Fight Colorectal Cancer

Actavis, Inc. is voluntarily recalling 14 lots of generic fentanyl pain patches sold in the United States because of a defect that may cause the potent fentanyl gel to leak.

There may be a fold-over defect in the patches that can expose patients or caregivers directly to fentanyl gel.  Although Actavis is not aware of any injuries that have been caused by faulty patches, they are recalling them as a precaution.

Unlike a recent recall of 25 mcg Duragesic patches by PriCara, this recall involves all strengths including 25, 50, 75, and 100 mcg/hr.

The FDA is involved in the recall and points out that Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc.  The pouches that contain the patches are labeled with an Abrika logo, but the outer carton has the Actavis logo and “Actavis Fentanyl Transdermal System.”

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Last legislative session State Senator David Thomas and Sate Representative Gilda Cobb Hunter introduced companion legislation (S561 & H3530) to mandate colorectal cancer screening coverage in South Carolina.

After pressure from advocates around South Carolina, Blue Cross and Blue Shield of South Carolina has voluntarily agreed to provide colorectal cancer screening coverage for all of their customers fifty years of age and older. This policy change will impact approximately 300,000 South Carolinians.
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Scientists have developed and validated a blood test for ovarian cancer that is more than 95 percent accurate in finding the disease. 

Using a panel of six biomarkers, the team was able to identify ovarian cancer in 95.3 percent of women who had recently been diagnosed with the disease.  None of the healthy controls were positive for the combination marker panel.

Ovarian cancer is a particularly deadly disease since it is hard to recognize and diagnose early when it is most curable.  In 2007, 22,430 women will be diagnosed with ovarian cancer and 15,280 will die.  A simple screening test for early detection would save many lives.

The assay tested for concentrations of leptin, prolactin, osteopontin, insulin-like growth factor II, macrophage inhibitory factor, and CA-125.  Although CA-125 is currently used as a test for ovarian cancer, it is not as accurate as the six-marker panel.  None of the biomarkers individually effectively diagnosed cancer, but used together they were both very sensitive in finding cancer and specific in not leading to false positive results.

The research team at the Yale School of Medicine wrote,

We describe the first blood biomarker test with a sensitivity of 95.3% and a specificity of 99.4% for the detection of ovarian cancer. Six markers provided a significant improvement over CA-125 alone for ovarian cancer detection. Validation was performed with a blinded cohort. This novel multiplex platform has the potential for efficient screening in patients who are at high risk for ovarian cancer.

Further testing involving over 2000 women is now underway.

Women who have a genetic mutation for colorectal and related cancers known as Lynch syndrome or HNPCC have about a 10 to 12 percent risk of developing ovarian cancer during their lifetimes.

SOURCE: Visintin et al. Clinical Cancer Research, Volume 14, Issue 4, February 15, 2008.

An additional article by Peter M. Crosta about the study appears online in Medical News Today.

Senator John McCain won the Wisconsin Primary on Tuesday night widening his margin of delegates over second place Mike Huckabee.

Though McCain pulls to an unreachable lead over Huckabee, the former Governor of Arkansas refuses to drop out of the race. “We see the last stand only when somebody has 1,191 delegates,” Huckabee said Tuesday.

On the Democratic side Senator Barack Obama came out on top in Wisconsin. The race between Obama and Senator Hilary Clinton remains tight with both candidates looking ahead to the March 4th primaries in Ohio and Texas, The winner of those states stand to gain a substantial bump in their number of delegates.

The fight for Commander in Chief wages on with all candidates fighting for their respected party’s nomination.

Stayed tuned to the never ending soap opera we like to call American Politics.

Clinical Trials at NIH Clinical Center

A clinical trial is recruiting patients with advanced colorectal cancer to test response rates when and oral drug Nexavar® (sorafenib) is added to to Erbitux® (cetuximab).  In addition, researchers will be evaluating the safety and side effects of the combination.

Erbitux blocks receptors on the surface of cancer cells for EGFR, a protein that stimulates growth and multiplication of cancer cells.  Nexavar works in a different way to block two other substances that promote cancer growth:  VEGF and raf kinase.  By blocking additional cancer cell activity, the research team hopes to increase the number of responses to treatment and also increase time until cancer begins to grow again.

In order to be eligible for the trial, patients must

• Have confirmed metastatic colorectal cancer
• Have already had their cancer progress on at least one chemotherapy regimen for metastatic cancer
• Have tumors that can be measured.
• Have tumors that can be reached for biopsies.
• Have tumors that are positive for EGFR
• Have received one or more 5FU (fluorouracil) containing chemotherapies.

Patients who are not eligible include those

• who are able to have their tumors surgically removed.
• with cancer that has spread to their brains.
• who have already received either Erbitux or Nexavar
• who cannot swallow pills
• are pregnant or nursing

The trial is being conducted at the NIH Clinical Center at the National Institutes of Health in Bethesda MD,outside of Washington, DC.

Dr. Shivaani Kummar is the principal investigator for the study.  She explains,

The majority of patients with metastatic colorectal cancer have tumors expressing EGFR. Cetuximab is approved by the FDA to treat EGFR-expressing metastatic colorectal cancer, but unfortunately, it produces significant tumor shrinkage in only about 10 percent of patients when used as a single agent. With this trial, we hope to see an improved response rate by augmenting the activity of cetuximab with an additional drug that blocks other processes important for tumor growth and cell proliferation.

Patients will be admitted to the hospital at the NIH Clinical center for two or three days at the beginning of treatment.  From then on, there will be weekly out-patient visits.  It is possible for outpatient treatment to be coordinated with local oncologists to reduce travel to Bethesda.

There is no cost for treatment at the NIH Clinical Center.  Patients will need to pay their own travel costs for the initial screening visit, but after that the National Cancer Institute will pay for all travel costs, as well as providing a small subsidy for housing and meals.

For more information contact:

Shivaani Kummar, M.D.
Principal Investigator
Phone: 301-435-5402
kummars@mail.nih.gov

Janelle Bingham, R.N.
Referral Coordinator
Phone: 301-435-2715
jbingham@mail.nih.gov

More information about the study is on the National Cancer Institute clinical trials website.