New treatment helps patients with advanced colorectal cancer live longer, have fewer side effects: study

CHAPEL HILL -- 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.

Patients who received FOLFOX 4 – a chemotherapy regimen including the recently approved drug oxaliplatin (Eloxatin) combined with 5-Fluorouracil (5-FU) and leucovovin – lived an average of 19.5 months after beginning treatment, the study found. 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 receiving FOLFOX 4 also had fewer serious side effects often associated with chemotherapy, including fewer infections, less diarrhea and vomiting and less frequent severe hair loss.

The phase-3 clinical study was sponsored by the National Cancer Institute and conducted by the North Central Cancer Treatment Group, based at the Mayo Clinic in Rochester, Minn. The study results will be published online today (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," said Dr. Richard Goldberg, the study’s lead researcher. Goldberg, formerly a medical oncologist at the Mayo Clinic, is associate director of the University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center.

About 153,000 people in the United States are diagnosed annually with colorectal cancer. Among the newly diagnosed patients and those previously treated for the disease, about 70,000 patients each year are told the cancer is in an advanced stage.

All study participants had been diagnosed with advanced colorectal cancer. These patients were from the United States and Canada and volunteered to participate in the study between March 1999 and April 2001. They were randomly assigned to one of three groups comparing the following combinations of chemotherapy regimens of 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 FOLFOX 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," said Goldberg.

In addition to increased survival, the study found that:

• Forty-five percent of the patients treated with FOLFOX 4 responded with shrinkage of their cancer, compared to a 31 percent 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.
  

A tingling sensation in the hands and feet that improved over time was the most commonly reported side effect, said Goldberg.

"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," he added.

The chemotherapy drug 5-Fluorouracil has been available for 40 years for treatment of advanced colorectal cancer. The U.S. Food and Drug Administration only approved oxaliplatin for use in the United States last year.

Colorectal cancer is the second leading cause of death from cancer nationwide, accounting for more than 10 percent of all cancer deaths. Over a lifetime, about one in 18 people is estimated to get colorectal cancer.

Sanofi-Synthelabo manufactures oxaliplatin (Eloxatin). Pfizer manufactures irinotecan (Camptosar).

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Note: The full text of the article about this study is available at http://www.asco.org or by calling (703) 519-1423.

Lineberger Center contact: Dianne Shaw, (919) 966-5905