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Azacitidine (AZA) is the standard of care for higher-risk myelodysplastic syndrome (HR-MDS) patients ineligible for intensive therapy. Clinical outcome discrepancies reported in clinical trials and real-life settings stimulate the search for new prognostic factors. We retrospectively evaluated 315 MDS, 20–30% blast acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) patients treated with azacitidine in 12 centers cooperating within the Polish Adult Leukemia Group (PALG). The median number of AZA cycles was 7 (1–69) and 24% patients received fewer than 4 cycles (early failure, EF). Serum albumin level was an independent predictor of EF occurrence. Complete remission (CR) was obtained in 20% and partial remission (PR) in 12% of patients. Hematologic improvement – erythroid (HI-E), neutrophil (HI-N), or platelet (HI-P) was achieved in 51%, 36%, and 48% of patients, respectively. No factors significantly predicted CR or PR in the multivariate analysis. For HI-E and HI-P, lower LDH level predicted response. Median survival was 15 (13–19) months. Lower serum albumin level, serious infection and receiving p < 0.05). Serum albumin assessment before azacitidine treatment can help to identify patients with higher risk of early failure and worse clinical outcome.

Background Single positive staphylococcal blood culture in a hematopoietic stem cell transplantation (HSCT) recipient is generally regarded as contamination. Such a blood culture (BC) does not fill the criteria for Laboratory-Confirmed Bloodstream Infection (LCBI) and could be described as Single Positive Commensal Blood Culture. The aim of this retrospective cohort analysis was to determine the clinical significance of SPCBC in HSCT recipients. Methods 206 patients transplanted between 2007 and 2013 were followed until January 2015. Results The 100-day survival for patients without positive BC was 99.6% compared with 83.9% for LCBI and 82.8% for SPCBC (p = 0.0036). The 5-year overall survival (5yOS) was 67.1% for patients without positive BC, 44.9% for LCBI, 34.0% for SPCBC (p Conclusion To our knowledge this is the first report that specifically shows that short- and long-term survival after HSCT is significantly lower in patients who experience an episode of SPCBC with Staphylococcus spp. during HSCT hospitalization.

Gut colonization by antibiotic-resistant bacteria may underlie hard-to-treat systemic infections. There is also accumulating evidence on the immunomodulatory function of gut microbiota after allogeneic stem cell transplantation (alloSCT) and its impact on graft-versus-host disease (GVHD). We investigated the epidemiology and clinical impact of gut colonization after alloSCT and retrospectively analyzed data on 107 alloSCTs performed at a single transplant center. Pretransplant microbiology screening identified colonization in 31% of cases. Colonization had a negative impact on overall survival after alloSCT in univariate (34% versus 74% at 24 months, P

Background Infections with human β-herpesviruses are common worldwide and are still frequent in patients after hematopoietic stem cell transplantation. Some data suggest that HHV-6 and HHV-7 could take part in CMV reactivation from latency and/or progression of CMV disease in immunosupressed patients. Objectives The aims of this study were: (1) to summarise retrospectively the results of β-herpesviruses DNA detection in a large group of adult allogeneic haematopoietic stem cell transplant recipients; and (2) to find a potential correlation between viruses belonging to this subfamily. Study design AlloHSCT recipients ( N =142) were examined in the early post-transplant period (median=89 days). The presence of CMV, HHV-6 and HHV-7 was confirmed through detection and quantification of viral DNA, isolated from 1679 sera samples. Results CMV DNA alone was detected in 23.9% of patients, while single HHV-6 and HHV-7 were detected in 14.8% and 9.9% of individuals, respectively. The reactivation of more than one virus was identified in 31% of analysed patients. In cases of concurrent infection, HHV-7 was detected at the same time as HHV-6, and both of them were usually reactivated before CMV. The kinetics of virus reactivation and measured viral load may suggest a potential role of HHV-6 and HHV-7 as co-factors in CMV reactivation. Conclusions The observed kinetics of virus reactivation may strongly suggest a potential role of HHV-6 and/or HHV-7 as co-factors of CMV reactivation. The co-infection with these β-herpesviruses could predispose patients after hematopoietic stem cell transplantation to a longer and more severe CMV infection.

