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)
E. Mamounas 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 CL ONCOL, 17(5), 1999, pp. 1349-1355
Purpose: Although the benefit from adjuvant chemotherapy has been clearly e
stablished in patients with Dukes' C colon cancer, such benefit has been qu
estioned in patients with Dykes' B disease. To determine whether patients w
ith Dukes' B disease benefit from adjuvant chemotherapy and to evaluate the
magnitude of the benefit, compared with that observed in Dukes' C patients
, we examined the relative efficacy of adjuvant chemotherapy according to D
ukes' stage in four sequential National Surgical Adjuvant Breast and Dowel
Project trials (C-01,C-02, C-03, and C-04) that compared different adjuvant
chemotherapy regimens with each other or with no adjuvant treatment.
Patients and Methods: The four trials included Dukes' B and C patients and
were conducted between 1977 and 1990. The eligibility criteria and follow-u
p requirements were similar for all four trials. Protocol C-01 compared adj
uvant semustine, vincristine, and fluorouracil(5-FU) (MOF regimen) with ope
ration alone. Protocol C-02 compared the perioperative administration of a
portal venous infusion of 5-FU with operation alone. Protocol C-03 compared
adjuvant 5-FU and leucovorin (LV) with adjuvant MOF. Protocol C-04 compare
d adjuvant 5-FU and LV with 5-FU and levamisole (LEV) and with the combinat
ion of 5-FU, LV,and LEV.
Results: Forty-one percent of the patients included in these four trials ha
d resected Dykes' B tumors. In all four studies, the overall, disease-free,
and recurrence-free survival improvement noted for all patients was eviden
t in both Dukes' B and Dykes' C patients. When the relative efficacy of che
motherapy was examined, there was always an observed reduction in mortality
, recurrence, or disease-free survival event, irrespective of Dukes' stage,
and in most instances, the reduction was as great or greater for Dykes' B
patients as for Dykes' C patients. When data from all four trials were exam
ined in a combined analysis, the mortality reduction was 30% for Dukes' B p
atients versus 18% for Dykes' C patients. The mortality reduction in Dukes'
B patients occurred irrespective of the presence or absence of adverse pro
gnostic factors.
Conclusion: Patients with Dukes' B colon cancer benefit from adjuvant chemo
therapy and should be presented with this treatment option. Regardless of t
he presence or absence of other clinical prognostic factors, Dukes' B patie
nts seem to benefit from chemotherapy administration. J Clin Oncol 17:1349-
1355. (C) 1999 by American Society of Clinical Oncology.