Gemzar is a brand name chemotherapy drug made by Eli Lilly with the generic name gemcitabine. It has been approved and in use 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 currently 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, and it is mostly being used in combination with other drugs, including chemotherapy drugs and more novel 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. It was approved by the U.S. Food and Drug Administration in 1996 and is now available as a generic made by other companies, including Teva Pharmaceuticals, Hospira, Fresenius, and others. Currently 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 for treating metastatic breast cancer in combination with paclitaxel.
Although unapproved for it, gemcitabine is sometimes used to treat bile duct cancer and bladder cancer. It is also unapproved for mesothelioma, but there have been many studies that 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 other chemotherapy drugs, gemcitabine is given as an intravenous injection. It travels through the bloodstream and targets fast growing cells, including cancer cells and some healthy cells. Gemcitabine belongs to a group of drugs called antimetabolites. These are drugs that interfere with the enzymes that make DNA in cells. They do this by mimicking the compounds the enzymes would normally bind to and this brings the action of those enzymes to a halt. Cancer cells can then no longer make DNA, which means they cannot grow and divide into new cells.
Because gemcitabine, like most chemotherapy drugs, does not specifically target only cancer cells, it can cause some uncomfortable, painful, and sometimes very serious side effects in patients. The most often reported side effects with gemcitabine 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. The effect on 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 to be used to treat patients with mesothelioma, researchers are hard at work determining if it should be used for this difficult type of cancer. Among these studies are several clinical trials, including those that have advanced to phase II clinical trials and that are showing there is great potential for gemcitabine in combination with other drugs to treat mesothelioma. While more work needs to be done to make this an approved medicine for mesothelioma, the early results are promising.
A 2002 study, for example, was conducted in Australia as a phase II clinical trial and tested the use of gemcitabine along with cisplatin in pleural mesothelioma patients. The results found that one-third of the patients saw at least some reduction in tumor size and nearly two-thirds experienced stabilization in the growth of tumors. Just eight percent of patients did not experience any benefit. Most of the patients in the trial also reported that they had a better quality of life after the treatment, which demonstrates that the treatment helped to reduce symptoms of the cancer.
Another phase II clinical trial published results in 2012 and used a combination of gemcitabine, cisplatin, and a drug called bevacizumab. The latter is an anti-angiogenesis drug, which means that it acts against tumors by reducing their ability to form new blood vessels. Without these the tumor doesn’t get a supply of blood necessary to grow. The combination of all of the drugs helped improve 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 the tumor starts to grow once again.
In 2013 researchers published the interesting results of an animal study using gemcitabine. Animal trials are studies that precede clinical trials with human participants. The 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. This shows that it may be possible to use lower doses, and to therefore have fewer side effects, while getting the same results in slowing tumor growth.
These and ongoing clinical trials show great promise for using gemcitabine to treat mesothelioma. More studies are needed and researchers are likely to continue combining it with other chemotherapy drugs, but also with more targeted and novel drugs like immunotherapy drugs and vaccine therapies. These advances in using chemotherapy drugs for unapproved uses are what lead to new treatments and greater hope for patients struggling with a difficult disease like mesothelioma.
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