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Oral Capecitabine Plus Irinotecan Lowers Burden on Health Care Workers and Patients with Advanced Metastatic Colorectal Cancer: Presented at ECCO

By Cameron Johnston

COPENHAGEN, DENMARK -- September 22, 2003 -- A twice-daily formulation of oral capecitabine (Xeloda, Roche) combined with irinotecan could prove just as effective as the traditional infusion of 5-fluorouracil/leucovorin (5FU/LV) as a first-line treatment for metastatic colorectal cancer, a phase II trial shows.

The trial results were presented here September 22^nd at the ECCO 12: The European Cancer Conference.

And while the newer regimen was not without toxicities, the burden of administering a bolus or infusion of 5FU/LV was eliminated, therefore saving a considerable amount of work for the health care system, as well as making the treatment somewhat less onerous on the patient.

Typically, a patient with metastatic colorectal cancer would be treated with 5FU/LV either in bolus, or intravenous infusion (the Mayo Clinic regimen), as well as another drug such as irinotecan. Administering the 5FU, however, is time consuming for health care workers, and bothersome for the patient.

In this study, headed by Dr. Yehuda Patt, gastrointestinal medical oncology, M.D. Anderson Cancer Centre, Houston, Texas, United States, patients were treated with irinotecan 250 mg/m² on day 1 and twice daily capecitabine 1000 mg/m² for the next 14 days across a 21-day schedule. Patients older than 65 years of age received slightly lower doses of each drug.

Preliminary results of the study involved 52 patients who were evaluable for safety and 51 who were evaluable for response. Mean age was 57 years; 85% had colon cancer, 11% had rectal cancer, and 4% had both. Four out of 5 patients had liver metastases and 3 out of 5 had advanced stage IV disease at initial diagnosis.

Patients received a median of 5 cycles, although 44% were able to tolerate more than 6 cycles, and 14% received 12 cycles. After a mean of 20 months of follow-up, a partial or complete response, or stable disease was seen in 71% of patients. Progressive disease was seen in 13%.

Overall response rate -- patients with partial or complete response, or stable disease -- was 71%. Overall survival was 15.6 months and time to progression was 7.1 months.

Response rates were encouraging enough that at 1 center, 8 patients were able to undergo resections following their therapy.

The side effect profile was not unlike what is typically seen with the older 5FU/LV regimen, with 22% experiencing grade III diarrhea, 12% experiencing dehydration, and 12% severe nausea and vomiting. Almost all of the patients required at least some dose modification as the study progressed, although only 12 patients withdrew because of adverse events.

The authors of the study said this study suggests that capecitabine could ultimately replace 5FU/LV as a first-line treatment for some patients with advanced colorectal cancer.

Capecitabine compares favorably with 5FU and irinotecan, as well as with 5FU/irinotecan/oxaliplatin to create an effective, safe and less burdensome treatment option for patients with this disease, the investigators noted.


[Study title: Capecitabine Plus Irinotecan (XELIRI) in First-Line Metastatic Colorectal Cancer (MCRC): Update on a Phase II Trial. Abstract 304]

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