Background: Azacitidine is the current standard of care for higher risk MDS patients (HR MDS) changing the natural course of diseases. Early drug discontinuation (receiving less than 4 azacitidine cycles - early failure - EF) is a poor prognostic marker, while factors affecting early failure are largely unknown. Objectives: To identify predictive factors for early azacitidine failure in MDS/CMML/low blast percentage AML patients Methods: The study included retrospectively MDS/CMML and 20-30% bone marrow blasts AML patients treated from 2008 to 2019 in 12 Polish hematologic centers cooperating within Polish Adult Leukemia Group (PALG). Baseline demographic, laboratory, clinical and treatment characteristics were obtained and were evaluated as potential EF predictors. Cox proportional hazard models were used to define statistical significance of variables using the R statistical platform. Results: We collected data on 315 patients with MDS (67%), CMML (12%) and with AML (21%). Median age was 69 years and 61% were male. Median number of azacitidine cycles was 7 (1-69) and 84 patients (29%) received maximum 3 cycles. Patients achieved more than 3 cycles showed better OS compared to those ≤ 3 cycles (20 months vs 4 months)(p Conclusions: Our analysis confirmed that patients with premature azacitidine treatment discontinuation ≤ 3 cycles have worse outcome. The pretreatment lower serum albumin level was identified as an independent predictor of early failure occurence. Figure 1. Overall survival in patients treated with ≤ 3 azacitidine cycles and > 3 cycles Disclosures Golos: Novartis: Honoraria. Basak:Celgene: Honoraria; Teva: Honoraria.

Introduction Dialysis-dependent (DD) multiple myeloma patients (MM) have a poor prognosis and high tumour burden, thus may benefit from autologous peripheral blood stem cell transplantation (auto-PBSCT), however, these patients have an increased risk of toxicity. Aims To evaluate the outcomes (toxicity, PFS, OS) of high dose therapy followed by auto-PBSCT during an observational study and after propensity score matching. Patients and methods Between 2004-2015, 24 DD patients, (aged 38-67 years), ISS 3, treated with auto-PBSCT, requiring dialysis at diagnosis and auto-PBSCT were evaluated, matched and compared to 55 normal renal function MM patients (NRF) with ISS 3 for outcomes of interest. Results In DD patients compared to NRF patients risk of mucositis (88% vs 55%), infection (79% vs 51%), parenteral nutrition (50% vs 24%), diarrhoea (71% vs 38%), prolonged duration of hospitalisation (medians: 30 vs 21 days), requirement for RBC transfusion (83% vs 36%) were significantly higher, while no significant differences were found in post-transplant response (ORR; 75% vs 87%), 5-year PFS (36% vs 20%) and OS (39% vs 50%). Subgroup analyses based on toxicity supported these results. Conclusions Despite the increased risk of toxicity in DD patients these events do not significantly affect both the PFS and OS.

The beginning of the twenty-first century saw a breakthrough in haematology, oncology and general medicine driven by the introduction of imatinib (Glivec) to the treatment of chronic myeloid leukaemia. For the first time, a neoplastic disease was successfully treated by a therapy targeting the genetic cause of the disease. At present, targeted therapy based on imatinib is the first one to enter a new stage which is the launch of generic drugs. Poland is the first country in the European Union which, from the beginning of July 2014, introduced generic imatinib. Hence, there is no reliable data on its use except for results from bioequivalence tests. The only data available comes from developing countries where other preparations are used, without reliable bioequivalence studies. However, all generic drugs of imatinib registered in Poland have successfully passed such tests. Undoubtedly, it is necessary to appropriately monitor patients with chronic myeloid leukaemia receiving generic drugs in order to ensure their safety and provide information to other countries where therapy based on generic drugs will be introduced in the following years.

