Intergel use in colorectal surgery leads to complications and is not recommended

Adhesions are a significant consequence of abdominal surgery, including surgery to treat colorectal cancer.  Intergel (ferric hyaluronate gel) has been used successfully in gynecologic surgery to prevent adhesions, but its use in colon resection wasn’t well understood.

Researchers randomized patients who were about to undergo colon resection to having Interget placed in the abdominal cavity during the operation or not having the treatment.  Initially their goal was to enroll 200 patients, but the study was halted after 32 patients because of the high number of complications in the Intergel group.

65% of the treatment group experienced a surgical complication compared to 27% of the controls.  Five patients in the Intergel group had leaks where the colon was reconnected (anastomosis) compared to one control.  Ten Intergel patients had prolonged time to recovery of bowel function (ileus) compared to 2 in the control group.  There was 1 case of peritonitis.  Wound healing problems were also common in the Intergel group but the difference was not significant.

The study, published in the April 2006 issue of Annals of Surgery concluded:

The use of Intergel in abdominal surgery where the gastrointestinal tract is opened leads to unacceptably high rates of postoperative complications.

adhesions colon resection Intergel

Posted by Kate Murphy on April 24th, 2006
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Younger colorectal cancer patients at higher risk for a second colorectal cancer

Some people who have been successfully treated for one colorectal cancer will be diagnosed with a new primary colorectal tumor later on — a metachronous tumor. Follow-up with colonoscopy can identify these cancers early so they can be treated.  However, it isn’t clear who might be at greatest risk for metachronous cancer.

Korean scientists reviewed over 5,400 cases of colorectal cancer treated at the Asan Medical Centre in Seoul between 1989 and 2004.  Overall there were 39 metachronous colorectal cancers (0.7%) in that time.  The new cancers were diagnosed from 6 months to nearly 18 years after treatment for the initial colorectal cancer with a third found more than 5 years later.

Patients with metachronous cancers were more likely to have had initial diagnosis:

• at an earlier age.  Average age for the first cancer was 53.
• in the right colon.
• with cancers or polyps in other locations in the colon at the same time (synchronous tumors).

Writing in the May 2006 issue of Colorectal Disease  I.J. Park and colleagues concluded,

We found that in patients aged < 50 years, existence of synchronous polyps or cancer influence on the development of metachronous colorectal cancer. Regular follow-up is necessary for early detection, even after 5 years, for these patients.

metachronous colorectal cancer

Posted by Kate Murphy on April 23rd, 2006
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Mutated gene predicts resistence to Erbitux therapy and poorer overall survival

Erbitux™ (cetuximab) blocks EGFR, a receptor on colorectal cancer cells that promotes the growth of the cell. Some patients who are treated with Erbitux™ will respond to the drug, and their tumors will get smaller.  For these patients, survival time is increased.  Others show no response and have no improved survival.

French scientists explored some of the genes that are associated with the EGFR (epidermal growth factor receptor) pathway for mutations that might affect response to Erbitux™.  Looking at 30 patients with metastatic colorectal cancer, they found that 11 (37%) responded to Erbitux treatment. 

One mutated gene — KRAS — was significantly associated with lack of drug response.  None of patients who responded had mutated KRAS, while nearly 70% of those who had no objective reductions in their tumors did have KRAS mutations.

In addition to Erbitux™ response, KRAS mutations predicted poorer survival.  Patients with mutated KRAS in their tumor had a median overall survival time of 6.9 months compared to those without mutations whose median survival was 16.3 months.

Study results were reported in the April 15, 2006 issue of Cancer Research.

The research team, headed by Astrid Lievre, reported:

In conclusion, in this study, KRAS mutations are a predictor of resistance to cetuximab therapy and are associated with a worse prognosis.

KRAS cetuximab resistance

Posted by Kate Murphy on April 21st, 2006
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Waist fat increase colon cancer risk in women

Women who have excess fat around their waists, so-called central adiposity, have an increased risk for colon cancer according to a study in the March 2000 issue of the International Journal of Cancer.

Studying 24,000 women over 10 years, researchers in Australia measured waist circumference and waist-to-hip ratios (WHT) ratios at the beginning of the study.  During the ten years, there were 212 colon cancers.  Women whose waist measurements were larger than their hips, a sign of central adiposity, were about 30% more likely to have colon cancer than  women with narrow waists.  Larger waist measurements (waist circumference) increaed colon cancer risk by about 15%.

There was some evidence that additional central fat predisposed women in the study to cancers in the proximal colon or the first section of colon.  Given their increased risk for colon cancer and the stronger possibility that the cancer might be located near the beginning of the colon, women with excessive waist fat probably should consider screening tests like colonoscopy that examine the entire colon.

Other studies have showed a similar increase in colorectal cancer risk for men with excess waist fat.

An article about the study is available from Reuters Health..

waist fat colon cancer risk colon cancer in women

Posted by Kate Murphy on April 20th, 2006
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Manufacturers can provide free drugs to low-income patients receiving Medicare Part D

Health and Human Services officials have clarified ways that drug manufacturers can continue to provide free medications to needy patients, even if those patients are enrolled in Medicare Part D prescription coverage.

HHS Inspector General Daniel Levinson clarifed his position on Tuesday, April 19, 2006 that there are “lawful avenues” for pharmaceutical companies to give financial assistance to needy Medicare patients.

Critical to such programs are:

• No Medicare payment is sought for free drugs.
• Assistance is based solely on financial need.
• There is a methodology for assistance that does not take into account the patient’s choice of a Medicare Part D drug plan.

In January 2006, HHS provided guidance to pharmaceutical companies and patient assistance programs to ensure that the programs operated legally and did not pressure any patient to take a particular drug.

There has been confusion over whether patients could be required to drop out of Part D in order to receive drug assistance or help with co-pays.  In addition, some pharmaceutical company patient assistance programs have required that patients enroll in Part D.  However, patients do not need to drop out of Part D or be compelled to enroll to meet federal requirements.

Pharmaceutical companies can help with Medicare Part D co-pays as long as there is no company pressure to persuade a patient to use a particular drug.  Many companies are turning to not-for-profit organizations to provide counseling and financial help with co-pays through unrestricted grant programs to those organizations.

Posted by Kate Murphy on April 20th, 2006
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