A randomized Phase III study indicates that the addition of AE-941, a shark cartilage derivative, to standard chemoradiotherapy does not improve survival in patients with unresectable Stage III non–small cell lung cancer (NSCLC). These findings were recently published in the Journal of the National Cancer Institute.
In 1997, Americans spent more than $27 billion on complementary and alternative medicine (CAM) therapies, exceeding out-of-pocket spending for all U.S. hospitalizations. In 1998, the Journal of the American Medical Association published an article in which CAM use by the general public was found to have increased from 34% in 1990 to 42% in 1997.
Shark cartilage is a CAM strategy that became very popular in the 1990s with reports of shark cartilage supplement use by 25% of cancer patients. In order to scientifically evaluate a shark cartilage derivative, the National Cancer Institute and the National Center for Complementary and Alternative Medicine funded this study to rigorously evaluate whether or not a standardized shark cartilage derivative provided a health benefit to NSCLC patients.
AE-941 (Neovastat) is a shark cartilage derivative that has shown antiangiogenic properties in preclinical studies. Angiogenesis is the process of creating new blood vessels necessary to transport food to cancer cells, which if inhibited may indirectly kill the cancer cells. AE-941 has been through the same pharmaceutical development process as other drugs and is standardized, unlike shark products that consumers may find in a health food store or drug store.
In this double-blinded, placebo-controlled Phase III study, NSCLC patients who were not eligible for surgery were treated with chemoradiotherapy and randomized to receive either AE-941 or a placebo. Although the study was closed early due to low accrual, 379 patients were enrolled. Median overall survival was 15.6 months for the placebo arm and 14.4 months for the AE-941 arm. No statistically significant differences in progression-free survival, time to progression, or response rates were reported.
The researchers concluded that NSCLC patients do not appear to have a survival benefit with the addition of the shark cartilage derivative, AE-941, to chemoradiotherapy. Additional studies providing scientifically rigorous evaluation of supplements and other CAM strategies may provide important information for cancer patients. Patients undergoing treatment for NSCLC or other cancers who are taking or planning on taking a supplement or other form of CAM need to speak with their healthcare team about the risks and benefits of supplements and whether or not they are contraindicated.
 Lu C, Lee J, Komaki R, et al. Chemoradiotherapy with or without AE-941 in stage III non–small cell lung cancer: a randomized phase III trial. Journal of the National Cancer Institute [early online publication]. May 26, 2010.