Working Party Research Articles

PM 8/15 (1) Tilia

Specific scopeThe purpose of the EPPO Standard on Tilia is to recommend to EPPO Member Governments the phytosanitary measures which they should use or require for Tilia plants and plant products moving in international trade to prevent the introduction and spread of quarantine pests of Tilia and other host plants through these pathways. Some of these recommendations are addressed to all EPPO Member Governments, others are addressed only to countries considered to face a certain level of risk from the introduction and spread of the regulated pests concerned. All these recommendations were derived from: EPPO Standards PM 1/2 (EPPO A1 and A2 lists) and the former EPPO Standards PM 2 (pest‐specific phytosanitary measures), or Pest Risk Analysis (PRA) carried out or reviewed by EPPO, or The Panel on Quarantine Pests for Forestry The Working Party on Phytosanitary Regulations. This Standard covers phytosanitary import requirements that the importing country is recommended to require for imported consignments. Measures that may be used in the importing countries such as post‐entry quarantine (which is sometimes an option recommended in PRAs), raising public awareness, and pest control and suppression are out of scope of this Standard. Post‐entry quarantine is primarily used in the EPPO region as a derogation when import phytosanitary requirements are not met.For wood packaging material, recommendations are based on ISPM 15 Regulation of wood packaging material in international trade.Specific approval and amendmentFirst approved in September 2021–09.

COVID-19 Infection in Vaccinated Adult Patients with Hematological Malignancies. Preliminary Results from Epicovideha (Epidemiology of COVID-19 infection in patients with hematological malignancies: A European Haematology Association Survey)

COVID-19 Infection in Vaccinated Adult Patients with Hematological Malignancies. Preliminary Results from Epicovideha (Epidemiology of COVID-19 infection in patients with hematological malignancies: A European Haematology Association Survey)

Inferior Outcomes for Multiple Myeloma (MM) Patients (pts) Harbouring t(11;14) and the Promise of Venetoclax, Real-World Australian Retrospective

Introduction/ BackgroundTraditionally, MM harbouring t(11;14) is considered standard risk disease. In the era of novel therapies, however, pts with t(11;14) are reported to have inferior outcomes to other standard risk pts. Evidence of response to the BCL-2 inhibitor, Venetoclax (Ven), has further increased interest in understanding outcomes of t(11;14) pts. In this study, we aimed to describe the historical outcomes of t(11;14) MM and response to Ven in a real-world cohort of Australian pts.MethodsThis was a retrospective, multicentre study conducted by members of the Australasian Leukaemia and Lymphoma Group, Myeloma Working Party. Cases were identified by interrogation of cytogenetics/FISH database from 2010 to 2019 inclusive. Baseline patient and disease characteristics, treatment exposure and outcomes were extracted from hospital medical records. Descriptive statistics, and survival analyses were performed as appropriate.ResultsSeventy-four pts [median age 65 years (yrs), range (43-85)] were identified across seven centres. 43% pts had ISS Stage III MM with 88% harbouring additional cytogenetic abnormalities, incl. 13% with gain in 1q and 12% with del(17p). The majority (81%) of pts received proteasome inhibitor (PI)-based 1 st line therapy with 60% having an upfront autologous stem cell transplant (ASCT) and 54% having immunomodulatory drug (IMiD)-based maintenance therapy. Two patients received an allogeneic stem cell transplant after ASCT. The overall response rate (ORR) was 86% with 38% achieving very good partial response (VGPR) or better. The median progression free survival-1 (PFS-1) was 1.91 yrs (95% CI 1.73-2.56) [PI-based, n=60, PFS 1.84yrs (95% CI 1.61-2.41) vs IMiD-based, n=5, PFS 4.58yrs (95% CI 1.16-5.51), HR 0.68 p=0.45] The median overall survival (OS) was 5.35 yrs (95% CI 4.12-6.56). Second and third line therapy was predominantly IMiD-based (see Table 1) with recent introduction of anti-CD38 monoclonal antibodies (mAbs). Median PFS-2 was 0.77 yrs (95% CI 0.39-0.98) while median PFS-3 was 0.65 yrs (95% CI 0.34-1.16). Eleven pts (median 3 prior lines of therapy) were given Ven [Six pts in combination with PI, three with PI and mAbs and two with dexamethasone]. ORR to Ven was 55% with 45% achieving VGPR or better. Median PFS with Ven was 0.54 yrs (85% CI 0.05-2.17). Median PFS for patients with 1-4 lines (n=6) was 1.22 years and median PFS for patients with 5 lines or more (n=5) was 0.54 years, HR 0.56 (95% CI 0.12-2.5).ConclusionFor pts harbouring t(11;14), the duration of response to PI-based 1 st line therapy is suboptimal even with the use of ASCT consolidation in the majority of patients. Despite multiple prior lines of therapy, Venetoclax shows promising results and every effort should be made for early identification of this cytogenetic lesion. Further studies are required to examine the impact of novel triplet and quadruplet combination therapy and use of venetoclax early in the disease course of this sub-group of patients. [Display omitted] DisclosuresTalaulikar: Takeda: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Jansenn: Honoraria, Research Funding; Roche: Honoraria, Research Funding; EUSA Pharma: Honoraria, Research Funding. Gibbs: Janssen, Celgene, Amgen, Takeda, BMS and Pfizer: Consultancy, Honoraria; AbbVie: Consultancy.

