How Gemcitabine (Gemzar) Works

Gemcitabine is a chemotherapy drug classified as anti-cancer, antineoplastic or cytotoxic. It is also included in the group of drugs called anti-mebolites, which are meant to mimic the normal molecules in the body, but are slightly different in its structure in order to stop the cancer cells from properly working. Gemcitabine is used for the treatment of cancer of the pancreas, non small cell lung cancer, breast cancer that has spread (in combination with paclitaxel), bladder cancer that has spread (in combination with cisplatin), or ovarian cancer (in combination with carboplatin). It is currently being studied to treat other types of cancer.

Gemcitabine is administered intravenously as an infusion is given through the vein and there is no form pill of it. The dosage recommended depend on variables like patient’s height and weight, general health and the type of cancer. Despite the effectiveness of the treatment with gemcitabine, there are also potential side effects. Problems like Flu-like symptoms including muscle pain, fever, headache, chills, fatigue, fever (within 6-12 hours of first dose), mild nausea, vomiting, poor appetite, skin rash, and low blood counts that increase the probability of infection, anemia or bleeding, occur in more than 30% of all patients treated with gemcitabine.

Gemcitabine (Gemzar) for Breast Cancer

Gemcitabine was approved by the US Food and Drug Administration (FDA) on May 19, 2004, and it is commercialized under the brand name Gemzar by Eli Lily and Company. While approved for numerous other indications, in the case of breast cancer, gemcitabine is indicated to be used in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer who were previously and unsuccessfully treated with anthracycline containing adjuvant chemotherapy, or for who anthracyclines are clinically contraindicated. The approval was based on a study that included 529 patients and compared the use of gemcitabine 1250 mg/m2 and paclitaxel 175 mg/m2 with the use of paclitaxel alone.

“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,” explain the National Cancer Institute regarding the multicenter, multinational, randomized trial that investigated the safety and efficacy of gemcitabine. “The combination of gemcitabine hydrochloride plus paclitaxel also showed a strong trend toward improved survival in an interim survival analysis.”

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