Final Results of ERASME-4: A Randomized Trial of First-Line Docetaxel plus either Capecitabine or Epirubicin for Metastatic Breast Cancer

Abstract

Objective: To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC). Patients and Methods: Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m² twice daily, days 1–14; docetaxel 75 mg/m², day 1) or ET (epirubicin 75 mg/m², day 1; docetaxel 75 mg/m², day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design. Results: Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months’ median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience. Conclusion: Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.

Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

“…Secondly, although analyses were stratified by line of therapy, some connections had to be forced to maintain a connected network. For example, the study by Bachelot et al [ 25 ] was classified as a second-line study, but it was also forced into first-line networks so that chemotherapy agents of interest, such as docetaxel and paclitaxel, could be included. Three studies were also forced into networks based on patient characteristics: Ackland et al [ 17 ], Dixon et al [ 19 ], and Paridaens et al [ 18 ].…”

Comparison of the effectiveness and toxicity of neoadjuvant chemotherapy regimens, capecitabine/epirubicin/cyclophosphamide vs 5-fluorouracil/epirubicin/cyclophosphamide, followed by adjuvant, capecitabine/docetaxel vs docetaxel, in patients with operable breast cancer

“…Capecitabine monotherapy or capecitabine-containing regimens can be used not only as first-line treatment in advanced breast cancer but also as second- or third-line treatment in locally advanced breast cancer due to its good tolerance to side effects. 32 – 35 After success with combination therapy, sequential treatment until single-drug maintenance could prolong the survival time in advanced breast cancer patients.…”

Capecitabine in Combination with Docetaxel in First Line in HER2-Negative Metastatic Breast Cancer: an Observational Study

“…A limitation of our study was the small size of the population included. Although the study design did not allow the evaluation of the safety, tolerability and efficacy of XT treatment in comparison with a control arm, since these data are well known from large phase II-III clinical studies [9][10][11][12][13][14][15][16][17][18][19][20], the main goal was the introduction of this new regimen into routine practice. Our findings raise the attention to the importance of appropriate patient selection and toxicity management.…”