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Key Words: breast cancer, capecitabine, chemotherapy, docetaxel. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ².)

Patients with advanced breast cancer who received a combination regimen of capecitabine and docetaxel survived for three months longer on average than patients who received docetaxel alone, according to an international study published in the June 15, 2002, issue of the Journal of Clinical Oncology (see the journal abstract).

The study involved 511 patients in 16 countries. All of the patients had inoperable advanced breast cancer that had recurred after treatment with anthracycline drugs, which included doxorubicin and epirubicin.

"Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated metastatic breast cancer," concluded the study authors, who were led by Joyce O'Shaughnessy, M.D., of the Baylor-Simmons Cancer Center in Dallas, Texas.

Patients who were randomly assigned to receive combination therapy survived for an average of 14.5 months compared with 11.5 months for patients who received docetaxel alone. Disease progression was delayed by six months in combination-therapy patients compared with four months in the docetaxel-alone group.

The number of patients experiencing side effects of treatment was similar in the two groups. Patients receiving combination therapy were more likely to suffer from gastrointestinal side effects and hand-foot syndrome, an inflammatory skin condition. Patients treated with docetaxel alone were more likely to suffer from fever and joint pain. Scores on quality-of-life questionnaires were similar in the two groups.

Thirty to 40 percent of all patients with breast cancer in Western countries develop advanced disease, according to the study authors. The treatment of advanced breast cancer is a challenge, they said, in part because anthracyclines and drugs of the class known as taxanes (which includes docetaxel) are now being used earlier in the course of the disease -- making it more likely that patients who experience recurrence will already have been treated with these drugs. Therefore further treatment with the same drugs is unlikely to be successful.

Capecitabine works in the body in a different way than either anthracycline or taxane drugs, offering the possibility of a fresh approach. Also, because capecitabine is less likely than other anticancer drugs to suppress the bone marrow (the spongy tissue inside large bones), researchers considered it a good candidate for use in combination therapy.

Previous studies of docetaxel and capecitabine used as single agents had shown promising results, leading researchers to think that combining them might further boost effectiveness. Using anticancer drugs in combination rather than one after another (sequentially) remains controversial, however. Previously, no combination therapy had been shown to significantly increase patient survival compared with sequential single-drug treatment.

"The present trial provides clear evidence that combination therapy offers a survival advantage compared with single-agent therapy," the authors concluded.

Glossary Terms

A type of antibiotic that comes from the fungus Streptococcus peucetius. Anthracyclines are used as treatments for cancer. Daunorubicin, doxorubicin, and epirubicin are anthracyclines.

A drug that is used in the treatment of cancer. It belongs to the family of drugs called antimetabolites.

Treatment with anticancer drugs.

An anticancer drug that belongs to the family of drugs called mitotic inhibitors.

GI. Refers to the stomach and intestines.

Having to do with metastasis, which is the spread of cancer from one part of the body to another.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A drug that inhibits cell growth by stopping cell division. Taxanes are used as treatments for cancer. Also called antimitotic or antimicrotubule agents or mitotic inhibitors. Docetaxel and paclitaxel are taxanes.