Paclitaxel (Page 10 of 15)

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 14. 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

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.

Percent of Patients
175/3 b (n=229) 135/3 b (n=229)
• Bone Marrow
— Neutropenia <2,000/mm3 90 81
<500/mm3 28 19
— Thrombocytopenia <100,000/mm3 11 7
<50,000/mm3 3 2
— Anemia <11 g/dL 55 47
<8 g/dL 4 2
— Infections 23 15
— Febrile Neutropenia 2 2
• Hypersensitivity Reaction c
— All 36 31
— Severe 0 <1
• Peripheral Neuropathy
— Any symptoms 70 46
— Severe symptoms 7 3
• Mucositis
— Any symptoms 23 17
— Severe symptoms 3 <1

Myelosuppression and peripheral neuropathy were dose related. There was one severe hypersensitivity reaction (HSR) observed at the dose of 135 mg/m2.

First-Line NSCLC in Combination

In the study conducted by the Eastern Cooperative Oncology Group (ECOG), patients were randomized to either paclitaxel (T) 135 mg/m2 as a 24-hour infusion in combination with cisplatin (c) 75 mg/m2 , paclitaxel (T) 250 mg/m2 as a 24-hour infusion in combination with cisplatin (c) 75 mg/m2 with G-CSF support, or cisplatin (c) 75 mg/m2 on day 1, followed by etoposide (VP) 100 mg/m2 on days 1, 2, and 3 (control).

The following table shows the incidence of important adverse events.

Table 15. Frequencya of Important Adverse Events in the Phase 3 Study for First-Line NSCLC

a Based on worst course analysis.

b Paclitaxel (T) dose in mg/m2 /infusion duration in hours; cisplatin (c) dose in mg/m2.

c Paclitaxel dose in mg/m2 /infusion duration in hours with G-CSF support; cisplatin dose in mg/m2.

d Etoposide (VP) dose in mg/m2 was administered IV on days 1, 2, and 3; cisplatin dose in mg/m2.

e p<0.05.

f All patients received premedication.

Severe events are defined as at least Grade III Toxicity.

Percent of Patients
T135/24 b c75 (n=195) T250/24 c c75 (n=197) VP100 d c75 (n=196)
• Bone Marrow
— Neutropenia <2,000/mm3 89 86 84
<500/mm3 74e 65 55
— Thrombocytopenia <normal 48 68 62
<50,000/mm3 6 12 16
— Anemia <normal 94 96 95
<8 g/dL 22 19 28
— Infections 38 31 35
• Hypersensitivity Reaction f
— All 16 27 13
— Severe 1 4e 1
• Arthralgia/Myalgia
— Any symptoms 21e 42e 9
— Severe symptoms 3 11 1
• Nausea/Vomiting
— Any symptoms 85 87 81
— Severe symptoms 27 29 22
• Mucositis
— Any symptoms 18 28 16
— Severe symptoms 1 4 2
• Neuromotor Toxicity
— Any symptoms 37 47 44
— Severe symptoms 6 12 7
• Neurosensory Toxicity
— Any symptoms 48 61 25
— Severe symptoms 13 28e 8
• Cardiovascular Events
— Any symptoms 33 39 24
— Severe symptoms 13 12 8

Toxicity was generally more severe in the high-dose paclitaxel treatment arm (T250/c75) than in the low-dose paclitaxel arm (T135/c75). Compared to the cisplatin/etoposide arm, patients in the low-dose paclitaxel arm experienced more arthralgia/myalgia of any grade and more severe neutropenia. The incidence of febrile neutropenia was not reported in this study.

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