Results of a phase II open-label study of capecitabine in combination with irinotecan as first-line treatment for metastatic colorectal cancer.

BACKGROUND

Between July 2001 and September 2002, 49 eligible patients were enrolled in an open-label phase II study to assess the efficacy and safety of first-line treatment with capecitabine/irinotecan in metastatic colorectal cancer.

PATIENTS AND METHODS

Patients received capecitabine (1000 mg/m2 twice daily) on days 1-14 and irinotecan (240 mg/m2) on day 1 of a 21-day cycle. Patients enrolled had a median age of 64.5 years, and 6% of patients had an Eastern Cooperative Oncology Group performance status of 2. Fifty-seven percent of patients were male.

RESULTS

Forty-two patients were evaluable for response. There was 1 complete response (2%), 18 partial responses (43%), 20 cases of stable disease (48%), and 3 cases of disease progression (7%), for an overall response rate of 45% (95% CI, 30%-60%). The median duration of response was 5.7 months (range, 2.5-II.3 months). Median survival was 13.4 months (range, 1.2-28.8 months) and median progression-free survival was 6.2 months (range, 1.2-17.5 months). At 1 year, the estimated survival rate was 54% and the estimated progression-free survival rate was II%. The median number of cycles received was 6 (range, 1-18 cycles), and most patients (80%) required a dose modification because of diarrhea, nausea, and/or neutropenia. Grade 1/2 hand-foot syndrome occurred in 8 patients (16%). Grade 3/4 toxicities experienced by > or = 5% of patients included diarrhea (20%), neutropenia (12%), dehydration (10%), nausea (10%), anemia (6%), fatigue (6%), pain (6%), and vomiting (6%).

CONCLUSIONS

First-line capecitabine/ irinotecan is an active combination for the treatment of metastatic colorectal cancer and feasible for use in the community-based setting. Despite significant toxicity with the regimen, the treatment was manageable with dose reduction or delay and should be investigated in phase III trials.