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Povzetek: The CDK4/6 inhibitor, ribociclib in combination with endocrine therapy significantly improved progression-free survival in the first line setting in post-menopausal patients with HR+/HER2- advanced breast cancer (ABC) in a pivotal phase 3, placebo-controlled trial (MONALEESA-2) and demonstrated superior overall survival in premenopausal patients with HR+/HER2- ABC (MONALEESA-7). The multinational, phase 3b, CompLEEment-1 trial, which assessed the safety and efficacy of ribociclib plus letrozole in a broader population of patients who have not received prior endocrine therapy for advanced disease, is the largest phase 3 clinical trial to date to evaluate the safety and efficacy of a CDK4/6 inhibitor. We report a subanalysis of data from patients (N = 339) enrolled in the central and south European countries of the SERCE (Southern Europe, RUC, Central Europe) cluster of CompLEEment-1. Patients and methods: Men and women of any menopausal status with HR+/HER2- ABC received once-daily oral ribociclib 600 mg (3-weeks on/1-week-off), plus letrozole 2.5 mg continuously. Men/premenopausal women also received a GnRH-agonist. The primary outcome was the number of patients with adverse events (AEs) over a timeframe of approximately 36 months. Time-to-progression, overall response rate, and clinical benefit rate were also measured. Results: Safety results in the SERCE subgroup were consistent with those in the pivotal clinical trials of ribociclib in combination with endocrine therapy. Treatment-related AEs leading to dose adjustments/interruption occurred in 63.1% of patients but led to treatment discontinuation in only 10.6%. The most common treatment-related AEs of grade ≥ 3 were neutropenia and transaminase elevations. There were no fatal treatment-related events. Conclusions: These findings from the SERCE subgroup support the safety and manageable tolerability of ribociclib in a broad range of patients with HR+/HER2- ABC more representative of patients in real-world clinical practice.
Ključne besede: CDK4/6 inhibitor, HER2−, HR+, advanced breast cancer, ribociclib
Objavljeno v DiRROS: 24.07.2024; Ogledov: 486; Prenosov: 290
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Povzetek: Prevalenca raka dojk hitro narašča, s tem pa tudi breme spremljanja bolnic z rakom dojk. Namen spremljanja bolnic z rakom dojk je odkrivanje zgodnje ponovitve bolezni in novega primarnega raka dojk, obvladovanje kratko- in dolgoročnih posledic zdravljenja in čim hitrejša vrnitev v normalen življenjski ritem, spodbujanje k nadaljevanju morebitnega zdravljenja in promocija zdravega življenjskega sloga. Pogostost kontrol je odvisna od ogroženosti za ponovitev bolezni. Bolnice prva tri leta spremljamo na 3-6 mesecev, od 3. do 5. leta na 6-12 mesecev in nato enkrat letno. Anamneza in klinični pregled sta osnova vsake kontrole, enkrat letno pa opravimo tudi mamografijo. Spremljanje z laboratorijskimi preiskavami, slikanjem prsnih organov, scintigrafijo skeleta, UZ trebuha in drugimi preiskavami ne izboljša preživetja pri asimptomatskih bolnicah, zato te preiskave opravimo le, če so navzoči klinični simptomi in znaki, sumljivi za ponovitev bolezni. V prispevku navajamo predloge za dolgoročno rešitev spremljanja bolnic z rakom dojk.
Ključne besede: bolniki, rak dojk, spremljanje bolnikov
Objavljeno v DiRROS: 06.06.2024; Ogledov: 1073; Prenosov: 284
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Ključne besede: breast cancer, neoadjuvant treatment, surgical treatment
Objavljeno v DiRROS: 18.04.2024; Ogledov: 820; Prenosov: 484
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Povzetek: Background. Triple negative breast cancer (TNBC) is defined by a lack of expression of both estrogen (ER) and progesteron(PgR) receptors as well as human epidermal growth factor receptor 2 (HER2). Our retrospective analysis addressed prognostic factors for short- and long-term outcomes of patients (pts) with TNBC pts treated in routine clinical practice. Patient and methods.Our retrospective study included 269 TNBC treated at Institute of Oncology Ljubljana between March 2000 and December 2006. The collected data included patientsć, tumoursć and treatmentsć characteristics. The survival analyses were performed using the Kaplan-Meier method. The Cox proportional hazard model was used in the multivariate analysis. Results. The median age ofour patients was 55.3 yrs (23-88.5) and the median follow-up was 5.9 yrs (0.3-9.6). Six (2%) pts experienced local only, 79 (92%) pts distal recurrenceand 66 (24%) died. The predominant localisation of the first relapsewas in visceral organs (70.4%). The 5-year disease-free survival (DFS) for the entire group was 68.2% and the 5-year overall survival (OS) was 74.5%.We found a pattern of high recurrence rate in the first 3 years following the diagnosis and a clear decline in recurrence rate over the next 3years. In the univariate analysis age, nodal status, size and lymphovascular invasion (LVI) were found to have a significant impact on DFS as well as on OS. In the multivariate analysis only age (HR=1.79; 95%CI=1.14-2.82; p=0.012) and nodal status (HR=2.71; 95%CI=1.64-4.46; p<0.001) retained their independent prognostic value for DFS and for OS only the nodal status (HR=2.96; 95%CI=1.51-5.82; p=0.002). (Abstract truncated at 2000 characters)
Objavljeno v DiRROS: 19.03.2024; Ogledov: 810; Prenosov: 229
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Povzetek: Urokinase plasminogen activator (uPA) and its inhibitors, PAI-1 and PAI-2, play an important role in iritercellular tissue degradation, thus promoting tumor cell invasion into the adjoining structures and metastasizing. Our studywas aimed to assess a possible prognostic value of uPA, PAI-1 and PAI-2 in a retrospective series of 87 patients with breast cancer stage I-III, whosecytosols were stored in the archives of the, Institute of Oncology in Ljubljana. The median follow-up was 35 months. The prognostic value of the established prognostic factors and uPA, PAI-1 and PAI-2 were evaluated by means of univariate statistical analysis and partial multivariate models. The obtained uPA values were very low and did not correlate with the disease free survival, whereas PAI-1 and PAI-2 significantly influenced the time to the first recurrence. Patients with PAI-1 values above 5 ng/mg proteins had statistically significantly worse disease free survival than the patients withlower PAI-1 values (58% vs. 85%). In the case of PAI-2, the situation wasjust the opposite: the patients with PAI-2 values exceeding 6.4 ng/mg proteins had statistically significantly better 3-year disease free survival than the patients with lower values (90% vs. 60%). Both, PAI-1 and PAl-2 retained their independent prognostic value, irrespective of the addition of the established prognostic factors to partial multivariate models, and only with locally advanced disease the prognostic value of PAI-1 was greater than that of PAI-2.
Objavljeno v DiRROS: 22.01.2024; Ogledov: 916; Prenosov: 198
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