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Study Conclusively Shows Patients With Advanced Colorectal Cancer Live Longer and Have Fewer Severe Side Effects on New Drug Treatment

CHICAGO — Nearly five years of clinical research and data analysis conclusively shows that patients who have advanced colorectal cancer and receive the oxaliplatin drug regimen, known as FOLFOX, live an average of five more months than patients treated with the standard therapy.

That finding represents the largest increase in survival time shown in a U.S. colorectal cancer study. In addition, patients receiving the FOLFOX regimen more often respond to treatment and experience fewer severe side effects associated with chemotherapy. Based on all these findings, researchers have concluded that FOLFOX should be considered as a first-line treatment for advanced colorectal cancer over the current standard irinotecan, 5-fluorouracil and leucovorin treatment program, known as IFL therapy.

Richard Goldberg, M.D., a medical oncologist at Mayo Clinic in Rochester, Minn., reports the updated data on the phase III clinical trial today (June 1, 2003) at the

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39th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Known as N9741, the clinical trial was sponsored by the National Cancer Institute (NCI) and conducted by a network of researchers led by the North Central Cancer Treatment Group (NCCTG), based at Mayo Clinic. Dr. Goldberg was the lead researcher for the international research study. At last year's ASCO meeting, he presented the promising early findings of the trial.

“The mature data that we are reporting today substantiates the early data presented last year that patients with advanced colorectal cancer definitely live longer with the FOLFOX regimen,” says Dr. Goldberg. “We found that patients with advanced colorectal cancer lived an average of 19.5 months on the FOLFOX regimen, compared with 14.8 months for patients receiving the standard IFL treatment. The one-year average survival was 72 percent for patients receiving the FOLFOX regimen versus

59 percent for patients on the IFL treatment.

“Furthermore, patients on the FOLFOX regimen showed on average no signs of their cancer worsening for 8.7 months compared with 6.9 months in patients on the standard treatment,” he says. “The FOLFOX regimen also proved to be a gentler treatment with patients experiencing fewer side effects commonly associated with chemotherapy, including fewer infections, less diarrhea and vomiting, and not as frequent or severe hair loss.”

Dr. Goldberg explains that the current fight against advanced colorectal cancer is being accomplished by incremental advancements in treatment, and the significance of an average of five additional months of survival demonstrated through this clinical trial is a matter of perspective.

“Five months on the FOLFOX treatment is an average improvement for people on this study, meaning many patients gained much more time than that from their treatments," says Dr. Goldberg. “For a healthy individual, five months may not seem significant, but I venture to say that for a patient facing imminent death from advanced colorectal cancer, five more months of life could be extremely significant.

“This is the greatest increase in survival time we have seen for several years,” he says.

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Colorectal cancer is the second leading cause of cancer death in the United States. Over a lifetime, about one in 18 people gets colorectal cancer. Each year, about 150,000 patients are diagnosed with colorectal cancer in the United States and more than 800,000 people develop the disease worldwide. Among the newly diagnosed American patients and patients previously treated, about 70,000 patients have an advanced stage of the disease.

The clinical trial studied 795 patients with advanced colorectal cancer from throughout North America between March 1999 and April 2001. Patients were randomly assigned into one of three groups that compared the following combinations of chemotherapy treatments:

• The standard IFL treatment of irinotecan/5-fluorouracil/leucovorin, which formed the control group of the study.

• The FOLFOX treatment of 5-fluorouracil/leucovorin/oxaliplatin.

• The IROX treatment of oxaliplatin and irinotecan.

“Our goal was to compare IFL and FOLFOX, and IFL and IROX for overall survival, response rate, tumor progression and toxicity,” says Dr. Goldberg.

He noted that the IROX regimen also surpassed the standard IFL treatment with patients living an average of 17.4 months, and 67 percent of the patients being alive one year after starting the treatment.

“Our research found that FOLFOX and IROX regimens resulted in significantly increased treatment response rates compared with IFL, and that FOLFOX showed significantly improved overall survival compared with IFL,” says Dr. Goldberg. “The level of toxicity also was less with FOLFOX than IFL.

“Based on these findings, we conclude that the FOLFOX regimen should be considered a first-line standard of treatment over IFL and IROX for patients with advanced colorectal cancer,” he says.

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The N9741 clinical trial was conducted by the North Central Cancer Treatment Group (NCCTG), and included these cancer research groups: Cancer and Leukemia Group B (CALGB), the Eastern Cooperative Oncology Group (ECOG), the Southwest Oncology Group (SWOG), and the National Cancer Institute of Canada Clinical Trials Group.

The North Central Cancer Treatment Group is an affiliation of approximately 31 community clinics and affiliates in 18 states and two Canadian provinces. Its research base is at Mayo Clinic Cancer Center in Rochester, Minn. Established in 1977, NCCTG's major scientific programs focus on gastrointestinal, breast, lung and brain cancers. NCCTG also has an extensive cancer control program, which fosters research in cancer screening, prevention and symptom control. Visit http://ncctg.mayo.edu/ for more information.


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