PHASE-II TRIAL OF PACLITAXEL AND CISPLATIN IN WOMEN WITH ADVANCED BREAST-CANCER - AN ACTIVE REGIMEN WITH LIMITING NEUROTOXICITY

Citation
C. Wasserheit et al., PHASE-II TRIAL OF PACLITAXEL AND CISPLATIN IN WOMEN WITH ADVANCED BREAST-CANCER - AN ACTIVE REGIMEN WITH LIMITING NEUROTOXICITY, Journal of clinical oncology, 14(7), 1996, pp. 1993-1999
Citations number
28
Categorie Soggetti
Oncology
ISSN journal
0732183X
Volume
14
Issue
7
Year of publication
1996
Pages
1993 - 1999
Database
ISI
SICI code
0732-183X(1996)14:7<1993:PTOPAC>2.0.ZU;2-L
Abstract
Purpose: A phase II study of paclitaxel and cisplatin in patients with advanced breast cancer was performed to determine the objective respo nse rate and make further observations about the toxicity of this regi men. Patients and Methods: Patients were required to have histological ly proven adenocarcinoma of the breast with no more than one chemother apeutic treatment for advanced disease. Treatment consisted of paclita xel 200 mg/m(2) administered as a 24-hour intravenous (IV) infusion fo llowed by cisplatin 75 mg/m(2) IV. Patients received granulocyte colon y-stimulating factor (G-CSF) 5 mu g/kg subcutaneously on day 3 until W BC recovery. Cycles were repeated every 21 days, Patients continued to receive therapy until disease progression or unacceptable toxicity. R esults: Forty-four patients entered the trial. Forty-two patients were assessable for response. Nineteen patients (43%) had no prior chemoth erapy and 41 had no chemotherapy for metastatic disease. The median nu mber of cycles administered per patient was five (range, one to seven) . There were five complete responses (CRs) (11.9%) and 17 partial resp onses (PRs) (40.5%), with an overall response rate of 52.4% (95% confi dence interval [Cl], 36.4% to 68.0%). Nine patients had stage III dise ase. The response rate for this group was 66.7% (95% Cl, 33.0% to 92.5 %), with three CRs and three PRs. Among 35 patients with stage IV dise ase, there were two CRs and 14 PRs, with an overall response rate of 4 8.5% (95% Cl, 30.8% to 66.5%). Overall, the median response duration w ets 10.6 months. Thirty patients (68%) developed transient grade 4 neu tropenia. Cumulative neuropathy was the major dose-limiting toxicity. After five cycles of chemotherapy, 96% of patients had at least grade 1 neurotoxicity and 52% of held at least grade 2 neurotoxicity, One pa tient had a toxic death after cycle 1 of therapy. Conclusion: The comb ination of paclitaxel and cisplatin as first-line chemotherapy for wom en with advanced breast cancer is an active regimen. However, the cumu lative neurotoxicity was significant and dose-limiting in the majority of patients.