Stage III Colon Cancer
Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)
Stage III colon cancer denotes lymph node involvement. Studies have indicated that the number of lymph nodes involved affects prognosis; patients with one to three involved nodes have a significantly better survival than those with four or more involved nodes.
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Drug combinations described in this section include the following:
- The FOLFOX4 regimen (oxaliplatin, leucovorin, and fluorouracil [5-FU]):
- Oxaliplatin (85 mg/m2) administered as a 2-hour infusion on day 1; leucovorin (200 mg/m2) administered as a 2-hour infusion on day 1 and day 2; followed by a loading dose of 5-FU (400 mg/m2) IV bolus, then 5-FU (600 mg/m2) administered via ambulatory pump for a period of 22 hours on day 1 and day 2 every 2 weeks.
- The Levamisole regimen (5-FU and levamisole):
- Bolus 5-FU (450 mg/m2 per day) on days 1 to 5, then weekly 28 days later plus levamisole (50 mg) administered orally 3 times a day for 3 days every 2 weeks.
- The Mayo Clinic or NCCTG regimen (5-FU and low-dose leucovorin):
- Bolus 5-FU-(450 mg/m2)-leucovorin (20 mg/m2) administered daily for 5 days every 28 days.
- The Roswell Park or NSABP regimen (5-FU and high-dose leucovorin):
- Bolus 5-FU-(500 mg/m2)-leucovorin (500 mg/m2) administered weekly for 6 consecutive weeks every 8 weeks.
Treatment options include the following:
- Wide surgical resection and anastomosis.
The role of laparoscopic techniques [1,2,3,4] in the treatment of colon cancer was examined in a multicenter prospective randomized trial (NCCTG-934653, now closed) comparing laparoscopic-assisted colectomy (LAC) with open colectomy. The quality-of-life component of this trial has been published and reported minimal short-term quality-of-life benefits with LAC.[5][Level of evidence: 1iiC]
Based on results from the MOSAIC trial, adjuvant FOLFOX4 demonstrated prolonged overall survival (OS) for patients with stage III colon cancer compared with patients receiving 5-FU/leucovorin without oxaliplatin. The 6-year OS of patients with stage III colon cancer was 72.9% in the patients receiving FOLFOX and 68.9% in the patients receiving 5-FU/LV (hazard ratio [HR] = 0.80; 95% confidence interval [CI], 0.65-0.97, P = .023).[6]
- Eligible patients should be considered for entry into carefully controlled clinical trials comparing various postoperative chemotherapy regimens.[7]
Adjuvant Chemotherapy
Chemotherapy regimens prior to 2000
Prior to 2000, 5-FU was the only useful cytotoxic chemotherapy in the adjuvant setting for patients with stage III colon cancer. Many of the early randomized studies of 5-FU in the adjuvant setting failed to show a significant improvement in survival for patients.[8,9,10,11] These trials employed 5-FU alone or 5-FU-semustine (methyl-CCNU). The North Central Cancer Treatment Group (NCCTG) conducted a randomized trial comparing surgical resection alone with postoperative levamisole or 5-FU-levamisole.[12][Level of evidence: 1iiA] A significant improvement in disease-free survival (DFS) was observed for patients with stage III colon cancer who received 5-FU-levamisole, but OS benefits were of borderline statistical significance. An absolute survival benefit of approximately 12% (49% vs. 37%) was seen in patients with stage III disease treated with 5-FU-levamisole.
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