NCCN: Colon Cancer Guidelines Detailed for Adjuvant Therapy
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NCCN: Colon Cancer Guidelines Detailed for Adjuvant Therapy

By Ed Susman

HOLLYWOOD, FL -- March 21, 2005 -- New guidelines from the National Comprehensive Cancer Network (NCCN) recommend that patients at high risk of colon cancer recurrence should receive adjuvant treatment with 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4).

Paul Engstrom, MD, senior vice president for population science, Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, said the addition of oxaliplatin is associated with a 24% reduction in the relative risk of cancer recurrence after 3 years when compared to patients taking a 5-FU/leucovorin regimen without oxaliplatin.

In reviewing the data from the Multicenter International Study of Oxaliplatin/5-FU/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) clinical trial, Dr. Engstrom said that for patients with Stage II colon cancer, less intense treatment -- without oxaliplatin -- appears to be equally effective in avoiding post-surgery return of disease compared to treatment with oxaliplatin.

"FOLFOX appears to be superior for Stage III patients but data do not support statistical superiority for Stage II patients," Dr. Engstrom said at the NCCN's 10th annual conference on Clinical Practice Guidelines and Data Outcomes Research.

In the adjuvant setting the new guidelines suggest that for T1-3, N1-2. M0 colon cancer, clinicians should provide 5-FU/leucovorin or capecitabine or FOLFOX, with treatment choice depending on the risk to the patient.

He said that in T1 and T2 disease, treatment without oxaliplatin would be appropriate. For T3 patients and some higher risk T2 patients, FOLFOX would be the treatment of choice. For T4, N1-2, M0 disease, the choices expand to include 5-FU/leucovorin in combination with radiation.

"This is importance guidance for oncologists," said Len Lichtenfeld, MD, deputy chief medical officer, American Cancer Society, Atlanta, Georgia, United States. "It helps tell us who should get these drugs -- some of which are expensive and have some serious side effects -- and who does not need them. These guidelines, especially in the area of colon cancer -- where there are so many drugs and regimens available -- are what we need to help the average doctor who treats patients."

Dr. Engstrom also outlined several other changes in the guidelines:

-- Changing the tumor staging from simply Stage 3 to stage IIIA, Stage IIIB and Stage IIIC, thus acknowledging significant differences in survival in the three disease settings. "Those differences can influence treatment," he said.

-- Encouraging surgeons to remove and sample a minimum of 12 lymph nodes to stage patients following primary resection of the tumor.

-- Addition of a section called "Principles of risk assessment for Stage II disease" that specifies patient involvement in discussions over treatment decisions.

-- Addition of a section called "Principles of adjuvant therapy" that acknowledges the various options open to doctors and patients depending upon stage of disease.

-- Restructuring the guidelines to including bevacizumab as part of the treatment cocktail for patients with advanced colon cancer and to specify those treatment choices.

The treatment algorithm gives equal weight to all commonly used regimens: FOLFOX, FOLFIRI (5-FU/leocovorin/irinotecan), irinotecan and bolus 5-FU/leucovorin (IFL) -- all with or without bevacizumab -- and 5-FU/leucovorin with bevacizumab.

-- Consideration of computer-assisted tomography use for patients at high risk for recurrence during surveillance.

-- Suggestion that laparoscopic-assisted colectomy can be used instead of open surgery, if the procedure is performed by experienced surgeons and if disease is limited.

[Presentation title: Update: Colon Cancer Guidelines.]

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