scholarly journals High Progression-Free Survival (PFS) in Adult Double Unit Cord Blood (dCB) Transplant Recipients with High Risk Disease after a Novel Intermediate Intensity Conditioning Regimen

2016 ◽  
Vol 22 (3) ◽  
pp. S76-S77 ◽  
Author(s):  
Satyajit Kosuri ◽  
Patrick Hilden ◽  
Sean M. Devlin ◽  
Yeon Yoo ◽  
Emily Lauer ◽  
...  
Keyword(s):  
High Risk ◽  
Cord Blood ◽  
Conditioning Regimen ◽  
Progression Free Survival ◽  
Transplant Recipients ◽  
Free Survival ◽  
High Risk Disease

Outcome Depend On Age But Not Comorbidity Score, In Patients treated With Fludarabine and Busulfan (FB4) As Conditioning Regimen In Allogeneic Stem Cell Transplantation

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4533-4533
Author(s):  
Javier Nunez ◽  
Arancha Bermudez ◽  
Lucrecia Yanez ◽  
Guillermo Martin ◽  
Andres Insunza ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
High Risk ◽  
Conditioning Regimen ◽  
Progression Free Survival ◽  
Free Survival ◽  
Myeloid Neoplasms ◽  
High Risk Disease ◽  
Comorbidity Index

Introduction The best conditioning regimen in allogeneic stem cell transplantation (SCT) for myeloid malignancies is unknown. In the last decade, conditioning regimens based on busulfan (BU) and fludarabine (FLU) have shown a good security profile with low early toxicity and mortality but long term follow up is needed to confirm the efficacy in the disease control. Objective To analyze retrospectively the efficacy (overall survival OS, progression free survival PFS) of the conditioning regimen with FLU (40mgr/m2/4 days) and BU (3,2 mgr/kg once daily/4 days) in adult patients with myeloid neoplasms after SCT. Outcome was assessed considering age, comorbidity, disease, and donor. Patients and transplant characteristics Between 2006 and 2012, 90 patients (40 males, 50 females) underwent SCT conditioned with FB4 in our center. The median age of patients was 50 (24-74) years and 34 patients (37%) were older than 55 years. The diagnoses were 65 AML (11 secondary AML and 19 with adverse cytogenetic), 19 MDS (11 with IPSS high/intermediate 2) and 6 MPD (3 CML, 3 myelofibrosis). At time of SCT, 52 patients (80%) with AML were in first CR. High risk disease (secondary AML or with adverse cytogenetic and MDS with high/intermediate IPSS) were considered in 41 patients (45%). The HCT comorbidity index (Sorror) was low, intermediate or high in 20 (22%), 31 (34%) and 39 (43%) patients, respectively. Donor type was matched related in 42 patients (47%), matched unrelated in 30 patients (33%) and mismatched unrelated in 18 patients (20%). Stem cell source were bone marrow in 81 cases (90%). GvHD prophylaxis was done with calcineurin inhibitor associated with short course of methotrexatre or mycophenolate in all patients and Thymoglobulin was administered in 8 patients (9%). Results All patients but one engrafted. The median time to recovery >500 ANC/uL and >50000 platelets/uL was 16 days (range, 9-28) and 16 days (range, 11-455) respectively. Donor complete chimerism was achieved during first or second month in 90% cases. The incidence of acute GVHD grade II-IV and III-IV was 45% and 12% respectively. Chronic GvHD was diagnosed in 60 patients (68%) (26 mild, 18 moderate and 16 severe) and 22 patients (36%) had pulmonary affectation. Transplant related mortality at 100 days and 1 year was 5.5% and 15%. With a median follow up of 26 months (IQL 12-45), the estimated overall survival (OS) was 64% and progression free survival (PFS) was 61%. To be more than 55 years at time of SCT had a negative impact on survival (estimated OS at 40 months: 42% vs 75%, p=0.005). Neither HCT comorbidity index nor disease type had a significant influence on estimated OS at 40 months (70%, 62% and 58% in low, intermediate and high risk) and (64% in AML and 51% in MDS) respectively. However considering the group of high risk disease had worse OS (53% vs 78%, p=0.07). Although there was no significant difference, the OS in mismatched unrelated SCT was worse than matched unrelated and related SCT (40%, 63 % and 71%). Conclusion Conditioning regimen with fludarabine and busulfan (FB4) offers a good effectiveness in patients with myeloid neoplasms and allow the use of myeloablative regimen in patients with high risk disease and significant comorbidities. Only the age at time of SCT had a statically significant impact on overall survival. Disclosures: No relevant conflicts of interest to declare.

Medulloblastoma

2017 ◽  
Author(s):  
Kevin C De Braganca ◽  
Roger J Packer
Keyword(s):  
High Risk ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Free Survival ◽  
High Risk Disease ◽  
Poor Treatment ◽  
Short And Long Term ◽  
Standard Risk

Medulloblastoma is the most common malignant brain tumor in pediatric patients. Patients are presently stratified to either standard or high-risk groups based on clinical and pathologic criteria. Approximately 80% of patients with standard risk disease are cured of their primary disease. High-risk and recurrent disease groups have a poorer outcome; 5-year progression-free survival is only 65% with high-risk disease. Disease control after recurrence is very poor. Treatment is multimodal and also aims to limit short- and long-term toxicities. Recent identification of four molecular subtypes of medulloblastoma may change risk assignment and therapy. Addressing the medical and psychosocial issues of survivors continues to improve the quality of life for these patients beyond the disease’s treatment.

