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    Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial
    (Amer Medical Assoc, 2019) Bastidas, Adriana; de la Serna, Javier; El Idrissi, Mohamed; Oostvogels, Lidia; Quittet, Philippe; Lopez-Jimenez, Javier; Vural, Filiz; Pohlreich, David; Zuckerman, Tsila; Issa, Nicolas C.; Gaidano, Gianluca; Lee, Je-Jung; Abhyankar, Sunil; Solano, Carlos; Perez de Oteyza, Jaime; Satlin, Michael J.; Schwartz, Stefan; Campins, Magda; Rocci, Alberto; Llamas, Carlos Vallejo; Lee, Dong-Gun; Tan, Sen Mui; Johnston, Anna M.; Grigg, Andrew; Boeckh, Michael J.; Campora, Laura; Lopez-Fauqued, Marta; Heineman, Thomas C.; Stadtmauer, Edward A.; Sullivan, Keith M.; Alonso Alonso, Aranzazu; Anagnostopoulos, Achilles; Andreadis, Charalambos (Babis); Angelopoulou, Maria; Anttila, Veli-Jukka; Aoun, Mickael; Barista, Ibrahim; Berkahn, Leanne; Bloor, Adrian J. C.; Broady, Raewyn; Brossart, Peter; Buadi, Francis K.; Bulabois, Claude-Eric; Cantin, Guy; Cellini, Claudia; Chandrasekar, Pranatharthi Haran; Chauncey, Thomas; Cuneo, Antonio; Dadwal, Sanjeet Singh; Dickinson, Michael; Eom, HyeonSeok; Esquirol Sanfeliu, Albert; Ferra Coll, Christelle; Flomenberg, Phyllis R.; Pilar Gonzalez-Rodriguez, Ana; Gottlieb, David J.; Grisariu, Sigal; Guenther, Andreas; Gutman, Jonathan; Hahn, Uwe; Heinz, Werner J.; Heras, Inmaculada; Ikeda, Takashi; Jarque, Isidro; Karthaus, Meinolf; Kerre, Tessa; Kiani, Alexander; Klein, Andreas K.; Kofla, Grzegorz; Kryuchkova, Irina V.; Kuo, Ching-Yuan; Kuruvilla, John; Kuvshinov, Aleksey; Kwak, Jae-Yong; Lee, Jae Hoon; Lepretre, Stephane; Lie, Albert Kwok-Wai; Lucchesi, Alessandro; Maertens, Johan; Marijt, Erik W. A.; Martinez Munoz, Carmen; Michieli, Mariagrazia; Milliken, Samuel T.; Milpied, Noel; Monserrat Coll, Jorge; Mossad, Sherif Beniameen; Murphy, John; Navarro Matilla, Maria Belen; Novak, Jan; Olney, Harold J.; Ona Navarrete, Raquel; Pascual Cascon, Maria Jesus; Peniket, Andy; Penka, Ganeva; Piatkowska-Jakubas, Beata; Polo Zarzuela, Marta; Quiel, Dimas; Rowley, Scott D.; Sabry, Waleed; Salmi, Tommi Mikael; Selleslag, Dominik L. D.; Shea, Thomas C.; Silling, Gerda; Sinisalo, Ulla Marjatta; Sohn, Sang Kyun; Staib, Peter; Szer, Jeff; Theunissen, Koen; Topcuoglu, Pervin; Tyurina, Natalya G.; Uvarov, Mikhail; Wahid, Fadilah S. Abdul; Yanez San Segundo, Lucrecia; Yegin, Zeynep Arzu; Yeh, Su-Peng; Yip, Sze-Fai; Yoon, Sung Soo; Young, Jo-Anne H.; Zachee, Pierre; Zaja, Francesco
    IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P<.001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P=.02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P=.02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P=.01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points. CONCLUSIONS AND RELEVANCE Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01610414
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    Hematopoietic Stem Cell Transplantation for Patients with Paroxysmal Nocturnal Hemoglobinuria with or without Aplastic Anemia: A Multicenter Turkish Experience
    (Galenos Yayincilik, 2021) Yilmaz, Fergun; Soyer, Nur; Seval, Guldane Cengiz; Bozdag, Sinem Civriz; Topcuoglu, Pervin; Unal, Ali; Kaynar, Leylagul
