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20 let Oddelka za eksperimentalno onkologijo na Onkološkem inštitutu Ljubljana: 2005–2025
Get PDFThe twentieth anniversary of the Department of Experimental Oncology marks an important milestone in the history of research activities at the Institute of Oncology Ljubljana. Research activity at the Institute of Oncology Ljubljana has a long and strong tradition, dating back to the establishment of the first laboratory for experimental cancerology at the Brežice Hospital by Asst. Prof. Dr. Cholewa. Since 2005, the small laboratory with six employees has grown into a modern research group of more than 20 researchers who are successfully implementing the vision of translational oncology, particularly in the fields of electrochemotherapy, gene electrotransfer, bleomycin electro-sclerotherapy, radiobiology, and veterinary oncology. With our commitment to translational research, interdisciplinary collaboration, and the transfer of knowledge into clinical practice, we have made an important contribution to the development of modern oncology therapy in Slovenia and beyond. We successfully completed a phase I clinical study, which demonstrated the safety and efficacy of plasmid gene electrotransfer with IL-12 encoding as part of the SmartGene.si project. In addition to scientific and research work, the department is substantially involved in educational activities and is a part of strong domestic and international networks in the field of biomedical applications of electroporation. We look forward to future collaborative efforts in further developing experimental, translational, and clinical oncology.Dvajsetletno delovanje Oddelka za eksperimentalno onkologijo predstavlja pomemben mejnik v zgodovini raziskovalne dejavnosti na Onkološkem inštitutu Ljubljana. Raziskovalna dejavnost na Onkološkem inštitutu Ljubljana obsega dolgo in močno tradicijo, že od ustanovitve prvega laboratorija za eksperimentalno kancerologijo v brežiški bolnišnici doc. dr. Cholewa. Iz majhnega laboratorija s šestimi zaposleni je od 2005 zrasla sodobna raziskovalna skupina več kot 20 raziskovalcev, ki uspešno uresničuje vizijo translacije v onkologiji, predvsem na področjih elektrokemoterapije, genskega elektroprenosa, bleomcin elektroskleroterapije, radiobiologije in veterinarske onkologije. Z zavezanostjo translacijskim raziskavam, interdisciplinarnemu sodelovanju in prenosu znanja v klinično prakso smo pomembno prispevali k razvoju sodobne onkološke terapije v Sloveniji in širše. Uspešno smo izpeljali klinično študijo faze I, s katero je bila dokazana varnost in učinkovitost genskega elektroprenosa plazmida z zapisom za IL-12 v sklopu projekta SmartGene.si. Poleg znanstveno-raziskovalnega dela je oddelek močno vpet v izobraževalno dejavnost ter v domače in mednarodno okolje na področju biomedicinskih aplikacij elektroporacije. Tudi v naslednjih 20. letih se veselimo skupnih dosežkov na poti razvoja eksperimentalne, translacijske in klinične onkologije
Dve desetletji delovanja Oddelka za molekularno diagnostiko na Onkološkem inštitutu Ljubljana
Get PDFThe Department of Molecular Diagnostics at the Institute of Oncology Ljubljana was established in 2005 at the initiative of Prof. Dr. Srdjan Novaković. Over the past 20 years, it has evolved into the central national laboratory for genetic testing of individuals with a higher risk of hereditary cancer syndromes, as well as for molecular genetic testing of various types of solid tumours, where tumour genotyping plays a key role in diagnosis, treatment planning, and prognosis. A special area of the department’s work involves pharmacogenetic testing, which identifies patients at increased risk of severe adverse drug effects. In terms of the complexity and quality of its diagnostic services, the Department of Molecular Diagnostics is comparable to internationally recognized centres performing molecular diagnostics. This is demonstrated by its extensive range of tests that follow international clinical guidelines for the management of