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Trial Shows Pill is as Effective as Standard Chemotherapy for Advanced Colorectal Cancer

Trial Shows Pill is as Effective as Standard Chemotherapy for Advanced Colorectal Cancer
M. D. Anderson News Release 04/12/01

A study led by The University of Texas M. D. Anderson Cancer Center shows that a small pink tablet may offer a less toxic, more convenient option in the treatment of advanced colorectal cancer.

In the study, researchers found that oral capecitabine, also known by its trade name of Xeloda, is an acceptable option to the intravenous chemotherapy regimen of fluorouracil plus leucovorin (5FU/LV), a standard treatment for metastatic colon cancer.

Investigators suggest that while it has been proven effective, the oral drug is most appropriate for patients who are highly motivated and able to take the pill twice a day as directed.  

Results of the Phase III trial, conducted at M. D. Anderson and sites throughout Canada and the United States, are published in the April 15 issue of the Journal of Clinical Oncology. More than 600 patients were enrolled on the trial, all with colon cancer that had spread to other organs.  
The oral drug, which produced a significantly higher tumor response than the intravenous chemotherapy, offers patients a much less toxic, convenient and home-based therapy. 

According to the study, patients experienced a significantly lower incidence of nausea, hair loss and fever, symptoms commonly associated with intravenous chemotherapy.  Fewer patients taking the capecitabine required hospitalization for adverse reactions than those patients taking the 5FU plus leucovorin.

But researchers say the trade-off for convenience is that patients must take responsibility for taking the pills as directed and communicating regularly with their health care team. For that reason, the pill remains an option, rather than a new standard treatment, for patients with metastatic colorectal cancer.

"The encouraging results of this trial give physicians additional latitude in recommending to each patient the optimal course of treatment.  It is especially important to remember that this oral drug was found to be equal to, not superior to, the intravenous chemotherapy regimen of F-5U plus leucovorin, " said Dr. Robert Wolff, assistant professor of gastrointestinal oncology at M. D. Anderson and a colon cancer specialist who enrolled many patients on the trial. "While the oral drug is much more convenient for patients and produces fewer side effects, this treatment depends on the patient's willingness and ability to take the pills as prescribed."

In the study, patients took oral capecitabine twice daily for two weeks.  The patients then took one week off from treatment.  The pills were taken approximately 12 hours apart, with water, within 30 minutes of breakfast and dinner.

"This treatment is definitely more convenient and less toxic than the intravenous chemotherapy," said Dr. Wolff.  "But it literally puts the treatment in the hands of the patient.  It is a consideration that physicians must acknowledge when devising a treatment plan."

According to the comparative study, tumors in approximately 25 percent of patients who took the oral capecitabine responded, compared to 15.5 percent of patients receiving intravenous chemotherapy.  Median survival was 12.5 months for the oral drug and 13.3 months for the intravenous therapy, and median times to disease progression were 4.3 months for the pill and 4.7 months for intravenous chemotherapy. 

According to the National Cancer Institute, colorectal cancer is the third most commonly diagnosed malignancy, accounting for 10 to 15 percent of newly diagnosed cancer cases in the United States and Europe. An estimated 783,000 new cases are diagnosed annually worldwide. Up to 30 percent of patients are diagnosed with metastatic disease while 50 to 60 percent eventually develop metastatic or advanced disease.  The five-year survival rate for advanced colon cancer is five percent or less.  Xeloda is manufactured by Hoffmann-La Roche.

© 2015 The University of Texas MD Anderson Cancer Center