1. Bleomycin electrosclerotherapy (BEST) for the treatment of vascular malformations : an International Network for Sharing Practices on Electrochemotherapy (InspECT) study group reportTobian Muir, Giulia Bertino, Aleš Grošelj, Lakshmi Ratnam, Erika Kis, Joy Odili, Ian McCafferty, Walter A Wohlgemuth, Maja Čemažar, Aljoša Krt, Maša Omerzel, Alessandro Zanasi, Michela Battista, Francesca De Terlizzi, Luca Giovanni Campana, Gregor Serša, 2023, review article Abstract: Biomedical applications of electroporation are expanding out of the field of oncology into vaccination, treatment of arrhythmias and now in the treatment of vascular malformations. Bleomycin is a widely used sclerosing agent in the treatment of various vascular malformations. The application of electric pulses in addition to bleomycin enhances the effectiveness of the drug, as demonstrated by electrochemotherapy, which utilizes bleomycin in the treatment of tumors. The same principle is used in bleomycin electrosclerotherapy (BEST). The approach seems to be effective in the treatment of low-flow (venous and lymphatic) and, potentially, even high-flow (arteriovenous) malformations. Although there are only a few published reports to date, the surgical community is interested, and an increasing number of centers are applying BEST in the treatment of vascular malformations. Within the International Network for Sharing Practices on Electrochemotherapy (InspECT) consortium, a dedicated working group has been constituted to develop standard operating procedures for BEST and foster clinical trials. By treatment standardization and successful completion of clinical trials demonstrating the effectiveness and safety of the approach, higher quality data and better clinical outcomes may be achieved.
Keywords: vascular malformations, electrosclerotherapy, bleomycin
Published in DiRROS: 25.07.2024; Views: 151; Downloads: 47
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2. Treatment of skin tumors with intratumoral interleukin 12 gene electrotransfer in the head and neck region : a first-in-human clinical trial protocolAleš Grošelj, Maša Omerzel, Tanja Jesenko, Maja Čemažar, Boštjan Markelc, Primož Strojan, Gregor Serša, 2022, original scientific article Abstract: Immune therapies are currently under intensive investigation providing in many cases excellent re-sponses in different tumors. Other possible approach for immunotherapy is a targeted intratumoral delivery of inter-leukin 12 (IL-12), a cytokine with anti-tumor effectiveness. Due to its immunomodulatory action, it can be used as an imunostimulating component to in situ vaccinating effect of local ablative therapies. We have developed a phIL12 plasmid devoid of antibiotic resistance marker with a transgene for human IL-12 p70 protein. The plasmid can be delivered intratumorally by gene electrotransfer (GET). Patients and methods. Here we present a first-in-human clinical trial protocol for phIL12 GET (ISRCTN15479959, ClinicalTrials NCT05077033). The study is aimed at evaluating the safety and tolerability of phIL12 GET in treatment of basal cell carcinomas in patients with operable tumors in the head and neck region. The study is designed as an ex-ploratory, dose escalating study with the aim to determine the safety and tolerability of the treatment and to identify the dose of plasmid phIL12 that is safe and elicits its biological activity. Conclusions. The results of this trail protocol will therefore provide the basis for the use of phIL12 GET as an adjuvant treatment to local ablative therapies, to potentially increase their local and elicit a systemic response.
Keywords: skin tumors, gene electrotransfer, interleukin 12, clinical trial
Published in DiRROS: 24.07.2024; Views: 107; Downloads: 43
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3. The importance of flaps in reconstruction of locoregionally advanced lateral skull-base cancer defects : a tertiary otorhinolaryngology referral centre experienceDomen Vozel, Peter Pukl, Aleš Grošelj, Aleksandar Aničin, Primož Strojan, Saba Battelino, 2021, original scientific article Abstract: Background. The aim of the study was to identify the value of extensive resection and reconstruction with flaps in the treatment of locoregionally advanced lateral skull-base cancer.Patients and methods. The retrospective case review of patients with lateral skull-base cancer treated surgically with curative intent between 2011 and 2019 at a tertiary otorhinolaryngology referral centre was made. Results. Twelve patients with locoregionally advanced cancer were analysed. Lateral temporal bone resection was performed in nine (75.0%), partial parotidectomy in six (50.0%), total parotidectomy in one (8.3%), ipsilateral selective neck dissection in eight (66.7%) and ipsilateral modified radical neck dissection in one patient (8.3%). The defect was reconstructed with anterolateral thigh free flap, radial forearm free flap or pectoralis major myocutaneous flap in two patients (17.0%) each. Mean overall survival was 3.1 years (SD = 2.5) and cancer-free survival rate 100%. At the data collection cut-off, 83% of analysed patients and 100% of patients with flap reconstruction were alive. Conclusions. Favourable local control in lateral skull-base cancer, which mainly involves temporal bone is achieved with an extensive locoregional resection followed by free or regional flap reconstruction. Universal cancer registry should be considered in centres treating this rare disease to alleviate analysis and multicentric research.
