Oral Drug is as Effective as Infusional Drug for Rectal Cancer when Combined with Radiation Therapy Before Surgery

Gastrointestinal Cancers Symposium
January 14, 2014

New results from a large clinical trial show that a drug taken by mouth is just as effective as one given by infusion for people with stage II or stage III rectal cancer.  These patients received radiation therapy and chemotherapy with either capecitabine (Xeloda) or 5-fluorouracil (5-FU, Adrucil) before surgery. The researchers also found that adding another drug, oxaliplatin (Eloxatin), did not provide any additional benefits and caused more side effects.

People diagnosed with stage II or stage III rectal cancer who can be treated with surgery usually receive chemotherapy and radiation therapy before surgery to help shrink the tumor. Chemotherapy with the drugs 5-FU, capecitabine, and oxaliplatin allows radiation therapy to more easily destroy the tumor. Currently, most doctors use 5-FU, which is given by continuous infusion and requires surgery to place a port (a small plastic or metal disc) beneath the skin. However, many doctors have suspected that capecitabine, a similar drug that can be taken orally (by mouth), would be equally effective.

To find out if capecitabine did in fact work as well as 5-FU, the researchers divided more than 1,600 volunteers into four treatment groups. Each group received five weeks of radiation therapy plus either 5-FU, 5-FU and oxaliplatin, capecitabine, or capecitabine and oxaliplatin. Then, about a month later, each group had surgery to remove the tumor. At the end of the study, the researchers found that all four treatments had similar effects. When surgeons were able to completely remove the tumor and no traces of cancer cells were left behind, 96% to 98% of patients with stage II cancer and 89% to 96% of patients with stage III cancer had no signs of the cancer returning in its original location within three years after surgery. And in all four treatment groups, about 80% of patients were alive five years after surgery. The only major difference between the groups was that patients who received oxaliplatin experienced more diarrhea and fatigue.

What this means for patients

“Oral capecitabine is certainly far more convenient for patients compared to infusional 5-FU,” said lead study author Carmen Joseph Allegra, MD, a professor of medicine at the University of Florida in Gainesville. “It means taking pills twice a day, rather than undergoing surgery to place an intravenous port and then wearing a pump on their belt for five weeks.” However, capecitabine is not currently approved by the U.S. Food and Drug Administration to be used with radiation therapy before surgery and may not be available for every patient. Talk with your doctor for more information about your treatment options.

Questions to ask your doctor

  • What stage of rectal cancer do I have? What does this mean?
  • What are my treatment options?
  • How will each treatment be given?
  • What short- and long-term side effects may be caused by each treatment?
  • How can these side effects be prevented or managed?

For More Information

Guide to Colorectal Cancer

ASCO Answers: Colorectal Cancer (PDF)

Understanding Chemotherapy

Understanding Radiation Therapy

Catheters and Ports in Cancer Treatment