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Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to Coronavirus disease 2019 (COVID-19) due to age, disease, and treatment-related immunosuppression. We aimed to assess risk factors of outcome and elucidate the impact of CLL-directed treatments on the course of COVID-19. We conducted a retrospective, international study, collectively including 941 patients with CLL and confirmed COVID-19. Data from the beginning of the pandemic until March 16, 2021, were collected from 91 centers. The risk factors of case fatality rate (CFR), disease severity, and overall survival (OS) were investigated. OS analysis was restricted to patients with severe COVID-19 (definition: hospitalization with need of oxygen or admission into an intensive care unit). CFR in patients with severe COVID-19 was 38.4%. OS was inferior for patients in all treatment categories compared to untreated (p

PURPOSE To prospectively validate the use of a simplified geriatric assessment (sGA) at diagnosis and to integrate it into a prognostic score for older patients with diffuse large B-cell lymphoma (DLBCL). METHODS We conducted the prospective Elderly Project study on patients with DLBCL older than 64 years who underwent our Fondazione Italiana Linfomi original geriatric assessment (oGA) (age, Cumulative Illness Rating Scale for Geriatrics, activities of daily living, and instrumental activities of daily living) before treatment. Treatment choice was left to the physician's discretion. The primary end point was overall survival (OS) (ClinicalTrials.gov identifier: NCT02364050 ). RESULTS We analyzed 1,163 patients (median age 76 years), with a 3-year OS of 65% (95% CI, 62 to 68). Because at multivariate analysis on oGA, age > 80 years retained an independent correlation with OS, we also developed a new, simplified version of the GA (sGA) that classifies patients as fit (55%), unfit (28%), and frail (18%) with significantly different 3-year OS of 75%, 58%, and 43%, respectively. The sGA groups, International Prognostic Index, and hemoglobin levels were independent predictors of OS and were used to build the Elderly Prognostic Index (EPI). Three risk groups were identified: low (23%), intermediate (48%), and high (29%), with an estimated 3-year OS of 87% (95% CI, 81 to 91), 69% (95% CI, 63 to 73), and 42% (95% CI, 36 to 49), respectively. The EPI was validated using an independent external series of 328 cases. CONCLUSION The Elderly Project validates sGA as an objective tool to assess fitness status and defines the new EPI to predict OS of older patients with DLBCL.

This chapter argues that, if France has been the home of administrative courts, Austria has greatly contributed to the development of administrative law with regard to administrative procedure. Thanks to the Austrian Administrative Court, established in 1875, administrative law has been increasingly important in the regulation of public affairs. The chapter analyses the causes, development, and effects of these features. One main theme is, of course, the scope and purpose of judicial review of administrative action. In this respect, the chapter shows the growth of litigation and the liberal approach followed by the Court. Moreover, the role of the Court as lawmaker is examined in the light of the general principles of law that it developed. . Such principles included legality and procedural fairness, with particular regard to the right to a hearing and the duty to give reasons. Considered as a whole, they required public administrations to act reasonably rather than arbitrarily. Finally, it was judge-made law that constituted the basis for the codification of 1925.

Enlarging melanocytic lesions with peripheral globular pattern (EMLPGP) are a pitfall in dermoscopy. Our aim was to evaluate the meaning of EMLPGP and to assess the use of dermoscopy and reflectance confocal microscopy (RCM) in order to improve the clinical management of this subtype of melanocytic lesions.A total of 135 EMLPGP were recruited and, accordingly to the dermoscopy features, were removed; later, an expert dermoscopist reviewed the lesions blinded to histology. Moreover, a subgroup of 63 lesions who underwent also to RCM, were reviewed by an expert confocalist.Patients had a median age of 41 years old and a female prevalence (61.5%). The main anatomic site was the trunk (86%). Histology of the 135 excised EMLPGP disclosed 116 nevi (86%; P0.0001) and 19 melanomas (14%). On dermoscopy, statistical significance was detected for small globules that were observed in 106 cases (78.5%; P0.0001), while globules distribution and color did not impact the diagnosis prediction, as well as age, sex or any other patient profile. Considering the RCM, atypical cytology and irregular architecture were detected in 100% of melanomas (P0.0001).Our study shows that EMLPGPs are detectable in every age and can be a pitfall in especially in high risk patients with an over-excision of lesions. The presence of peripheral globules should be evaluated considering the overall dermoscopic features. RCM can contribute significantly in the management of lesions trough the detection of cyto-architectural atypia. Therefore, RCM in combination with dermoscopy can optimize the reduction of harmless lesions.

