Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer

Abstract

BACKGROUND Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor–positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P<0.001). Patients who were randomly assigned to capecitabine were twice as likely to have a relapse and almost twice as likely to die as patients who were randomly assigned to standard chemotherapy (P = 0.02). At 3 years, the rate of relapse-free survival was 68% in the capecitabine group versus 85% in the standard-chemotherapy group, and the overall survival rate was 86% versus 91%. Two patients in the capecitabine group died of treatment-related complications; as compared with patients receiving capecitabine, twice as many patients receiving standard chemotherapy had moderate-to-severe toxic effects (64% vs. 33%). CONCLUSIONS Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. (ClinicalTrials.gov number, NCT00024102.)

Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study

“…Results indicated that the efficacy of UFT as an adjuvant treatment was comparable with that of CMF. On the other hand, Cancer and Leukemia Group B (CALGB) reported that a 4.5-month administration of capecitabine was inferior to CMF/AC (doxorubicin (ADM) þ CPA) in elderly breast cancer patients (Muss et al, 2009). This disagreement among results, including those of this study, might be partly explained by the difference in the duration of treatment with oral fluoropyrimidines.…”

Study on Adherence to Capecitabine Among Patients With Colorectal Cancer and Metastatic Breast Cancer

“…Others studies on adherence to capecitabine were published, and the data were similar to what was observed in the present study, especially in relation to breast cancer. Only 76% of the elderly patients with breast cancer received 80% or more of the prescribed doses (19) . On the other hand, in a younger breast cancer population, the mean adherence found was greater than 96% (18) .…”

Lack of Survival Gain for Elderly Women with Breast Cancer

“…Because women aged Ͼ80 years make up almost 15% of the breast cancer population, it is worrisome that these women apparently do not profit from the advances made. A number of authors have argued that older breast cancer patients may not get appropriate treatment [5][6][7]9]. In a Swiss population-based study of breast cancer patients diagnosed in 1989 -1999, it was shown that the treatment of older women differed from that of the younger age groups.…”

“…For younger patients, a strong increase in adjuvant chemotherapy was seen, but very few elderly patients received adjuvant chemotherapy. However, recent trials suggest that, in fit elderly patients, standard chemotherapy is both effective and tolerated [5].…”