Latest information from the FDA says that manufacturing delays will prevent shipments of leucovorin from Teva Pharmaceuticals until next April.

Teva has leucovorin calcium lyophilized powder 100 mg and 350 mg vials on back order and the company does not anticipate release until April 2011.

Bedford Laboratories also cites manufacturing delays but is “releasing product as it becomes available.”

Fusilev® (levoleucovorin) continues to be available from Spectrum Pharmaceuticals.  However, special care needs to be taken with dosing.  It cannot be substituted one-to-one for leucovorin.  Patients need to be aware of its cost and the possibility that insurance may not cover its administration for colorectal cancer.

Update (11/9/2010): Coalition Board member Nancy Roach was quoted in an article on ReporterNews.com about this issue

Previously: More Leucovorin Woes

The November issue of American Journal of Roentgenology described a program in which specially trained technicians performed computed tomography (virtual) CT colonoscopies in two Navajo Nation health centers and transmitted the tests for interpretation by radiologists hundreds of miles away at the University of Arizona Health Sciences Centers.

A retrospective review of 320 patients found that more than 90% of the tests showed adequate patient preparation and technical performance of the procedure.  Researchers did report a relatively high (54%) rate of false-positives, but “If there was any doubt, I called it positive and recommended a colonoscopy,” said Dr. Arthur Friedman, the lead radiologist for the study.

The study authors acknowledged that a better study would be a randomized trial comparing annual FOBT screening, optical and CT colonoscopy but, they noted, many residents in these and other rural areas live far from post offices or in homes lacking adequate plumbing, so compliance with fecal screening tests is poor, and there are not medical personnel to perform optical colonoscopies or sigmoidoscopies.

Source: Medscape, Oct. 29, 2010

When women come in for a mammography, that might be an excellent chance to discuss—and schedule—a screening colonoscopy. In particular, this could help increase colorectal cancer screening among minority women, according to a study reported online by the journal Cancer.

For two years between 2003 and 2005, researchers offered colonoscopies to more than 2,600 women who came to the Breast Examination Center of Harlem—an outreach program serving a mostly black and Hispanic community. All the women were over age 50 with no history of either colorectal cancer or screening. Read the rest of this entry »

There is some evidence that patients having a specific type of KRAS gene mutation may respond better to Erbitux® (cetuximab) chemotherapy than others who have KRAS-gene mutations.

Previous studies have shown that people with KRAS-mutated tumors did not respond to Erbitux®, and practice guidelines now recommend testing all tumor cells for the mutation before starting Erbitux therapy in patients with recurrent, advanced colorectal cancer.

The study, reported in the Oct. 27 Journal of the American Medical Association (JAMA), examined both the data and tissue samples of 579 patients in several studies who received Erbitux® between 2001 and 2008 for chemotherapy-refractory cancer. Those patients with “codon-13” mutations had longer overall and progression-free survival by several months than those with other KRAS mutated tumor cells. Laboratory tests of tumor cell responses also showed that codon-13-mutated cells responded to cetuximab when other KRAS-mutated cells did not.

The study authors concluded that “Evaluation of cetuximab therapy in these tumors in prospective randomized trials may be warranted.”

What it means for patients:

Current evidence has shown the codon-13 type of KRAS mutation to be relatively rare, and more research on therapy response is necessary. It is probably too soon to change recommendations for therapy for those having the codon-13 mutation.

Source: Journal of the American Medical Association, Oct. 27, 2010

Disclosure:  The Colorectal Cancer Coalition has received funding from Eli Lilly & Company, Bristol-Myers Squibb and ImClone Systems, the companies that manufacture and market Erbitux, in the form of unrestricted educational grants.  The Coalition has ultimate authority over website content.

Dr. Lenz

I wanted to share with you an amazing story which began a few weeks ago.  A 28 year old woman with metastatic colon cancer with intra-abdominal spread came for a second opinion. She is well-educated and knows what she wants. She already had two opinions from the National Institutes of Health and the University of California at San Diego, and was open to hear what we would suggest.

I love patients who are informed (although it does not necessarily mean they have all the statistics and data correct). The discussion can move more quickly to create a plan, and there is no need to spend much time on the basics. But sometimes the problem with having a lot of information, especially from the internet and all the good friends you have, is prioritizing it. You have to decide what is the most important, what is validated, and what is a scam. Read the rest of this entry »