Researchers affiliated with a multi-center U.S. trial reported in the July 20, 2008 issue of the Journal of Clinical Oncology that the combination of Alimta® (pemetrexed) and Gemzar® (gemcitabine) was active in patients with peritoneal mesothelioma.

Peritoneal mesothelioma is much less common than pleural mesothelioma, making up less than 20% of all cases. Moreover, the latency period for peritoneal mesothelioma (sometimes referred to as abdominal mesothelioma) appears to be 20-30 years, which is shorter than the latent period for pleural mesothelioma. The most common treatment strategy for peritoneal mesothelioma involves a multimodality approach with surgical debunking followed by systemic and/or intraperitoneal chemotherapy.

Due to the relative rarity of this disease, controlled trials of various treatment options are not available for peritoneal mesothelioma. Therefore, few studies of chemotherapy for peritoneal mesothelioma, treatment regimens are derived from studies in patients with pulmonary mesothelioma.

This current study involved 20 patients treated between 2002 and 2004. Patients received Alimta and Gemzar every 21 days. In addition, patients also received folic acid, vitamin B12, and dexamethasone. The results from the study are listed below.

- The overall response rate was 15%.

- The disease control rate was 50%.

- The median time to disease progression was 10.4 months.

- The median survival time was 26.8 months.

- Toxicities appeared to be tolerable but with a grade 3-4 neutropenia rate of 60%.

The researchers have concluded that Gemzar and Alimta is an active regimen that is an alternative to standard therapies. This is one of the first studies devoted to systemic chemotherapy treatment of peritoneal mesothelioma and provides important baseline information.

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In June, I blogged about a California bill addressing end-of-life rights for patients. A similar bill is currently stuck in committee in Vermont and a proposition for a federal bill is being brought to the Senate's attention. It would be the first act of its kind to gain national passage.

The California bill requires doctors to teach terminal patients about end-of-life options such as hospice homes and palliative care, so that the patients know they are not obligated to continue aggressive treatment regiments. Under the bill, doctors must give this straight talk to patients who are expected to survive less than a year.

This bill puts the patient in power of decision-making. Without this provision, physicians control how much patients knows. This bill ensures that the patient is fully informed and can make educated and knowledgeable choices regarding their health, treatment, and end-of-life environment.

Physicians are obligated to present options to patients, but not endorse any. Nevertheless, the bill has garnered opposition from politicians who believe that it is setting the stage for assisted suicide cases. While palliative care aims only to comfort a patient in their last days, it has been known hasten the process of dying.

California's measure is known as the "Terminal Patients' Right to Know End-of-Life Options Act." Under the bill, physicians who do not comply with the terminal patient's wishes must refer the person to a new doctor who will carry out his or her intentions.

Many doctors fear that compliance with the bill will be hard to guarantee, as it is often difficult to predict a patient's likelihood of surviving a year. To this point, some oncologists believe that discussing end-of-life options too early can cause the patient harm. Though this point was essentially debunked in a recent study, physicians struggle to find a balance between informing their patients and overwhelming them. Some doctors warn against divulging details too soon: "What most people want to know about are hospice and palliative care. They may not be asking about last-resort options like palliative sedation and stopping eating and drinking," said Dr. Quill, director of the University of Rochester Medical Center's palliative care program in New York.

Thomas J. Smith, MD, an oncologist and co-author of a Journal of the American Medical Association article on poor communication between cancer patients and doctors, said the California law "is something that could be tested in one state, and if it works, then it could potentially be applied to other states. It certainly raises awareness of the issues."

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When used in conjunction with chemotherapy, a new treatment has been shown to increase life-span by five weeks among lung cancer patients.

A study released last week indicates that the drug Erbitux, created by ImClone Systems Inc, can both help lung cancer survival and decrease tumor size when used with chemotherapy treatments. The study involved 1,125 patients; overall survival was 11.3 months for patients on the combination therapy, compared with 10.1 months for the group receiving just chemotherapy. Tumors shrunk in 36.3 percent of patients treated with Erbitux, also known as cetuximab, compared with 29.2 percent of patients on chemotherapy alone, according to a statement from the American Society of Clinical Oncology.

