The primary analysis of the FeDeriCa study (NCT03493854; Tan AR, et al. Lancet Oncol 2021) showed that PH FDC SC cycle 7 P and H serum trough concentrations were non-inferior to intravenous (IV) P and H, with comparable total pathological complete response rates and safety profiles when given as neoadjuvant therapy for HER2-positive EBC. Here we report long-term efficacy and safety data. Patients (pts) had HER2-positive operable, locally advanced or inflammatory stage II–IIIC BC and left ventricular ejection fraction ≥55%. They received eight cycles of neoadjuvant chemotherapy (one of two standard regimens chosen by the investigator) + P IV (840 mg loading dose then 420 mg maintenance) + H IV (8 mg/kg then 6 mg/kg) or PH FDC SC (1200 mg P/600 mg H then 600 mg each as FDC SC) every 3 weeks during cycles 5–8 in a 1:1 randomisation design. Pts continued adjuvant HER2-targeted treatment after surgery, per randomisation, to complete 18 cycles. Secondary endpoints included invasive disease-free survival (iDFS), event-free survival (EFS), distant recurrence-free interval (DRFI), overall survival (OS) and safety (focusing on cardiac adverse events). Data cut-off was 2 Jun, 2023; median follow-up was 51.4 months in the P + H IV arm and 51.2 months in the PH FDC SC arm. Long-term efficacy data are shown in the table. No new safety signals, including for cardiac safety, were observed.Table: 114PP + H IV n = 252PH FDC SC n = 248iDFSPts who underwent surgery, n239234Pts with event, n (%)23 (9.6)26 (11.1)Unstratified hazard ratio (HR)(95% confidence interval [CI])1.13 (0.64, 1.97)4-year event-free rate (95% CI)89.5 (85.4, 93.6)88.5 (84.3, 92.7)EFSPts, n252248Pts with event, n (%)29 (11.5)32 (12.9)HR (95% CI)1.20 (0.72, 1.98)4-year event-free rate (95% CI)88.5 (84.4, 92.5)86.6 (82.2, 90.9)DRFIPts, n252248Pts with event, n (%)18 (7.1)19 (7.7)HR (95% CI)1.17 (0.61, 2.24)4-year event-free rate (95% CI)92.5 (89.2, 95.8)91.9 (88.4, 95.4)OSPts, n252248Pts with event, n %12 (4.8)14 (5.6)HR (95% CI)1.26 (0.58, 2.72)4-year event-free rate (95% CI)95.5 (92.9, 98.1)94.1 (91.1, 97.1) Open table in a new tab The long-term efficacy of PH FDC SC was comparable to that of P + H IV. Safety remained similar to P + H IV and consistent with P + H + chemotherapy. Overall, these findings support the primary analysis results. PH FDC SC is established as a faster, more convenient, less invasive, pt- and healthcare professional-preferred alternative to P + H IV for pts with HER2-positive BC.
No takes yet. Share an insight, caveat, or question.
Jackisch et al. (2024) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: