (25%), thrombocytopenia (5%), nausea/vomiting (7%), myalgias/arthralgias (4%), allergic reaction, neurotoxicity, and infection (2% each). Alopecia has been universal. Median time to progression is 8.9 months; median survival has not yet been reached. We conclude that the combination of paclitaxel and carboplatin has significant activity in advanced breast cancer and can easily be administered on an outpatient basis with manageable toxicity.[ONCOLOGY 12(Suppl 1):45-48, 1998]

Paclitaxel (Taxol) is one of the most exciting new anticancer drugs, with impressive clinical activity in several tumor types, such as ovarian, breast, lung, and head and neck cancers.[1] Furthermore, a number of clinical trials have established the activity of this drug in patients with advanced breast cancer, even in those previously treated with anthracyclines.[2-4]

Two studies have reported the combination of paclitaxel and cisplatin (Platinol) to be highly effective in advanced breast cancer.[5,6] Substitution of carboplatin (Paraplatin) for cisplatin allows the treatment to be given on an outpatient basis, even in patients with compromised cardiac or renal function. Carboplatin has also demonstrated significant activity in untreated patients with advanced breast cancer.[7]

Our group recently published the results of a phase II study of the combination of paclitaxel and carboplatin in anthracycline-resistant advanced breast cancer.[8] The excellent tolerability and definite activity of this combination prompted us to conduct the present phase II study evaluating its use as first-line chemotherapy in patients with advanced breast cancer.

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