Paclitaxel-ifosfamide for anthracycline-resistant advanced breast cancer.

ABSTRACT

Thirty-one patients with advanced breast cancer either resistant to anthracycline-based regimens or relapsing after anthracycline-based adjuvant chemotherapy received a combination of a 3-h infusion of paclitaxel 135 mg/m2 on day 1 and a 4-h infusion of ifosfamide 1.7 g/m2 on days 2 to 4 of a 22-day cycle. For inclusion in the study, patients had to have measurable or evaluable progressive metastasis or local disease, and to have received only one prior regimen for metastatic disease; 31 patients with a median age of 49 years (range 30-69) entered the study. Nine patients (29%) had lung metastasis, while 17 (55%) had liver metastasis, and 19 (61%) had bone metastasis. Only seven patients (23%) had lymph node metastasis and four (13%) had skin metastasis. A median of seven cycles of treatment was delivered. Responses were evaluated according to World Health Organization (WHO) guidelines and side effects according to National Cancer Institute (NCI) criteria. A panel of oncologists and one radiologist reviewed all responses. At baseline, only three patients (10%) were free from the adverse effects of the prior therapy; severe nonhematological toxicity occurred in less than 8% of patients. However neutropenia grade 3-4 occurred in 88%, while only 3% had severe infections. Severe thrombocytopenia and anemia were rare (4% and 8%, respectively). The overall response rate was 42% (13% complete response). Median survival and progression-free survival rates after initiation of treatment were 19.3 months and 6.1 months, respectively. With an objective response rate of 42% and median survival of 19 months, the combination of paclitaxel and ifosfamide seems to offer a promising regimen with acceptable side effects in advanced breast cancer patients relapsing after anthracycline-based adjuvant treatment or resistant to anthracycline treatment.