Prior to the publication of these promising results, the only non-chemo treatment for lung cancer had been Genentech Inc's Avastin, which combats non-small cell lung cancer.

Erbitux is an antibody already approved for treating colorectal as well as head and neck cancers. It is designed to block a protein called epidermal growth factor, and has so far exhibited only minor side effects. The most common complaint among trial participants was the appearance of an acne-like rash, seen among 10.4% of patients using the combination therapy, compared to .2% of patients receiving only chemo.

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Researchers announced on Sunday that a simple blood test may be the key to detecting lung cancer in its earliest stages, in turn increasing the likelihood of survival.

Lung cancer is typically detected in advanced stages, which is a major reason that only 15% of lung cancer patients survive two years after diagnosis. A new study, however, indicates that a specific genetic profile for lung cancer is present in the blood and can be perceived with 88% accuracy.

This discovery was presented at the annual meeting of the American Society of Clinical Oncology this past weekend. Though more studies on this initial research will soon follow, the findings indicate that detecting a genetic disposition for lung cancer in the blood can help predict the disease's occurrence within two years.

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Within a decade, cancer is expected to surpass heart disease as America's biggest killer.  Currently, the disease strikes one in three Americans and kills one in four; it claims the lives about 1,500 Americans daily.

To combat these climbing numbers, the government has channeled about $75 billion into oncology studies since 1971. But even in the midst of generous funding and tireless research, the cancer death rate has only dropped by 7% over the past three decades. Why?

As this question becomes more pressing, attention is shifting to the FDA and its methods of approving cancer treatments. Some authorities believe the FDA is so wrought with red tape and inefficiency that it is significantly jeopardizing the survival capacity of American cancer patients. A recent study at Tufts revealed that only 8% of experimental cancer drugs receive FDA approval, compared to 20% of medicines for all other diseases. Steven Creel of Austin, Texas, can speak to this problem personally.

Steven was diagnosed with an aggressive form of kidney cancer in 2003. Because he was at high risk of the cancer recurring after surgery, he began to explore other options. Steven entered a clinical trial for the experimental treatment Oncophage and encountered impressive results. Essentially, Oncophage is a vaccine that summons the immune system to fight off cancer cells. "There were literally no side effects. I would have the treatment and then play tennis," he said. Steven has been cancer-free for five years. "I feel very, very fortunate."

Despite success with patients such as Steven, Oncophage--like so many other experimental cancer drugs--hit a wall late in the clinical trial stages. Because of FDA criteria, 124 patients had to be removed from the trial, rendering the results less definitive. Oncophage's developer, Antigenics, suffered a huge financial loss because the study's outcome was consequentially inconclusive; the drug showed an increase in life span for only a small margin of patients--possibly because of the diminished pool of subjects--so the FDA did not deem the improvement substantial. Antigenics uprooted and moved to a country more receptive to their research needs: Russia. Within 10 months, the drug that saved Steven's life but was rejected in America became approved for use in Russia. Now, Antigenics is working the European Union for approval abroad. The company hopes to establish solid financial footing so it can return to America for another round of clinical trials in order to satisfy the FDA.

The FDA knows there is a problem with the slow and infrequent approval of cancer drugs, but is unwilling to adjust trial requirements. Richard Padzur heads the FDA's Office of Oncology Drug Products. Dr. Padzur has garnered criticism for his unrelenting and decisive views on cancer drug approvals, but he insists that the patient's safety and the drug's efficacy are the FDA's top priorities. "Believe me, if there were a clear survival effect, the drug would be approved," says Pazdur.

For many, the solution lies in the manner in which the FDA examines clinical trials. In 2004, the FDA launched the Critical Path Initiative to expedite and streamline clinical trials for cancer drugs, but since 2005 only 18 new treatments have been approved while hundreds wait in the pipeline. Many FDA officials hope to see the agency overhaul its approval methods for cancer medicines, much like it did for AIDS drugs in the '80s and '90s.

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