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    Activity of CDK4/6 inhibitors and parameters affecting survival in elderly patients in age-subgroups: Turkish Oncology Group (TOG) retrospective study
    (BMC, 2024) Kahraman, Seda; Hizal, Mutlu; Çakan Demirel, Burçin; Güven, Deniz Can; Gümüşay, Özge; Oyan Uluç, Başak; Bayram, Ertuğrul; Özkanlı, Gülhan
    Highly selective inhibitors of cyclin-dependent kinase 4 and 6 (CDK4/6is) have emerged as a standart of care for first- and second-line therapies in combination with endocrine therapy (ET) for HR+/HER2- metastatic breast cancer (MBC) patients. It has been reported that combination therapy is more effective than ET alone and is safe in elderly patients as well as young patients. Nevertheless, elderly and very old patients with HR+/HER2-MBC treated with CDK4/6 inhibitor (CDK4/6i) combinations are relatively underrepresented in randomized controlled trials. To contribute to the literature, we investigated the real-world efficacy, factors associated with survival and the rates of adverse events (AEs) of the treatment with palbociclib or ribociclib plus ET in the HR+/HER2- MBC patient cohort over the age of 65 for age subgroups. In this retrospective study, 348 patients were divided into subgroups: 65-69 years old, 70-79 years old and 80 years and older. Median PFS (mPFS) for whole group was 18.3 (95% CI,14.3-22.3) months. There was no significant difference in mPFS between age groups (p = 0.75). The estimated median OS (mOS) was 39.5 (95% CI, 24.9-54.1) months and there was no significant difference between age groups (p = 0.15). There was a meaningfull numerical difference that did not reach statistical significance in patients who received CDK4/6i treatment as the first line for MBC. Grade 3-4 AEs were reported in 42.7% for the entire group, and neutropenia was the most common (37.3%). It can be concluded that combination therapy with palbociclib or ribociclib with an ET partner has similar efficacy and is safe among subgroups of older patients diagnosed with HR+/HER2-MBC.
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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.