No difference in irinotecan (camptosar) effectiveness for patients on two difference treatment schedules (Journal of Clinical Oncology) March 2003 -- A randomized Phase III trial compared irinotecan given weekly to a regimen of a higher dose every three weeks.

There was no significant difference in 1 year survival, median survival, or time to progression. However, there was significantly more diarrhea in the patients treated weekly. 36% experienced grade 3 or 4 diarrhea which is serious enough to cause hospitalization.

The authors, Charles S. Fuchs and his associates, conclude that "Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea."

Read the abstract here in the Journal of Clinical Oncology.

New methods of colorectal cancer screening -- (ACS News Today) February 20, 2003 -- An expert panel from the American Cancer Society's Colorectal Cancer Advisory Group recently examined some new technologies for CRC screening including virtual colonoscopy, immunochemical fecal occult blood testing, and stool DNA tests.

They concluded that there are drawbacks to virtual colonscopy and stool DNA testing that must be addressed before recommending them for general screening. However, the newer FOBT test based on immunochemicals rather than guaiac was added to the recommendations.

While the experts agreed that the new test had many of the same problems as the traditional FOBT -- it is only able to detect tumors that are bleeding at the time of sampling -- it is more specific, returns fewer false positives, and is more patient-friendly. The test does not require special diets or stopping the use of certain drugs as does the guaiac-based FOBT.

in CA: A Cancer Journal for Clinicians (Vol. 53: 44-55).

Read the article on Yahoo! Health News: ACS News Today
)

Wealthy man sues for access to an experimental drug. SAN FRANCISCO (San Francisco Chronicle) February 16, 2003 -- Joseph Stendig, an affluent man with a serious lung disease idiopathic pulmonary fibrosis (IPF) is suing to be able to purchase an experimental drug that he believes might help him.

Intermume, the company that manufactures the drug pirfenidone says that it has not completed trials for safety or effectiveness and refuses to sell it to him. There is currently no compassionate use program for the drug.

Stendig has already spent $80,000 on a similar experimental drug rather than be part of a clinical trial where he might not have received the drug itself.

Compassionate use programs can turn into public relations nightmares if they are not run well. Two years ago, CBS's "60 Minutes" arbitarily gave some colon cancer patients the experimental drug cetuximab (Erbitux) and denied it to others. Fairness became a critical issue in those decisions which were later investigated by a congressional committee.

ImClone now has an expanded access program that will select eligible patients by lottery similar to one developed by another biotech company Genentech in 1996 for its experimental drug Herceptin.

Heather Schwartz of Genentech's patient advocacy office told the Chronicle, "Regardless of financial status or socioeconomic status, it's essential that you do not have any single-patient exceptions -- for the good of ensuring that you develop the drug as quickly as possible for everyone."

The article was written by Bernadette Tansey, Chronicle Staff Writer.

Read the article here in the San Francisco Chronicle.

Despite a reduction in colorectal incidence, no survival benefit was found (1986-1997) -- (American Journal of Gastroenterology) February 2003

Linda Rabeneck MD, MPH, and her colleagues analyzed data from the cancer registries of the Surveillance, Epidemiology, and End Results (SEER) Program at the National Cancer Institute to see what effect advances in colorectal screening and treatment had had on the incidence and survival of colorectal cancer in the US between 1986 and 1997.

They found that the incidence of CRC cancer in the rectosigmoid and left colon fell over time for both white men and white women. Incidence of CRC in the right colon fell for white men, but not white women. Incidence of CRC in all sites showed no significant change in African-Americans.

Despite the lowered incidence rate, no significant difference in survival rates were seen over time in whites or blacks.

SOURCE: American Journal of Gastroenterology Volume 98, Issue 2, Pages 471-477.

Read the abstract here.

Cetuximab (Erbitux (TM)) now available in an expanded access program for colorectal cancer patients who have exhausted all other treatment options -- NEW YORK & PRINCETON, NJ (Business Wire) February 6, 2003 -- The Cetuximab Access Program is now enrolling patients who are not eligible for current clinical trials and whose cancer has progressed on all other treatments.

NORD (the National Organization for Rare Disorders) will administer a randomized, unbiased selection process for patient entry into the program.

Patients must be enrolled in the cetuximab Access Program by their physician. If a person with colorectal cancer is interested in participating in the cetuximab Access Program, his or her physician should call (877) 925-6631 to determine if he or she meets the specific medical eligibility criteria for the program.

Read the Press Release from ImClone Systems and Bristol-Myers Squibb here.

Mayo Clinic regimen can result in severe toxicity --(American Journal of Clinical Oncology) The Mayo Clinic regimen treats colorectal cancer with 5FU and leucovorin daily for a 5 days, repeated every four weeks. A prospective study of 243 patients found 13% were hospitalized for chemotherapy-related toxicity with 5 treatment related deaths. (2%)

Female patients showed a higher incidence of severe toxicity (18%), Four of the five deaths were women. Men had a 7% incidence of toxicity severe enough to cause hospitalization.

Elderly patients over the age of 70 were much more likely to have problems with toxicity (24%) and toxic death than younger patients. Four of the five treatment-related deaths occured in the 89 patients older than 70.

Major toxicities in study patients included neutropenic fever in 9%, grades III and IV mucositis (mouth sores) in 10%, and grades III and IV diarrhea in 8%.

Most episodes of severe toxicity occured after the first cycle.

The study authors write , "We conclude that the Mayo Clinic regimen can be associated with severe toxicity, usually occurring after the first cycle. Female gender and advanced age predict severe toxicity; therefore, dose reduction in high-risk patients should be considered, especially during the first cycle.

SOURCE: American Journal of Clinical Oncology 2003; 26(1):103-106

Read the study abstract here.

Study shows that older patients can handle chemotherapy -- NEW YORK (Reuters) February 7, 2003 -- People over age 70 are less likely to be given chemotherapy when they have cancer than younger patients. It is thought that doctors may underestimate the patient's overall life expectancy or believe that side effects may be too toxic.

A small study of 37 patients at the University of South Florida in Tampa showed that older patients can tolerate chemo without an unacceptable toxicity. Dr. Hongbin Chen and his colleagues reported in Cancer.

"Older cancer patients undergoing chemotherapy may experience toxicity but generally can tolerate it with limited impact on independence, comorbidity (other illnesses) and quality of life levels," writes Chen

In addition, Chen says that "It is important to recognize and monitor these changes during geriatric oncology treatment."

SOURCE: The study article appears in Cancer 2003;97:1107-1114.

Read it here on Yahoo! News

Herbal Medicine: Let the Buyer Beware -- NEW YORK (NY Times) February 4, 2003 - Jane Brody discusses lack of regulation and standardization of herbal medicines.



Herbal Remedies: Natural Does Not Mean Safe

Perforation of the Colon Twice as Frequent During Colonoscopy vs Sigmoidoscopy -- (Journal of the National Cancer Institute) February 5, 2003 -- Risk of perforating the colon during sigmoidoscopy is about half that of colonoscopy. However, the risk during colonoscopy has decreased in recent years.

Nicolle M. Gatto, of the Mailman School of Public Health at Columbia University, Alfred I. Neugut, M.D., Ph.D., of Columbia University and New York-Presbyterian Hospital, and their colleagues reviewed Medicare data and identified elderly people who were cancer-free and had undergone either sigmoidoscopy or colonoscopy between 1991 and 1998. They then searched for record of perforation within 7 days of the procedure.

There were 77 perforations in just over 39,000 colonoscopies (1.96 per 1000) and 31 in 35,000 (0.88 per 1000). Roughly 5% of those who had a perforation died.

Read it here in InteliHealth: Health News.