One of the newest and most potent chemotherapies for colon cancer is as safe and effective for the elderly as it is for younger patients, based on a University of North Carolina at Chapel Hill-led data review.

The analysis focused on nearly 4,000 colon cancer patients who had been enrolled in four large-scale clinical trials that began in the 1990s nationwide and in Europe. The four studies helped establish the value against colorectal cancer of the chemotherapy regimen known as FOLFOX4, a combination of the standard anticancer drugs 5-fluorouracil (5-FU), leucovorin and the new drug oxaliplatin.

“These four studies redefined the treatment standards for colorectal cancer in the United States,” said Dr. Richard Goldberg, professor of medicine in UNC’s School of Medicine and chief of hematology-oncology at UNC Health Care.

“At the time the trials were designed, FOLFOX was experimental; now it is standard.”

Goldberg also is associate director of clinical research at UNC Lineberger Comprehensive Cancer Center.

He presented the findings of his review Jan. 25 to a gastrointestinal cancer symposium in San Francisco convened by the American Society of Clinical Oncology, the American Society of Radiation Oncology, the American Gastroenterological Association and the Society of Surgical Oncology.

Although the average age of people nationwide with colorectal cancer is 67 years, individuals older than age 70 accounted for only about 16 percent of patients enrolled in the four FOLFOX clinical trials.

According to Goldberg, this shows that older patients are under-enrolled in clinical trials and also explains why doctors who must manage older colon cancer patients “are not as certain what to do for them as they are for the population that is most represented in clinical trials: those under the age of 65.”

In our aging society, an increasing number of people with colorectal cancer are going to be in their seventies and eighties, Goldberg said. “So doctors need to sort out what to do for these patients,” he added.

In response to that need, he led a study that reviewed a sample of 3,743 patients drawn from enrollees in each of the FOLFOX trials. His study sought to gather from the data analysis information including whether or not benefits of FOLFOX therapy depended on patient age, older patients had the same side effects as younger patients, older patients received the same doses as younger patients, and whether or not older patients were on the treatment as long as younger patients.

“The major findings were that the benefit of treatment was consistent across all age groups,” Goldberg said. “Seventy-year-olds benefited as much as 30-year-olds, and even 75- and 80-year-olds benefited as much as their younger peers.”

In terms of side effects, only two laboratory parameters were significantly worse in the older patients than in the younger patients: low white blood cell and low platelet counts. “These low blood counts did not, however, compromise the doses that older patients were able to receive,” Goldberg added.

“In side effects that bother patients – nausea, vomiting, diarrhea – older patients fared just as well as younger patients,” he said.

Thus, the study showed that age alone should not exclude an otherwise healthy elderly patient from receiving FOLFOX therapy. This includes people who had just undergone surgery for colon cancer, those with advanced disease who are receiving their first chemotherapy treatments and patients with advanced disease who are getting a second treatment regimen.

“Doctors should be willing to offer their patients who are good candidates for treatment the best chemotherapy available in these situations. We know from this study that FOLFOX is safe and effective in both older and younger patients with colorectal cancer,” Goldberg said.

Study collaborators with Goldberg were from the Mayo Clinic in Rochester, Minn.; Jules Bordet Institute in Brussels, Belgium; Saint-Antoine Hospital in Paris; Tenon Hospital in Paris; Vanderbilt University Hospital in Nashville; and Sanofi-Aventis’ U.S. headquarters in Bridgewater, N.J., and global headquarters in Paris.

The clinical trials reviewed in this study were supported by the National Cancer Institute and Sanofi-Synthelabo Inc. The combined analysis was supported by a grant to the investigators from Sanofi-Aventis.