Taking chemotherapy medicine orally (by mouth) may seem like a better option than getting chemotherapy intravenously for some women, especially older women. But the study reviewed here found that women older than 65 who got standard intravenous chemotherapy after surgery to remove early-stage breast cancer were less likely to have breast cancer come back or to die compared to women who got Xeloda (chemical name: capecitabine), an oral chemotherapy.
Chemotherapy often is used after breast cancer surgery to reduce the risk of breast cancer coming back. This type of chemotherapy -- called adjuvant chemotherapy -- aims to weaken and destroy any cancer cells that may be left behind after surgery.
The women in this study were all 65 or older and received one of three adjuvant chemotherapy regimens:
Xeloda currently isn't approved as adjuvant chemotherapy for early-stage breast cancer, but is approved to treat advanced (metastatic) breast cancer. Because Xeloda is taken by mouth, the researchers wanted to know if it would work as well as traditional intravenous adjuvant chemotherapy regimens in older women.
The women also received adjuvant hormonal therapy medicine if the breast cancer was hormone-receptor-positive.
The researchers ended this study early because it became clear that women who got Xeloda were more than twice as likely to have the breast cancer come back or to die during the 3 years after they were diagnosed compared to the women who got one of the other two intravenous chemotherapy regimens. Women who got Xeloda also were twice as likely to have severe side effects. This study supports other research that has shown that older women tend to tolerate traditional intravenous chemotherapy as well as younger women.
If you've been diagnosed with early-stage breast cancer, work with your doctor to create a treatment plan that makes the most sense based on available research results and your unique situation. Your age should be a factor only if research results suggest that it should be. As this and other studies show, treatment approaches that may seem easier for an older woman may turn out to cause more side effects and not work as well. Together, you and your doctor can decide on the treatment plan that is best for YOU.
To learn more about chemotherapy medicines, visit the Breastcancer.org Chemotherapy section.
HOUSTON, May 13 (MedPage Today) -- Older women with early-stage breast cancer fared better with conventional adjuvant chemotherapy than with the newer agent capecitabine (Xeloda) in a large multicenter clinical trial.
Patients treated with capecitabine had almost twice the risk of relapse or death compared with those who received an older combination regimen, Hyman Muss, M.D., of the University of North Carolina in Chapel Hill, and colleagues reported in the May 14 issue of the New England Journal of Medicine.
After three years of follow-up, patients assigned to conventional adjuvant chemotherapy had better disease-free and overall survival.
"Our data are part of a developing body of evidence that the choice of adjuvant chemotherapy really matters in older women with breast cancer and that standard chemotherapy is superior to the oral agent capecitabine," the authors concluded.
Age is the major risk factor for breast cancer in the United States, and most breast cancer deaths involve women 65 or older. Ironically, older patients have been underrepresented in clinical trials of adjuvant chemotherapy, and patients do not always receive guideline-supported treatment, the authors said.
Moreover, older women tolerate adjuvant chemotherapy about as well as their younger counterparts, and more severe toxicity has not had a meaningful impact on the benefits, they added.
To examine the benefits of adjuvant chemotherapy in older women, investigators in Cancer and Leukemia Group B conducted a trial to compare oral capecitabine to standard therapy in women ages 65 and older.
Standard therapy was either cyclophosphamide, methotrexate, and 5-fluorouracil, or cyclophosphamide plus doxorubicin.
Patients with hormone receptor-positive cancer also received endocrine therapy.
The trial's statistical design allowed for a patient population of 600 to 1,800 patients. The trial was stopped after enrollment of the 600th patient when an interim analysis showed that capecitabine was likely to be inferior to the conventional regimens with longer follow-up.
With follow-up for one year beyond enrollment of the last patient, patients randomized to capecitabine had a hazard ratio for recurrence or death of 2.09 versus conventional therapy (95% CI 1.38 to 3.17, P<0.001).
Capecitabine-treated patients had a mortality hazard ratio of 1.85 versus standard adjuvant therapy (P=0.02).
The three-year relapse-free survival was 68% with capecitabine and 85% in women assigned to standard therapy. Overall survival was 86% with capecitabine and 91% with standard chemotherapy.
Capecitabine was associated with almost twice the incidence of moderate-to-severe toxicity (64% versus 33%).
The study was supported by the National Cancer Institute, the National Institute on Aging, the Breast Cancer Research Foundation, the Coalition of Cancer Cooperative Groups, and Roche Biomedical Laboratories.
Dr. Muss and co-authors Donald A. Berry, Clifford A. Hudis, Larry Norton, Julie Gralow, Edith Perez, and Antonio C. Wolff disclosed relationships with Hoffman-La Roche.
Primary source: New England Journal of Medicine Source reference: Muss HB et al. "Adjuvant chemotherapy in older women with early-stage breast cancer." N Engl J Med. 2009;360(20):2055-2065.
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