Related Pages Ovarian Cancer Home Page 1 NCI's gateway for information about ovarian cancer. Breast Cancer Home Page 2 NCI's gateway for information about breast cancer. Drug Information Summaries 3 NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer.

Brand name(s): Gemzar®

• Approved for ovarian cancer
• Approved for breast cancer

Full prescribing information ⁴ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

Ovarian Cancer

On July 14, 2006, the U.S. Food and Drug Administration granted approval to gemcitabine hydrochloride (Gemzar®, made by Eli Lilly and Company) in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy.

The approval was based on a single multicenter, international, open-label, randomized trial enrolling 356 ovarian cancer patients whose disease had relapsed at least six months after first-line platinum-based therapy. Patients were randomized to receive either gemcitabine hydrochloride 1000 mg/m2 on days 1 and 8 of a 21-day cycle plus carboplatin (AUC 4) administered on day 1 of each cycle (GC) or to receive carboplatin (AUC 5) administered on day 1 of each 21-day cycle (C).

One hundred seventy-eight patients received GC and 178 patients received C. Patients were comparable for age, baseline ECOG performance status, platinum-free interval, and first-line therapy regimen.

GC treatment resulted in a significant improvement in progression-free survival (PFS). Median PFS was 8.6 months for GC-treated patients and 5.8 months for C-treated patients [log rank p=0.0038; hazard ratio 0.72 (95 percent, C.I. 0.57, 0.90)]. A significant improvement in the investigator-assessed overall response rate was demonstrated for the addition of gemcitabine hydrochloride to carboplatin (47 percent versus 31 percent, p=0.0016), but not in the independently reviewed response rate that excluded sonography or physical exam findings (46 percent versus 36 percent, p=0.11).

Approximately 75 percent of patients in each arm received post-study chemotherapy, including 13 of 120 patients on the C treatment arm for whom post-progression chemotherapy drugs were known and who received gemcitabine hydrochloride after progression. No significant difference in overall survival was observed. The median survival was 18.0 months for GC-treated patients compared to 17.3 months for those receiving single-agent carboplatin [p=0.8977, hazard ratio 0.98 (95 percent C.I. 0.78, 1.24)].

Hematologic toxicity was the most frequent adverse event. Grade 4 (CTC) neutropenia, anemia and thrombocytopenia occurred in 29 percent, 6 percent and 5 percent, respectively, of patients receiving GC compared to 1 percent, 2 percent, and 1 percent of those receiving single-agent carboplatin. Red blood cell and platelet transfusions were more common in GC-treated patients. Grade 3 neurosensory toxicity was observed in 1 percent receiving GC and 2 percent of C-treated patients.

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Breast Cancer

Safety and efficacy were demonstrated in one multicenter, multinational, randomized trial in 529 patients comparing the combination of gemcitabine hydrochloride and paclitaxel with paclitaxel alone. Gemcitabine hydrochloride 1250 mg/m2 (intravenous infusion over 30 minutes) was administered on Days 1 and 8 of a 21-day cycle with paclitaxel 175 mg/m2 (intravenous infusion over 3 hours) administered prior to gemcitabine hydrochloride on Day 1 of each cycle. Single-agent paclitaxel 175 mg/m2 (intravenous infusion over 3 hours) was administered on Day 1 of each 21day cycle as the control arm.

The primary endpoint of the study was overall survival. Time to documented progressive disease was a co-primary endpoint. Gemcitabine hydrochloride in combination with paclitaxel resulted in statistically significant improvement in time to documented disease progression (median TtDPD 5.2 months versus 2.9 months, p<0.0001), and overall response rate (RR 40.6 percent versus 22.1 percent, p<0.0001) compared to monotherapy with paclitaxel. The combination of gemcitabine hydrochloride plus paclitaxel also showed a strong trend toward improved survival in an interim survival analysis.

The principal Grade 3 and 4 adverse effects of the gemcitabine hydrochloride plus paclitaxel regimen were hematologic (neutropenia, anemia and thrombocytopenia). Grade 3 and 4 liver enzyme elevation was also more common with gemcitabine hydrochloride plus paclitaxel treatment. Grade 3 and 4 non-laboratory toxicities associated with gemcitabine hydrochloride plus paclitaxel therapy included fatigue, neuropathy and myalgias.

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Glossary Terms

Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called induction therapy, primary therapy, and primary treatment.

A statistics term. The middle value in a set of measurements.

A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).

A measure of how well a patient is able to perform ordinary tasks and carry out daily activities.

A tiny piece of a cell found in the blood that breaks off from a large cell found in the bone marrow. Platelets help wounds heal and prevent bleeding by forming blood clots. Also called thrombocyte.

A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.

The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. Also called PFS.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

A condition in which there is a lower-than-normal number of platelets in the blood. It may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.