P-0239 Capecitabine and Oxaliplatin (XELOX) Combination Chemotherapy as First-Line Treatment for Metastatic Colorectal Cancer- A Phase II Study

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ABSTRACT Introduction Capecitabine has been combined successfully with oxaliplatin (XELOX) in a variety of different schedules to produce an effective and viable treatment option in both the first and second-line settings for patients with metastatic colorectal cancer (MCRC). The present phase II single institution study designed with an aim to assess the efficacy and safety of XELOX regimen as first-line therapy for patients with MCRC at Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital. Methods Thirty-six patients aged >18 years with MCRC, adequate hematologic, renal and hepatic function, at least one measurable lesion, and a Karnofsky performance status ≥70% were enrolled to receive XELOX regimen (oxaliplatin 130 mg/m2, day 1 as an intravenous infusion followed by oral capecitabine 1000 mg/m2 twice daily from day 1 evening to day 15 morning) on a 3 weekly schedule. No prior chemotherapy was allowed for treatment of metastatic disease, no prior adjuvant or neoadjuvant chemotherapy with capecitabine and/or oxaliplatin. Treatment was continued till disease progression, unacceptable toxicity or a maximum of 12 cycles. Results Objective response was observed in 55.6% of patients (20/36), and tumor control rate was 86.1% (31/36). Only one patient (2.8%) experienced complete response following treatment. The median duration of response was 10.17 months, the estimated median progression-free survival (PFS) and overall survival (OS) were 8.13 and 16.17 months, respectively. The 1-year OS and PFS rates were 66.7% and 20.3%, respectively. Most adverse events were mild to moderate. The most common grade 3/4 hematological toxicities were neutropenia (11.1%), and anemia (5.6%), while the most common grade 3/4 non-hematological toxicities were paresthesia (27.8%) and Diarrhea (25%). One (2.8%) patient treatment-related mortality was noted in this cohort due to fatal bleeding. Conclusion XELOX as first-line therapy in patients with MCRC appeared to offer an acceptable clinical profile and easy to administer in outpatients. The substitution of capecitabine for 5-fluorouracil and leucovorin (FU/LV) in combination with oxaliplatin for MCRC is not only feasible, but may be in the patients' best interest.