AVELUMAB KAO TERAPIJA ODRŽAVANJA U UZNAPREDOVALOM UROTELNOM KARCINOMU – HRVATSKA ISKUSTVA. (Croatian)

Introduction: Introduction: Platinum-based chemotherapy followed by avelumab switch maintenance in non-progressors is the standard of care first line (1L) treatment for aUC. In this study, we describe clinical characteristics and outcomes in a ‘real-world’ cohort of Croatian patients treated with avelumab maintenance for aUC. Methods: In this retrospective cohort study, we included patients from 9 Croatian institutions who received maintenance avelumab after platinum-based chemotherapy for aUC. Anonymized data were jointly analyzed. We calculated overall response rate, as well as progression-free survival and median overall survival. had mixed urothelial cancer) with median age at avelumab initiation 68, 18% upper tract primary, 27% prior cisplatin, 19% liver metastasis and 65% ECOG PS 0 at time of chemotherapy initiation. Following chemotherapy, we observed complete response in 5%, partial response in 66%, and stabile disease in 29% of patients, respectively. 47 patients (70%) were available for response assessment. Overall response rate with avelumab maintenance was 26% (complete response [CR] for 4%, partial response [PR] for 21%), stable disease (SD) 47%; progression as best response was noted in 28% of patients. Median follow-up time was 5 months (95%CI 4-16), median progression-free survival 14 months (95%CI 4-16), while median overall survival was not reached. 16% of grade 2 and 3% of grade 3 immunotherapy-related side-effects were observed, respectively. Conclusion: Early ‘real world’ outcomes with avelumab maintenance in Croatian patients with aUC revealed low prevalence of cisplatin-based chemotherapy, relatively high overall response rate (higher than in JavelinBladder100 trial) and lower incidence of immunotherapy-related side-effects. Longer follow-up is needed to objectively assess mature oncologic outcomes. [ABSTRACT FROM AUTHOR]

Uvod: Terapija održavanja avelumabom u bolesnika koji nisu progredirali na kemoterapiju baziranu na platini čini standardnu prvu liniju liječenja uznapredovalog urotelnog karcinoma (uUK). Cilj ovog istraživanja bio je opisati kliničke osobine bolesnika i ishode liječenja avelumabom u terapiji održavanja uUK u hrvatskoj onkološkoj praksi. Metode: Proveli smo retrospektivno kohortno istraživanje u koje smo uključili 9 hrvatskih onkoloških ustanova u kojima se liječe bolesnici sa uUK. Na taj način identificirani su svi bolesnici koji su liječeni avelumabom u RH. Anonimizirani podaci su skupno analizirani. Izračunata je ukupna stopa odgovora, medijan preživljenja bez progresije bolesti, kao i medijan ukupnog preživljenja. Rezultati: Identificirali smo ukupno 67 bolesnika sa uUK koji su liječeni avelumabom u terapiji održavanja. Njih 13 (19%) imalo je miješanu histološku sliku, medijan dobi kod početka terapije avelumabom bio je 68godina, 18% sa primarnim sijelom u gornjem uro-traktu, 65% izvedbenog statusa ECOG 0, 27% je liječeno kemoterapijom na bazi cisplatine, 19% je imalo jetrene metastaze. Odgovori nakon kemoterapije su bili sljedeći: kompletni odgovor 5%, parcijalni odgovor 66%, stabilna bolest 29%. 47 (70%) bolesnika bilo je dostupno za analizu ukupne stope odgovora na terapiju održavanja avelumabom koja iznosi 26%. Kompletnih odgovora bilo je 4%, parcijalnih 21%, stabilne bolesti 47%, dok je progresija kao najbolji odgovor zabilježena u 28% za analizu dostupnih bolesnika. Medijan praćenja je 5 mjeseci (95% CI 4-16), medijan preživljenja bez progresije bolesti 14 mjeseci (95% CI 7-15), dok medijan ukupnog preživljenja nije dosegnut. Incidencija gradusa 2 imunoterapijom uvjetovanih nuspojava bila je 16%, a gradusa 3 3%. Zaključak: Rani podaci praćenja učinkovitosti avelumaba u hrvatskoj onkološkoj praksi u terapiji održavanja uUK ukazuju na nisku prevalenciju cisplatine, visoku stopu odgovora na avelumab (veća nego u JAVELIN Bladder 100 studiji) te nižu stopu imunoterapijom uvjetovanih nuspojava. Potrebno je daljnje praćenje da bi se objektivno ocijenili drugi onkološki ishodi. [ABSTRACT FROM AUTHOR]

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