nbsp; ≥3
43.4%
41.2%
Visceral disease
73.4%
72.9%
Prior anthracycline
96.6%
95.8%
Time to Documented Disease Progression†
p<0.0001
Median (95%, C.I.), months
5.2 (4.2, 5.6)
2.9 (2.6, 3.7)
Hazard Ratio (95%, C.I.)
0.650 (0.524, 0.805)
p<0.0001
Overall Response Rate†
p<0.0001
(95%, C.I.)
40.8% (34.9, 46.7)
22.1% (17.1, 27.2)
Figure 2: Kaplan–Meier Curve of Time to Documented Disease Progression in Gemzar Plus Paclitaxel Versus Paclitaxel Breast Cancer Study (N=529)
Non–Small Cell Lung Cancer (NSCLC)
Data from 2 randomized clinical studies (657 patients) support the use of Gemzar in combination with cisplatin for the first–line treatment of patients with locally advanced or metastatic NSCLC.
Gemzar plus cisplatin versus cisplatin: This study was conducted in Europe, the US, and Canada in 522 patients with inoperable Stage IIIA, IIIB, or IV NSCLC who had not received prior chemotherapy. Gemzar 1000 mg/m2 was administered on Days 1, 8, and 15 of a 28–day cycle with cisplatin 100 mg/m2 administered on Day 1 of each cycle. Single–agent cisplatin 100 mg/m2 was administered on Day 1 of each 28–day cycle. The primary endpoint was survival. Patient demographics are shown in Table 5. An imbalance with regard to histology was observed with 48% of patients on the cisplatin arm and 37% of patients on the Gemzar plus cisplatin arm having adenocarcinoma.
The Kaplan–Meier survival curve is shown in Figure 3. Median survival time on the Gemzar plus cisplatin arm was 9.0 months compared to 7.6 months on the single–agent cisplatin arm (Log rank p=0.008, two–sided). Median time to disease progression was 5.2 months on the Gemzar plus cisplatin arm compared to 3.7 months on the cisplatin arm (Log rank p=0.009, two–sided). The objective response rate on the Gemzar plus cisplatin arm was 26% compared to 10% with cisplatin (Fisher’s Exact p<0.0001, two–sided). No difference between treatment arms with regard to duration of response was observed.
Gemzar plus cisplatin versus etoposide plus cisplatin: A second, multicenter, study in Stage IIIB or IV NSCLC randomized 135 patients to Gemzar 1250 mg/m2 on Days 1 and 8, and cisplatin 100 mg/m2 on Day 1 of a 21–day cycle or to etoposide 100 mg/m2 IV on Days 1, 2, and 3 and cisplatin 100 mg/m2 on Day 1 of a 21–day cycle (Table 5).
There was no significant difference in survival between the two treatment arms (Log rank p=0.18, two–sided). The median survival was 8.7 months for the Gemzar plus cisplatin arm versus 7.0 months for the etoposide plus cisplatin arm. Median time to disease progression for the Gemzar plus cisplatin arm was 5.0 months compared to 4.1 months on the etoposide plus cisplatin arm (Log rank p=0.015, two–sided). The objective response rate for the Gemzar plus cisplatin arm was 33% compared to 14% on the etoposide plus cisplatin arm (Fisher’s Exact p=0.01, two–sided).
Quality of Life (QOL): QOL was a secondary endpoint in both randomized studies. In the Gemzar plus cisplatin versus cisplatin study, QOL was me |