    Objective: Although inhibition of the complement system at different steps is a promising therapy modality in patients with paroxysmal nocturnal hemoglobinuria (PNH), allogeneic hematopoietic stem cell transplantation (HCT) is still the only curative therapy, especially for patients with intractable hemolysis or bone marrow failure. The aim of this study is to evaluate the outcomes of allogeneic HCT in PNH patients with aplastic anemia (PNH-AA) or without. Materials and Methods: Thirty-five PNH/PNH-AA patients who were treated with allogeneic HCT in 10 transplantation centers in Turkey were retrospectively analyzed. Results: Sixteen (45.7%) and 19 (54.3%) patients were diagnosed with classical PNH and PNH-AA, respectively. The median age of the patients was 32 (18-51) years. The 2-year overall survival (OS) rate and rate of graft-versus-host disease-free, failure-free survival (GFFS) was 81.2% and 78.1%, respectively. The 2-year OS in cases of classical PNH and PNH-AA was 81.3% and 79.9%, respectively (p=0.87), and 2-year GFFS in cases of PNH and PNH-AA was 79% and 76% (p=0.977), without statistical significance. The OS and GFFS rates also did not differ between transplantations with matched sibling donors (MSDs) and matched unrelated donors (MUDs). Conclusion: Allogeneic HCT with MSDs or MUDS is a good option for selected patients with classical PNH and PNH-AA. In particular, patients with debilitating and refractory hemolysis and patients with bone marrow failure might form an excellent group of candidates for allogeneic HCT.
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    Incidence and risk factors for hepatic sinusoidal obstruction syndrome after allogeneic hematopoietic stem cell transplantation: A retrospective multicenter study of Turkish hematology research and education group (ThREG)
    (Pergamon-Elsevier Science Ltd, 2020) Soyer, Nur; Gunduz, Mehmet; Tekgunduz, Emre; Deveci, Burak; Ozdogu, Hakan; Sahin, Handan Haydaroglu; Topcuoglu, Pervin
    Hepatic sinusoidal obstruction syndrome (HSOS) is a potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT). We retrospectively evaluated the incidence, risk factors, treatment and survival for HSOS after allo-HSCT in Turkey. We also reported our experience of defibrotide (DF) for HSOS prophylaxis in high-risk (HR) patients. Across Turkey, 1153 patients from 10 centers were enrolled in the study. We evaluated the medical records of patients who were treated with allo-SCT between January 2012 and December 2015. The study included 1153 patients (687 males/466 females) with median age of 38 (15 - 71) years. The incidence of HSOS was 7.5 % (n = 86). The incidences of HSOS in the HR/DF +, HR/DF- and standard risk (SR) group were 8%, 66.7 % and 6.2 %, respectively. The rate of HSOS development was not statistically different between HR/DF + and SR group (p = 0.237). HSOS prophylaxis (defibrotide) was significantly decreased HSOS-related mortality (p = 0.004). The incidence of HSOS was found similar to literature in this large Turkish cohort. Defibrotide prophylaxis appears to be associated with low incidence of HSOS development and reduced HSOS-related mortality. Although these results are promising, future studies are needed to support the efficacy of defibrotide prophylaxis in patients with risk of HSOS.
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    Incidence and risk factors for hepatic sinusoidal obstruction syndrome after allogeneic transplantation: Retrospective multicenter study of Turkish hematology research and education group (THREG), updated data
    (Nature Publishing Group, 2019) Soyer, Nur; Gunduz, Mehmet; Tekgunduz, Emre; Deveci, Burak; Ozdogu, Hakan; Sahin, Handan Haydaroglu; Turak, Esra Ermis; Okay, Mufide; Kuku, Irfan; Hindilerden, Ipek Yonal; Topcuoglu, Pervin; Altuntas, Feviz; Karadogan, Ihsan; Pehlivan, Mustafa; Unal, Ali; Goker, Hakan; Erkurt, Mehmet Ali; Besisik, Sevgi Kalayoglu; Vural, Filiz