I have an opinion on how Co-Factor should be used. It is fairly long, including the backgrond info.
"Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
9/25/2007
BARCELONA, Spain, Sept. 25 /PRNewswire/ -- Five-year follow-up overall survival data from the X-ACT (Xeloda in Adjuvant Colon Cancer Trial) study show that oral chemotherapy Xeloda(R) (capecitabine) is as effective as the current standard treatment - intravenous bolus 5-FU/LV (5-fluorouracil/ leucovorin) - in the adjuvant treatment of Dukes' C colon cancer. These data were presented today at the 14th European Cancer Conference (ECCO) in Barcelona, Spain.
Results show five-year overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm. Additional data presented at the meeting from a previous analysis show that Xeloda is also comparable to 5- FU/LV with respect to disease-free survival (DFS) and relapse-free survival (RFS).
"These updated five-year overall survival data provide further proof that Xeloda can be a safe and effective alternative to the current standard of care for adjuvant colorectal cancer, which can require upwards of 30 clinic visits over the 24-week treatment course," said Dr. Howard Burris of the Sarah Cannon Research Institute, Nashville, Tenn., and lead U.S. investigator in the study. "Based on this evidence, physicians - especially those who have relied on 5- FU/LV - should feel confident about exploring Xeloda as a treatment option with their patients who could benefit from the flexibility of oral chemotherapy."
Previous results from the X-ACT study also show that Xeloda is more cost- effective than the Mayo Clinic regimen (the current standard treatment) and is associated with fewer side effects. Additionally, many of the side effects can be easily managed by altering the dose without compromising efficacy.(1,2) In the same analysis, costs for medicines to treat side effects, such as nausea and diarrhea, were cut by nearly 75 percent in the Xeloda arm compared to use of intravenous 5-FU/LV.
"We are pleased to see that Xeloda is standing up to its initial promise as an alternative to 5-FU/LV," said Lars Birgerson, Vice President, Medical Affairs, Roche. "Roche is committed to providing colon cancer patients with the safest and most effective treatment options that allow patients to continue their active lifestyles."
Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2007 more than 153,500 people in the U.S. will be diagnosed and about 52,000 people will die from the disease, accounting for almost 10 percent of all cancer deaths. When colorectal cancer is detected at an early, localized stage, the five-year survival is 90 percent; however, only 39 percent of colorectal cancers are diagnosed at this stage, mostly due to low rates of screening.
About the X-ACT Trial
The international, Phase III X-ACT trial enrolled 1,987 patients (1,004 patients were randomly assigned to Xeloda; 983 patients were assigned to intravenous 5-FU/LV) who were treated for a period of 24 weeks between 1998 and 2001 at 164 centers worldwide. The primary study objective was to show equivalence in disease-free survival between Xeloda and intravenous 5-FU/LV. Secondary objectives included: relapse-free survival, overall survival and safety.
Xeloda three-year disease-free survival and relapse-free survival rates demonstrated non-inferiority to 5-FU/LV (intent-to-treat analysis, P < 0.0001; P=0.0407, respectively). Xeloda was associated with fewer adverse events than 5-FU/LV (P < 0.001)
****My take
I would like to see Co-Factor used orally with Xeloda. I think that there was a trial which showed that Xeloda with leucovorin was no better than Xeloda alone. I believe results would be different with Co-Factor. I think less Xeloda would be needed to achieve efficacy, thus cost and toxicity would be less. Clearly, Roche has no motivation to do such a trial, but a government would support it.
The price of Xeloda is high enough that giving out pills is about equivalent to bringing patients into a clinic for intraveneous infusions of 5-Fu and leucovorin.
With the ease of oral administration, long term use of Co-Factor and Xeloda
would be possible. If toxiciy is also low, and if the drugs slow disease progression as I hope, the patients could continue a reasonably pleasant life until they ran out of money.
Norman |
