Toxicity profile and efficacy of oral capecitabine as adjuvant chemotherapy for Chinese patients with Stage III colon cancer.

PURPOSE

The Xeloda in Adjuvant Cancer Therapy trial, conducted in a white population of patients, established capecitabine (Xeloda) as adjuvant chemotherapy for Stage III colon cancer. Given the ethnical difference in toxicity of adjuvant chemotherapy in colon cancer, this study was designed to evaluate the safety and efficacy of adjuvant capecitabine in Chinese patients with colon cancer.

METHODS

Chinese patients with curatively resected Stage III colon adenocarcinoma, who received adjuvant capecitabine, were entered into a prospective database. Oral capecitabine was given at 1,250 mg/m(2) twice daily, Days 1 to 14, every 21 days, for 8 cycles. Toxicities, laboratory abnormalities, and survival outcomes were evaluated.

RESULTS

Fifty-eight patients were entered into the database between August 2004 and October 2005. The median age was 63.9 years with a male-to-female ratio of 1.15:1. With a median follow-up duration of 20.9 months, 14 patients relapsed and 3 patients died. Disease-free and overall survival at two years was 69 and 97 percent, respectively. Grade 3 toxicities occurred as follows: stomatitis (1.7 percent), diarrhea (0 percent), hand-foot syndrome (41.4 percent), leucopenia (1.7 percent), neutropenia (3.4 percent), and hyperbilirubinemia (1.7 percent). No Grade 4 or 5 toxicity was noted. Compared with the Xeloda in the Adjuvant Cancer Therapy trial, a much higher incidence of serious hand-foot syndrome and a lower rate of severe diarrhea were found in this study.

CONCLUSIONS

A different toxicity profile of adjuvant capecitabine was noted in this study on Chinese patients with colon cancer compared with that reported in the Xeloda in Adjuvant Cancer Therapy trial, whereas the efficacy outcomes were comparable.