RESUMO
BACKGROUND: Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2â) metastatic breast cancer (MBC). OBJECTIVE: To assess whether clinical or demographic characteristics limit access to first-line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017 and April 2020. In addition, effectiveness will be described in an exploratory analysis. METHODS: Physicians from 12 centers participated in selecting demographic and clinical characteristics, treatment, and outcome data from women with HR + /HER2- MBC treated with or without CDK4/6i in addition to hormonal in the first-line setting, in a 3:1 proportion. Kaplan-Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). RESULTS: A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). Patients in the CDK 4/6i treatment group were younger (p = 0.0011), the biopsies of the metastatic site at the moment of the relapse were most commonly performed (p = 0.0454), and had multiple metastatic sites (p = 0.0025). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6-28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. CONCLUSIONS: Younger patients, biopsies of metastatic disease and with multiple metastatic sites were more frequently treated with CDK4/6i in our daily clinical practice.
RESUMO
BACKGROUND: Sleep-disordered breathing (SDB) has been associated with cancer aggressiveness, but studies focused on specific tumors are lacking. In this pilot study we investigated whether SDB is associated with breast cancer (BC) aggressiveness. METHODS: 83 consecutive women <65 years diagnosed with primary BC underwent a home respiratory polygraphy. Markers of SDB severity included the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI4). The Ki67 proliferation index, lack of hormone receptors (HR-), Nottingham Histological Grade (NHG), and tumor stage were used as markers of BC aggressiveness. The association between SDB and molecular subtypes of BC was also assessed. RESULTS: The mean (SD) age was 48.8 (8.8) years and body mass index was 27.4 (5.4) Kg/m2. 42 women (50.6%) were post-menopausal. The median (IQR) AHI was 5.1 (2-9.4), and ODI4 was 1.5 (0.5-5.8). The median (IQR) AHI did not differ between the groups with Ki67>28% and Ki67<29% [5.1 (2.6-8.3) vs 5.0 (1.5-10), p = 0.89)], HR- and HR+ [5.7 (1.6-12.4) vs 4.9 (2-9.4), p = 0.68], NHG (Grade3, Grade2, and Grade1; p = 0.86), tumor stage (stage III-IV, stage II, and stage I; p = 0.62), or molecular subtypes (Luminal A, Luminal B, HER2, and triple negative; p = 0.90). The prevalence of an AHI≥5 did not differ between the groups with Ki67>28% and Ki67<29% (51.2% vs 52.3%, p = 0.90), HR- and HR+ (58.3% vs 49.1%, p = 0.47), NHG categories (p = 0.89), different tumor stages (p = 0.71), or molecular subtypes (p = 0.73). These results did not change when the ODI4 was used instead of the AHI. CONCLUSION: Our results do not support an association between the presence or severity of SDB and BC aggressiveness.
