Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).
Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.
Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.
Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.
Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324