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Breast Cancer Treatment Studies / HER2/EGFR in Cancer Research / Advanced Breast Cancer Therapies · Journal article
Acta Medica Alanya · August 15, 2026
Early or partial results. Treat as a signal, not a conclusion.
This single-center retrospective study of 76 patients with HR+/HER2− metastatic breast cancer evaluated whether the NOLUS score—derived from ER, PR, and Ki-67 expression—could predict survival outcomes in those receiving CDK 4/6 inhibitors. The NOLUS score was not a significant predictor of progression-free or overall survival, and the study's primary hypothesis was not supported.
Retrospective single-center cohort study. 76 patients with HR+/HER2− metastatic breast cancer treated with CDK 4/6 inhibitors and endocrine therapy between 2018 and 2024 at a single center; median age 58.2 years.. Intervention: CDK 4/6 inhibitor therapy (ribociclib in 78.9%, palbociclib in 21.1%) plus endocrine therapy.. Compared with: Stratification by NOLUS score into low-NOLUS and high-NOLUS groups based on ROC-derived population-specific cutoff.. n = 76. Single center (not further specified)..
Median PFS in low-NOLUS vs high-NOLUS groups: 36.6 vs 27.9 months (p=0.265); not significantly different 48-month OS rates in low-NOLUS vs high-NOLUS groups: 50.4% vs 59.1% (p=0.772); not significantly different Palbociclib use was independently associated with higher progression risk than ribociclib (HR 2.12; p=0.026)
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The failure of NOLUS score to stratify prognosis suggests that this composite biomarker lacks clinical utility in predicting survival in CDK 4/6 inhibitor-treated patients. Clinicians should not rely on NOLUS for prognostic counselling; established factors such as ECOG status and Ki-67 remain relevant, and comparative efficacy differences between specific CDK 4/6 inhibitors warrant further investigation.
Single-center retrospective study of 76 patients testing a novel biomarker score (NOLUS) that failed to show prognostic significance; generates null findings on the primary hypothesis and real-world comparative data but lacks the rigor and external validation needed for clinical recommendation.
As stated by the source record.
Quoted from the source exactly as published.
The failure of NOLUS score to stratify prognosis suggests that this composite biomarker lacks clinical utility in predicting survival in CDK 4/6 inhibitor-treated patients. Clinicians should not rely on NOLUS for prognostic counselling; established factors such as ECOG status and Ki-67 remain relevant, and comparative efficacy differences between specific CDK 4/6 inhibitors warrant further investigation.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Aim: Breast cancer is the most common cancer, and in the metastatic hormone-positive group, CDK-4-6 inhibitors are used. We aimed to examine the prognostic value of the “NOLUS” score, calculated from the estrogen receptor (ER), progesterone receptor (PR), and Ki-67 index, in patients with breast cancer receiving CDK 4/6 inhibitors.Materials and Methods: This retrospective single-center study included 76 patients with HR+/HER2- metastatic breast cancer who were treated with CDK 4/6 inhibitors (ribociclib or palbociclib) and endocrine therapy between 2018 and 2024. The NOLUS score was calculated using the following formula: −0.45*ER% −0.28*PR% + 0.27*Ki67% + 73. A population-specific cutoff was determined via ROC analysis based on 2-year progression-free survival (PFS), classifying patients into “low-NOLUS” or “high-NOLUS” groups.Results: The median patient age was 58.2 years. Ribociclib and palbociclib were used in 78.9% and 21.1% of the patients, respectively. During a median follow-up of 38.4 months, no significant difference was observed in the median PFS between the low- and high-NOLUS groups (36.6 vs. 27.9 months; p=0.265). Similarly, 48-month overall survival (OS) rates were comparable (50.4% vs. 59.1%; p=0.772). Multivariate analysis revealed that palbociclib use was independently associated with a higher risk of progression than ribociclib use (HR, 2.12; p=0.026). ECOG performance status and Ki-67 index were identified as independent prognostic factors for OS.Conclusion: The NOLUS score was not a significant predictor of survival in patients with metastasis treated with CDK 4/6 inhibitors. However, this study provides real-world evidence regarding the differences in efficacy between CDK 4/6 inhibitors and highlights the prognostic value of ECOG status and Ki-67.
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