1.1%
Table 3: Gemzar Plus Carboplatin Versus Carboplatin in Ovarian Cancer – Results of Efficacy Analysis *
Log Rank, unadjusted
Treatment adjusted for performance status, tumor area, and platinum–free interval.
Chi Square
Partial response non–measurable disease
Independent reviewers could not eva luate disease demonstrated by sonography or physical exam.
Independently reviewed cohort – Gemzar/Carboplatin N=121, Carboplatin N=101
Gemzar/Carboplatin
(N=178)
Carboplatin
(N=178)
PFS
Median (95%, C.I.) months
8.6 (8.0, 9.7)
5.8 (5.2, 7.1)
p=0.0038*
Hazard Ratio (95%, C.I.)
0.72 (0.57, 0.90)
Overall Survival
Median (95%, C.I.) months
18.0 (16.2, 20.3)
17.3 (15.2, 19.3)
p=0.8977*
Hazard Ratio (95%, C.I.)
0.98 (0.78, 1.24)
Adjusted† Hazard Ratio (95%, C.I.)
0.86 (0.67, 1.10)
Investigator Reviewed
Overall Response Rate
47.2%
30.9%
p=0.0016‡
CR
14.6%
6.2%
PR+PRNM
32.6%
24.7%
Independently Reviewed
Overall Response Rate
46.3%
35.6%
p=0.11‡
CR
9.1%
4.0%
PR+PRNM
37.2%
31.7%
Figure 1: Kaplan–Meier Curve of Progression Free Survival in Gemzar Plus Carboplatin Versus Carboplatin in Ovarian Cancer (N=356)
Breast Cancer
Data from a multi–national, randomized Phase 3 study (529 patients) support the use of Gemzar in combination with paclitaxel for treatment of breast cancer patients who have received prior adjuvant/neoadjuvant anthracycline chemotherapy unless clinically contraindicated. Gemzar 1250 mg/m2 was administered on Days 1 and 8 of a 21–day cycle with paclitaxel 175 mg/m2 administered prior to Gemzar on Day 1 of each cycle. Single–agent paclitaxel 175 mg/m2 was administered on Day 1 of each 21–day cycle as the control arm.
The addition of Gemzar to paclitaxel resulted in statistically significant improvement in time to documented disease progression and overall response rate compared to monotherapy with paclitaxel as shown in Table 4 and Figure 2. Further, there was a strong trend toward improved survival for the group given Gemzar based on an interim survival analysis.
Table 4: Gemzar Plus Paclitaxel Versus Paclitaxel in Breast Cancer *
Karnofsky Performance Status.
These represent reconciliation of investigator and Independent Review Committee assessments according to a predefined algorithm.
Gemzar/Paclitaxel
Paclitaxel
Number of patients
267
262
Median age, years
53
52
Range
26 to 83
26 to 75
Metastatic disease
97.0%
96.9%
Baseline KPS*≥90
70.4%
74.4%
Number of tumor sites
1–2
56.6%
58.8%
&
