Trial reportBreast cancer research : BCR2026
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.
Trial report in Breast cancer research : BCR, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients
Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients
Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients
Phase III Trial Comparing Efficacy and Tolerance of Fulvestrant for 3 Years (y) Combined With Anastrozole 5 y Versus Anastrozole 5 y as Adjuvant Hormonotherapy in Postmenopausal With Early Breast Cancer and Positive Hormone Receptors
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21 authors.
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Abstract
purposeEndocrine 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.
methodsThis 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%).
resultsThe 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).
conclusionsIntermediate-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).
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