FDA rejects health claims that tomatoes and lycopene reduce cancer risk

Posted by Kate Murphy on July 11th, 2007

The United States Food and Drug Administration has refused to allow health claims that tomatoes or lycopene reduce the risk of getting cancer.  For such claims to appear on the labels of food products or dietary supplements, the FDA must approve them before they are marketed. 

According to a review in the Journal of the National Cancer Institute, the FDA found

  • No credible evidence that there was an association between lycopene intake and a reduced risk of prostate, lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic cancer.
  • No credible evidence for an association between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer
  • Very limited evidence to support an association between tomato consumption and reduced risks of prostate, ovarian, gastric, and pancreatic cancers.

In 2004 the FDA received two petitions for qualified health claims supporting the association between tomatoes, lycopene, and the risk of certain cancers.

In an accompanying editorial, Paul M. Coates from the Office of Dietary Supplements at the National Institutes of Health points out the difficulties of finding strong evidence to support tomato and lycopene claims.  Many studies were preclinical, small, or based on observation.  However, he defends the importance of clear and transparent evidence-based reviews and points out that such reviews can be updated if new information becomes available.

A second editorial writer, Edward Giovannucci, from the Department of Nutrition at the Harvard School of Public Health points out that studies supporting an association between tomato sauce, lycopene, and prostate cancer were done before PSA testing became common in the United States.  More recent studies don’t agree.  However, he believes that there may be a connection between more advanced prostate cancer and tomatoes that should be studied further, along with possible genetic associations and combinations of tomatoes, lycopene and other antioxidants.

More information is available in a JCNI press release.

SOURCE: Kavanaugh et. al, Journal of the National Cancer Institute, advance access, July 10, 2007.

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Weighing complications and survival in treating pelvic recurrences of rectal cancer

Posted by Kate Murphy on July 9th, 2007

Even after successful surgery to remove rectal cancer, pelvic recurrences can happen.  Surgery to remove the cancer offers a possibility of cure, but also has risks.

Surgical oncologists at Fox Chase Cancer Center in Philadelphia retrospectively reviewed surgeries to remove pelvic recurrences after rectal cancer surgery from 1988 through 2003 where the goal was curing the cancer. 

Studying outcomes for 90 patients, they found

  • 4 (4.4%) died during surgery
  • 53 percent had surgical complications
  • 5-year survival rate was 40%
  • 51 of 86 patients had another recurrence: 15 locally, 16 to distant organs, and 20 both locally and distant

Carcinoembryonic antigen level (CEA) before surgery and clear surgical margins helped predict successful treatment.

Writing in the Annals of Surgical Oncology, Leonard B. Henry, MD, concluded,

The resection of pelvic recurrences after colorectal surgery for cancer can be performed with low mortality and good long-term outcome; however, morbidity from such procedures is high. Low preoperative carcinoembryonic antigen and negative margin of resection predict improved survival.

SOURCE: Henry et. al. Annals of Surgical Oncology, Volume 14, Issue 7, July 2007.

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Anti-cancer virus shows early promise for colorectal cancer

Posted by Kate Murphy on July 8th, 2007

Early information shows that a genetically engineered virus is safe and shrinks colorectal cancer tumors.  The specially modified version of the herpes simplex virus is designed to attack and destroy cancer cells while leaving healthy tissue unaffected.

Once inside the cancer cell, the virus begins to divide and grow killing the cell and shrinking the tumor.

Dr. Axel Mescheder, from the Munich-based biotech company MediGene, presented safety information and a patient case study at the ESMO Conference in Lugano, Switzerland (ECLU).  Describing the virus, called NV1020, Dr. Mescheder said,

It doesn’t replicate in normal, healthy cells, so our hope is that it will help fight cancers without causing side-effects in the rest of the body.

In the current study, the scientists are testing the treatment in patients with colorectal cancer that have not responded to chemotherapy and where the cancer has spread to the liver. We are hoping to extend overall survival.

