(Breast Cancer) Xeloda Plus Standard Chemotherapy: Is It Effective?

• May 15, 2020
• 2 min read

On April 10, 2020, Junjie Li published results in the Journal of Clinical Oncology from the CBCSG010 Phase 3 clinical trial evaluating the efficacy and safety of adjuvant capecitabine (Xeloda) plus docetaxel (Taxotere) as post-operative chemotherapy in early triple-negative breast cancer patients.

This Phase 3 trial was a multi-center, open-label, prospective study randomizing early TNBC patients (N=585) into two groups, with disease-free survival (DFS) as the primary endpoint:

1. Capecitabine group (N=297): Capecitabine 1000 mg/m² + docetaxel 75 mg/m² (21-day cycle × 3), followed by capecitabine 1000 mg/m² + epirubicin 75 mg/m² + cyclophosphamide 500 mg/m² (21-day cycle × 3).

2. Control group (N=288): Docetaxel 75 mg/m² (21-day cycle × 3), followed by 5-FU 500 mg/m² + epirubicin 75 mg/m² + cyclophosphamide 500 mg/m² (21-day cycle × 3).

The trial was initiated because capecitabine plus chemotherapy had shown utility as post-operative chemotherapy in HER2-negative breast cancer in other clinical trials, but data supporting its use specifically in TNBC as adjuvant therapy were limited.

Results at median follow-up of 67 months:

Primary endpoint 5-year DFS: Capecitabine group 86.3% vs. control group 80.4% — a statistically significant improvement in the capecitabine group.

Secondary endpoint 5-year overall survival (OS): Capecitabine group 93.3% vs. control group 90.7% — numerically higher in the capecitabine group, but not statistically significant.

Safety:

Most common Grade 3 or higher adverse events: neutropenia (capecitabine 45.8% vs. control 41.0%), febrile neutropenia (capecitabine 16.8% vs. control 16.0%). Capecitabine safety profile was consistent with previously known clinical trial data; no new adverse events were identified.

Conclusion: Based on the CBCSG010 trial results, Junjie Li concluded that capecitabine plus standard chemotherapy significantly improved the primary endpoint of DFS in early TNBC patients.

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Source: Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010). J Clin Oncol. 2020 Apr 10: JCO1902474. doi: 10.1200/JCO.19.02474.

Breast Cancer | Capecitabine

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