-I'm not sure what you mean by Stage 2 plus 3 minus. There have been some here on folfox so watch for other replies. What info would you like to know, please?

-As J said, we need to know the stage. "stage 2 plus 3 minus" is not a stage

-Study Finds New FOLFOX 4 Treatment Helps Patients With Advanced Colorectal Cancer Live Significantly Longer, With Fewer Chemotherapy Side Effects Researchers recommend FOLFOX 4 for first line treatment of patients with advanced colorectal cancer

The results of a five-year study of 795 patients show that a new combination of chemotherapy drugs, known as FOLFOX 4, outperforms the standard chemotherapy treatment for advanced colorectal cancer.

The study found that patients who received FOLFOX 4 -- a chemotherapy regimen that includes the recently approved drug oxaliplatin (Eloxatin) combined with 5-Fluorouracil (5-FU) and leucovovin -- lived an average of
19.5 months after beginning treatment. This compared to 14.8 months for patients who received the standard IFL treatment, which uses the chemotherapy drugs irinotecan (Camptosar, CPT-11) with 5-FU and leucovorin.

Participants who received FOLFOX 4 also had fewer serious side effects often associated with chemotherapy, including fewer infections, less diarrhea and vomiting and did not as frequently experience severe hair loss.

The phase-3 clinical study was sponsored by the National Cancer Institute and conducted by the North Central Cancer Treatment Group (NCCTG), based at Mayo Clinic. Results of the entire study will be published online Dec. 9 by the Journal of Clinical Oncology.

"This is the greatest increase in survival time recorded to date with a new treatment used by patients enrolled in a large randomized study of colorectal cancer in the United States," says Richard Goldberg, M.D., the lead researcher on the study. Dr. Goldberg was formerly a medical oncologist at Mayo Clinic in Rochester, Minn., and is now associate director of the Lineberger Comprehensive Cancer Center at the University of North Carolina in Chapel Hill.

According to Dr. Goldberg, "A tingling sensation in the hands and feet that got better over time was the most commonly reported side effect of FOLFOX
4."

The findings from this study could potentially affect thousands of patients. About 153,000 people are diagnosed with colorectal cancer annually in the United States. Among the newly diagnosed patients and those previously treated for the disease, about 70,000 patients each year are told they have an advanced stage of the disease.

All of the participants in the study were patients who had been diagnosed with advanced colorectal cancer. These patients were from the United States and Canada, and had volunteered to participate in the study between March 1999 and April 2001. They were randomly assigned to one of three groups that compared FOLFOX 4, IFL and IROX, another chemotherapy regimen for colorectal cancer treatment that includes the drugs oxaliplatin and irinotecan.

"Our goal was to compare the IFL and FOLFOX4 treatments, and the IFL and IROX treatments to determine overall survival, response rate, the length of time between when patients began their assigned treatments to when their cancer began to grow, and to establish the side effects associated with each treatment," says Dr. Goldberg.

In addition to increased survival, the study found: * 45 percent of the patients treated with FOLFOX 4 responded with shrinkage of their cancer, compared to a 31 percent response rate for IFL and 34 percent for IROX. * After beginning treatment, the average time before the cancer was observed to spread or progress was 8.7 months for FOLFOX 4, 6.9 months for IFL and
6.5 months for IROX. * One year after beginning treatment, 72 percent of patients receiving FOLFOX 4 were alive compared to 67 percent of patients in the IROX group and 59 percent of those receiving the IFL treatment.

"Based on these findings, we conclude that the FOLFOX 4 treatment should be considered as a first-line treatment over IFL and IROX for patients with advanced colorectal cancer," says Dr. Goldberg.

The chemotherapy drug 5-Fluorouracil has been available 40 years for treatment of advanced colorectal cancer. The Food and Drug Administration
(FDA) approved oxaliplatin last year.

Colorectal cancer is the second leading cause of death from cancer in the United States. It accounts for more than 10 percent of all cancer deaths. Over a lifetime, about one in 18 people gets colorectal cancer.

The following cancer cooperative groups -- Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B -- collaborated with the North Central Cancer Treatment Group to conduct this clinical study.

Sanofi-Synthelabo manufactures oxaliplatin (Eloxatin). Pfizer manufactures irinotecan (Camptosar). The full text of the article about this study is available at http://www.asco.org or by calling 703-519-1423.