ABSTRACT
The value of adjuvant chemotherapy in patients with Dukes C carcinoma has been well documented.1
Based on the results of a variety of randomized clinical trials, adjuvant therapy can both reduce the risk of recurrence and extend survival.2-5 It is estimated that for every 100 patients treated with adjuvant 5-fluorouracil (5-FU) and leucovorin (folinic acid), 10-12 lives are saved. This benefit, coupled with the definite but typically tolerable toxicity profile, make this approach clinically acceptable. In the case of Dukes B2 carcinoma of the colon, considerable controversy exists regarding the relative benefit of treatment. Some analyses have suggested that adjuvant chemotherapy may be of benefit; others have not.6-8
The conflicting results are in part related to differences in clinical trial design and differences in methods of statistical analysis. However, the primary reason for the controversy relates to the relatively low occurrence of outcome events, i.e. deaths, and the corresponding need for extremely large sample sizes to delineate an effect when the impact of treatment is small. Nevertheless, in practice, we are faced with the challenge of how to best manage patients who present with Dukes B2 carcinoma of the colon. It is our premise that three questions must be addressed before a rational conclusion can be drawn about the utility of adjuvant chemotherapy in the subset of patients who present with Dukes B2 carcinoma of the colon. The questions are:
• Is there statistically significant evidence that chemotherapy is more effective than no treatment in patients with B2 colon cancer?
