114P Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) plus chemotherapy in HER2-positive early breast cancer (EBC): Long-term efficacy and safety analysis of the randomised, open-label, multicentre phase III (neo)adjuvant FeDeriCa study
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".