Capecitabine Monotherapy in Patients with Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer

Abstract

The selection of chemotherapeutic regimens is challenging for metastatic breast cancer (MBC) patients whose diseases have failed to respond to anthracyline and taxane. Capecitabine has advantages of oral administration and favorable toxicity profiles. This study was conducted to evaluate the efficacy of capecitabine and to identify the subgroup of patients who would potentially have benefit from capecitabine monotherapy in patients with anthracycline- and taxane-pretreated MBC. Female patients with MBC who had been previously treated with anthracycline and taxane received oral capecitabine 2500 mg/m(2) divided in two doses daily for 2 wk with 1-wk rest period. Between September, 1999, and December, 2002, a total of 38 patients were enrolled. Among the 36 evaluable patients, one patient achieved a complete response (CR), 9 patients had partial responses (PRs), and 13 patients had stable diseases (SDs). Response rate was 26% [95% confidence interval (CI), 12-40%] and the tumor control rate (TCR, CR+PR+SD) was 61% (95% CI, 45-77%). The median follow-up duration was 27.8 mo. The median duration of response was 8.9 mo, the median time to progression was 4.6 mo, and the median overall survival was 18.1 mo. The major toxicities were hand-foot syndrome, diarrhea, and emesis. There was no treatment-related death. The predictors of better overall survival were positivity of hormone receptor, disease-free survival longer than 1 yr, non-refractoriness to anthracycline, and fewer number (<or= 3) of involved organs. Capecitabine monotherapy is effective and well tolerated for MBC patients who had previously been treated with anthracycline and taxane. The TCR could predict overall survival as well as the objective response in this study, suggesting a possible role of TCR as a surrogate marker for survival in MBC patients on salvage chemotherapy. The patients who have relatively slow growing tumor and less tumor burden could have benefit from capecitabine monotherapy following anthracycline- and taxane-based chemotherapy.

Capecitabine and Mitomycin C Is an Effective Combination for Anthracycline- and Taxane-Resistant Metastatic Breast Cancer

“…Moreover, capecitabine alone emerged as an alternative to paclitaxel [25] or CMF [7] in patients for whom anthracycline-based combinations may not be appropriate, such as frail or elderly patients, patients with considerable comorbidities, or patient preference for oral chemotherapy. Other studies have shown that capecitabine monotherapy is effective in patients with metastatic breast cancer failing previous anthracycline- and taxane-based regimens [3,4,5,6]. …”

“…Moreover, capecitabine is converted into fluorouracil by thymidine phosphorylase and therefore has the advantage of preferentially generating fluorouracil in the tumor tissue where thymidine phosphorylase is at a higher concentration [2]. The antitumor activity of single-agent capecitabine in metastatic breast cancer has been reported more frequently in anthracycline- and taxane-pretreated patients [3,4,5,6] than as first-line chemotherapy [7]. Treatment with capecitabine monotherapy allowed 15–29% of patients with metastatic breast cancer to achieve a clinical response despite treatment failure with taxane- and/or anthracycline-based therapy [3,4,5,6].…”

“…The antitumor activity of single-agent capecitabine in metastatic breast cancer has been reported more frequently in anthracycline- and taxane-pretreated patients [3,4,5,6] than as first-line chemotherapy [7]. Treatment with capecitabine monotherapy allowed 15–29% of patients with metastatic breast cancer to achieve a clinical response despite treatment failure with taxane- and/or anthracycline-based therapy [3,4,5,6]. Preclinical studies suggest that the activity of capecitabine can be further enhanced by other antiblastic drugs, such as taxanes [8].…”

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

“…A phase II RCT by Talbot et al [42] compared the safety profile of single-agent capecitabine with that of singleagent paclitaxel in patients who had failed or were resistant to anthracycline-based therapy and/or who had undergone 19 (14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26) All regimens used twice daily dosing, 2 weeks on/1 week off, unless otherwise noted.…”

“…Lee et al [24] www.TheOncologist.com prior 5-FU therapy. The overall incidence of grade 3 AEs was lower but not statistically significant for those treated with single-agent capecitabine than for those treated with single-agent paclitaxel (36% vs. 68%; p = .06).…”