Background Infections caused by human α-herpesviruses usually have a benign course with recurrencies. However, they may become dangerous in immunocompromised hosts. In this case, molecular methods constitute a reliable diagnostic tool enabling rapid assessment of the efficacy of antiviral treatment strategies. Objectives We estimated the frequency of alphaherpesviral DNAemia and the viral load during early post-transplantation period after alloHSCT; we also analyzed association of the DNAemia and chosen parameters of the patients. Study design A cohort of 190 alloHSCT recipients from two hospitals in Warsaw, Poland, was examined weekly during 100-day early post-transplantation period using quantitative real time PCR assays. A total of 2475 sera samples were evaluated for the presence of α-herpesviral DNA in patients, of whom 117 (62%) received unrelated grafts, while the remaining 73 (38%) received grafts from sibling donors. All patients received standard antiviral prophylaxis with acyclovir. In the examined group, anti-HSV-1, anti-HSV-2 and anti-VZV IgGs were examined prior to transplantation, Results Within the study period, DNA of α-herpesviruses was detected in 44 patients (23.2%). Most patients tested positive for HSV-1 DNA (43 patients, 22.6%), single patient for HSV-2, and no patient positive for VZV. Clinical symptoms such as pneumonia, skin changes, elevated levels of aminotransferases were observed in five patients, four of these patients presented symptoms of GvHD at the same time. (2,6%). Statistics shows that GvHD ( P P = 0.048) are associated with the development of HSV-1 DNAemia. Conclusions Although our data demonstrate frequent reactivation of HSV-1 in the early post-transplant period, the rate of symptomatic infections was low. We did not find association between HSV-1 viremia and mortality, but significant association with GvHD and donor source was observed.

Infections caused with a variety of bacteria, fungi and viruses are still responsible for high level of mortality and morbidity in immunosupressed individuals. A case of fatal post-transplant reactivation with four herpesviruses in 49-year-old immunocompromised male with MDS-RAEB2, subjected to allogeneic haematopoietic stem cell transplantation was described.Full microbiological examination of was performed in different types of clinical samples (whole blood, stool). Sera specimens were tested for the presence of different viral DNA using the real-time PCR assays.DNA of HSV-1, VZV, HHV-6 and EBV in serum samples was detected using molecular biology techniques. Viral level of HSV-1 and VZV was constantly increasing despite routine applied oral acyclovir therapy. These findings underline the value of real-time PCR technique used in current therapeutic procedures and for monitoring of antiviral therapy with nucleoside analogs. We found that real-time PCR is a useful tool in detection and monitoring of disseminated herpesviral infection, especially for the detection of low-copy viraemia in clinical specimens.

Human adenoviruses (HAdV) are important viral pathogens recognized increasingly in immunocompromised hosts, especially in allogeneic haematopoietic stem cell transplant recipients (alloHSCT). The clinical spectrum of HAdV disease ranges from asymptomatic viraemia and mild self-limiting disease to lower respiratory tract infection, multi-organ involvement and even death. Early detection and quantification of HAdV in peripheral blood using real-time PCR (qPCR) assay has been suggested as a useful monitoring tool, but is seldom used for regular surveillance of HAdV in haematology centers. A group of 112 alloHSCT recipients from two hospitals in Warsaw (Poland) was examined in the early post-transplant period using a quantitative qPCR assay. A total of 1,245 serum samples were evaluated for presence of HAdV DNA in patients where 66 (59 %) patients received grafts from unrelated donors whereas the other 46 (41 %) from sibling donors. HAdV sequences were detected in 64 (57 %) of the 112 patients. In 22 of all patients (20 %) HAdV DNA was detected only in a single positive sample, while 42 (37 %) had positive results in two or more subsequent sera. In total, DNAemia was present in 202 sera samples (16 %) with median time to observation of 47 days. Graft-versus-host disease (GvHD) was observed in 18 (28 %) adenovirus-infected transplant recipients and a significant correlation between HAdV infections and GvHD clinical presentation was found (p = 0.018). There is a high prevalence of HAdV infections in HSCT recipients in Poland during early post-transplant period. In consequence, we could only speculate if HAdV DNAemia could be also related to GvHD symptoms, enforcing the important pathogenic role of these viral infections in clinical complications post-alloHSCT.