Dose-Dense Adjuvant Chemotherapy in Early-Stage Breast Cancer: 15-Year Italian Trial Update

By: Celeste L. Dixon
Posted: Friday, November 4, 2022

Dose-dense chemotherapy should be considered the standard adjuvant schedule for patients with early-stage node-positive breast cancer, according to the end-of-study analysis of the open-label, phase III GIM 2 trial.), explained Lucia Del Mastro, MD, of the National Cancer Institute of Genoa, Italy, and colleagues at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 134O). Based on follow-up data, both the 15-year disease-free and overall survival rates were better with dose-dense chemotherapy than the standard interval of therapy. These findings confirm the primary analysis published in 2015.

In the study, which included 2,003 participants randomly assigned on a 1:1 basis, patients received epirubicin/cyclophosphamide and paclitaxel either every 2 weeks (dose dense) or every 3 weeks (standard interval). About half of the patients in each arm were further designated to receive fluorouracil in conjunction with the other drugs.

After a median follow-up of 15.1 years in the dose-dense arm, the 15-year disease-free survival rate was 61% with dose-dense therapy versus 52% in the control arm (P < .001). The 15-year overall survival rate was 76% and 69% in the two arms, respectively (P < .001). As for patients with hormone receptor–positive disease (n = 1,611), the 15-year overall survival rate was 76% with dose-dense therapy versus 71% with the standard schedule. In those with hormone receptor–negative disease (n = 335), the 15-year overall survival rate was 76% versus 63%, respectively. In addition, the addition of fluorouracil was found to be of no benefit in terms of either disease-free or overall survival.

Disclosure: The study authors’ disclosure information can be found at cslide.ctimeetingtech.com.

ESMO Congress 2022

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