European journal of cancer (Oxford, England : 1990) · 2025
Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the recurrence score® in node-positive breast cancer: Independent validation in the PACS-01 trial.
СтатьяВалидационное 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, Fraser Symmans W
Аннотация
AIM: To independently confirm whether the combination of sensitivity to endocrine therapy (SET2,3) index and Recurrence Score® (RS) improves prognostic assessment for patients with hormone receptor-positive (HR+) lymph node-positive (LN+) breast cancer. Secondly, to evaluate SETER/PR index, the component of SET2,3 that measures endocrine transcriptional activity.
METHODS: HR+ tumor samples from the PACS-01 trial were tested for RS and SET2,3 index. Pre-defined cut points defined high-risk if RS > 25 or SET2,3 < 2.10. The primary analysis assessed 8-year distant recurrence-free interval (DRFI) in patients who received endocrine therapy (ET). Hazard ratios were calculated with 95 % confidence interval (HR, 95 %CI) from multivariable Cox proportional hazards models, with two-sided tests and nominal significance at p < 0.05.
RESULTS: RS and SET2,3 results were available from 659 patients including 490 who received ET. Primary multivariable analysis showed that SET2,3 status added significant prognostic information to RS status (SET2,3: HR 0.29, 95 %CI 0.18-0.47; RS: HR 2.62, 1.62-4.25). SET2,3 and RS status were discordant in 27 % of patients. Among those, DRFI rate at 8 years was 22 % higher in patients with high SET2,3 despite high-risk RS (80.5 % versus 58.5 %), and 17.2 % lower with low SET2,3 despite low-risk RS (77.3 % versus 94.5 %). The SETER/PR index predicted the ET effect on DRFI (Pinteraction <0.001) and added prognostic information to RS in ET subset (SETER/PR: HR 0.58, 95 %CI 0.36-0.91).
CONCLUSION: SET2,3 improved prognostic assessment by RS, with its SETER/PR index component adding significant endocrine-predictive information to RS in the patients who received ET.
TRIAL REGISTRATION: PACS-01.
METHODS: HR+ tumor samples from the PACS-01 trial were tested for RS and SET2,3 index. Pre-defined cut points defined high-risk if RS > 25 or SET2,3 < 2.10. The primary analysis assessed 8-year distant recurrence-free interval (DRFI) in patients who received endocrine therapy (ET). Hazard ratios were calculated with 95 % confidence interval (HR, 95 %CI) from multivariable Cox proportional hazards models, with two-sided tests and nominal significance at p < 0.05.
RESULTS: RS and SET2,3 results were available from 659 patients including 490 who received ET. Primary multivariable analysis showed that SET2,3 status added significant prognostic information to RS status (SET2,3: HR 0.29, 95 %CI 0.18-0.47; RS: HR 2.62, 1.62-4.25). SET2,3 and RS status were discordant in 27 % of patients. Among those, DRFI rate at 8 years was 22 % higher in patients with high SET2,3 despite high-risk RS (80.5 % versus 58.5 %), and 17.2 % lower with low SET2,3 despite low-risk RS (77.3 % versus 94.5 %). The SETER/PR index predicted the ET effect on DRFI (Pinteraction <0.001) and added prognostic information to RS in ET subset (SETER/PR: HR 0.58, 95 %CI 0.36-0.91).
CONCLUSION: SET2,3 improved prognostic assessment by RS, with its SETER/PR index component adding significant endocrine-predictive information to RS in the patients who received ET.
TRIAL REGISTRATION: PACS-01.