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Purpose <p>Endocrine therapy (ET) with or without abemaciclib/ribociclib is the current standard for intermediate- and high-risk hormone receptor (HR)-positive/HER2-negative early breast cancer (EBC) patients. The NATALEE trial showed that adding 3&#xa0;years of ribociclib to ET improves the 4-year invasive Disease-Free Survival (iDFS) by 4.9% compared with ET alone. Real world data on long-term risk of relapse is crucial when taking decisions about the prescription of new adjuvant drugs.</p> Methods <p>This is a retrospective analysis of 8,825 HR-positive/HER2-negative EBC patients recruited from 5 adjuvant GEICAM trials enrolled from 1999 to 2010 and <i>El Álamo IV</i> registry (diagnosed between 2002 and 2005). To estimate their long-term outcomes, patients were grouped into 3 cohorts: cohort 1 (high-risk, stage III); cohort 2 (intermediate-risk, T0–2N1, T3N0 or T2N0 and either histological grade (G)3, or GX/G2 with Ki-67 ≥ 20%); and cohort 3 (low-risk, stage I and T2N0 and either G1, or GX/G2 with Ki-67 &lt; 20%).</p> Results <p>The distribution was 20.0% of patients in cohort 1, 36.0% in cohort 2 and 44.0% in cohort 3. With a median follow-up of 10.7&#xa0;years, the 10-year iDFS were 53.8%, 73.8% and 84.0%, 10–y distant Disease-Free Survival were 56.3%, 77.3% and 87.8%, and 10-year overall survival (OS) were 66.7%, 84.6% and 91.9%, in cohorts 1, 2 and 3 respectively. In cohort 1, invasive relapse rate (IRR) and distant relapse rate (DDR) had a peak in years 2–3 and a second peak in year 7, while in cohorts 2 and 3 the rates increased steadily (higher at all time-points in cohort 2). In cohort 1, death rate (DR) had a soft peak in years 3–4 and years 7–8 while in cohorts 2 and 3 they increased steadily (also higher at all time-points in cohort 2).</p> Conclusions <p>Intermediate-risk patients have a 10-year iDFS of 73.8%, and 10-year OS of 84.6%. The IRR, DDR and DR increased steadily in cohort 2 (as in cohort 3), in contrast to cohort 1. Further follow-up of the NATALEE trial is needed to determine the true benefit of adjuvant ribociclib in intermediate-risk patients and to decide the best ET strategy for these patients.</p> <p><i>Trial registration number</i> ClinTrials.gov: GEICAM/9805: NCT00121992 (Study Registration Date: 2005-07-18); GEICAM/9906: NCT00129922 (Study Registration Date: 2005-08-10); GEICAM/2003-02: NCT00129389 (Study Registration Date: 2005-08-10); GEICAM/ 2003-10: NCT00129935 (Study Registration Date: 2005-08-11) and GEICAM/ 2006-10: NCT00543127 (Study Registration Date: 2007-10-11).</p>

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Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies

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  • 发表日期：

    2026年5月25日

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  • Sonia Servitja,
  • Eva Carrasco,
  • Raquel Andrés,
  • Álvaro Rodríguez-Lescure,
  • Miguel Martín,
  • Manuel Ruiz-Borrego,
  • Ángel Guerrero,
  • Begoña Bermejo,
  • Antonio Antón,
  • Montserrat Muñoz,
  • Mireia Margeli,
  • Isabel Álvarez,
  • Luis Antonio Fernández,
  • Jose Ponce,
  • Josefina Cruz,
  • Purificación Martínez,
  • Sara López-Tarruella,
  • Margarita Amenedo,
  • Andrea Blasco,
  • Óscar Polonio,
  • Miguel Gil-Gil

摘要

Purpose

Endocrine therapy (ET) with or without abemaciclib/ribociclib is the current standard for intermediate- and high-risk hormone receptor (HR)-positive/HER2-negative early breast cancer (EBC) patients. The NATALEE trial showed that adding 3 years of ribociclib to ET improves the 4-year invasive Disease-Free Survival (iDFS) by 4.9% compared with ET alone. Real world data on long-term risk of relapse is crucial when taking decisions about the prescription of new adjuvant drugs.

Methods

This is a retrospective analysis of 8,825 HR-positive/HER2-negative EBC patients recruited from 5 adjuvant GEICAM trials enrolled from 1999 to 2010 and El Álamo IV registry (diagnosed between 2002 and 2005). To estimate their long-term outcomes, patients were grouped into 3 cohorts: cohort 1 (high-risk, stage III); cohort 2 (intermediate-risk, T0–2N1, T3N0 or T2N0 and either histological grade (G)3, or GX/G2 with Ki-67 ≥ 20%); and cohort 3 (low-risk, stage I and T2N0 and either G1, or GX/G2 with Ki-67 < 20%).

Results

The distribution was 20.0% of patients in cohort 1, 36.0% in cohort 2 and 44.0% in cohort 3. With a median follow-up of 10.7 years, the 10-year iDFS were 53.8%, 73.8% and 84.0%, 10–y distant Disease-Free Survival were 56.3%, 77.3% and 87.8%, and 10-year overall survival (OS) were 66.7%, 84.6% and 91.9%, in cohorts 1, 2 and 3 respectively. In cohort 1, invasive relapse rate (IRR) and distant relapse rate (DDR) had a peak in years 2–3 and a second peak in year 7, while in cohorts 2 and 3 the rates increased steadily (higher at all time-points in cohort 2). In cohort 1, death rate (DR) had a soft peak in years 3–4 and years 7–8 while in cohorts 2 and 3 they increased steadily (also higher at all time-points in cohort 2).

Conclusions

Intermediate-risk patients have a 10-year iDFS of 73.8%, and 10-year OS of 84.6%. The IRR, DDR and DR increased steadily in cohort 2 (as in cohort 3), in contrast to cohort 1. Further follow-up of the NATALEE trial is needed to determine the true benefit of adjuvant ribociclib in intermediate-risk patients and to decide the best ET strategy for these patients.

Trial registration number ClinTrials.gov: GEICAM/9805: NCT00121992 (Study Registration Date: 2005-07-18); GEICAM/9906: NCT00129922 (Study Registration Date: 2005-08-10); GEICAM/2003-02: NCT00129389 (Study Registration Date: 2005-08-10); GEICAM/ 2003-10: NCT00129935 (Study Registration Date: 2005-08-11) and GEICAM/ 2006-10: NCT00543127 (Study Registration Date: 2007-10-11).