Randomized Phase II Multi-Center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan As Conditioning Therapy for Autologous Transplantation in Patients with Non-Hodgkin's Lymphoma: A Multicenter Study from Consortium for Improving Survival of Lymphoma (CISL)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3466-3466
Author(s):  
Kyoung Ha Kim ◽  
Lee Jae Hoon ◽  
Mark Lee ◽  
Kim Hoon-Gu ◽  
Young Rok Do ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Survival Rates ◽  
Conditioning Regimen ◽  
Progression Free Survival ◽  
High Dose ◽  
Free Survival

Abstract Background High dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard approach for relapsed or high risk non-Hodgkin's lymphoma (NHL). Several different high dose therapy (HDT) conditioning regimens have been used for NHL, such as BEAM(carustine, etoposide, cytosine arabinoside, melphalan), BEAC( carmustine, etoposide, cytosine arabinoside, cyclophosphamide), and CBV(cyclophosphamide, carmustine etoposide). Carmustine is an active drug in the HDT of NHL but the supply of carmustine is limited in some countries. Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies. We and CISL have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide conditioning regimen has been extensively utilized in ASCT for NHL. Therefore, based on the encouraging results, we conducted a randomized phase II multicenter trial of busulfan/etoposide/cyclophosphamide (BCT) versus busulfan/etoposide/ melphalan/ (BMT) as conditioning therapy for ASCT in patients with NHL. Methods Patients with chemosensitive high risk NHL or relapsed or primary refractory NHL underwent high dose chemotherapy at 16 centers in Korea. Patients were randomly assigned to receive BCT conditioning chemotherapy or BMT conditioning chemotherapy. BCT regimen consisted of iv busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, etoposide 400mg/m2 day i.v. on days -5 and -4 and cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 and BMT regimen were iv busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, etoposide 400mg/m2 day i.v. on days -5 and -4 and melphalan 50mg/m2/day i.v. on days -3 and -2. The primary efficacy end points were 2 year progression free survival. Results Seventy five patients were enrolled onto the study. Patients randomly assigned to the BCT group (39 patients) or the BMT group (36 patients). Main subgroups were DLBCL (n=42, 56%) and T cell lymphoma (n=27, 36%). Thirteen patients (33.3%) in the BCT group and 11 patients (30.5%) in the BMT group had disease progression or died. 2 year progression free survival rate was 62.5% in the BCT group and 63.1% in the BMT group (p=0.924) (Fig 1). There was no treatment related mortality. Conclusions No significant differences were observed in progression free survival between BCT group and BMT group. Accordingly, busulfan based conditioning regimen may be regarded as an important treatment option to substitute for BEAM regimen. Further, considering R-CHOP or CHOP regimes are standard induction regimens, BMT conditioning will be good alternative to patients who can't be used cyclophosphamide. Figure PFS after autologous stem cell transplantation. Survival rates among all patient who underwent randomiazation Figure. PFS after autologous stem cell transplantation. Survival rates among all patient who underwent randomiazation Disclosures Kim: Celltrion, Inc.: Consultancy, Honoraria.

scholarly journals Fludarabine, Melphalan, and Alemtuzumab Conditioning in Adults With Standard-Risk Advanced Acute Myeloid Leukemia and Myelodysplastic Syndrome

2005 ◽  
Vol 23 (24) ◽  
pp. 5728-5738 ◽  
Author(s):  
Koen van Besien ◽  
A. Artz ◽  
S. Smith ◽  
D. Cao ◽  
S. Rich ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Myelodysplastic Syndrome ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Progression Free Survival ◽  
Free Survival ◽  
High Risk Disease ◽  
Standard Risk ◽  
Acute Myeloid

Purpose This prospective phase II study evaluated toxicity, relapse rate, progression-free survival, and overall survival after allogeneic transplantation and conditioning with fludarabine, melphalan, and alemtuzumab in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Patients and Methods Fifty-two consecutive adults with AML and MDS were enrolled onto the study. Median age was 52 years (range, 17 to 71 years) and the majority of patients had high-risk disease, comorbidities, and/or modest reduction in performance status. Fifty-six percent of patients had unrelated or mismatched related donors. Results After a median follow-up of 18 months (range, 2 to 34 months), 1-year survival was 48% (95% CI, 34% to 61%), progression-free survival was 38% (95% CI, 25% to 52%), relapse rate was 27% (95% CI, 15% to 40%), and treatment-related mortality was 33% (95% CI, 20% to 46%). The cumulative probability of extensive chronic graft-versus-host disease (GVHD) was only 18% (95% CI, 8% to 40%); extensive chronic GVHD was only observed in recipients of unrelated donor transplants. Performance score and disease status were the major predictors of outcome. High-risk disease (ie, active AML or MDS with > 5% blasts) or even modest decreases in performance status were associated with poor outcomes. Patients with standard-risk leukemia (first or second complete remission) or MDS (< 5% blasts) had excellent outcomes despite unfavorable disease characteristics. Conclusion Fludarabine and melphalan combined with in vivo alemtuzumab is a promising transplantation regimen for patients with AML or MDS and low tumor burden. For patients with active disease, this regimen provides at best modest palliation. Despite a low incidence of GVHD, transplantation is still associated with considerable nonrelapse mortality in patients with decreased performance status.

