XELOX Effective First-Line Treatment for Elderly Patients With Metastatic Colorectal Cancer

ORLANDO-XELOX (capecitabine [Xeloda] and oxaliplatin(Drug information on oxaliplatin) [Eloxatin]) is effective and well tolerated as first-line treatment for elderly patients with advanced/metastatic colorectal cancer, according to Antonieta Salud, MD. Dr. Salud of the Hosp Arnau de Vilanova, Lleida, Spain, reported on a pilot study of 50 elderly patients (abstract 3620). "With only one clinic visit required every 3 weeks (for oxaliplatin infusion), XELOX is more convenient than fluorouracil(Drug information on fluorouracil) (5-FU)-based regimens such as FOLFOX," Dr. Salud said. This study enrolled patients aged 70 or older with histologically/cytologically confirmed metastatic colorectal adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2, and at least one measurable lesion. Patients had no previous chemotherapy with capecitabine(Drug information on capecitabine) or oxaliplatin. Patients received oxaliplatin (130 mg/m² IV on day 1) followed by oral capecitabine (1,000 mg/m² twice daily for 14 days; 750 mg/ m² if creatinine clearance = 30-50 mL/ min) every 3 weeks. The primary study endpoint was response rate. Secondary endpoints included safety, time to disease progression, and overall survival. Dr. Salud said that the 50 patients evaluated for safety included 36 males and 14 females, with a median age of 75 years. Ninety percent of the patients in this group had no comorbidities, 90% had mild dependence on help, and most were autonomous. The median number of metastatic sites was one. The median number of cycles given was 4.5. The mean capecitabine relative dose intensity was 98%, and the median oxaliplatin relative dose intensity was 92%. Positive Results The intent-to-treat analysis showed 5 complete responses (10%), 13 partial responses (26%), and 12 cases of stable disease (24%), for a tumor growth control rate of 60%. "With a median follow-up of 7.5 months, median time to progression (TTP) was 6.9 (95% confidence inter- val:4.8-9) months. There was one treatment- related death, from diarrhea and asthenia," Dr. Salud said. The most common adverse events were diarrhea, vomiting, asthenia, and nausea (Table 1). "XELOX is a highly active combination in first-line metastatic colorectal cancer, comparable to FOLFOX, with less neutropenia and a convenient 3-weekly cycle length," Dr. Salud concluded. "As a well-tolerated, more home-based therapy, XELOX merits investigation in a more elderly patient population."