Led by Dr. Tony Reid, the Phase I and II clinical trial is underway at seven cancer centers in the United States.  Eligible patients include those who have

  • colorectal cancer that has spread to the liver
  • the liver as the major metastatic site
  • progressed on standard chemotherapies

In his poster presentation at ECLU, Dr. Mescheder described a patient in the trial who had extensive colorectal cancer tumors in his liver and several tumors in the lungs.  Six months after treatment, the liver metastases had nearly disappeared.  The patient lived for 12 months.

More information about the trial is available from:

MediGene Incorporated

Moores Cancer Center at the University of California at San Diego

UPDATE:  C3 has received information that the current clinical trial is full and is closed to more patients. 

 

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Smoking reduces amount of irinotecan available in the blood

Posted by Kate Murphy on July 6th, 2007

Cancer patients who smoke have significantly lower levels of irinotecan and its active metabolite than non-smokers.  They also had much less toxicity leading researchers to question whether or not they are at risk for treatment failure.

Analyzing the available dose of irinotecan in the blood of both smokers and non-smokers, scientists found less drug for smokers.  In addition, smokers had an almost 40 percent reduction in the level of SN-38.  Irinotecan is converted to SN-38 by body enzymes, and SN-38 attacks cancer cells. 

Only 6 percent of smokers being treated with irinotecan developed serious low white cell counts (neutropenia) compared to 38 percent of non-smokers in the study.  There was no significant difference in diarrhea.

Jessica M. van der Bol and her colleagues in the Netherlands, Sweden, and the United States speculated that cigarette smoke interferes with the enzymes that metabolize irinotecan.  They concluded,

This study indicates that smoking significantly lowers both the exposure to irinotecan and treatment-induced neutropenia, indicating a potential risk of treatment failure. Although the underlying mechanism is not entirely clear, modulation of CYP3A and uridine diphosphate glucuronosyltransferase isoform 1A1 may be part of the explanation. The data suggest that additional investigation is warranted to determine whether smokers are at increased risk for treatment failure.

SOURCE:  van der Bol et.al. Journal of Clinical Oncology, Volume 25, Number 19, July 1, 2007.

WHAT THIS MEANS FOR PATIENTS

If you are receiving Camptosar® (irinotecan or CPT-11) chemotherapy and smoke, talk to your doctor about dosage.  Stopping smoking might make the treatment more effective for you.

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Chinese herbal medicine helps control chemo nausea, but not other side effects

Posted by Kate Murphy on July 4th, 2007

In a randomized, doubled-blinded study, Chinese herbal medicine was compared to a placebo in managing the side effects of chemotherapy.  While there was a significant difference in nausea among those taking the herbal medicine, there was no effect on serious anemia, low white cell counts, or reduced blood platelets.

To provide consistency, patients with early stage breast or colon cancer were randomly assigned to one of three Chinese medicine herbalists who prescribed a package of active single-item granules or a placebo package with non-therapeutic herbs with artificial smell and taste similar to the active herbal medicine.

Taking herbs decreased moderate nausea significantly from 35.7 percent to 14.6 percent.  However, none of the severe chemo effects on the blood were impacted — anemia, leukopenia, neutropenia, or thrombocytopenia.

TSK Mok and team concluded,

Traditional CHM does not reduce the hematologic toxicity associated with chemotherapy. CHM, however, does have a significant impact on control of nausea.

SOURCE:  Mok et. al. Annals of Oncology, Volume 18, Number 4, April 2007.

WHAT THIS MEANS FOR PATIENTS

This study tried to control for many different varieties of Chinese herbal medicine by limiting prescriptions to three herbalists.  It also controlled for the placebo effect by randomly providing a similar, non-active treatment.

The study does not provide any information about whether or not the herbal medicine affected the effectiveness of the chemotherapy.

Patients are strongly urged to discuss any medication, herb, or vitamin that they are taking during chemotherapy with their oncologist.  Herbs can and do both reduce treatment effectiveness and increase some side effects.

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