Colorectal Cancer News in Brief: October 9

Briefly: In research this week, human embryonic stem cells produced an immune response in mice with colon cancer, and discussing strong pain medicines with cancer patients reduces their pain by about 20 percent.

The Food and Drug Administration has found many dietary supplements contaminated with prescription drugs not listed on the label, some at several times higher than the recommended dose.  In other FDA news, Spectrum Pharmaceuticals was unable to get FDA approval for use of Fusilev® for metastatic colorectal cancer.

Research Reports

  • Stem cell researchers at the University of Connecticut have laid groundwork for a possible cancer vaccine. Injecting human embryonic stem cells into mice with colon cancer induced a strong immune response that reduced tumor growth. Dr. Bei Liu, one of the study’s leaders said, “Although we have only tested the protection against colon cancer, we believe that stem cells might be useful for generating an immune response against a broad spectrum of cancers, thus serving as a universal cancer vaccine.
  • Pooled analysis of 21 studies of cancer pain found that talking to patients about how the strong pain drugs worked, how best to take them, and myths about them improved pain relief by a full point on a 10 point scale.  In discussing the research at the United Kingdom’s National Cancer Research Institute’s Cancer Conference in Birmingham  on October 7, Professor Michael Bennett said, “Helping people manage pain is a major challenge for doctors and our research shows for the first time that education is an effective, easy and cheap way to do this.” Hear an interview with Professor Bennett from NCRI.

Other Headlines

  • The FDA has identified over 140 contaminated dietary supplements, but this is only the tip of the iceberg according to American Roulette — Contaminated Dietary Supplements, an article in the New England Journal of Medicine. Many of the supplements contain drugs that aren’t listed on the label among so-called “natural” ingredients.  Supplements are regulated under the 1994 Dietary Supplement Health and Education Act (DSHEA) which does not require safety testing before dietary supplements can be placed on the market or label warnings about side effects.  However, they must include all ingredients on their labels and cannot have prescription medicine as an ingredient.  Some prescription stimulants in dietary supplements sold for weight loss are three times what would be a safe dose.
  • The FDA has refused to approve Spectrum Pharmaceutical’s application to extend indications for Fusilev® (levoleucovorin) to include metastatic colorectal cancer. Their response to Spectrum said that the company’s submission did not demonstrate the Fusilev was not inferior to leucovorin.  However, they recommended that Spectrum meet with them to discuss options for continuing to seek approval for the use of the drug in colorectal cancer.  Spectrum says that they will seek an FDA meeting promptly.  Fusilev is the active part of the leucovorin (folinic acid) molecule and can be used at a lower dose than leucovorin.  Last year, when there was a shortage of leucovorin in the United States, some oncologists substituted Fusilev for leucovorin, which is a critical part of many colorectal cancer chemotherapy regimens.  Fusilev is FDA-approved to rescue overdoses of methotrexate but not to treat colorectal cancer.

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