NAPLES-The combination of oral capecitabine(Drug information on capecitabine) (Xeloda) plus oxaliplatin(Drug information on oxaliplatin) (Eloxatin) is safe and highly active in elderly patients with advanced colorectal carcinoma, reported Pasquale Comella, MD, of the National Tumor Institute in Naples, Italy (ASCO abstract 2939). Dr. Comella explained the choice of capecitabine for the study. "Capecitabine given orally 2 of every 3 weeks has demonstrated a similar activity and a better toxicity profile compared with IV leucovorin- modulated fluorouracil(Drug information on fluorouracil) (5-FU) for 5 days (Mayo regimen) in advanced colorectal cancer. Oxaliplatin 130 mg/m2 combined with capecitabine 1,000 mg/m2 bid is a safe and highly active 3-weekly regimen (XELOX) in advanced colorectal cancer. This combination could also be a suitable option for elderly patients," he said. "The number of elderly patients receiving palliative chemotherapy for colorectal carcinoma is still limited because of a diffuse concern about the compliance and tolerability of chemotherapy in such patients," Dr. Comella explained. "However, some investigators have stressed that the performance status, and the associated morbidities-more than the age of the patients-may adversely affect outcome." Median of Six Cycles In the first cycle, patients received oxaliplatin 85 mg/m2 IV day 1, followed by oral capecitabine 1,000 mg/m2 bid from day 2 to day 15. According to the original dose escalation scheme, if toxicity on the first cycle was less than or equal to World Health Organization (WHO) grade 1 toxicity, patients received a second cycle of oxaliplatin 100 mg/m2 IV day 1, followed by oral capecitabine 1,000 mg/m2 bid, from day 2 to day 15. Then, if toxicity on the second cycle was less than or equal to WHO grade 1, on the third and subsequent cycles, patients received oxaliplatin 100 mg/m2 IV day 1, followed by oral capecitabine 1,250 mg/m2 bid, from day 2 to day 15. The median number of administered cycles was 6 (range, 1 to 12) per patient. Patient Assessments To be eligible, patients were required to be over 70 years, have a life expectancy equal to or greater than 3 months, an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2, one or more measurable lesions, and a Charlson score less than or equal to 4. The median age was 75 (range 70 to 81 years). The site of the primary tumor was the colon in 57% of patients and the rectum in 43% of patients. Eighty percent of patients had previous surgery, and 23% had previous adjuvant chemotherapy. ECOG performance status was 0 in 43% of patients, 1 in 51% of patients, and 3 in 6% of patients. Forty-six percent had one disease site, 31% had two sites, and 23% had three plus sites. Of the 35 patients in the study, 6 were not assessed for response. Response rates among the 29 that were assessed were: 6% complete response, 31% partial response, 34% stable disease greater than 4 months, and 11% progressive disease (11%). Therefore, a temporary control of tumor growth was achieved in 71% of patients. The overall response rate was 37%, and the median duration of responses was 6.9 months. No patient suffered from grade 4 toxicity. Patients experienced severe diarrhea (9%), grade 3 peripheral neuropathy (11%), and mild/moderate hand-foot syndrome (11%). With a median follow-up of 10 months (range, 5.5 to 19 months), the 1-year probability of survival was 58%. In Summary "The combination of capecitabine with oxaliplatin (XELOX) seems to represent a well-tolerated and very active regimen for these patients, provided that a careful, comprehensive geriatric assessment is carried out," Dr. Comella summarized. "A preliminary assessment of intrapatient dose escalation seems to suggest that a further increase of oxaliplatin dosage to 130 mg/m2 could be attempted. However, the investigators recommend that the capecitabine dosage remain at 1,000 mg/m2 bid for 2 weeks."