Gemzar is a brand name chemotherapy drug made by Eli Lilly with the generic name gemcitabine. It has been approved andused for more than 20 years but is still considered a newer chemotherapeutic agent with the potential to be used effectively in treating types of cancers that it has yet to be approved for, including mesothelioma. It is approved to treat certain cases of ovarian, pancreatic, and non-small cell lung cancer.
Among the many approved uses for gemcitabine are treatment of ovarian, breast, and non-small cell lung cancer. Studies are ongoing into the use of gemcitabine for treating mesothelioma. It is mostly used in combination with other drugs, including chemotherapy drugs and newer targeted drugs. The potential benefits of this drug have to be weighed against the risk of side effects and serious consequences.
What is Gemcitabine?
Gemcitabine is the brand name Eli Lilly drug called Gemzar. The U.S. Food and Drug Administration approved it in 1996 and it is now available as a generic made by other companies, including Teva Pharmaceuticals, Hospira, Fresenius, and others. Approved uses for gemcitabine include treating relapsed and advanced ovarian cancer in combination with carboplatin, treating non-small cell lung cancer in combination with cisplatin, and treating pancreatic cancer without other drugs. It is also approved to treat metastatic breast cancer in combination with paclitaxel.
Gemcitabine is sometimes used, although it hasn’t been approved for, treating bile duct cancer and bladder cancer. It has not been approved for mesothelioma, but many studies have used it in combination with other drugs to treat this difficult cancer. The results are mixed but largely positive and are expected to lead to further clinical trials and eventually to new combination therapies that will help more mesothelioma patients.
How it Works
Like most chemotherapy drugs, gemcitabine is injected in a patient’s vein. Traveling through the bloodstream, it targets fast-growing cells, including cancer cells, but also some healthy cells. Gemcitabine belongs to a class of drugs called antimetabolites, which interfere with the enzymes that make DNA in cells. They do this by mimicking the compounds the enzymes would normally bind to, halting the action of those enzymes. Unable to make DNA, which is required for growth and division, cancer cells stop spreading.
Because gemcitabine, like most chemotherapy drugs, does not specifically target cancer cells, it can cause uncomfortable, painful, and sometimes serious side effects, the most common of which are nausea and vomiting, anemia, hair loss, mouth sores, loss of appetite, reduced white blood cell count, excessive protein in the urine, fever, skin rashes, labored breathing, swelling in the arms or legs and hands or feet, low platelet count in the blood, and an increase in liver enzymes.
Some patients are not good candidates for gemcitabine because of its toxic effects. These include pregnant women, who may see birth defects after using the drug. Patients who already have a weakened immune system may not be able to use gemcitabine. Suppression of white blood cell production in bone marrow can be very serious, making patients susceptible to life-threatening infections. Patients with liver disease may also be more susceptible to liver damage from gemcitabine.
Gemcitabine and Mesothelioma – Studies
While gemcitabine has not yet been approved by the FDA for mesothelioma, researchers are hard at work determining if it works against this difficult cancer. Several tests, including those that have advanced to phase II clinical trials, show great potential for gemcitabine in combination with other drugs to treat mesothelioma. While more work needs to be done to win regulatory approval of this medicine for mesothelioma, early results are promising.
A 2002 phase II trial in Australia tested gemcitabine along with cisplatin in pleural mesothelioma patients. One-third of patients saw at least some reduction in tumor size and nearly two-thirds experienced stabilization in the growth of tumors. Just 8 percent of patients saw no benefits. Most patients in the trial reported a better quality of life after the treatment, showing it helped to reduce symptoms of the cancer.
Another phase II clinical trial, which published results in 2012, used a combination of gemcitabine, cisplatin, and bevacizumab, an anti-angiogenesis drug, which acts against tumors by reducing their ability to grow new blood vessels. A tumor cannot keep growing without a blood supply. The combination of three drugs improved overall survival times for patients in the study. It also improved progression-free survival times, the time between the treatment and the point at which a tumor starts to grow again.
In 2013 researchers published interesting results from an animal study using gemcitabine. Animal trials typically precede clinical trials done in people. Researchers treated mice with peritoneal mesothelioma with a combination of drugs that included gemcitabine, a compound from green tea called EGCG, and vitamin C. The researchers used a lower dose of gemcitabine than would normally be used and added the supplements. The results were as effective as using higher doses of gemcitabine alone. So it may be possible to use lower doses, reducing side effects, while still slowing tumor growth.
These and ongoing clinical trials show great promise for gemcitabine as a mesothelioma treatment, though more studies are needed. Researchers are likely to continue combining it with other chemotherapy drugs, but also with new, more targeted compounds like immunotherapy drugs and vaccine therapies. Tesing chemotherapy drugs for unapproved uses leads to new treatments and greater hope for patients struggling with a difficult disease like mesothelioma.
Page edited by Dave Foster
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