Gemzar

Clinical Pharmacology

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Clinical Pharmacology

Gemzar

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

	Gemzar/Paclitaxel	Paclitaxel
Number of patients	267	262
Median age, years	53	52
Range	26 to 83	26 to 75
Metastatic disease	97.00%	96.90%
Baseline KPS^a ≥ 90	70.40%	74.40%
Number of tumor sites
1-2	56.60%	58.80%
≥3	43.40%	41.20%
Visceral disease	73.40%	72.90%
Prior anthracycline	96.60%	95.80%
Time to Documented Disease			p<0.0001
Progression^b
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 Rateb (95%, C.I.)	40.8% (34.9, 46.7)	22.1% (17.1, 27.2)	p<0.0001
^a Karnofsky Performance Status.
^b These represent reconciliation of investigator and Independent Review Committee assessments according to a predefined algorithm.

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.

Brand Name: Gemzar
Generic Name: Gemcitabine Hcl