The Influence of Atopic Dermatitis on Health-Related Quality of Life in Bangladesh.

Atopic dermatitis (AD) is the foremost non-fatal skin-related disease that affects all age groups. Despite the growing prevalence of AD in low- and middle-income countries, its physiological consequences remain overlooked in countries like Bangladesh. Therefore, we aim to assess and characterize the influence of AD on the health-related quality of life (HRQoL) in Bangladeshi patients. A cross-sectional study comprising 184 eligible adults (83 men and 101 women; mean age, 33.46 ± 15.44 years) was conducted at the dermatology outpatient department of Shaheed Suhrawardy Medical College Hospital (a tertiary hospital in Dhaka, Bangladesh). AD was determined using the UK Working Party criteria. A structured questionnaire, Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI) were administered to obtain information on patient characteristics, AD severity, and HRQoL. The mean DLQI score for the entire sample was 11.29 ± 5.27 (range, 1–26), and 51.60% reported the disease greatly affected their lives. Bivariate analysis revealed significant differences in self-rated health measures of DLQI scores in terms of self-reported AD severity, overall health, and the EASI. In multivariable regression models adjusted for patient characteristics, the self-perceived severe AD group reported significantly higher DLQI scores (coefficient = 2.72; 95% confidence interval (CI) = 0.38–5.05; p = 0.022) than the mild group. Concurrently, we observed a substantial increase in the DLQI scores among patients with moderate and severe EASI scores (coefficient = 1.96, 95% CI = 0.08–3.92, p < 0.05 and coefficient = 4.35, 95% CI = 1.98–6.72, p < 0.001, respectively) than in those with mild EASI scores, suggesting that HRQoL was markedly influenced by greater AD severity. These findings highlight the need for a more patient-centric approach to the management of AD in order to alleviate patient suffering and, thereby, improve HRQoL.

‘A Procedure Without a Problem’, or the face transplant that didn’t happen. The Royal Free, the Royal College of Surgeons and the challenge of surgical firsts

Face transplants are an innovative and unusual form of modern surgery. There have been 47 face transplants around the world to date, but none as yet in the UK. Yet...

Evaluación de la calidad del agua a lo largo de una cuenca heterogénea (Río Grande, Jujuy, Argentina)

The aim of this work is to evaluate the ecological quality of waters along an environmentally heterogeneous basin, using macroinvertebrate biotic indices (BI). Twelve sampling sites were selected in the Río Grande basin, following an altitudinal gradient across the Puna, Monte and Yungas ecoregions. Sampling was conducted in the dry and rainy seasons, during three consecutive years (2012 to 2014). At each site, physico-chemical parameters were measured and benthic macroinvertebrates were collected. Principal component analysis (PCA) was applied to explore environmental variability in terms of physico-chemical parameters. The water quality of the basin was assessed by means of different biotic indices. Correlation analyses were performed between the biotic indices and the physicochemical parameters. Altitude, NaCl, total dissolved solids (TDS) and electrical conductivity were higher at the Puna and Monte sites, while river discharge, width and depth were higher at the Yungas sites. Biotic indices suggested good water quality. The BMWP (Biomonitoring Working Party) and family richness were the most suitable indices to simultaneously compare the rivers of the different ecoregions. The change in the composition of macroinvertebrate assemblages was observed at an altitude of 1500 m a. s. l., separating arid and humid zones and coinciding with inflection points of conductivity, NaCl and TDS.

