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Capecitabine Research Points to New Combinations for Metastatic Breast Cancer

Capecitabine Research Points to New Combinations for Metastatic Breast Cancer

MANHASSET, New York—Early clinical results suggest that capecitabine
(Xeloda) may work well in several new combinations for metastatic breast
cancer, according to Daniel R. Budman, MD, professor of medicine at New York
University and associate director of medical oncology at North Shore
University Hospital, Manhasset, New York.

Beyond its successful pairing with docetaxel (Taxotere), capecitabine may
have potential in combination with paclitaxel (Taxol), vinorelbine
(Navelbine), irinotecan (CPT-11, Camptosar), and in triplet therapy with
docetaxel and epirubicin (Ellence).

Speaking at an industry-sponsored symposium held in conjunction with the
38th Annual Meeting of the American Society of Clinical Oncology, Dr. Budman
said that the docetaxel/capecitabine experience suggests several new directions for combination therapy, including different
schedules of giving docetaxel and substituting a
different taxane, such as paclitaxel (Taxol).

In a 47-patient phase II study of paclitaxel (175 mg/m² on day 1 every 3
weeks) and capecitabine (825 mg/m² twice a day on days 1 to 14), the median time to progression was more
than 44 weeks, and the total response rate was nearly 40% when given as
first-line therapy and more than 50% as second-line therapy (see Figure 1).

In another approach, capecitabine is being studied in combination with
vinorelbine. Results of three small phase I or II
trials indicate overall response rates around 50%.

In one study of 36 women age 65 or older—the Swiss SAKK 25/99 trial—all
patients received, as first-line therapy, 20 mg/m² of vinorelbine on days 1
and 8, but the capecitabine dose varied from 800 mg/m² to 1,250 mg/m² twice daily on days 1 to 14. Dose-limiting toxicities were
neutropenia, stomatitis, diarrhea, and thrombosis (Hess DD et al: Proc
Am Assoc Clin Oncol
21(part 2):247b, 2002, abstract 2915).

"Antitumor responses were seen at all dosage levels," Dr.
Budman said. "This brings up a different point because all of us try to
use next to the maximum tolerated dose. But if you can get true synergism,
it’s entirely conceivable—although we haven’t really clinically
studied it up front—to see whether we can give a relatively less toxic
combination and yet get the same activity, which then becomes a major
quality-of-life advantage."

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