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Results from a multi-institutional clinical trial demonstrated that Xeloda (capecitabine), an oral chemotherapy agent, provides similar treatment outcomes for colon cancer when compared to 5-Fluorouracil (5-FU) plus Leucovorin (LV) and allows patients to be treated at home with fewer side effects.

Cancer of the colon and rectum is the second leading cause of cancer related deaths in the United States. Advanced colorectal cancer means that cancer has spread from its site of origin to distant places in the body, often invading vital organs. Chemotherapy remains an essential treatment component for this disease.

Colorectal Colon Rectal CancerConnect 490

Most chemotherapy used for treating cancer is administered intravenously (through a vein). Intravenous (I.V.) infusion requires patients to receive treatment at a hospital or clinical setting staffed with trained healthcare professionals. In addition, I.V. infusion is associated with infection, pain and increased medical costs. Therefore, researchers have recently been evaluating oral forms of chemotherapy in order to avoid the associated inconvenience of I.V. therapy.

Currently, intravenous chemotherapy combinations consisting of 5-FU/LV is a standard initial treatment for the majority of patients with colon cancer. Based on the results of a recent clinical trial, Xeloda, an oral chemotherapy agent, may be substituted for 5-FU/LV in patients.  Xeloda gets converted to 5-FU through the metabolic processes of an enzyme (protein) called thymidine phosphorylase. Thymidine phosphorylase is predominantly active in cancer cells, strategically creating high levels of 5-FU from capecitabine within cancer cells.

A multi-institutional clinical trial directly comparing Xeloda to 5-FU/LV in the treatment of patients with advanced colon cancer reported superior initial anti-cancer response rates for patients receiving Xeloda and average time to disease progression and length of overall survival were statistically similar between the two patient groups. Of significant importance was the decrease in side effects caused by Xeloda compared with 5FU/LV. Significantly fewer patients taking Xeloda were hospitalized due to adverse treatment complications compared with patients who received 5-FU/LV. Medical expenses and resource use were dramatically reduced as well.

Xelox Yields Impressive Survival in Pre-Treated Metastatic Colorectal Cancer

The chemotherapy combination referred to as Xelox (Xeloda® and Eloxatin®) appears to be a highly effective regimen for patients with advanced colorectal cancer who have received prior chemotherapy.

Researchers from Italy conducted a clinical trial to evaluate the combination of Xeloda ) plus Eloxatin (oxaliplatin), (known as Xelox when combined) in a new administration schedule for patients with advanced colorectal cancer. This trial included 36 patients with metastatic colorectal cancer who had stopped responding to prior chemotherapy. Forty-four percent had received one prior chemotherapy regimen consisting of 5-fluorouracil and/or Camptosar-based chemotherapy; 56% had received two prior chemotherapy regimens consisting of these agents; and 33% had stopped responding to prior Eloxatin-based chemotherapy. Treatment was administered over a 21-day cycle. Eloxatin was administered into a vein (intravenously) for 12 hours continuously on the first and eighth days of the 21-day cycle, and Xeloda was administered orally at 8:00 am (25% of dose), 6:00 pm (25% of dose), and 11:00 pm (50% of dose) every day for the first 14 days of the 21-day cycle (chronomodulated administration).

A majority, over 66%, of patients achieved an anticancer response or disease stabilization with the Xelox regimen. Among patients who had stopped responding to prior Eloxatin-based therapy, nearly 70% achieved an anticancer response or disease stabilization. The average time before cancer progressed was nearly 7 months, and over half of the patients (54%) were still alive at one year following therapy. The most common severe side effects were weakness, fatigue, and diarrhea.

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The researchers concluded that Xelox administered according to this novel schedule yields high anti-cancer response rates and prolongs survival in this group of heavily pre-treated patients with metastatic colorectal cancer, including those who stopped responding to prior Eloxatin-based chemotherapy. 

Xeloda® Approved for Adjuvant Treatment of Colon Cancer

The Food and Drug Administration (FDA) approved the oral chemotherapy agent Xeloda® for post-surgery treatment in patients with Duke’s C colon cancer in 2005. 

The trial that prompted FDA approval of Xeloda as adjuvant therapy included patients diagnosed with Duke’s C colon cancer who were treated with either Xeloda or 5-FU following the complete surgical removal of their cancer. At three years, cancer-free survival rates were up for patients treated with Xeloda-66% versus 63% in the group treated with 5-FU. Overall, patients with Xeloda also experienced fewer severe side effects than those treated with 5-FU.

The researchers, who published their findings in the New England Journal of Medicine, concluded that Xeloda® is an effective post-surgical treatment alternative to the historical 5-FU standard for patients with Duke’s C (stage III) colon cancer. 

Duke’s C (stage III) colorectal cancer refers to cancer that has spread from the colon to nearby lymph nodes, but not to distant sites in the body. Patients with Duke’s C colon cancer are generally treated with surgery to remove the cancer and later with adjuvant chemotherapy (secondary treatment given to increase the effectiveness of the primary treatment). A chemotherapy regimen typically consists of the agent 5-fluorouracil (5-FU) alone or in combination with other agents.

The clinical trial conducted by researchers affiliated with the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) trial directly compared Xeloda to 5-FU as adjuvant therapy. The trial included 1,987 patients who had been diagnosed with Duke’s C colon cancer. They were treated with either Xeloda or 5-FU following the complete surgical removal of their cancer. At three years, cancer-free survival rates were up for patients treated with Xeloda-64% versus 61% in the group treated with 5-FU. Overall, patients given Xeloda also experienced fewer severe side effects than those treated with 5-FU.

Patients diagnosed with Duke’s C colorectal cancer who are candidates for adjuvant treatment consisting of 5-FU only may wish to speak with their physician regarding their individual risks and benefits of treatment with Xeloda.

Colorectal Colon Rectal Newsletter 490

References

  1. Journal of Clinical Oncology, Vol 19, No 8, pp 2282-2292) (European Journal of Cancer, Vol 37, No 5, pp 597-604, 2001)
  2. Santini D, Vincenzi B, La Cesa A, et al. Continuous Infusion of Oxaliplatin plus Chronomodulated Capecitabine in 5-fluorouracil- and Irinotecan-Resistant Advanced Colorectal Cancer Patients. Oncology. 2005; 69:27-34.
  3. Twelves C, Wong A, Nowacki M, et al. Capecitabine as Ajuvant Treatment for Stage III Colon Cancer. The New England Journal of Medicine. 2005; 352:2696-2704.
  4. Roche. FDA approves oral Xeloda for the adjuvant (after surgery) treatment of colon cancer. Available at: http://www.roche.com/med-cor-2005-06-15. Accessed: June 2005.