- In a previous report of the phase 3 GBG 69-GeparSepto trial, nab-paclitaxel improved complete pathologic response vs solvent-based paclitaxel in early breast cancer (eBCa).
- In this long-term update of the GBG 69-GeparSepto trial, nab-paclitaxel prolonged invasive disease-free survival (iDFS) by 34% vs solvent-based (sb) paclitaxel in women with eBCa.
Why this matters
- Nab-paclitaxel (nanoparticle albumin-bound paclitaxel developed to avoid toxicities) may become standard of care for eBCa.
- Phase 3 randomized controlled trial (n=1206) of weekly nab-paclitaxel (150 mg/m2) vs weekly sb-paclitaxel (80 mg/m2) followed by, every 3 weeks in both groups, 4 times epirubicin 90 mg/m2+cyclophosphamide 600 mg/m2.
- Subgroup with human epidermal growth factor receptor 2-positive (HER2+) tumor also received trastuzumab and pertuzumab.
- Funding: Celgene Germany; Roche Germany.
- Median follow-up, 49.6 months.
- Nab-paclitaxel yielded 34% longer iDFS than sb-paclitaxel (HR, 0.66; P=.002).
- In subgroup analysis, only hormone receptor-positive (HR+)/HER2− tumors showed prolonged iDFS (P=.030).
- No difference between groups in OS (P=.260).
- The nab-paclitaxel group (125 mg/m2) showed a shorter median time to resolve grade 2-4 to grade 1 peripheral sensory neuropathy (PSN) vs nab-paclitaxel (150 mg/m2; 6.4 vs 12.7 weeks; P=.014).
- Open-label design.
- Possible overestimation of PSN benefit with lower-dose nab-paclitaxel because of the small sample size.