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Query: "keywords" (HER2) .

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1.
Učinkovitost in varnost zdravljenja s trastuzumab derukstekanom : analiza podatkov iz realnega sveta
Nina Privšek, Simona Borštnar, Cvetka Grašič-Kuhar, 2024, original scientific article

Abstract: Nova generacija zdravil, ki se imenuje konjugat protitelesa in zdravila (ADC), trenutno predstavlja eno najučinkovitejših zdravil pri zdravljenju raka. Usmerjena je proti specifični tarči (antigenu), selektivno izraženi na tumorski celici, po vezavi nanjo sledi tarčna znotrajcelična dostava citostatika, ki povzroči celično smrt. Pri razsejanem raku dojk je ADC z imenom trastuzumab derukstekan (T-DXd) pokazal izjemno učinkovitost v več raziskavah pod imenom DESTINY. Naprej so bili na voljo podatki pri razsejanem HER2+ raku dojk, kasneje še pri drugih HER2+ solidnih rakih ter nato še pri raku dojk z nizko izraženostjo HER2. V prispevku predstavljamo prve podatke o učinkovitosti in varnosti T-DXd v Sloveniji. V retrospektivno raziskavo smo vključili bolnike, zdravljene na Onkološkem inštitutu Ljubljana od novembra 2021 do aprila 2024. Ugotavljamo dobre odgovore na zdravljenje (objektivni odgovor 59 % pri HER2+ raku dojk, 38 % pri drugih HER2+ solidnih rakih ter 33 % pri nizkem izražanju HER2). Po kratkem srednjem času spremljanja 8,8 (95 % IZ 0,8–33,3) meseca je preživetje brez progresa v realnem svetu (rwPFS) 13 mesecev pri HER2+ raku dojk, 5,8 meseca pri raku dojk z nizko izraženostjo HER2 in 7,7 meseca pri ostalih solidnih HER2+ ali HER2 mutiranih rakih. Varnostni profil je v skladu s poročili v registracijskih raziskavah, razen za pnevmonitis, ki smo ga beležili v bistveno nižjem odstotku (le 1 %). Zaključimo lahko, da je kljub poznim linijam zdravljenja in heterogeni populaciji delež odgovorov na T-DXd visok, ocena rwPFS pa je ob kratkem času spremljanja še nezanesljiva.
Keywords: rak dojk, HER2, trastuzumab derukstekan
Published in DiRROS: 21.05.2025; Views: 387; Downloads: 166
.pdf Full text (244,06 KB)

2.
Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy : subgroup safety analysis from the phase 3b CompLEEment-1 trial
Simona Borštnar, Marketa Palacova, Aleksandra Łacko, Constanta Timcheva, Einav Nili Gal-Yam, Konstantinos Papazisis, Juraj Beniak, Pavol Kudela, Gábor Rubovszky, 2022, original scientific article

Abstract: 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.
Keywords: CDK4/6 inhibitor, HER2−, HR+, advanced breast cancer, ribociclib
Published in DiRROS: 24.07.2024; Views: 895; Downloads: 432
.pdf Full text (462,13 KB)
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