The decision of the Bundesverfassungsgericht of May 5th 2020 on ECB has already been criticized from different point of views. The majority of the critics are focused on the institutional consequences of the judgment. This article aims at highlighting some intrinsic contradictions of the decision that make it unsustainable. The inconsistencies regard various profiles: the addressee of the decision, the definition of the CJEU ruling as an ultra-vires judgment, the nature of the functions of ECB, the denied repercussions on the Purchase Program related to the Coronavirus crisis. Finally, the article tries to draw some hypotheses about what the reactions and the consequences of this decision might be.

Chronic lymphocytic leukemia (CLL) is a disease of the elderly, characterized by immunodeficiency. Hence, patients with CLL might be considered more susceptible to severe complications from COVID-19. We undertook this retrospective international multicenter study to characterize the course of COVID-19 in patients with CLL and identify potential predictors of outcome. Of 190 patients with CLL and confirmed COVID-19 diagnosed between 28/03/2020 and 22/05/2020, 151 (79%) presented with severe COVID-19 (need of oxygen and/or intensive care admission). Severe COVID-19 was associated with more advanced age (≥65 years) (odds ratio 3.72 [95% CI 1.79–7.71]). Only 60 patients (39.7%) with severe COVID-19 were receiving or had recent (≤12 months) treatment for CLL at the time of COVID-19 versus 30/39 (76.9%) patients with mild disease. Hospitalization rate for severe COVID-19 was lower (p < 0.05) for patients on ibrutinib versus those on other regimens or off treatment. Of 151 patients with severe disease, 55 (36.4%) succumbed versus only 1/38 (2.6%) with mild disease; age and comorbidities did not impact on mortality. In CLL, (1) COVID-19 severity increases with age; (2) antileukemic treatment (particularly BTK inhibitors) appears to exert a protective effect; (3) age and comorbidities did not impact on mortality, alluding to a relevant role of CLL and immunodeficiency.

Background Phthalates, potential endocrine disruptors added to plastics, are found in numerous products and contaminate many environmental matrices, resulting in a widespread human exposure virtually interfering with fetal and neonatal development. This study aims to evaluate, by repeated mothers and children urine monitoring, the exposure to phthalates in newborns and to investigate its potential effects in early life. Methods A cohort study, recruiting mothers and newborns at an Italian hospital, is ongoing. Prenatal exposure is assessed by measuring 6 phthalates in maternal and neonatal urine; while postnatal exposure is assessed in the infants urines at 3rd and 6th month. Infants undergo periodic visits (t0, t3, t6, t12, t24) to assess growth, neurocognitive development and urinary sex hormone levels; mothers fill in exposure questionnaires at t0 and t6. Results To date, 148 mother-child couples have been enrolled, 74 children checked at t3 and 35 at t6. The newborns (3.4±0.3kg weight, 50.2±1.7cm length), show physiological hormonal levels: LH 0.6±1.8mIU/ml; FSH 1.5±1.6mIU/ml, testosterone 10.3±4.8ng/ml, estradiol 843.9±972.4pg/ml. Phthalates appear highly widespread both in mothers and infants, although at low levels. MEP shows the highest levels (mothers: 37.3±83.2µg/L; infants: 19.6±32.8µg/L), followed by MnBP (mothers: 11.3±14.4µg/L; infants: 21.3±25.5µg/L) and MBzP (mothers: 3.9±3.9µg/L; infants: 8.1±9.8µg/L). All mothers report frequent contact with products potentially containing phthalates, however mother-child couples levels showed very low correlations. Conclusions Exposure to phthalates for infants appears widespread, albeit at low levels. Neonatal urine biomonitoring is a valid tool to evaluate child exposure, able to produce more accurate information than maternal urine. Key messages Biomonitoring of childhood urine produces accurate data on pre and postnatal exposure to phthalates. Biomonitoring of childhood urinary phthalates can enhance the assessment of their potential effects on growth and development.