Keywords: temporal bone, microsurgery, parotid region, free tissue flaps, neoplasm staging, ear
Published in DiRROS: 22.07.2024; Views: 137; Downloads: 118
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4. Long term response of electrochemotherapy with reduced dose of bleomycin in elderly patients with head and neck non-melanoma skin cancerČrt Jamšek, Gregor Serša, Maša Omerzel, Aleš Grošelj, 2020, original scientific article Abstract: . Electrochemotherapy (ECT) is a local cancer treatment based on electroporation where the electric field is used to enhance cell membrane permeability and thereby facilitating the transition of chemotherapeutic agents into the cell. For the treatment of non-melanoma skin cancer, a standard dosage of 15,000 IU/m2 bleomycin (BLM) is used. The aim of the present study was to evaluate the long-term ECT response in the group of elderly patients with non-melanoma skin cancer treated with a reduced dose of BLM in comparison to the outcome in the patients treated with the standard dose of BLM. Patients and methods. Twenty-eight patients older than 65 years, with a total of 52 non-melanoma skin lesions were included in the study. Twelve patients (24 lesions) in the experimental group received a reduced dose of BLM (10,000 IU/m2), 16 patients (28 lesions) were treated with a standard dose of BLM (15,000 IU/m2). Results. No statistically significant difference in tumor control was observed between both groups. In the experimental group, tumors recurred in 39.0% of treated lesions in a median follow-up time of 28 months. In the control group, the recurrence rate of treated lesions was 15.4% in a median follow-up time of 40 months. Conclusions. ECT with a reduced dose of BLM is a feasible treatment option for elderly patients with equal efficacy to standard dose treatment and should be considered as a treatment modality in advanced aged patients with comorbidities, where overall life expectancy is poor
Keywords: electrochemotherapy, bleomycin, non-melanoma skin cancer
Published in DiRROS: 12.07.2024; Views: 145; Downloads: 43
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5. Distant metastasis of rectal adenocarcinoma in a temporary tracheostomaRobert Šifrer, Primož Strojan, Nina Zidar, Miha Žargi, Aleš Grošelj, Milena Krajinović, 2014, review article Keywords: temporary tracheostoma, distant metastasis, rectal adenocarcinoma, rak (medicina), traheostoma, zasevki, metastaziranje, žlezni rak
Published in DiRROS: 11.04.2024; Views: 312; Downloads: 158
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6. Bleomycin concentration in patientsʹ plasma and tumors after electrochemotherapy : a study from InspECT GroupAleš Grošelj, Maša Omerzel, Mojca Kržan, Tina Kosjek, Krisztina Bottyán, Helena Plešnik, Črt Jamšek, Maja Čemažar, Erika Kis, Gregor Serša, 2021, original scientific article Keywords: electrochemotherapy, electroporation, bleomycin
Published in DiRROS: 10.10.2022; Views: 692; Downloads: 338
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7. Electrochemotherapy in mucosal cancer of the head and neck : a systematic reviewPrimož Strojan, Aleš Grošelj, Gregor Serša, Christina Caroline Plaschke, Jan B. Vermorken, Sandra Nuyts, Remco De Bree, Avraham Eisbruch, William M. Mendenhall, Robert Smee, Alfio Ferlito, 2021, review article Abstract: Electrochemotherapy (ECT) is a local ablative treatment that is based on the reversible electroporation and intracellular accumulation of hydrophilic drug molecules, which greatly increases their cytotoxicity. In mucosal head and neck cancer (HNC), experience with ECT is limited due to the poor accessibility of tumors. In order to review the experience with ECT in mucosal HNC, we undertook a systematic review of the literature. In 22 articles, published between 1998 and 2020, 16 studies with 164 patients were described. Curative and palliative intent treatment were given to 36 (22%) and 128 patients (78%), respectively. The majority of tumors were squamous cell carcinomas (79.3%) and located in the oral cavity (62.8%). In the curative intent group, complete response after one ECT treatment was achieved in 80.5% of the patients, and in the palliative intent group, the objective (complete and partial) response rate was 73.1% (31.2% and 41.9%). No serious adverse events were reported during or soon after ECT and late effects were rare (19 events in 17 patients). The quality-of-life assessments did not show a significant deterioration at 12 months post-ECT. Provided these preliminary data are confirmed in randomized controlled trials, ECT may be an interesting treatment option in selected patients with HNC not amenable to standard local treatment.
