Adjuvant Chemotherapy
Current Clinical Trials

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.)

Treatment options:

1. Wide surgical resection and anastomosis. The role of laparoscopic techniques [1-4] in the treatment of colon cancer is under evaluation in a multicenter prospective randomized trial (NCCTG-934653) comparing laparoscopic-assisted colectomy (LAC) to open colectomy. The quality-of-life component of this trial has been published and minimal short-term quality-of-life benefits with LAC were reported.[4][Level of evidence: 1iiC]



2. Following surgery, patients should be considered for entry into carefully controlled clinical trials such as the GRECCR-03 and NCRI-QUASAR1) trials, for example, which are evaluating the use of systemic or regional chemotherapy or biologic therapy. Adjuvant therapy is not indicated for most patients unless they are entered into a clinical trial.

The potential value of adjuvant chemotherapy for patients with stage II colon cancer remains controversial. Although subgroups of patients with stage II colon cancer may be at higher-than-average risk for recurrence (including those with anatomic features such as tumor adherence to adjacent structures, perforation, complete obstruction, or with biologic characteristics such as aneuploidy, high S-phase analysis, or deletion of 18q),[5-7] evidence is inconsistent that adjuvant 5-fluorouracil (5-FU)–based chemotherapy is associated with an improved overall survival (OS) compared to surgery alone.[8] Investigators from the National Surgical Adjuvant Breast and Bowel Project have indicated that the reduction in risk of recurrence by adjuvant therapy in patients with stage II disease is of similar magnitude to the benefit seen in patients with stage III disease treated with adjuvant therapy, though an OS advantage has not been established.[9]

A meta-analysis of 1,000 stage II patients whose experience was amalgamated from a series of trials indicates a 2% advantage in disease-free survival (DFS) at 5 years when adjuvant therapy-treated patients treated with 5-FU-leucovorin are compared with untreated controls.[10][Level of evidence: 1iiDii];[11] Patients with stage II colon cancer remain candidates for clinical trials such as the CLB-9581, NSABP-C-06, and SWOG-9415 trials, for example, in which either surgery alone or 5-FU-leucovorin represent standard therapy.

Recently the Cancer Care Ontario Practice Guideline Initiative Gastrointestinal Cancer Disease Site Group undertook a meta-analysis of the English language published literature consisting of randomized trials where adjuvant chemotherapy was compared with observation for patients with stage II colon cancer. The mortality risk ratio was 0.87 (95% CI, 0.75–1.01; P = .07).[12] Based on these data, the American Society of Clinical Oncology issued a guideline stating “direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer.”[13]

Features in patients with stage II colon cancer that are associated with an increased risk of recurrence include inadequate lymph node sampling, T4 disease, involvement of the visceral peritoneum, and a poorly differentiated histology. The decision to use adjuvant chemotherapy for patients with stage II colon cancer is complicated and requires thoughtful consideration for both patients and their physicians.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II colon cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Bokey EL, Moore JW, Chapuis PH, et al.: Morbidity and mortality following laparoscopic-assisted right hemicolectomy for cancer. Dis Colon Rectum 39 (10 Suppl): S24-8, 1996.  [PUBMED Abstract]
   
   
2. Franklin ME Jr, Rosenthal D, Abrego-Medina D, et al.: Prospective comparison of open vs. laparoscopic colon surgery for carcinoma. Five-year results. Dis Colon Rectum 39 (10 Suppl): S35-46, 1996.  [PUBMED Abstract]
   
   
3. Fleshman JW, Nelson H, Peters WR, et al.: Early results of laparoscopic surgery for colorectal cancer. Retrospective analysis of 372 patients treated by Clinical Outcomes of Surgical Therapy (COST) Study Group. Dis Colon Rectum 39 (10 Suppl): S53-8, 1996.  [PUBMED Abstract]
   
   
4. Weeks JC, Nelson H, Gelber S, et al.: Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 287 (3): 321-8, 2002.  [PUBMED Abstract]
   
   
5. Lanza G, Matteuzzi M, Gafá R, et al.: Chromosome 18q allelic loss and prognosis in stage II and III colon cancer. Int J Cancer 79 (4): 390-5, 1998.  [PUBMED Abstract]
   
   
6. Jen J, Kim H, Piantadosi S, et al.: Allelic loss of chromosome 18q and prognosis in colorectal cancer. N Engl J Med 331 (4): 213-21, 1994.  [PUBMED Abstract]
   
   
7. Merkel S, Wein A, Günther K, et al.: High-risk groups of patients with Stage II colon carcinoma. Cancer 92 (6): 1435-43, 2001.  [PUBMED Abstract]
   
   
8. Moertel CG, Fleming TR, Macdonald JS, et al.: Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer. J Clin Oncol 13 (12): 2936-43, 1995.  [PUBMED Abstract]
   
   
9. Mamounas E, Wieand S, Wolmark N, et al.: Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04) J Clin Oncol 17 (5): 1349-55, 1999.  [PUBMED Abstract]
   
   
10. Efficacy of adjuvant fluorouracil and folinic acid in B2 colon cancer. International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators. J Clin Oncol 17 (5): 1356-63, 1999.  [PUBMED Abstract]
    
    
11. Harrington DP: The tea leaves of small trials. J Clin Oncol 17 (5): 1336-8, 1999.  [PUBMED Abstract]
    
    
12. Figueredo A, Charette ML, Maroun J, et al.: Adjuvant therapy for stage II colon cancer: a systematic review from the Cancer Care Ontario Program in evidence-based care's gastrointestinal cancer disease site group. J Clin Oncol 22 (16): 3395-407, 2004.  [PUBMED Abstract]
    
    
13. Benson AB 3rd, Schrag D, Somerfield MR, et al.: American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol 22 (16): 3408-19, 2004.  [PUBMED Abstract]
    
    

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