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    HER2-low expression in patients with hormone receptor positive and HER2 negative advanced breast cancer treated with ribociclib or palbociclib in combination with endocrine therapy
    (2025) Kahraman, Seda; Hizal, Mutlu; Gumusay, Ozge; Basaran, Gul; Seyyar, Mustafa; Sahin, Elif; Cabuk, Devrim
    Aim: Hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer which represents the most common subgroup of metastatic breast cancer (MBC). Recently, further subclassification for HER2-negative tumors has emerged as HER2-low. There is limited knowledge regarding the effect of HER2-low expression on outcomes of patients with HR-positive and HER2-negative MBC treated with CDK 4/6 inhibitors plus hormonal therapy. Therefore, we evaluated survival parameters according to HER2-low status for this patient group in this study. Material and Methods: As the Turkish Oncology Group (TOG) Project, retrospectively collected data from 423 patients with HR-positive/HER2-negative MBC treated with ribociclib and palbociclib plus letrozole therapy was assessed. Included patients had metastatic first-line therapy and endocrine-sensitive disease. Survival outcomes were compared between HER2-negative and HER2-low patient groups. Conclusion: HER2-low status had no statistically significant impact on survival in patients treated with palbociclib or ribociclib plus letrozole.
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    Real-World Treatment Efficacy of Ribociclib or Palbociclib Plus Fulvestrant in Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Turkish Oncology Group (TOG) Study
    (Elsevier Inc., 2025) Kahraman, Seda; Erul, Enes; Gümüşay, Özge; Güven, Deniz Can; Aksoy, Sercan; Başaran, Gül; Seyyar, Mustafa; Özkanlı, Gülhan
    Background: Real-world (RW) data provide valuable information about the effectiveness and safety of treatment modalities in the general population that is not limited by selection criteria in clinical studies. The aim of this study was to evaluate the effectiveness of palbociclib or ribociclib plus fulvestrant in hormone receptor-positive and human epidermal factor 2-negative metastatic breast cancer (HR+/HER2-MBC). Materials and methods: We conducted a multicenter, retrospective cohort study that included 522 patients with HR+/HER2-MBC treated with ribociclib or palbociclib in combination with fulvestrant. Results: Median real-world progression-free survival (mPFS) was 12.9 months (95% CI, 11.16-14.65) for the entire cohort, and no statistically significant difference was present between the palbociclib and ribociclib groups (P = .70). Real-world median overall survival (mOS) was estimated to be 43.3 months (95% CI, 20-66.6) for the palbociclib group and 48.5 months (95% CI, NA-NA) for the ribociclib group and similar between the 2 groups (P = .56). When evaluated for the entire group, there was a significant difference in mPFS between patients with primary and secondary endocrine resistance (8.6 and 13.5 months, P = .002), and this difference was more pronounced in the palbociclib arm (6.6 and 14.4 months, P = .006) than in the ribociclib arm (11.6 and 13.3 months, P = .064). Conclusion: Although the 3 CDK4/6 inhibitors did not seem to differ significantly from each other in terms of effectiveness in a real-world context, they may vary depending primarily on the specific characteristics of the patient population being treated. © 2025 Elsevier Inc.
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    Treatment efficacy of ribociclib or palbociclib plus letrozole in hormone receptor-positive/HER2-negative metastatic breast cancer
    (Newlands Press Ltd, 2023) Kahraman, Seda; Erul, Enes; Seyyar, Mustafa; Gümüşay, Özge; Bayram, Ertuğrul; Aksoy, Sercan; Özkanlı, Gülhan
    Background: Ribociclib, palbociclib and abemaciclib are currently approved CDK4/6 inhibitors along with aromatase inhibitors as the first-line standard-of-care for patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Methods: The authors report retrospective real-life data for 600 patients with estrogen receptor- and/or progesterone receptor-positive and HER2-negative metastatic breast cancer who were treated with ribociclib and palbociclib in combination with letrozole. Results & conclusion: The results demonstrated that the combination of palbociclib or ribociclib with letrozole has similar progression-free survival and overall survival benefit in real life for the patient group with similar clinical features. Specifically, endocrine sensitivity may be a factor to be considered in the treatment preference.