Keywords: electrochemotherapy, head and neck cancer, mucosal cancer
Published in DiRROS: 23.09.2022; Views: 706; Downloads: 354
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8. Priporočila za zobozdravstveno obravnavo odraslih bolnikov z rakom glave in vratu v Sloveniji, zdravljenih z obsevanjemAleš Fidler, Aleksandar Aničin, Vojislav Didanovič, Tadej Dovšak, Boris Gašpirc, Aleš Grošelj, Andrej Kansky, Matic Koren, Jana Krapež, Hojka Kuralt, Marko Kuralt, Boštjan Lanišnik, Romana Mance Kristan, Jošt Pavčič, Luka Prodnik, Peter Pukl, Tadej Ostrc, Milan Kuhar, Eva Skalerič, Robert Šifrer, Valerija Skopec, Primož Strojan, 2022, original scientific article Abstract: Priporočila za zobozdravstveno obravnavo bolnikov z rakom glave in vratu (RGV) v Sloveniji, zdravljenih z obsevanjem sledijo priporočilom The Royal College of Surgeons of England v sodelovanju z The British Society for Disability and Oral Health, dopolnjujejo Priporočila za obravnavo bolnikov z rakom glave in vratu v Sloveniji in hkrati upoštevajo obstoječe zmožnosti slovenskega zdravstvenega sistema. Namen priporočil je prepre-čevanje oz. zmanjšanje zapletov v ustni votlini, ki nastanejo zaradi obsevanja. Opredeljujejo način zobozdravstvene oskrbe pred, med in po zdravljenju raka na vseh treh nivojih zobozdra-vstvene oskrbe, kar zagotavlja njeno pravočasnost in dostopnost. Priporočila predstavljajo poenoteno mnenje vseh deležnikov na področju zobozdravstvene obravnave bolnikov z RGV v državi.
Keywords: onkologija, zobozdravstvena obravnava, obsevanje, ustna votlina, priporočila
Published in DiRROS: 14.07.2022; Views: 757; Downloads: 278
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9. Genska terapija v onkologiji, prvi razvojni koraki v SlovenijiMaja Čemažar, Tanja Jesenko, Maša Omerzel, Boštjan Markelc, Urška Kamenšek, Simona Kranjc Brezar, Špela Kos, Urša Lampreht Tratar, Katarina Žnidar, Andrej Renčelj, Urška Matkovič, Teja Valant, Kristina Levpušček, Živa Pišljar, Tilen Komel, Tim Božič, Urša Kešar, Barbara Starešinič, Katja Uršič Valentinuzzi, Monika Savarin, Primož Strojan, Gorana Gašljević, Maja Ota, Aleš Grošelj, Črt Jamšek, Rosana Hudej, Matjaž Peterka, Franc Smrekar, Barbara Hubad, Marjan Hosta, Jaka Kužnik, Alojz Hosta, Damijan Miklavčič, Matej Reberšek, Aleksandra Cvetkoska, Anja Zajc, Janja Dermol-Černe, Nataša Tozon, Nina Milevoj, Alenka Nemec Svete, Gregor Serša, 2022, professional article Abstract: Genska terapija postaja čedalje bolj zanimiva tudi v onkologiji. Med aplikacijami je morda najzanimivejša imunostimulacija. Pripravimo lahko plazmidno DNA, ki nosi zapis za različne imunostimulatorne molekule, ki jih vnesemo v celice tumorjev ali normalnih tkiv. Ta tkiva postanejo proizvajalci teh molekul, ki lahko delujejo lokalno ali pa se izločajo tudi sistemsko v krvni obtok. Ker plazmidna DNA ne prehaja celične membrane, so potrebni dostavni sistemi, virusni ali nevirusni. V naših študijah uporabljamo predvsem nevirusni dostavni sistem – elektroporacijo. Interlevkin 12 (IL-12) je eden od zanimivih citokinov, za katerega je znano protitumorsko