P-051: Inferior outcomes for Multiple Myeloma (MM) patients (pts) harbouring t(11;14) and the promise of venetoclax, real-world Australian retrospective

<h3>Background</h3> Traditionally, MM harbouring t(11;14) is considered standard risk disease. In the era of novel therapies however, pts with t(11;14) are reported to have inferior outcomes to other standard risk pts. Evidence of response to the BCL-2 inhibitor, Venetoclax (Ven), has further increased interest in understanding outcomes of t(11;14) pts. Here we aim to describe the historical outcomes of t(11;14) MM and response to Ven in a real-world cohort of Australian pts. <h3>Methods</h3> This was a retrospective, multicentre study conducted by members of the Australasian Leukaemia and Lymphoma Group, Myeloma Working Party. Cases were identified by interrogation of cytogenetics/FISH database from 2010 to 2019 inclusive. Baseline patient and disease characteristics, treatment exposure and outcomes were extracted from hospital medical records. Descriptive statistics, and survival analyses were performed as appropriate. <h3>Results</h3> Seventy-four pts [median age 65 years (yrs), range (43-85)] were identified across seven centres. 43% pts had ISS Stage III MM with 88% harbouring additional cytogenetic abnormalities, incl. 13% with gain in 1q and 12% with del(17p). The majority (81%) of pts received proteasome inhibitor (PI)-based 1st line therapy with 60% having an upfront autologous stem cell transplant (ASCT) and 54% having immunomodulatory drug (IMiD)-based maintenance therapy. Two patients received an allogeneic stem cell transplant after ASCT. The overall response rate (ORR) was 86% with 38% achieving very good partial response (VGPR) or better. The median progression free survival-1 (PFS1) was 1.91 yrs (95% CI 1.73-2.56) [PI-based, n=60, PFS 1.84yrs (95% CI 1.61-2.41) vs IMiD-based, n=5, PFS 4.58yrs (95% CI 1.16-5.51), HR 0.68 p=0.45] The median overall survival (OS) was 5.35 yrs (95% CI 4.12-6.56). Second and third line therapy was predominantly IMiD-based with recent introduction of anti-CD38 monoclonal antibodies (mAbs). Median PFS-2 was 0.77 yrs (95% CI 0.39-0.98) while median PFS-3 was 0.65 yrs (95% CI 0.34-1.16). Eleven pts (median 3 prior lines of therapy) were given Ven [Six pts in combination with PI, three with PI and mAbs and two with dexamethasone]. ORR to Ven was 55% with 45% ≥ VGPR. Median PFS with Ven was 0.54 yrs (85% CI 0.05-2.17). Median PFS for patients with 1-4 lines (n=6) was 1.22 years and median PFS for patients with 5 lines or more (n=5) was 0.54 years, HR 0.56 (95% CI 0.12-2.5). <h3>Conclusion</h3> For pts harbouring t(11;14), the duration of response to PI-based 1st line therapy is suboptimal even with the use of ASCT consolidation in the majority of patients. Despite multiple prior lines of therapy, Venetoclax shows promising results and every effort should be made for early identification of this cytogenetic lesion. Further studies are required to examine the impact of novel triplet and quadruplet combination therapy and use of venetoclax early in the disease course of this sub-group of patients.

Evaluación de la calidad del agua a lo largo de una cuenca heterogénea (Río Grande, Jujuy, Argentina)

The aim of this work is to evaluate the ecological quality of waters along an environmentally heterogeneous basin, using macroinvertebrate biotic indices (BI). Twelve sampling sites were selected in the Río Grande basin, following an altitudinal gradient across the Puna, Monte and Yungas ecoregions. Sampling was conducted in the dry and rainy seasons, during three consecutive years (2012 to 2014). At each site, physico-chemical parameters were measured and benthic macroinvertebrates were collected. Principal component analysis (PCA) was applied to explore environmental variability in terms of physico-chemical parameters. The water quality of the basin was assessed by means of different biotic indices. Correlation analyses were performed between the biotic indices and the physicochemical parameters. Altitude, NaCl, total dissolved solids (TDS) and electrical conductivity were higher at the Puna and Monte sites, while river discharge, width and depth were higher at the Yungas sites. Biotic indices suggested good water quality. The BMWP (Biomonitoring Working Party) and family richness were the most suitable indices to simultaneously compare the rivers of the different ecoregions. The change in the composition of macroinvertebrate assemblages was observed at an altitude of 1500 m a. s. l., separating arid and humid zones and coinciding with inflection points of conductivity, NaCl and TDS.

