G. Rosati et al., A phase II study of paclitaxel/cisplatin combination in patients with metastatic breast cancer refractory to anthracycline-based chemotherapy, TUMORI, 86(3), 2000, pp. 207-210
Aims and background: To investigate the safety and efficacy of a paclitaxel
and cisplatin regimen in a selected group of metastatic breast cancer pati
ents with primary or acquired chemoresistance to anthracycline-based chemot
herapy.
Patients and methods: Thirty-eight consecutive women with metastatic breast
cancer (PS less than or equal to 2) were entered in this phase II trial; a
ll patients had been previously treated for metastatic disease with chemoth
erapy containing anthracyclines and had shown a progression of the disease
during drug administration or after a clinical response lasting less than 6
months. Fifteen patients had received 2 or more chemotherapeutic regimens
for advanced disease; 31 patients had greater than or equal to 2 sites of m
etastatic disease. Paclitaxel (135 mg/m(2)) was administered iv by a 3-hr i
nfusion followed by iv infusion of cisplatin (75 mg/m(2)) on day 1, every 3
weeks for 6 cycles, After the completion of the planned chemotherapy admin
istration, 9 responsive patients continued to receive paclitaxel alone (175
mg/m(2)) iv, on day 1, every 3 weeks, until disease progression or unaccep
table toxicity.
Results: A partial clinical response was recorded in 17 cases (45%; 95% CI,
30-64%), The median duration of overall response was 8 months; for the 9 r
esponsive patients who continued treatment with paclitaxel alone, 4 had mai
ntained the partial clinical response at the median follow-up of 24 months
from the onset of therapy. The median time to progression was 6 months and
median overall survival 8 months. Neurotoxicity was the most frequent adver
se effect and caused treatment discontinuation in 5 cases for grade 3-4 par
esthesia and/or an arthralgia/myalgia syndrome. Grade 3-4 neutropenia occur
red in 16 patients (44%).
Conclusions: Paclitaxel/cisplatin is an active regimen for the treatment of
patients with metastatic breast cancer refractory to anthracycline-based c
hemotherapy. However, the cumulative neurotoxicity should limit the efficac
y of prolonged paclitaxel monotherapy in responsive patients.