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Title: Oxaliplatin/Capecitabine Combination Effective First- and Second-Line Therapy in Metastatic Colorectal Cancer: Presented at ICACT

"Oxaliplatin/Capecitabine Combination Effective First- and Second-Line Therapy in Metastatic Colorectal Cancer: Presented at ICACT"

By Paula Moyer PARIS, FRANCE -- February 12, 2004 -- A chemotherapy cocktail combining oxaliplatin (Eloxatin) and capecitabine (Xeloda) is effective as either first- or second-line therapy in metastatic colorectal cancer, according to study findings. The combination, known as CAPOX, may broaden treatment options for metastatic colorectal cancer beyond existing options, according to principal investigator Alberto Muñoz, MD, a medical oncologist at the Hospital de Cruces in Barakaldo, Spain. However, he stressed that the next step is to compare CAPOX and FOLFOX as first- and second-line treatments in a prospective trial. Dr. Muñoz presented these findings here February 10th at the 15th International Congress of Anti-Cancer Treatment. Investigators recruited 57 patients, 28 to receive the combination as a first-line treatment, and 29 to receive it as a second-line treatment. The investigators defined the therapy as first-line if the patient had not undergone prior chemotherapy for metastatic disease. Second-line patients had not experienced a response to either 5-FU or irinotecan, either as sequential monotherapy or as combination therapy. The first-line patient group consisted of 22 men and 6 women who were an average of 67 years old. Their baseline Eastern Cooperative Oncology Group (ECOG) performance statues were 0 in 43% of patients, 1 in 43%, and 2 in 14%. Among the patients, 64% had 1 metastatic site, 25% had 2 sites and 11% had 3 or more. The second-line patient group consisted of 22 men and 7 women who were an average of 63 years old. Their baseline ECOG performance statuses were 0 in 35% of the patients (35%), 1 in 48%, and 2 in 17%. Among these patients, 48.2% had undergone a combination consisting of irinotecan, 5-FU, and leucovirin (IFL) known as the IFL Saltz regimen while 34.5% had received a combination of irinotecan and capecitabine, and 17.3% had received 5-FU and irinotecan sequentially. The regimen used in the investigation consisted of an intravenous infusion of 130 mg/m2 of oxaliplatin on day 1 of the treatment cycle and 1,000 mg/m2 of orally twice daily for days 2 to 15. The patients underwent this cycle every three weeks. Prior to receiving oxaliplatin, patients received intravenously 8 mg of ondansetron (Zofran) in order to prevent nausea and vomiting. To date, the investigators have administered a total of 231 courses of the investigative regimen, with a median of 4 cycles per patient and a range of 1 to 9 cycles per patient. The researchers have observed no Grade 4 toxicities. Grade 3 toxicities included the following incidents: 1 of thrombocytopenia, 2 of nausea, 1 of vomiting, 3 of mucositis, 8 of diarrhoea, 6 of hand-foot syndrome; 9 of asthenia; 1 event of acute neurotoxicity, 3 cases of hypersensitivity to oxaliplatin, and 3 cases of infection without neutropenia. No patients died due to toxicity. One patient died early during treatment. For the first-line patient group, the median follow-up has been 31 weeks, during which time neither the median overall survival nor the disease-free survival has been reached. For the second-line patients, the median overall survival had not been reached at 43 of follow-up; the median disease-free survival was 16 weeks. These findings show that the CAPOX regimen appears to be safe and well tolerated, and should be studied further, according to Dr. Muñoz. [Study title: Oxaliplatin and capecitabine (CAPOX) is an active combination as first and second line treatment for patients with. Abstract P28]

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