asured using the FACT–L, which assessed physical, social, emotional and functional well–being, and lung cancer symptoms. In the study of Gemzar plus cisplatin versus etoposide plus cisplatin, QOL was measured using the EORTC QLQ–C30 and LC13, which assessed physical and psychological functioning and symptoms related to both lung cancer and its treatment. In both studies no significant differences were observed in QOL between the Gemzar plus cisplatin arm and the comparator arm.
Figure 3: Kaplan–Meier Survival Curve in Gemzar Plus Cisplatin Versus Cisplatin NSCLC Study (N=522)
Table 5: Randomized Trials of Combination Therapy With Gemzar Plus Cisplatin in NSCLC *
28–day schedule — Gemzar plus cisplatin: Gemzar 1000 mg/m2 on Days 1, 8, and 15 and cisplatin 100 mg/m2 on Day 1 every 28 days; Single–agent cisplatin: cisplatin 100 mg/m2 on Day 1 every 28 days.
21–day schedule — Gemzar plus cisplatin: Gemzar 1250 mg/m2 on Days 1 and 8 and cisplatin 100 mg/m2 on Day 1 every 21 days; Etoposide plus Cisplatin: cisplatin 100 mg/m2 on Day 1 and I.V. etoposide 100 mg/m2 on Days 1, 2, and 3 every 21 days.
N/A Not applicable
Karnofsky Performance Status.
p–value for tumor response was calculated using the two–sided Fisher’s Exact test for difference in binomial proportions. All other p–values were calculated using the Log rank test for difference in overall time to an event.
Trial
28–day Schedule
21–day Schedule
Treatment Arm
Gemzar/
Cisplatin
Cisplatin
Gemzar/
Cisplatin
Cisplatin/
Etoposide
Number of patients
260
262
69
66
Male
182
186
64
61
Female
78
76
5
5
Median age, years
62
63
58
60
Range
36 to 88
35 to 79
33 to 76
35 to 75
Stage IIIA
7%
7%
N/A‡
N/A‡
Stage IIIB
26%
23%
48%
52%
Stage IV
67%
70%
52%
49%
Baseline KPS§ 70 to 80
41%
44%
45%
52%
Baseline KPS§ 90 to 100
57%
55%
55%
49%
Survival
p=0.008
p=0.18
Median, months
9.0
7.6
8.7
7.0
(95%, C.I.) months
8.2, 11.0
6.6, 8.8
7.8, 10.1
6.0, 9.7
Time to Disease Progression
p=0.009
p=0.015
Median, months
5.2
3.7
5.0
4.1
(95%, C.I.) months
4.2, 5.7
3.0, 4.3
4.2, 6.4
2.4, 4.5
Tumor Response
26%
10%
p<0.0001
33%
14%
p=0.01
Pancreatic Cancer
Data from 2 clinical trials eva luated the use of Gemzar in patients with locally advanced or met |
