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

August 1, 2005

ORLANDO-XELOX (capecitabine[Xeloda] and oxaliplatin [Eloxatin])is effective and well tolerated asfirst-line treatment for elderly patients

ORLANDO-XELOX (capecitabine[Xeloda] and oxaliplatin [Eloxatin])is effective and well tolerated asfirst-line treatment for elderly patientswith advanced/metastatic colorectalcancer, according to Antonieta Salud,MD. Dr. Salud of the Hosp Arnau deVilanova, Lleida, Spain, reported on apilot study of 50 elderly patients (abstract3620)."With only one clinic visit requiredevery 3 weeks (for oxaliplatin infusion),XELOX is more convenient thanfluorouracil (5-FU)-based regimenssuch as FOLFOX," Dr. Salud said.This study enrolled patients aged70 or older with histologically/cytologicallyconfirmed metastatic colorectaladenocarcinoma, Eastern CooperativeOncology Group (ECOG)performance score ≤ 2, and at least onemeasurable lesion. Patients had noprevious chemotherapy with capecitabineor oxaliplatin. Patients receivedoxaliplatin (130 mg/m2 IV on day 1)followed by oral capecitabine (1,000mg/m2 twice daily for 14 days; 750 mg/m2 if creatinine clearance = 30-50 mL/min) every 3 weeks.The primary study endpoint wasresponse rate. Secondary endpointsincluded safety, time to disease progression,and overall survival. Dr. Saludsaid that the 50 patients evaluatedfor safety included 36 males and 14females, with a median age of 75 years.Ninety percent of the patients in thisgroup had no comorbidities, 90% hadmild dependence on help, and mostwere autonomous. The median numberof metastatic sites was one.

The median number of cycles givenwas 4.5. The mean capecitabinerelative dose intensity was 98%, andthe median oxaliplatin relative doseintensity was 92%.Positive ResultsThe intent-to-treat analysis showed5 complete responses (10%), 13 partialresponses (26%), and 12 cases ofstable disease (24%), for a tumorgrowth control rate of 60%."With a median follow-up of 7.5months, median time to progression(TTP) was 6.9 (95% confidence inter-val:4.8-9) months. There was one treatment-related death, from diarrhea andasthenia," Dr. Salud said. The mostcommon adverse events were diarrhea,vomiting, asthenia, and nausea (Table1)."XELOX is a highly active combinationin first-line metastatic colorectalcancer, comparable to FOLFOX,with less neutropenia and a convenient3-weekly cycle length," Dr. Saludconcluded. "As a well-tolerated,more home-based therapy, XELOXmerits investigation in a more elderlypatient population."