cancer patients, as well as by its regular participation and successful performance in external quality assessment schemes. As a result, Slovenian cancer patients have access to comprehensive molecular genetic testing within the country, without the need for referral abroad. An important step forward has also been the agreement with the Health Insurance Institute of Slovenia (ZZZS) on the funding of these services, ensuring patients have access to high-quality diagnostics and personalized treatment with targeted therapies, in accordance with the most up-to-date international guidelines and without any additional costs to patients. Patients from healthcare institutions across Slovenia may be referred for molecular genetic testing to the Department of Molecular Diagnostics.Oddelek za molekularno diagnostiko je bil na Onkološkem inštitutu Ljubljana ustanovljen leta 2005 na pobudo znan. svet., dr. Srdjana Novakovića. V 20-letnem obdobju je Oddelek za molekularno diagnostiko postal osrednji laboratorij v Sloveniji tako za genetsko testiranje posameznikov z večjo ogroženostjo za dedne oblike raka kakor tudi za molekularno-genetsko testiranje različnih vrst solidnih tumorjev, kjer je informacija o genotipu tumorja pomembna pri načrtovanju zdravljenja, pomoč pri diagnozi ali prognozi bolezni. Posebno področje dela oddelka predstavljajo farmakogenetske preiskave, s katerimi ocenimo napoved presnavljanja zdravil ter opredelimo bolnike z večjim tveganjem za hude neželene učinke. Oddelek za molekularno diagnostiko se lahko po zahtevnosti in kakovosti svojih preiskav primerja z mednarodno priznanimi centri na področju molekularne diagnostike. To potrjuje z obsežnim naborom preiskav, ki sledijo priporočilom mednarodnih strokovnih smernic za obravnavo onkoloških bolnikov, ter z rednim sodelovanjem in uspešno opravljenimi zunanjimi kontrolami kakovosti. Slovenskim onkološkim bolnikom je s tem omogočen dostop do celovitih molekularno- -genetskih preiskav znotraj države, brez potrebe po napotitvah v tujino. Pomemben mejnik predstavlja tudi dogovor z Zavodom za zdravstveno zavarovanje Slovenije o financiranju teh storitev, kar bolnikom zagotavlja dostopno in visokokakovostno diagnostiko ter bolniku prilagojeno zdravljenje s tarčnimi zdravili v skladu z najsodobnejšimi mednarodnimi smernicami in brez dodatnih stroškov za bolnike. Na molekularno-genetsko testiranje na Oddelek za molekularno diagnostiko lahko svoje bolnike napotujejo zdravniki iz različnih zdravstvenih ustanov iz celotne Slovenije
Priporočila za sistemsko onkološko in radioterapevtsko zdravljenje rakov biliarnega trakta
Get PDFBiliary tract cancers are a rare and heterogeneous group with increasing incidence and high mortality. They have a poor prognosis with an overall survival of less than 1 year. New insights into the molecular genetic heterogeneity of biliary tract cancers and new therapeutic approaches allow these patients to survive longer and have a better quality of life. The Recommendations present the latest recommendations for systemic oncological treatment and radiotherapy of this group of cancers, which, according to international agreements, now include gallbladder carcinoma, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, with perihilar cholangiocarcinoma and carcinoma of the distal bile duct. The recommendations for systemic treatment are summarized and prepared on the basis of international recommendations, American National Comprehensive Cancer Network (NCCN) and European, European Association for Internal Oncology - European Society of Medical Oncology (ESMO).Raki biliarnega trakta so redka in heterogena skupina z naraščajočo incidenco in visoko umrljivostjo. Imajo slabo prognozo s celokupnim preživetjem manj od 1 leta. Nova dognanja o molekularno genetski heterogenosti rakov biliarnega trakta in novi terapevtskih pristopi omogočajo tem bolnikom daljša preživetja in boljšo kvaliteto življenja. V Priporočilih so predstavljena najnovejša priporočila za sistemsko onkološko zdravljenje in radioterapijo te skupine rakov, med katere po mednarodnih propročilih sedaj prištevamo karcinom žolčnika, intrahepatalne holangiokarcinome in ekstrahepatične holangiokarcinome, s perihilarnim holangiokarcinomom in karcinomom distalnega žolčevoda. Priporočila za sistemsko zdravljenje so povzeta in pripravljena na podlagi mednarodnih priporočil, ameriških, National Comprehensive Cancer Network (NCCN) in evropskih, Evropskega združenja za internistično onkologijo – European Society of Medical oncology (ESMO)