Mental health and well-being of Aboriginal and Torres Strait Islander peoples in Australia during COVID-19.

In May 2020, an independent working party was convened to determine the mental health and well‐being needs of Aboriginal and Torres Strait Islander peoples in Australia, in response to COVID‐19. Thirty Aboriginal and Torres Strait Islander leaders and allies worked together in a two‐month virtual collaboration process. Here, we provide the working party's five key recommendations and highlight the evidence supporting these proposals. Aboriginal and Torres Strait Islander self‐determination and governance must be prioritised to manage the COVID‐19 recovery in Aboriginal and Torres Strait Islander communities. To mitigate long‐term social and economic impacts of COVID‐19 to Australian society, the historical underinvestment in Aboriginal and Torres Strait Islander peoples must be reconciled. Equitable, needs‐based funding is required to support strengths‐based, place‐based initiatives that address the determinants of health. This includes workforce and infrastructure development and effective evaluation. There is a clear, informed pathway to health and healing for Aboriginal and Torres Strait Islander peoples being enacted by Aboriginal and Torres Strait Islander leadership and community organisations; it remains to be seen how these recommendations will be implemented.

Benthic Macroinvertebrates as Ecological Indicators: Their Sensitivity to the Water Quality and Human Disturbances in a Tropical River

Macroinvertebrate metrics are helpful tools for the assessment of water quality and overall aquatic ecosystem health. However, their degree of sensitivity and the most reliable metrics for the bioassessment program development are very poorly studied in Togo. This study aimed to test the sensitivity of metrics calculated at the family and genus levels. A total of 21 water quality parameters and macroinvertebrates' data were collected during three periods at 20 sampling sites within the Zio River. The canonical correspondence analysis (CCA), factor analysis (FA), and Spearman's correlation analysis were conducted on water quality parameters and macroinvertebrates' data. The results reveal that macroinvertebrate structure and composition were affected by water quality parameters related to human disturbances. In this study, three groups of macroinvertebrate communities were identified including sensitive taxa such as Ephemeroptera, Plecoptera, Trichoptera, and Odonata (EPTO) taxa; the resistant or resilient taxa such as Oligochaeta, Hirudinea, Diptera, and Pulmonates (OHDP) taxa; and tolerant taxa such as Prosobranchia, Bivalvia, Lepidoptera, Heteroptera, and Coleoptera (PBLHC). All the 13 macroinvertebrate-based metrics were found to be sensitive in the detection of water quality and human disturbance gradients. However, metrics related to EPTO and the tolerance measure [multimetric index of the Zio River basin (MMIZB), Average Score per Taxon (ASPT), and Biological Monitoring Working Party (BMWP)] are the most robust in discrimination of pressure gradients. This study reveals that macroinvertebrates are sensitive and can be used for the bioassessment program development at the order, family, or genera taxonomic level.

Concordance of local guidelines with national guidelines on perioperative antibiotic and antiseptic prophylaxis in elective oral and maxillofacial surgery: A cross-sectional survey in the Netherlands