delovanje s spodbujanjem imunskega odziva in antiangiogenim delovanjem. Namen projekta SmartGene.si je bil pripraviti plazmid z zapisom za interlevkin 12 (plazmid phIL12) in pripraviti vse potrebno za njegovo klinično testiranje za zdravljenje kožnih tumorjev. V konzorciju smo združili moči s partnerji z akademskega in industrijskega področja. Treba je bilo pripraviti plazmid za uporabo v humani onkologiji po zahtevah Evropske agencije za zdravila (EMA). Za prijavo klinične študije na Javno agencijo za zdravila in medicinske pripomočke (JAZMP) smo morali izvesti tudi vse neklinične raziskave o varnosti in učinkovitosti zdravila. Nato je bilo treba razviti postopek priprave zdravila, zagotoviti primerne prostore za pripravo in izvedbo postopka priprave zdravila. V treh letih smo dosegli vse te zastavljene cilje in dobili dovoljenje za izvajanje klinične študije na kožnih tumorjih, ki ga je izdala JAZMP na osnovi pozitivnega mnenja Komisije Republike Slovenije za medicinsko etiko. Zdaj poteka klinična študija faze I preizkušanja plazmida phIL12 na kožnih tumorjih glave in vratu z namenom preveriti varnost in sprejemljivost genskega elektroprenosa plazmida v tumorje. Cilj študije je prav tako določiti primeren odmerek zdravila, ki bi ga v nadaljnji klinični študiji uporabili kot adjuvantno zdravljenje k ablativnim terapijam, kot sta radioterapija ali elektrokemoterapija.
Keywords: genska terapija, interlevkin-12, plazmidna DNA, elektroprenos genov, rak kože
Published in DiRROS: 01.07.2022; Views: 1528; Downloads: 295
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10. Priporočila za obravnavo bolnikov z rakom glave in vratu v SlovenijiPrimož Strojan, Aleksandar Aničin, Jelena Azarija, Saba Battelino, Bogdan Čizmarevič, Vojislav Didanovič, Tadej Dovšak, Marta Dremelj, Aleš Fidler, Matic Glavan, Cvetka Grašič-Kuhar, Aleš Grošelj, Andrej Kansky, Katarina Barbara Karner, Marko Kokalj, Matic Koren, Jana Krapež, Hojka Kuralt, Boštjan Lanišnik, Primož Levart, Jure Orel, Jošt Pavčič, Gaber Plavc, Luka Prodnik, Peter Pukl, Robert Šifrer, Matija Švagan, Jure Urbančič, Branko Zakotnik, Nina Zidar, Barbara Žumer, 2021, professional article Abstract: Priporočila za obravnavo rakov glave in vratu (RGV) v Sloveniji sledijo priporočilom in usmeritvam, povzetim v publikaciji neprofitne mreže 30 vodilnih severnoameriških inštitucij za obravnavo raka, National Comprehensive Cancer Network,1 in hkrati upoštevajo obstoječe zmožnosti slovenskega zdravstvenega sistema. Smernice predstavljajo poenoteno mnenje vseh štirih najpomembnejših deležnikov na področju obravnave rakov glave in vratu v državi: Klinike za otorinolaringologijo in cervikofacialno kirurgijo, Kliničnega oddelka za maksilofacialno in oralno kirurgijo ter Stomatološke klinike UKC Ljubljana, Klinike za otorinolaringologijo, cervikalno in maksilofacialno kirurgijo UKC Maribor ter Onkološkega inštituta Ljubljana
Keywords: rak glave in vratu, zdravljenje, onkolško zdravljenje
Published in DiRROS: 11.06.2021; Views: 1826; Downloads: 422
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