Četrt stoletja specializacije iz internistične onkologije v Sloveniji
Get PDFSystemic therapy has been shown to improve survival in many cancer patients. The number of anticancer drugs has increased dramatically in recent decades and more than half of all cancer patients are treated with these drugs. The specificity of the disease, the specificity of the treatment, and the drugs, which often have a very narrow therapeutic window, have necessitated the development of a new specialty, medical oncology, separate from internal medicine. Since 2000, medical oncology has been recognized in Slovenia as an independent specialization separate from internal medicine. The incidence of cancer in Slovenia is increasing, and there are more and more patients who need systemic treatment and management by medical oncologists. Unfortunately, the number of oncologists is not increasing at the same rate as the number of patients, and the existing facilities are becoming inadequate.Sistemsko zdravljenje dokazano izboljša preživetje številnihbolnikov z rakom. Nabor protirakavih zdravil se je v zadnjihdesetletjih močno povečal, z njimi zdravimo več kot polovicoobolelih. Specifičnost bolezni, specifičnost zdravljenja in zdravil, ki imajo pogosto zelo ozko terapevtsko okno, so zahtevale razvoj nove, od klasične interne medicine ločene specializacije, internistične onkologije. Specializacija iz internistične onkologije je kot samostojna veja specializacije iz interne medicine v Sloveniji priznana od leta 2000. Pojavnost raka v Sloveniji narašča, vse več je bolnikov, ki potrebujejo tudi sistemsko zdravljenje in obravnavo pri internistu onkologu. Žal pa skladno z rastjo števila bolnikov ne raste tudi število internistov onkologov, premajhne postajajo tudi obstoječe prostorske zmogljivosti
Uvealni melanom: priporočila zdravljenja
Get PDFUveal melanoma is the most common primary malignant intraocular tumor in adults. Uveal melanomas include choroidal melanoma (90%), ciliary body melanoma (6%), and iris melanoma (4%). Between 2017 and 2021, an average of 23 people were diagnosed with uveal melanoma annually in Slovenia, representing 3.7% of all melanomas.The first comprehensive and multidisciplinary treatment guidelines in Slovenia cover choroidal and ciliary body melanomas and are based on the American NCCN guidelines. These recommendations provide a holistic overview of risk factors, clinical presentation, andlocal treatment options for this cancer, as well as modern approaches to the multidisciplinary management of distant metastases—including the possibility of full blood genotyping for the presence of the human leukocyte antigen (HLA)-A*02:01. The aim of these guidelines is to support specialists from various fields in both communicating with patients and their families, and inchoosing the most appropriate treatment options.Uvealni melanom je najpogostejši primarni maligni znotrajočesni tumor pri odraslih. Med uvealne melanome uvrščamo melanom žilnice (90 %), ciliarnika (6 %) in šarenice (4 %). Med leti 2017 in 2021 je za uvealnim melanomom v Sloveniji letno zbolelo povprečno 23 oseb, kar predstavlja 3,7 % vseh melanomov. Prva slovenska celostna in multidisciplinarna priporočila zdravljenja vključujejo melanome žilnice in ciliarnika in so povzeta poameriških smernicah NCCN. Priporočila celostno predstavijotako dejavnike tveganja, kot klinično sliko in možnosti lokalnega zdravljenja tega raka, kot tudi sodobne načine multidisciplinarnega zdravljenja oddaljenih zasevkov vključno z možnostjo genotipizacije polne krvi na prisotnost človeškega levkocitnega antigena (HLA)-A*02:01).S priporočili želimo specialistom različnih strok olajšati takopogovor z bolnikom in svojci, kot izbiro ustreznega zdravljenja
