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Title: Reduced-Dose Capecitabine Effective as First-Line Therapy in Older, Less Fit Patients With Advanced Colorectal Cancer: Presented at ASCO

"Reduced-Dose Capecitabine Effective as First-Line Therapy in Older, Less Fit Patients With Advanced Colorectal Cancer: Presented at ASCO"

By Cameron E. Johnston ORLANDO, FL -- May 17, 2005 -- Most studies looking at the use of capecitabine in the treatment of advanced colorectal cancer have concentrated on patients who would otherwise be considered reasonably healthy and fit. However, this disqualifies a sizeable percentage of patients with the disease, such as those who are older, had prior pelvic radiation, or a poor performance status. A study conducted in Canada looked specifically at patients who would not be fit or healthy enough to undergo conventional treatment for advanced colorectal cancer. Mark Vincent, MD, medical oncologist, London Regional Cancer Centre, London, Ontario, Canada, presented the findings of this study here on May 15[^th at the American Society of Clinical Oncology Annual Meeting (ASCO).

The study involved 214 patients who met at least 2 of the following criteria: older than 65 years; performance status score > 1; prior pelvic radiation; liver enzyme abnormality; elevated lactate dehydrogenase (LDH).

Patients were treated with 1000 mg of capecitabine twice daily for 15 days, followed by a week of rest then another cycle of 1000 mg twice daily. Patients who developed signs of a dose-limiting toxicity had a dose reduction to 750 mg twice daily.

The mean number of treatment cycles was 7.5 unless they experienced a dose-limiting toxicity.

Just over 200 patients were evaluated for toxicity. The most common adverse events were hand-foot syndrome, diarrhea, and lethargy. Dose reductions were required in 14% of patients and dose delays were needed in 21%.

Of the 153 patients who progressed on capecitabine and were able to have further chemotherapy, 26% received irinotecan, 17% received cisplatin, 46% received 5-fluorouracil, and 32% received additional capecitabine.

Out of 191 patients who were evaluable 19% responded, of whom 81% achieved disease control. Median progression-free survival was 5.3 months. Median overall survival was 14.8 months. After a median follow-up of 11.1 months, 82 patients remained alive.

A subgroup analysis found that the most reliable predictor of outcomes was Eastern Cooperative Oncology Group (ECOG) performance status. Patients with patients with ECOG status of 0 showed a median survival of 19.7 months. Survival for those with an ECOG of 1 and 2 were 13.2 and 6.8 months, respectively. Elevated LDH and homocysteine levels were also predictors of poor outcome.

Dr. Vincent said these results were "respectable", especially given that larger trials using higher doses of capecitabine in healthier subjects failed to show such strong survival data.

This study, he added, provides valuable information on outcomes in these under-studied individuals for whom chemotherapy might not be a preferred option.

[Presentation title: Dose Reduced First-Line Capecitabine (Xeloda) Monotherapy in Older and Less Fit Patients With Advanced Colorectal Cancer (ACRC). Abstract 3577]

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