Abstract P5-14-05: Capecitabine in early breast cancer: A meta-analysis of randomized controlled trials

Abstract

Background

Capecitabine is an effective therapy for metastatic breast cancer. Its role in early breast cancer is uncertain due to conflicting data from randomized controlled trials (RCTs).

Methods

PubMed and major conference proceedings were searched to identify RCTs comparing standard chemotherapy (defined as cyclophosphamide/methotrexate/5-fluorouracil, anthracycline-based regimens or anthracycline/taxane combinations) with or without capecitabine in the neo-adjuvant or adjuvant setting. Hazard ratios (HR) for disease-free (DFS) and overall survival (OS), as well as odds ratios (ORs) for safety and tolerability were extracted or calculated and pooled in a meta-analysis. Subgroup analysis compared triple negative breast cancer (TNBC) to non-TNBC and whether capecitabine was given in addition to or in place of standard chemotherapy. Meta-regression was used to explore the influence of TNBC on OS.

Results

Eight studies comprising 9302 patients were included. In unselected patients, capecitabine did not influence DFS (HR 0.99, p=0.93) or OS (HR 0.90, p=0.36). There was a significant difference in DFS when capecitabine was given in addition to, compared to in place of standard treatment (HR 0.92 vs. 1.62, interaction p=0.002). Addition of capecitabine to standard chemotherapy was associated with significantly improved DFS in TNBC vs non-TNBC (HR 0.72 vs. 1.01, interaction p=0.02). Meta-regression confirmed this association with OS (R=-0.967, p=0.007). Capecitabine increased Grade 3/4 diarrhea (OR 2.33, p<0.001) and hand foot syndrome (OR 8.08, p<0.001), and resulted in more frequent treatment discontinuation (OR 3.80, p<0.001).

Conclusion

Adding capecitabine to standard chemotherapy appears to improve DFS and OS in TNBC, but increases adverse events in keeping with its known toxicity profile. Consideration of this treatment is warranted, especially in high-risk patients.

Citation Format: Natori A, Ethier J-L, Amir E, Cescon DW. Capecitabine in early breast cancer: A meta-analysis of randomized controlled trials [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-14-05.