; < 11 g/dL
84
90
68
88
< 8 g/dL
11
12
6
10
- Infections
26
29
20
18
• Hypersensitivity Reactionc
- All
41
45
38
45
- Severe†
2
0
2
1
• Peripheral Neuropathy
- Any symptoms
63
60
55
42
- Severe symptoms†
1
2
0
0
• Mucositis
- Any symptoms
17
35
21
25
- Severe symptoms†
0
3
0
2
a Based on worst course analysis.
b Paclitaxel dose in mg/m2/infusion duration in hours
c All patients received premedication.
† Severe events are defined as at least Grade III toxicity.
Myelosuppression was dose and schedule related, with the schedule effect being more prominent. The development of severe hypersensitivity reactions (HSRs) was rare; 1% of the patients and 0.2% of the courses overall. There was no apparent dose or schedule effect seen for the HSRs. Peripheral neuropathy was clearly dose-related, but schedule did not appear to affect the incidence.
Breast Cancer After Failure of Initial Chemotherapy: For the 458 patients who received single-agent paclitaxel in the Phase 3 breast carcinoma study, the following table shows the incidence of important adverse events by treatment arm (each arm was administered by a 3-hour infusion).
Table 6: Frequencya of Important Adverse Events in the Phase 3 Study of Breast Cancer after Failure of Initial Chemotherapy or Within 6 Months of Adjuvant Chemotherapy
Percent of Patients
175/3b
(n=229)
135/3b
(n=229)
• Bone Marrow
- Neutropenia < 2,000/mm3
90
81
< 500/mm3
28
19
- Thrombocytopenia < 100,000/mm3
11
7
