ents enrolled, 60% had symptomatic disease with impaired performance status at study entry, and 73% had visceral metastases. These patients had failed prior chemotherapy either in the adjuvant setting (30%), the metastatic setting (39%), or both (31%). Sixty-seven percent of the patients had been previously exposed to anthracyclines and 23% of them had disease considered resistant to this class of agents.
The overall response rate for the 454 eva luable patients was 26% (95% CI: 22% to 30%), with 17 complete and 99 partial responses. The median duration of response, measured from the first day of treatment, was 8.1 months (range: 3.4-18.1+ months). Overall for the 471 patients, the median time to progression was 3.5 months (range: 0.03-17.1 months). Median survival was 11.7 months (range: 0-18.9 months).
Response rates, median survival and median time to progression for the 2 arms are given in the following table.
Table 3: Efficacy in Breast Cancer after Failure of Initial Chemotherapy or Within 6 Months of Adjuvant Chemotherapy
175/3
(n=235)
135/3
(n=236)
• Response
- rate (percent)
28
22
- p-value
0.135
• Time to Progression
- median (months)
4.2
3.0
- p-value
0.027
• Survival
- median (months)
11.7
10.5
- p-value
0.321
The adverse event profile of the patients who received single-agent Paclitaxel Injection in the Phase 3 study was consistent with that seen for the pooled analysis of data from 812 patients treated in 10 clinical studies. These adverse events and adverse events from the Phase 3 breast carcinoma study are described in the ADVERSE REACTIONS section in tabular (Tables 4 and 6) and narrative form.
INDICATIONS AND USAGE
Paclitaxel Injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
CONTRAINDICATIONS
Paclitaxel Injection is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL* (Polyoxyl 35 Castor Oil, NF).
Paclitaxel Injection should not be used in patients with solid tumors who have baseline neutrophil counts of <1,500 cells/mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1,000 cells/mm3.
WARNINGS
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2%-4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. (See DOSAGE AND ADMINISTRATION section.) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity
