Therapies

Gemcitabine HCL

Gemzar

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SUMMARY

Company: Eli Lilly
Approval Status:  FDA Approved May 1996
Specific Treatments: Pancreatic cancer
Drug: Gemcitabine HCL  

 

GENERAL INFORMATION

Gemzar (Gemcitabine HCL) has been approved for the treatment of locally advanced or metastatic Pancreatic cancer.

 

CLINICAL RESULTS

Gemzar improved median survival in people with advanced and metastatic Pancreatic cancer, as demonstrated by data from a study comparing Gemzar with 5-Fluorouracil (5-FU), which has been the most common treatment of Pancreatic cancer. A second study followed subjects treated with Gemzar who had previously been treated with 5-FU.

The Phase III study of Gemzar involved 126 Pancreatic cancer subjects–63 of these subjects received Gemzar therapy and the other 63 subjects received treatment with 5-FU. Of these subjects, more than 70% entered the study with metastatic disease, the most advanced stage of Pancreatic cancer. Gemzar demonstrated a statistically significant advantage in survival over 5-FU. Gemzar subjects had a 5.7 month median survival as compared with 4.2 months for 5-FU subjects. From this trial, the six-month probability estimate for survival of subjects treated with Gemzar is 46% (30 patients), compared with 29% (19 subjects) for 5-FU subjects. After one year, the survival probability estimate was 18% (9 subjects) for Gemzar subject, compared with 2% (two subjects) for 5-FU subjects. (Survival probability estimates take results from the clinical trial and, using a mathematical equation, generalize them to the larger population of Pancreatic cancer subjects.)

This study also demonstrated that 24% of previously untreated subjects who received Gemzar experienced a clinical benefit response, compared with 5% of subjects treated with 5-FU. This difference also is statistically significant.

A phase II trial of Gemzar, conducted among 63 subjects who had previously been treated with 5-FU, showed median survival time of 3.9 months. In this trial, 87% of subjects entered the study with metastatic disease. Of these subjects, 31% survived for six months, and 4% survived for one year. In addition, clinical benefit response was observed in 27% of subjects.

SIDE EFFECTS

Gemzar’s side effects were generally manageable with less than 1% of subjects discontinuing their therapy for any of the following side effects. A decrease in some infection-fighting white blood cells, called neutropenia, was observed in 63% of subjects, with moderate to severe decreases in 25% of subjects. This effect on the blood was the most frequent reason for reducing or limiting the dose of Gemzar. Common adverse effects in clinical trials included nausea and vomiting (69%), fever (41%), edema or fluid retention (up to 34%), rash (30%), and flu-like symptoms (19%). Only about 10% of all subjects participating in Gemzar clinical trials discontinued therapy due to side effects.

Hair loss was reported in 15% of subjects. This side effect was reversible, and none of the subjects experienced complete hair loss from their treatment.

MECHANISM OF ACTION

Gemzar (Gemcitabine HCL) is a nucleoside analogue that mimics a natural building block of DNA.

Source: centerwatch