As part of the research into the administrative procedures of the European Union, this study is aimed at developing a case study analysis that allows the highlighting of any inconsistencies or unequal treatment in adjudication procedures in tax matters. This sector, often overlooked by scholars of public law, instead appears to be particularly interesting and fruitful for the investigation that we intend to carry out, since it has always represented a field of choice for the tricky balance between the requirements of taxation and the protection of the freedoms and rights of the individual

We analyzed 160 young Waldenström Macroglobulinemia (WM) patients with a median age of 49 years (range 23-55 years), diagnosed between January 2000 and January 2019 in 14 Italian centers. At diagnosis, 70% of patients were asymptomatic. With a median follow-up of 5.6 years, 57% have been treated. As initial therapy 79% of patients received chemo-immunotherapy, 13% a chemo-free induction and 8% chemotherapy only. At relapse or progression, 6% underwent an autologous stem cell transplantation. Overall, 19% of patients received ibrutinib during the course of the disease. According to IPSSWM, 63% were classified as low risk, 27% as intermediate risk and 10% as high risk. Five-year OS was shorter in high-risk as compared with low or intermediate risk patients (92.9% vs 100% P = .002). According to revised IPSSWM, 92% were classified as very low or low risk and 8% as intermediate risk, with a shorter 5-year OS in the latter group (87.5% vs 100%, P = .028). The OS of young WM patients was not significantly reduced as compared with age-matched, sex-matched and calendar year-matched general population. Early diagnosis, absence of high-risk features in symptomatic patients and high efficacy of modern treatments are the main determinants of the excellent outcome of young WM patients.

BACKGROUND: Cutaneous involvement in Hodgkin lymphoma (HL) is a rare finding. Few cases have been reported in literature, most describing paraneoplastic manifestations. Only very few papers have described primary HL skin infiltration, reporting a wide range of clinical presentations that frequently include ulcers; plaques, nodules and papules have also been noticed. CASE SUMMARY: We report the case of a 56-year-old man who presented fever, multiple adenomegalies of neck and axilla and thick serpiginous skin lesions involving bilateral pectoral regions. After an initial diagnostic workup for a suspected active infectious disease, a lymph node biopsy was performed, which showed a neoplastic invasion from a mixed cellularity classical HL. The same histological pattern was described in a cutaneous biopsy of the chest lesions. The other staging procedures performed revealed an advanced disease, with unfavourable clinical prognostic features. The patient was prescribed 6 cycles of ABVD chemotherapy scheme (doxorubicin, bleomycin, vinblastine, dacarbazine), a regiment that requires demonstration of metabolic response achievement at the interim PET/CT scan to confirm continuation or to change therapeutic strategy. CONCLUSION: Skin involvement in HL is a rare finding and may represent a challenging clinical presentation due to extremely various types of lesions observed.