Local antibiotic guidelines should comply with national guidelines on perioperative antibiotic prophylaxis to adequately reduce surgical site infections in high-risk oral and maxillofacial (OMF) operations. To inform antibiotic committees on opportunities for improvement, a survey was sent to twenty-one OMF surgery departments in the Netherlands that performed more extensive OMF procedures. We determined (1) the local recommendations on perioperative antibiotic and antiseptic prophylaxis of sixteen elective OMF surgeries and (2) the local compliance with national guidelines. The response rate was 76.1%. Antibiotic prophylaxis was recommended in 78.8% of the OMF procedures and the regimens varied considerably between departments. Postoperative continuation of antibiotic prophylaxis was advised for 39.7% of the procedures and concerned 5–7 days in 81.0%. Antiseptic prophylaxis was recommended in 66.5% of the operations. The mean percentages of local recommendations that fully complied with the three national guidelines were 5.4% (range 0.0–55.6%) for the Dutch Working Party on Antibiotic Policy guideline, 27.7% (20.0–44.4%) for the 2018 guideline of the Dutch OMF Surgery Association (NVMKA) and 25.5% (16.7–44.4%) for the 2019 NVMKA guideline. In conclusion, deviation from national guidelines occurred frequently. Unification of the national guidelines in combination with guideline revisions are warranted, followed by better local implementation.

Karabal Çayı’nın (Gediz Nehri, Türkiye) Su Kalitesinin Değerlendirilmesi ve Kullanılan Endeks Performanslarının Karşılaştırılması

We used seven biotic indices to determine the water quality of Karabal Stream (Gediz River) in West Anatolia, Turkey. The indices were based on benthic macroinvertebrate and physicochemical parameters: Saprobi Index (SI), Biological Monitoring Working Party (BMWP), Average Score per Taxon (ASPT), Family Biotic Index (FBI), Belgian Biotic Index (BBI), EPT-Taxa [%] were used as biotic indices and Shannon-Weaver index (SWDI), Simpsons index (SDI) and Margalef index (MDI) for diversity. Ten taxonomic groups were found in Karabal Stream consisting of Crustacea, Oligochaeta, Gastrapoda, Ephemeroptera, Plecoptera, Trichoptera, Odonata, Coleoptera, Diptera, and Hemiptera. The water quality along the stream varied from good class in the upstream stations, to moderate in downstream stations according to the most suitable indices. According to canonic correspondence analysis (CCA), the distributions of Diptera, Oligochaeta, and Hemiptera species are positively correlated to EC, Cl, Turbidity, Temperature, NH4-N, NO2-N, and NO3-N while they are negatively correlated to DO, DOS and pH. The distributions of EPT species are positively correlated to DO, DOS and pH. According to Pearson’s correlation, the BBI, BMWP (Original), BMWP (Spanish), and EPT-Taxa [%] metrics were sufficient in the estimation of water quality in the examined watercourse. Considering studies in surface waters of Turkey, the BMWP and EPT-Taxa [%] indices reflect the water quality as correctly in all studies we examined, however, BBI did not always show reliable results. Therefore there is a need for the establishment of a Turkish Biotic Index which takes into account country-specific macroinvertebrates, their abundance, biology, and ecology.

Editorial introductions.

Editorial introductions.

Temporal Variability of Macroinvertebrate Assemblages in a Mediterranean Coastal Stream: Implications for Bioassessment.

Macroinvertebrates from a small forest stream in central-south Chile were sampled monthly from September 2017 to August 2018 to assess temporal variability in the assemblage and the effects of that variability on ecological indicators. Higher precipitation and flows occurred in winter months, and water quality varied among months. We collected 59 macroinvertebrate taxa, finding higher taxa richness and abundances in summer months than in winter months. Four taxa demonstrated marked seasonality, being abundant in some months and then decreasing in following months (Limnoperla jaffueli (Navás), Nousia maculata (Demoulin), Smicridea sp. (McLachlan), Chironomidae spp.). The scores of the family Hilsenhoff Biotic Index (HBI), Hilsenhoff Species-level Biotic Index (HSBI), Multimetric Macroinvertebrate Index (MMI), and Chilean Biological Monitoring Working Party (ChBMWP) index varied throughout the year reflecting natural variability. However, only HBI and HSBI scores were significantly different among seasons, ranging across three water quality classes (excellent, very good, and good), showing the lowest water classes in spring, coinciding with higher abundances of tolerant species. The MMI and ChBMWP indicated good and very good site conditions throughout the year, respectively. Shannon-Weaver diversity ranged between 2.59 (April) and 1.78 (February); however, Pielou evenness had high values throughout the year (> 0.62), except in February. Changes in macroinvertebrates composition throughout the year were explained primarily by discharge, water temperature, and conductivity. Our findings indicate that natural monthly variability in macroinvertebrate assemblages influences the scores of biological indices throughout the year. Therefore, we recommend that natural stream variability be accounted for in biomonitoring programs. We also emphasize the need to use caution when interpreting biological index scores to avoid misinterpretations in stream quality classification.

