Real-World Treatment Efficacy of Ribociclib or Palbociclib Plus Fulvestrant in Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Turkish Oncology Group (TOG) Study.
Seda Kahraman, Enes Erul, Ozge Gumusay, Deniz Can Guven, Sercan Aksoy, Gul Basaran, Mustafa Seyyar, Elif Sahin, Devrim Cabuk, Ertugrul Bayram, Semra Paydas, Burcin Cakan Demirel, Arzu Yaren, Burcu Gulbagci, Ilhan Hacibekiroglu, Naziyet Kose Baytemur, Umut Demirci, Sena Ece Davarci, Hacer Demir, Eda Eylemer Mocan, Ozlem Dogan, Ebru Cilbir, Alper Yasar, Ibrahim Vedat Bayoglu, Mutlu Hizal, Erkan Kayikcioglu, Bulent Cetin, Omer Acar, Atike Pinar Erdogan, Merve Keskinkilic, Tugba Yavuzsen, Olcun Umit Unal, Funda Yilmaz, Mutlu Dogan, Sibel Oyucu Orhan, Erdem Cubukcu, Cihan Erol, Teoman Sakalar, Ozgecan Dulgar, Yusuf Karakas, Gulhan Ozkanli, Berna Bozkurt Duman, Deniz Isik, Muge Karaoglanoglu, Sadi Kerem Okutur, Nilgun Yildirim, Esra Aydin, Basak Oyan Uluc, Murat Keser, Burak Bilgin, Asude Aksoy, Onder Eren, Nurhan Onal Kalkan, Muhammed Muhiddin Er, Hakan Yucel, Veli Sunar, Nail Paksoy, Dincer Aydin, Nazim Serdar Turhal, Serkan Menekse, Engin Kut, Musa Baris Aykan, Ozlem Ozdemir, Melike Ozcelik, Yakup Iriagac, Fatih Selcukbiricik, Ali Inal, Nuri Karadurmus, Muhammed Bulent Akinci, Mehmet Ali Nahit Sendur
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引用次数: 0
Abstract
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.
期刊介绍：
Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.
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