International audience; Background: International guidelines suggest hepatitis C virus (HCV) eradication by direct-acting antivirals (DAAs) after first-line immunochemotherapy (I-CT) in patients with HCV-positive diffuse large B-cell lymphoma (DLBCL), although limited experiences substantiate this recommendation. Moreover, only a few data concerning concurrent administration of DAAs with I-CT have been reported.Subjects, materials, and methods: We analyzed hematological and virological outcome and survival of 47 consecutive patients with HCV-positive DLBCL treated at 23 Italian and French centers with DAAs either concurrently (concurrent cohort [ConC]: n = 9) or subsequently (sequential cohort [SeqC]: n = 38) to first-line I-CT (mainly rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP]-like).Results: Median age was 61 years, 89% of patients had stage III/IV, and 25% presented evidence of cirrhosis. Genotype was 1 in 56% and 2 in 34% of cases. Overall, 46 of 47 patients obtained complete response to I-CT. All patients received appropriate DAAs according to genotype, mainly sofosbuvir-based regimens (n = 45). Overall, 45 patients (96%) achieved sustained virological response, 8 of 9 in ConC and 37 of 38 in SeqC. DAAs were well tolerated, with only 11 patients experiencing grade 1-2 adverse events. Twenty-three patients experienced hepatic toxicity (grade 3-4 in seven) following I-CT in SeqC, compared to only one patient in ConC. At a median follow-up of 2.8 years, two patients died (2-year overall survival, 97.4%) and three progressed (2-year progression-free survival, 93.1%).Conclusion: Excellent outcome of this cohort of HCV-positive DLBCL suggests benefit of HCV eradication by DAAs either after or during I-CT. Moreover, concurrent DAAs and R-CHOP administration appeared feasible, effective, and ideally preferable to deferred administration of DAAs for the prevention of hepatic toxicity.Implications for practice: Hepatitis C virus (HCV)-associated diffuse large B-cell lymphomas (DLBCLs) represent a great therapeutic challenge, especially in terms of hepatic toxicity during immune-chemotherapy (I-CT) and long-term hepatic complications. The advent of highly effective and toxicity-free direct-acting antivirals (DAAs) created an exciting opportunity to easily eradicate HCV shortly after or in concomitance with first-line immunochemotherapy (usually R-CHOP). This retrospective international study reports the real-life use of the combination of these two therapeutic modalities either in the concurrent or sequential approach (DAAs after I-CT) in 47 patients. The favorable reported results on long-term outcome seem to support the eradication of HCV with DAAs in all patients with HCV-positive DLBCL. Moreover, the results from the concurrent approach were effective and safe and displayed an advantage in preventing hepatic toxicity during I-CT.

This paper provides a case-study analysis that allows the highlighting of any inconsistencies or unequal treatment in adjudication procedures in tax matters, a sector particularly interesting and fruitful for an investigation concerning the tricky balance between the requirements of taxation and the protection of the freedoms and rights of the individual. First of all, tax is not a subject of harmonisation, so the procedural autonomy of the states is even more marked insofar as it is grafted on to a standardisation that varies greatly between the various states. Moreover, in this case European law interfaces with a traditional sort of administration rather than with a national regulatory authority. The methodology used is inductive, starting from an empirical analysis which considers both normative data, and a number of important and recent judgments of the Court of Justice, selected using the criterion of the invoked applicability of the right to be heard in disputes in tax matters. Both national proceedings in implementation of EU law, and composite proceedings in which tax administrations from various Member States intervene are included, in order to highlight any discrepancies related to the type of proceedings adopted.

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The purpose of this phase 2, multicenter study was to determine the activity and safety of nonpegylated liposomal doxorubicin as part of "R-COMP" combination in patients with diffuse large B-cell lymphoma and coexisting cardiac disorders. The study was conducted using a Bayesian continuing assessment method using complete remission rate and rate of cardiac events as study endpoints. Between November 2009 and October 2011, 50 evaluable patients were enrolled (median age, 76 years). Median baseline left ventricular ejection fraction (LVEF) was 60%. Ischemic cardiopathy was the most frequent preexisting cardiac disorder (35%), followed by atrial fibrillation (15%), left ventricular hypertrophy (13%), and baseline LVEF

The purpose of this paper is to identify the standards of judicial control over administrative activity developed by the Austrian Administrative Court between the late XIX and early XX centuries. This analysis will highlight the considerable development of administrative law as early as the end of the nineteenth century. Indeed, even at that time the Austrian Administrative Court had elaborated a series of principles for administrative action on the basis of which to carry out judicial review. For this purpose, the paper will analyze various emblematic cases decided by the Verwaltungsgerichtshof.

Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44% (95% CI, 39% to 49%) and 48% (95% CI, 43% to 53%), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95% CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95% CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83% (95% CI, 79% to 87%), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83% 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.