Design, implementation and evaluation of novel work-based clinical assessment tool: An e-portfolio with embedded Entrustable Professional Activities

BackgroundA new concept in work-based assessment, Entrustable Professional Activities (EPAs) describe key activities a work-ready practitioner can perform independently. EPAs are widely used in medicine to support competency-based education and are gaining acceptance in other professions such as nursing, pharmacy and dietetics. There is currently no widely accepted work-based assessment tool for student clinical placement assessment in dietetics and EPAs offer potential to address this gap. ObjectivesTo design, implement and evaluate a work-based assessment tool using EPAs embedded in an e-portfolio for use in clinical dietetics. SettingAn accredited dietetic training program in Australian university and affiliated metropolitan and rural hospitals. ParticipantsThree consecutive cohorts of final year dietetic students (n = 126) and their professional placement supervisors (n = 101). MethodsA working party consisting of dietetic academics with experience in clinical dietetics and education developed clinical dietetic EPAs and milestones that were mapped to the National Competency Standards for Dietitians in Australia. A design model incorporating multiple rounds of user feedback was used to create an e-portfolio with the EPAs embedded. Students and supervisors were invited to complete anonymous on-line surveys with Likert responses (1 = highly dissatisfied, 5 = highly satisfied) to evaluate the face validity, acceptability and feasibility of the tool. ResultsA total of 37 EPAs were developed with an accompanying four-point entrustment scale to measure performance. Evaluation survey response rates were high and ranged from 35 to 45% for students and 57-83% for supervisors across the study period. Both students and supervisors evaluated the tool positively with a mean overall satisfaction of 4.12 ± 0.69 and 4.03 ± 0.68, respectively. Survey items evaluating face validity, feasibility and acceptability scored >3.75 for both groups of users. ConclusionsThe EPA based e-portfolio demonstrated face validity, feasibility and acceptability and offers potential for a widely accepted tool for work-based assessment of clinical dietetic students.

Immune tolerance induction in severe haemophilia A: A UKHCDO inhibitor and paediatric working party consensus update.

In good risk patients (historic inhibitor peak<200BU), the International Immune Tolerance Study demonstrated equal efficacy to induce tolerance between high (200iu/kg/day) and low dose (50iu/kg ×3 times/week) immune tolerance induction (ITI) regimens. However, the trial stopped early on account of the excessive bleed rate in the low dose ITI arm. United Kingdom Haemophilia Centre Doctors' Organization (UKHCDO) Paediatric and Inhibitor working parties considered available ITI data alongside the bi-phenotypic antibody emicizumab (Hemlibra®) efficacy and safety data to develop a consensus guideline for the future UK ITI guideline. This revision of UKHCDO ITI guidance incorporates the recommendation to use emicizumab as a prophylaxis haemostatic agent to reduce bleeding rates and to facilitate low dose and reduced frequency of FVIII CFC for ITI in the majority of children. This consensus protocol will facilitate future evaluation of ITI outcomes in the evolving landscape of haemophilia therapeutics and ITI strategies.

How to Improve Prognostication in Acute Myeloid Leukemia with CBFB-MYH11 Fusion Transcript: Focus on the Role of Molecular Measurable Residual Disease (MRD) Monitoring.

Acute myeloid leukemia (AML) carrying inv(16)/t(16;16), resulting in fusion transcript CBFB-MYH11, belongs to the favorable-risk category. However, even if most patients obtain morphological complete remission after induction, approximately 30% of cases eventually relapse. While well-established clinical features and concomitant cytogenetic/molecular lesions have been recognized to be relevant to predict prognosis at disease onset, the independent prognostic impact of measurable residual disease (MRD) monitoring by quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR), mainly in predicting relapse, actually supersedes other prognostic factors. Although the ELN Working Party recently indicated that patients affected with CBFB-MYH11 AML should have MRD assessment at informative clinical timepoints, at least after two cycles of intensive chemotherapy and after the end of treatment, several controversies could be raised, especially on the frequency of subsequent serial monitoring, the most significant MRD thresholds (most commonly 0.1%) and on the best source to be analyzed, namely, bone marrow or peripheral blood samples. Moreover, persisting low-level MRD positivity at the end of treatment is relatively common and not predictive of relapse, provided that transcript levels remain stably below specific thresholds. Rising MRD levels suggestive of molecular relapse/progression should thus be confirmed in subsequent samples. Further prospective studies would be required to optimize post-remission monitoring and to define effective MRD-based therapeutic strategies.

