Breast (Edinburgh, Scotland) · 2026
Prediction of benefit from docetaxel chemotherapy for HR-positive breast cancer in the PACS-01 trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Penault-Llorca Frédérique, Lusque Amelie, Filleron Thomas, Tran Kevin, Du Lili, Baehner Rick, Dalenc Florence, Lacroix-Triki Magali, Bachelot Thomas, Andre Fabrice, Boucher Pascal, Lemonnier Jérôme, Symmans W Fraser
Аннотация
BACKGROUND: Adjuvant chemotherapy for hormone receptor-positive (HR+) breast cancer relies on taxanes, but existing tests do not identify which patients benefit from them. The SETER/PR index, a measure of endocrine-related transcriptional activity in HR + tumors, recently predicted benefit from paclitaxel when low (<0.75), but not for anthracycline-based therapy. We tested whether SETER/PR could predict benefit from docetaxel in node-positive, HR + patients enrolled in the PACS-01 trial (docetaxel after fluorouracil-epirubicin-cyclophosphamide (3FEC+3D) versus 6FEC).
PATIENTS AND METHODS: SETER/PR index and Recurrence Score (RS) were obtained for 490 patients. SETER/PR was quantified using the QuantiGene Plex assay from RNA remaining after RS testing. Pre-specified analyses assessed SETER/PR as a continuous variable and using the predefined <0.75 cut point, as well as continuous RS and the >25 cut point. The primary endpoint was distant recurrence-free interval (DRFI). Predictive value was assessed using Cox models including biomarker, treatment arm, and interaction term.
RESULTS: Continuous SETER/PR demonstrated significant interaction with treatment on DRFI (Pinteraction = 0.028), whereas predefined <0.75 cut point was not predictive (Pinteraction = 0.668). Exploratory analyses identified a cut point at 1.50 (Pinteraction = 0.013): patients with SETER/PR ≥ 1.50 had worse outcomes with 3FEC+3D versus 6FEC (HR 3.16, 95%CI 1.28-7.85), while outcomes were similar between arms when SETER/PR < 1.50 (HR 0.83, 95%CI 0.51-1.35). RS did not predict differential benefit, either continuously (Pinteraction = 0.670) or at the >25 threshold (Pinteraction = 0.534).
CONCLUSION: Including sequential docetaxel (3FEC+3D) was less effective than continued anthracycline chemotherapy (6FEC) when breast cancer had high endocrine-related transcriptional activity (i.e., SETER/PR index ≥1.50).
TRIAL REGISTRATION: PACS-01.
PATIENTS AND METHODS: SETER/PR index and Recurrence Score (RS) were obtained for 490 patients. SETER/PR was quantified using the QuantiGene Plex assay from RNA remaining after RS testing. Pre-specified analyses assessed SETER/PR as a continuous variable and using the predefined <0.75 cut point, as well as continuous RS and the >25 cut point. The primary endpoint was distant recurrence-free interval (DRFI). Predictive value was assessed using Cox models including biomarker, treatment arm, and interaction term.
RESULTS: Continuous SETER/PR demonstrated significant interaction with treatment on DRFI (Pinteraction = 0.028), whereas predefined <0.75 cut point was not predictive (Pinteraction = 0.668). Exploratory analyses identified a cut point at 1.50 (Pinteraction = 0.013): patients with SETER/PR ≥ 1.50 had worse outcomes with 3FEC+3D versus 6FEC (HR 3.16, 95%CI 1.28-7.85), while outcomes were similar between arms when SETER/PR < 1.50 (HR 0.83, 95%CI 0.51-1.35). RS did not predict differential benefit, either continuously (Pinteraction = 0.670) or at the >25 threshold (Pinteraction = 0.534).
CONCLUSION: Including sequential docetaxel (3FEC+3D) was less effective than continued anthracycline chemotherapy (6FEC) when breast cancer had high endocrine-related transcriptional activity (i.e., SETER/PR index ≥1.50).
TRIAL REGISTRATION: PACS-01.