This study provides the dietary intakes of six trace elements (cadmium, chromium, copper, manganese, selenium and zinc), generally characterized by both nutritional and toxicological features depending on their exposure. Being diet the most relevant source of exposure to trace elements in non-professionally exposed subjects, we measured content of these trace elements in foods composing the typical Italian diet using inductively coupled plasma-mass spectrometry, and assessing dietary habits using a validated semi-quantitative food frequency questionnaire we eventually estimated dietary daily intake of trace elements in a Northern Italian community. In the 890 analyzed food samples, the main contributors to cadmium intake are cereals, vegetables and sweets, while cereals, beverages and vegetable are to primary source of manganese. The primary contributors for copper are cereals, fresh fruits and vegetables, while for chromium are beverages, cereals and meat. The main source of selenium intake are cereals and meat, followed by fish, seafood and milk and dairy products, while of zinc intake are meat, cereals, milk and dairy products. In our Italian population sample, the estimated median (interquartile range) dietary daily intakes are 5.00 (3.17-7.65), 56.70 (36.08-86.70) and 66.53 (40.04-101.32) μg/day for cadmium, chromium and selenium, and corresponding figures are 0.98 (0.61-1.49), 2.34 (1.46-3.52) and 8.50 (5.21-12.48) mg/day for copper, manganese and zinc. The estimated intakes are generally within the average intake reported in other European populations, and in such cases well above the daily dietary intakes recommended by national international agencies, avoiding the risk of excess or deficiency. The present estimated intake data can be used to examine a specific trace element of interest and would afford enhanced health protection from those trace elements characterized by both nutritional and toxicological effects.

Several studies have demonstrated the prognostic value of neutrophil‐lymphocyte ratio (NLR) in patients with solid tumors and non–Hodgkin lymphoma. In contrast, there is only sparse data on its prognostic role in patients with classical Hodgkin lymphoma (cHL). The aim of our study was to establish whether NLR could serve as an independent prognostic factor in a cohort of 990 patients with nodular sclerosis (NS)‐cHL. After analysis of the log hazard ratio (HR) as a function of NLR, we chose the value 6 as cutoff. Patients with NLR >6 had a worse progression‐free survival and overall survival compared to those with NLR ≤6; 84% vs 75% and 92% vs 88%, at 5 years, with an HR of 1.65 and 1.82, respectively. Multivariate analysis showed that the risk remained high with HR 1.44 and HR 1.54 in progression‐free survival and overall survival, respectively. In summary, our study shows that NLR is a robust and independent prognostic parameter in NS‐cHL, both in early and advanced disease. It is inexpensive and simple to apply. Thus, we conclude that NLR, possibly in combination with the international prognostic score and absolute monocyte count, is a useful guide for physicians treating NS‐cHL patients.

In this past decade, new therapeutic approaches based on the use of rituximab, high-dose cytosine-arabinoside, and autologous stem cell transplantation (ASCT) have changed the paradigm of mantle cell lymphoma (MCL) treatment, significantly improving the quality and duration of response and

Background/Objectives The clinical and dermoscopic differential diagnosis of flat pigmented facial lesions represents a great challenge for the clinicians. Our aim was to report a quantitative method based on dermoscopic features to better classify pigmented facial lesions. Methods This is a retrospective case-series study that analysed the dermoscopic features of 582 pigmented facial lesions. Results The individual patient probability of lentigo maligna (LM) was predicted by a multivariate model, with an accuracy of 0.72. According to the odds ratio at the multivariate analysis, an individual scoring index was assigned to each criterion, and a value of 4.56 was identified as optimal cut-off point. Up to a score of 2.5, the probability that a lesion is an LM is 0. The probability increases from 10 to 50% for a score ranging between 4.5 and 6. It is about 90% for a score of 7. Conclusion The optimal cut-off point obtained and the curve that identifies the probability of a patient having a LM could improve the classification and the management strategies of equivocal pigmented facial lesions.

Background Several studies have shown that professional drivers are at risk of developing work-related stress. Stress may be responsible for a variety of adverse effects and may also be associated with an increased number of accidents. Objective Perform an integrated, objective and subjective evaluation of work-related stress in bus drivers, that also considered the role of personality traits. Methods Salivary α-amylase and cortisol were measured in 42 bus drivers. Subjective stress evaluation was performed with the Perceived Stress Scale (PSS-10) and Driver Stress Inventory (DSI). To evaluate personality traits, we administered the Eysenck Personality Questionnaire-Revised (EPQ-R) and the Impulsivity Inventory (IVE). Results Salivary biomarkers showed no associations with PSS-10 and personality traits. Cortisol levels were positively correlated with fatigue (r = 0.44) at the middle of the work-shift and with aggression (r = 0.51) at the end of a day off. At the end of the work-shift, cortisol levels were negatively correlated with hazard monitoring (r = -0.37) and salivary α-amylase was positively correlated with thrill-seeking (r = 0.36). Neuroticism (β= 0.44) and impulsiveness (β= 0.38) were predictors of perceived stress by multiple regression. Conclusions An integrated method, considering both objective and subjective indicators, seems adequate to evaluate work-related stress in professional drivers. Personality traits are relevant in determining perception of stress.