Analiza obravnav na Oddelku za onkološko klinično genetiko po posamezni lokaciji raka in pomen genetskih izvidov pri načrtovanju zdravljenja
Get PDFIntroduction: The Institute of Oncology Ljubljana (IOL) provides genetic assessment for cancer patients who require test results for treatment planning and whenever there is a risk of a hereditary cancer syndrome. In this study, we aimed to analyse the trend of referrals of cancer patients and to assess the pathogenic / likely pathogenic variant (PV/LPV) detection rate in tested individuals according to family history. Methods: In the Department of Clinical Cancer Genetics, IOL, we performed data analysis using descriptive statistical methods and the Microsoft Excel tool. It was based on the number of referrals, patients’ family history data and their genetic test results for germline PV/LPV, focusing on specific cancer site (breast, ovaries, pancreas, and prostate) between 01/01/2020 and 30/06/2024. Results: In a period of 4.5 years, 4,252 patients were referred for genetic counselling, in particular breast cancer patients (3,074). On average, it took 4.3 years from cancer diagnosis to germline genetic testing. 16.5% of all patients tested were diagnosed with germline PV/LPV. Germline PV/LPV were mostly found in ovarian cancer patients (25.2%), followed by pancreatic cancer patients (16.2%), breast cancer patients (16.2%), and prostate cancer patients (11.1%). PV/LPV were most frequent in the genes BRCA1/2. The percentage of patients with a positive family history who tested positive was 19.5%, whereas the percentage of patients with a negative family history was 12.4%. Conclusion: The survey proves the importance of germline genetic testing for cancer patients and their relatives. In fact, 16.5% of patients tested positive for germline PV/LPV and the results were used for treatment planning and prevention. Therefore, it would be reasonable to consider introducing universal genetic testing for certain cancer patients in a safe clinical setting and to be able to identify all those at higher cancer risk.Izhodišče: Na Onkološkem inštitutu Ljubljana (OIL) obravnavamo bolnike z rakom, pri katerih je izvid genetskega testiranja pomemben za načrtovanje zdravljenja in če obstaja velika verjetnost, da je pri njih prisoten dedni sindrom za raka. Namen raziskave je bil analizirati trend obravnav pri bolnikih z rakom in oceniti stopnjo odkrivanja nosilcev zarodnih genetskih okvar. Prav tako smo analizirali stopnjo odkrivanja zarodnih patogenih različic/verjetno patogenih različic (PR/VPR) glede na družinsko anamnezo. Metode: S pomočjo programa MS Excel in deskriptivnih statističnih metod smo na Oddelku za onkološko klinično genetiko, OIL, analizirali podatke o številu napotitev, družinski anamnezi in genetskih rezultatih po štirih lokacijah raka (dojk, jajčnikov, prostate in trebušne slinavke) za obdobje od 1. 1. 2020 do 30. 6. 2024. Rezultati: V 4,5 leta je bilo na genetsko svetovanje poslanih 4.252 bolnikov, največ z rakom dojk (3.074). V povprečju je od diagnoze do testiranja za zarodne PR/VPR minilo 4,3 leta. Med vsemi testiranimi smo pri 16,5 % odkrili zarodno PR/VPR. Največja stopnja odkrivanja zarodnih PR/VPR je bila pri testiranih bolnicah z rakom jajčnikov (25,2 %), sledijo bolniki z rakom trebušne slinavke (16,2 %) in dojk (16,2 %) ter bolniki z rakom prostate (11,1 %). Najpogosteje so bile najdene zarodne PR/VPR v genih BRCA1/2. Delež bolnikov s pozitivnim genetskim izvidom med vsemi, ki so imeli pozitivno družinsko anamnezo je bil 19,5 %, med bolniki z negativno družinsko anamnezo pa 12,4 %. Zaključek: Analiza potrjuje pomen genetskega testiranja zarodnih PR/VPR pri bolnikih z rakom. Pri 16,5 % bolnikov je bil rezultat testiranja lahko uporabljen za načrtovanje zdravljenja in preventive za njihove svojce. Menimo, da bi bilo smiselno razmisliti o uvedbi univerzalnega genetskega testiranja za bolnike z določenimi diagnozami raka in kaskadnega testiranja svojcev v varnem kliničnem okolju
