nbsp;21
8
0
Alopecia
77
13
0
92
51
0
Stomatitis
20
4
0
18
2
0
Somnolence
3
0
0
3
2
0
Paresthesias
38
0
0
16
2
0
Grade based on criteria from the World Health Organization (WHO).
N=67–69; all Gemzar plus cisplatin patients with laboratory or non–laboratory data. Gemzar at 1250 mg/m2 on Days 1 and 8 and cisplatin at 100 mg/m2 on Day 1 every 21 days.
N=57–63; all cisplatin plus etoposide patients with laboratory or non–laboratory data. Cisplatin at 100 mg/m2 on Day 1 and IV etoposide at 100 mg/m2 on Days 1, 2, and 3 every 21 days.
Regardless of causality.
Percent of patients receiving transfusions. Percent transfusions are not WHO–graded events.
Non–laboratory events were graded only if assessed to be possibly drug–related.
Pain data were not collected.
Combination Use in Breast Cancer: In the Gemzar plus paclitaxel versus paclitaxel study, dose reductions occurred with 8% of Gemzar injections and 5% of paclitaxel injections on the combination arm, versus 2% on the paclitaxel arm. On the combination arm, 7% of Gemzar doses were omitted and <1% of paclitaxel doses were omitted, compared to <1% of paclitaxel doses on the paclitaxel arm. A total of 18 patients (7%) on the Gemzar plus paclitaxel arm and 12 (5%) on the paclitaxel arm discontinued the study because of adverse events. There were two deaths on study or within 30 days after study drug discontinuation that were possibly drug–related, one on each arm.
Table 11 presents the safety data occurrences of ≥10% (all grades) from the Gemzar plus paclitaxel versus paclitaxel study in breast cancer.
Table 11: Adverse Events From Comparative Trial of Gemzar Plus Paclitaxel Versus Single–Agent Paclitaxel in Breast Cancer* CTC Grades (% incidence)
Gemzar plus Paclitaxel
(N=262)
Paclitaxel
(N=259)
All Grades
Grade
3
Grade
4
All Grades
Grade
3
Grade
4
Laboratory†
Hematologic
Anemia
69
6
1
51
3
<1
Neutropenia
69
31
17
31
4
7
Thrombocytopenia
26
5
<1
7
<1
<1
Leukopenia
21
10
1
12
2
0
Hepatobiliary
ALT
18
5
<1
6
<1
0
AST
16
2
0
5
<1
0
Non–laboratory‡
Alopecia
90
14
4
92
19
3
Neuropathy–sensory
64
5
<1
58
3
0
Nausea
50
1
0
31
2
0
Fatigue
40
6
<1
28
1
<1
Myalgia
33
4
0
33
3
<1
Vomiting
29
2
0
15
2
0
Arthralgia
24
3
0
|
