Key clinical point: Adding denosumab to anthracycline/taxane-based neoadjuvant chemotherapy (NACT) did not improve pathological complete response (pCR) rates, but a weekly vs. every-3-week nanoparticle albumin-bound ( nab)-paclitaxel regimen improved pCR rates in patients with early breast cancer (BC), although the toxicity was higher.
Major finding: The addition of denosumab did not improve pCR rates ( P = .61). However, a weekly vs. every-3-week nab-paclitaxel regimen resulted in a higher pCR rate (odds ratio [OR] 1.27; 90% CI 1.00-1.62) in the overall population and in patients with triple-negative BC (OR 1.52; 90% CI 1.05-2.21) , but the grade 3-4 nonhematologic adverse event frequency was higher ( P = .004).
Study details: Findings are from the 2 × 2 phase 2b, GeparX trial including 780 patients with primary BC who were randomly assigned to receive NACT with or without denosumab and a weekly or every-3-week nab-paclitaxel regimen.
Disclosures: The study was sponsored by the German Breast Group. The authors declared holding patents or receiving personal fees, honoraria, grants, trial funding, nonfinancial support, or travel support from several sources.
Source: Blohmer JU et al. Effect of denosumab added to 2 different nab-paclitaxel regimens as neoadjuvant therapy in patients with primary breast cancer: The GeparX 2 × 2 randomized clinical trial. JAMA Oncol. 2022 (May 19). Doi: 10.1001/jamaoncol.2022.1059