Purpose The randomized HD2000 trial compared six cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine), four escalated plus two standard cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), and six cycles of COPP-EBV-CAD (cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxorubicin, vincristine, procarbazine, vinblastine, and bleomycin; CEC) in patients with advanced-stage Hodgkin lymphoma. After a median follow-up of 42 months, patients who received BEACOPP were reported to have experienced better progression-free survival (PFS) but not better overall survival (OS) results than those receiving ABVD. We here report a post hoc analysis of this trial after a median follow-up of 10 years. Patients and Methods Three hundred seven patients were enrolled, 295 of whom were evaluable. At the time of our analysis, the median follow-up for the entire group was 120 months (range, 4 to 169 months). Results The 10-year PFS results for the ABVD, BEACOPP, and CEC arms were 69%, 75%, and 76%, respectively; corresponding OS results were 85%, 84%, and 86%. Overall, 13 second malignancies were reported: one in the ABVD arm and six each in the BEACOPP and CEC arms. The cumulative risk of developing second malignancies at 10 years was 0.9%, 6.6%, and 6% with ABVD, BEACOPP, and CEC, respectively; the risk with either BEACOPP or CEC was significantly higher than that reported with ABVD (P = .027 and .02, respectively). Conclusion With these mature results, we confirm that patients with advanced Hodgkin lymphoma have similar OS results when treated with ABVD, BEACOPP, or CEC. However, with longer follow-up, we were not able to confirm the superiority of BEACOPP over ABVD in terms of PFS, mainly because of higher mortality rates resulting from second malignancies observed after treatment with BEACOPP and CEC.

Follicular lymphoma (FL) is the most common indolent B-cell lymphoma in western countries. Overall, 70% of patients achieve complete remission after first treatment.[1][1] However, it is characterized by a pattern of relapsing and remitting disease. The outcome of patients with FL has clearly

We present the final results of a Phase II study that evaluated safety and efficacy of lenalidomide in combination with rituximab in 39 patients with recurrent small lymphocytic lymphoma (N=18), marginal zone lymphoma (N=8), or lymphoplasmacytic lymphoma (N=13). Patients received oral doses of lenalidomide 20 mg once daily on days 1-21 and rituximab 375 mg/m2 on day 14 of each 28-day course. Patients received up to 6 courses. The overall response was 54%, with a complete response of 21%. At 2 years, progression free survival, duration of remission, and overall survival were 45%, 76%, and 78%, respectively. The evaluation of treatment response by histology showed an overall response rates of 75%, 46%, and 50%, in marginal zone, lymphoplasmacytic and small lymphocytic lymphoma, respectively. Histology-based estimates of remission durations at 2 years were 100%, 100%, and 51% for marginal zone, lymphoplasmacytic, and small lymphocytic lymphomas, respectively. A log rank test showed that the marginal zone and lymphoplasmacytic lymphoma curves were marginally significantly different from the small lymphocytic lymphoma curve. Our results demonstrated that patients with recurrent marginal zone and lymphoplasmacytic lymphomas that responded to the combination treatment had long-lasting responses. Of note, no other studies have published the effects of this combination treatment on patients with relapsed lymphoplasmacytic lymphoma. Our findings showed a mild, predictable, and manageable toxicity profile. Confirmation of these results in Phase III trials will facilitate moving towards a chemotherapy-free approach in the management of indolent non-Hodgkin lymphoma. ClinicalTrials.gov; Identifier: [NCT01830478][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01830478&atom=%2Fhaematol%2Fearly%2F2016%2F02%2F01%2Fhaematol.2015.139329.atom

Aims: To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. newgeneration zotarolimuseluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R. Methods and results: All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia crosssectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Sixmonth OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At sixmonth clinical followup, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group. Conclusions: In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at sixmonth OCT analysis.