Shark Cartilage Shows No Benefit in Lung Cancer

[Christine]

http://www.cancerwise.org/July_2007/dis ... &color=red

Compound Was Given With Chemotherapy, Radiation

Shark cartilage, long rumored to have anti-cancer properties, has shown to be of no value as a therapeutic agent when combined with chemotherapy and radiation in patients with advanced non-small cell lung cancer, researchers say.

Significance of results

Results of the trial involving the shark cartilage extract AE-941 (Neovastat) were announced June 2 at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO).

“This is the first large Phase III randomized trial of shark cartilage as a cancer agent," says Charles Lu, M.D., an associate professor in M. D. Anderson’s Department of Thoracic/Head and Neck Medical Oncology and the national study's principal investigator.

“Clearly, these results demonstrate that AE-941 is not an effective therapeutic agent for lung cancer. So, too, these findings have to cast major skepticism on shark cartilage products that are being sold for profit and have no data to support their efficacy as a cancer-fighting agent.”

Research methods

The international Phase III study enrolled 384 patients with newly diagnosed, untreated Stage III non-small cell lung cancer (NSCLC) at 53 sites in the United States and in Canada from June 2000 to February 2006. M. D. Anderson enrolled 60 patients in the trial.

Study participants received the standard treatment of chemotherapy and radiation therapy. In addition, they received four ounces of shark cartilage or a placebo, both in liquid form, each day during and after standard therapy.

Primary results

Researchers say the shark cartilage extract studied did not meet its primary endpoint, which was to significantly increase life expectancy. The average survival for patients taking shark cartilage was 14.4 months, while the average survival for those taking placebo was 15.6 months. This difference in survival was not statistically significant.

Background

Shark cartilage has been of interest because:

Laboratory studies have shown promise

Its lack of blood vessels suggests anti-cancer properties

In addition, early, smaller clinical studies using higher doses of Neovastat suggested longer survival, but the larger, multi-center study disproved the findings.

The study was initiated and supported by the National Cancer Institute (NCI), which sought proposals for shark cartilage agents from pharmaceutical companies.

Unlike other shark cartilage compounds previously investigated, the product in this study never was sold over the counter. The pharmaceutical company Aeterna Zentari developed the compound as a pharmaceutical agent, not as a compound widely available to the public.

What's next?

Patients taking shark cartilage should be very cautious in believing the therapy will be beneficial, Lu warns.

“We have absolutely no data showing improvements in survival, tumor shrinkage and/or clinical benefits to patients,” he says. “Now when patients ask their oncologists about shark cartilage, physicians can point to this large NCI-sponsored Phase III trial and tell patients that, at this point, the only studies that have been done with cartilage-derived products have been negative