Editorial / Uvodnik
No full textThis editorial is a translation of the Slovenian original, which we published in the previous issue of the journal in December 2023. We have added some content that also appeals to international readership.This editorial is a translation of the Slovenian original, which we published in the previous issue of the journal in December 2023. We have added some content that also appeals to international readership
Priporočila za obravnavo bolnikov z melanomom kože
Get PDFThe incidence of cutaneous melanoma in the world and in Slovenia is still increasing, but survival has improved in the last 20 years, mainly due to earlier detection of melanoma and uniform appro- aches in primary treatment. The updated Recommendations in 2024 bring a lot of novelties, especially in diagnostic procedures for detecting the early stages of melanoma, as well as precise follow-up recommendations after primary treatment, in the field of surgical treatment, and especially in the field of systemic treatment, both, of metastatic disease, and in adjuvant systemic treatment in high-risk stage II, also neoadjuvant systemic treatment of operable cutaneous melanoma. We have also included chapters on the nutrition and palliative care in this Recommendations.Incidenca melanoma v svetu in Sloveniji še vedno narašča, se je pa preživetje v zadnjih 20 letih izboljšalo, predvsem zaradi zgodnejšega odkrivanja melanoma in enotnih pristopov v primarnem zdravljenju. Posodobljena Priporočila v letu 2024 prinašajo precej novosti, predvsem v diagnostičnih postopkih odkrivanja in zamejitve zgodnjih stadijev melanoma, kot tudi natančnih priporočil sledenja po primarnem zdravljenju, na področju kirurškega zdravljenja in pa predvsem sistemskega zdravljenja, tako metastatske bolezni, predvsem pa v adjuvan- tnem sistemskem zdravljenju v visoko rizičnem stadiju II, in neo- adjuvantnem sistemskem zdravljenju operabilnega melanoma. V tokratna Priporočila smo vključili tudi poglavji prehranskega in paliativnega tima
Ocena pridobljenih let življenja v populacijskih presejalnih programih za raka
Get PDFDue to the potential negative consequences of cancer screening programmes and the substantial resources invested in them, it is important to monitor their effectiveness. Mortality in the target population is one indicator that can be used to demonstrate the long-term effectiveness of organized, population-based screening programmes—after 10 to 20 years, mortality in the target population is expected to decrease by 20–30%. One of the main limitations of the mortality indicator is that, particularly for cancers with good survival rates, it only shows the effectiveness of screening over a long period of time. Therefore, survival analysis, where results are available earlier, is often used to evaluate the effectiveness of population- based cancer screening programmes. It is recognized that a number of biases can creep into the results of survival analysis (e.g. lead, length and overdiagnosis bias). Recently, Slovenian researchers have proposed a new analytical approach that allows a comparison of survival rates for cancers detected and undetected in the screening programme, taking into account all relevant biases. The calculated survival rates form the basis for the calculation of life years gained, a measure that expresses the additional number of years of life that people live as a result of participating in the screening programme. In the test case, we assessed the impact of the introduction of the National Breast Cancer Screening Programme DORA, which was first offered to residents in 2008 and expanded to the entire population in 2018. Women invited to the DORA programme in the period 2008–2022 gained a total of 90.6 life years. If all women had been included in the DORA programme since 2008, they would have gained 552.7 years of life. The total number of life years gained increases with each additional year of observation that individual