Study Finds Combination Xeloda and Taxotere More Beneficial for Advanced Breast Cancer Patients than Taxotere Alone (dateline December 12, 2000)
Two chemotherapy drugs, Xeloda (generic name, capecitabine) and Taxotere (generic name, docetaxel), have both been shown to be effective treatments for some women with advanced breast cancer. Now researchers have found that combining the two drugs helps women with advanced breast cancer live longer. The combination treatment also appears to help improve the time in which a tumor responds to therapy and helps slow tumor progression.
The study, which included patients from 16 countries, was presented at the San Antonio Breast Cancer Symposium last week by Joyce O'Shaughnessy, MD, co-director of breast cancer research at Baylor-Sammons Cancer Center and U.S. Oncology, Inc. "This study of Xeloda and Taxotere in combination represents an important step forward in the battle against breast cancer," said Dr. O'Shaughnessy, in a U.S. Oncology press release. "This combination will give us a powerful new option to treat women with metastatic breast cancer."
In the study, researchers randomly assigned the 511 advanced breast cancer patients who had not responded well to treatment with a class of chemotherapy drugs called anthracyclines (such as Adriamycin; generic name, doxorubicin) to take either a combination of Xeloda and Taxotere or Taxotere alone for over one year. According to Dr. O'Shaughnessy and her colleagues, patients who received the combination treatment lived longer than patients who received Taxotere alone (the average survival time was 13.7 months for patients on Xeloda/Taxotere and 11.1 months for patients on Taxotere alone). While the difference in this survival time may not seem remarkable, Dr. O'Shaughnessy noted that it is very difficult to extend survival time for advanced breast cancer patients, and that even a small increase is a noteworthy advance.
The researchers also noted improvements in tumor response with combination Xeloda and Taxotere treatment: 42% of tumors showed a response to Xeloda/Taxotere treatment compared with 30% to Taxotere alone. The time it took for tumors to progress was also slowed more with Xeloda and Taxotere than with Taxotere alone: it took an average of 6.1 months for tumors to progress with Xeloda/Taxotere compared with 4.2 months for tumors with Taxotere.
While the results are promising, the side effects were more severe among the women who took both Xeloda and Taxotere than those who took Taxotere alone. Patients who took the combination therapy experienced more episodes of diarrhea, stomatitis (sores in mouth and throat), hand and foot syndrome (palms of the hands or soles of the feet feel numb or swollen), nausea and vomiting. According to the researchers, these side effects were manageable in most patients with proper medical intervention, including dose interruptions or dose reductions when necessary. Patients who took Taxotere alone experienced more episodes of fever (due to neutropenia; a decrease in a type of white blood cell) and muscle and joint pain (myalgia and arthralgia).
Advanced, or metastatic breast cancer is classified as a Stage IV breast cancer (the most advanced stage). Advanced breast cancer has spread past the breast and axillary (armpit) lymph nodes to other organs of the body, such as the bone, liver, lung, or brain. Treatment of advanced breast cancer generally focuses on relieving cancer symptoms and extending a woman's lifetime. Promising new research is giving advanced breast cancer patients more treatment options.
Taxotere was approved by the U.S. Food and Drug Administration (FDA) in 1996 to treat advanced breast cancer in patients who have not responded well to chemotherapy with Adriamycin. Taxotere is classified in the taxane family of drugs and works by inhibiting the division of breast cancer cells by acting on the cell's internal skeleton.
Xeloda was approved by the FDA in 1998 for advanced breast cancer patients who have not responded well to chemotherapy that included Taxol (generic name, paclitaxel) and an anthracycline (such as Adriamycin). Xeloda works by converting to a substance called 5-fluorouracil in the body. In some patients, Xeloda kills cancer cells and decreases the size of the tumor.