Introduction to Diagnostics Standards

Introduction to Diagnostics Standards

The dynamics in applied COVID-19 pharmacotherapy and the influence of national guidance in The Netherlands: a quantitative and qualitative study

ObjectiveAt the beginning of the COVID-19 pandemic in the Netherlands, the Dutch Working Party on Antibiotic Policy constructed an advisory document about off-label drug treatment options that was regularly updated...

Prognostic Factors and Response to the Hypomethylating Agents in Hypocellular Myelodysplastic Syndromes: A Retrospective Study from the Korean Society of Hematology AML/MDS Working Party

Introduction: Hypocellular myelodysplastic syndrome (h-MDS) comprised approximately 10-20% of total MDS cases. The difference in clinical features and prognosis between h-MDS and normo/hypercellular MDS (NH-MDS) remains uncertain and the treatment strategy of h-MDS patients has not been well-defined in epigenetic therapy era. Therefore, we conducted this study to define the prognostic factors and response to the hypomethylating agents (HMA) for Korean h-MDS patients.Methods: We collected clinical and laboratory data from web-based Korean MDS registry (www.mdsregistry.or.kr). A total of 1976 evaluable MDS patients, who were diagnosed between the years 1993 and 2014, form 23 Korean hospitals were registered in Korean MDS Registry. Hypocellularity was defined as less than 30% of cellularity in patients <70 years, and <20% in patients 70 years or older in the bone marrow biopsy specimens.Results: We identified 358 (18.1%) h-MDS patients among 1976 evaluable MDS patients. Gender, performance status, Hemoglobin, platelet counts, prior transfusion and bone marrow blast percentage did not differ between h-MDS and NH-MDS patients. However, h-MDS patients were younger (median 59.8 years vs 63.4 years, p=0.002), more neutropenic (median ANC 0.9x109/L vs. 1.14x109/L, p=0.000), with lower level of LDH (median 357 unit/L vs. 386 unit/L, p=0.041).There was no difference in overall survival (OS) between the h-MDS and the NH-MDS patients (110.9 months vs. 71.8 months, P=0.174) and 9% of h-MDS patients and 15.1% NH-MDS patients transformed to acute leukemia (p=0.075).The IPSS and IPSS-R were able to identify different risk groups within each group and were not significantly different between the groups. Based on IPSS-R, the overall survival for h-MDS patients were very low, low, intermediate, high and very high in 115.4, 110.9, Not reached, 30.5 and 29.8 months, respectively. The IPSS-R was a lesser ability to predict OS for h-MDS patients. Of the 358 h-MDS patients, 141 h-MDS patients were treated with HMA (60.3% azacitidine and 39.7% decitabine). The median OS after the treatment of HMA was 31.4 months and 32 months for h-MDS and NH-MDS patients (p=0.909) and leukemic transformation rate at 3 years was 24.1% and 27.6%, respectively (p=0.224).At univariate analysis to define prognostic factors in h-MDS, the factors associated with a poor overall survival were age (≥70), poor performance status, low albumin (<4.0g/dL), anemia (<10g/dL), neutropenia (<0.8x109/L), prior transfusion and high LDH (≥600IU/L). Using the Cox proportional hazard regression model, older age, neutropenia, low albumin and prior transfusion were independent prognostic indicators. Based on those independent factors, h-MDS patients were divided into 3 risk groups and it discriminated 3 discreet groups with distinct survival rates (median OS, 150.2 vs. 46.9 vs.21.5 months, p<0.0001).Conclusions: h-MDS had similar clinical features and survival compared to NH-MDS and response to HMA treatment was not different. However, IPSS-R was less powerful in detecting difference for h-MDS and h-MDS patients had a different pattern from those of NH-MDS regarding prognostic factors. Further study and validation are warranted to stratify the risk of h-MDS patients. DisclosuresNo relevant conflicts of interest to declare.