women survive after enrolment in the DORA programme. The new method will help in the management of existing cancer screening programmes, their promotion and the evaluation of the impact of changes in screening policy.Zaradi možnih negativnih zdravstvenih posledic presejalnih programov in velikih sredstev, vloženih vanje, je pomembno spremljati njihovo učinkovitost. Umrljivost v ciljni populaciji je eden od kazalnikov, ki služi za prikaz dolgoročne učinkovitosti organiziranih populacijskih presejalnih programov – po 10 do 20 letih se pričakuje padec umrljivosti v ciljni populaciji za 20 % do 30 %. Ena od glavnih omejitev kazalnika umrljivosti je, predvsem pri rakih z dobrim preživetjem, da pokaže učinkovitost presejanja šele v daljšem časovnem obdobju. Mnogokrat se zato za oceno učinkovitosti populacijskih presejalnih programov za raka uporablja analiza preživetja, pri kateri so rezultati dostopni prej. Tudi analiza preživetja ima svoje omejitve, saj se lahko v rezultate prikradejo številne pristranosti (npr. pristranost časa trajanja, prednosti in prediagnosticiranja). Nedavno smo slovenski raziskovalci predlagali nov analitični pristop, ki omogoča primerjavo preživetja pri rakih, ki so oz. niso odkriti v presejalnem programu, z upoštevanjem vseh pomembnih pristranosti. Izračunana preživetja so osnova za izračun pridobljenih let življenja, to je mere, ki izraža dodatno število let življenja, ki bi jih osebe preživele zaradi vključitve v presejalni program. V testnem primeru smo ocenili učinke uvedbe Državnega presejalnega program za raka dojk DORA, ki smo ga prvim prebivalkam ponudili leta 2008, na celotno populacijo pa je bil razširjen leta 2018. Ženske, ki so bile povabljene v program DORA v obdobju 2008–2018, so do leta 2022 pridobile skupaj 90,6 leta življenja, če bi bile v program DORA že od leta 2008 vključene vse ženske, pa bi pridobile 552,7 leta življenja. Z vsakim dodatnim letom opazovanja, ko posamezne ženske od vključitve v program DORA preživijo, se seštevek pridobljenih let življenja poveča. Nova metoda bo v pomoč pri upravljanju obstoječih presejalnih programov za raka, njihovi promociji in vrednotenju učinkov pri spremembah presejalnih politik
Učinkovitost in varnost zdravljenja s trastuzumab derukstekanom: analiza podatkov iz realnega sveta
Get PDFAntibody-drug conjugates (ADCs) are a new generation of drugs that currently represent one of the most effective treatment options for cancer. ADCs target a specific target (antigen) that is selectively expressed on a tumour cell. Binding of ADCs to a tumour cell results in targeted intracellular delivery of cytotoxic drugs which causes cell death. An ADC called trastuzumab deruxtecan (T-DXd) has shown remarkable efficacy in several clinical trials called DESTINY. Initial data were available for patients with metastatic HER2-positive breast cancer, followed by data on other HER2-positive solid cancers and breast cancer with low HER2 expression. In this article, we present the first data on the efficacy and safety of T-DXd in Slovenia. We conducted a retrospective study of patients treated with T-DXd at the Institute of Oncology Ljubljana from November 2021 to April 2024. We observed good responses to treatment (objective response 59% in HER2-positive breast cancer, 38% in other HER2-positive solid cancers and 33% in breast cancer with low HER2 expression). After a short median follow-up of 8.8 (95% CI 0.8-33.3) months, real world progression-free survival (rwPFS) was 13 months in HER2-positive breast cancer, 5.8 months in HER2-low breast cancer, and 7.7 months in other HER2 positive or HER2-mutated solid cancers. The safety profile was consistent with that reported in the registration studies, with the exception of pneumonitis, which was reported in a much lower percentage (only 1%). We can conclude that the response rate to T-DXd is high despite the late treatment lines and the heterogeneous population, while rwPFS assessment is unreliable due to the short observation period.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