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. 2024 Dec 30;24(1):1592.
doi: 10.1186/s12885-024-13357-5.

Activity of CDK4/6 inhibitors and parameters affecting survival in elderly patients in age-subgroups: Turkish Oncology Group (TOG) retrospective study

Seda Kahraman  1 , Mutlu Hizal  2 , Burcin Cakan Demirel  3 , Deniz Can Guven  4 , Ozge Gumusay  5 , Basak Oyan Uluc  5 , Ertugrul Bayram  6 , Burcu Gulbagci  7 , Alper Yasar  8 , Sena Ece Davarci  9 , Eda Eylemer Mocan  10 , Omer Acar  11 , Deniz Isik  12 , Esra Aydin  13 , Yusuf Karakas  14 , Melike Ozcelik  15 , Murat Keser  16 , Sadi Kerem Okutur  17 , Onder Eren  18 , Serkan Menekse  19 , Dincer Aydin  20 , Funda Yilmaz  21 , Ozlem Dogan  22 , Gulhan Ozkanli  23 , Hakan Yucel  24 , Veli Sunar  25 , Musa Baris Aykan  26 , Ozlem Ozdemir  27 , Berna Bozkurt Duman  28 , Merve Keskinkilic  29 , Teoman Sakalar  30 , Ali Inal  31 , Muge Karaoglanoglu  32 , Asude Aksoy  33 , Muhammed Muhiddin Er  34 , Nazim Serdar Turhal  35 , Nurhan Onal Kalkan  36 , Mehmet Ali Nahit Sendur  2
Affiliations

Activity of CDK4/6 inhibitors and parameters affecting survival in elderly patients in age-subgroups: Turkish Oncology Group (TOG) retrospective study

Seda Kahraman et al. BMC Cancer. .

Abstract

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.

Keywords: CDK 4/6 inhibitors; Geriatric population; Metastatic breast cancer.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the Clinical Research Ethics Committee chaired by the Ankara City Hospital Institutional Review Board. Informed consent was waived by our institutional review board because no experimental procedures were performed. The preparation of the article was followed in accordance with the STROBE guidelines. We conducted this study according to the Declaration of Helsinki. Consent for publication: Not Applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
mPFS for age subgroups
Fig. 2
Fig. 2
mOS for age subgroups
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Fig. 3
Association between the presence of liver metastasis at CDK4/6i initiation and mPFS
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Fig. 4
Association between receiving treatment for MBC before CDK4/6i and mPFS
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Fig. 5
mPFS in patient age-groups who received treatments prior to CDK4/6is
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Fig. 6
mPFS in patients untreated for MBC before CDK4/6i treatment according to age-groups
See this image and copyright information in PMC

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