scholarly journals A Novel Epigenetic Machine Learning Model to Define Risk of Progression for Hepatocellular Carcinoma Patients

2021 ◽  
Vol 22 (3) ◽  
pp. 1075
Author(s):  
Luca Bedon ◽  
Michele Dal Bo ◽  
Monica Mossenta ◽  
Davide Busato ◽  
Giuseppe Toffoli ◽  
...  
Keyword(s):  
Machine Learning ◽  
Hepatocellular Carcinoma ◽  
High Risk ◽  
Progression Free Survival ◽  
Low Risk ◽  
Functional Enrichment ◽  
Free Survival ◽  
High Risk Patients ◽  
Risk Of Progression ◽  
Risk Patients

Although extensive advancements have been made in treatment against hepatocellular carcinoma (HCC), the prognosis of HCC patients remains unsatisfied. It is now clearly established that extensive epigenetic changes act as a driver in human tumors. This study exploits HCC epigenetic deregulation to define a novel prognostic model for monitoring the progression of HCC. We analyzed the genome-wide DNA methylation profile of 374 primary tumor specimens using the Illumina 450 K array data from The Cancer Genome Atlas. We initially used a novel combination of Machine Learning algorithms (Recursive Features Selection, Boruta) to capture early tumor progression features. The subsets of probes obtained were used to train and validate Random Forest models to predict a Progression Free Survival greater or less than 6 months. The model based on 34 epigenetic probes showed the best performance, scoring 0.80 accuracy and 0.51 Matthews Correlation Coefficient on testset. Then, we generated and validated a progression signature based on 4 methylation probes capable of stratifying HCC patients at high and low risk of progression. Survival analysis showed that high risk patients are characterized by a poorer progression free survival compared to low risk patients. Moreover, decision curve analysis confirmed the strength of this predictive tool over conventional clinical parameters. Functional enrichment analysis highlighted that high risk patients differentiated themselves by the upregulation of proliferative pathways. Ultimately, we propose the oncogenic MCM2 gene as a methylation-driven gene of which the representative epigenetic markers could serve both as predictive and prognostic markers. Briefly, our work provides several potential HCC progression epigenetic biomarkers as well as a new signature that may enhance patients surveillance and advances in personalized treatment.

scholarly journals RTID-05. INDIGO: A GLOBAL, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF VORASIDENIB (AG-881) VS PLACEBO IN PATIENTS WITH RESIDUAL/RECURRENT GRADE II GLIOMA WITH AN ISOCITRATE DEHYDROGENASE 1/2 (IDH1/2) MUTATION

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii194-ii194
Author(s):  
Ingo Mellinghoff ◽  
Martin van den Bent ◽  
Jennifer Clarke ◽  
Elizabeth Maher ◽  
Katherine Peters ◽  
...  
Keyword(s):  
High Risk ◽  
Dose Escalation ◽  
Objective Response ◽  
Data Monitoring Committee ◽  
Progression Free Survival ◽  
High Risk Population ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Grade Ii

Abstract BACKGROUND Low-grade gliomas (LGGs; WHO grade II) are incurable and ultimately progress to high-grade gliomas. The current treatment options are surgery followed by observation (“watch and wait”) for patients with lower risk for disease progression or postoperative chemoradiotherapy (high-risk population). There are no approved targeted therapies. IDH1 and IDH2 mutations (mIDH1/2) occur in approximately 80% and 4% of LGGs, respectively, and promote tumorigenesis via neomorphic production of D-2-hydroxyglutarate. Vorasidenib, an oral, potent, reversible, brain-penetrant pan-inhibitor of mIDH1/2, was evaluated in 76 patients with glioma in two phase 1 studies (dose escalation and perioperative) and was associated with a favorable safety profile at daily doses below 100 mg. Preliminary clinical activity was observed in non-enhancing glioma patients in both studies, with an objective response rate (ORR) of 18.2% and median progression-free survival of 31.4 months in the dose escalation study. METHODS Approximately 366 patients will be randomized 1:1 to vorasidenib (50 mg QD) or matched placebo and stratified by 1p19q status (intact vs co-deleted). Key eligibility criteria: age ≥ 12 years; grade II oligodendroglioma or astrocytoma (per WHO 2016 criteria) not in need of immediate treatment and without high-risk features; centrally confirmed mIDH1/2 status; ≥ 1 surgery for glioma with most recent ≥ 1 year but ≤ 5 years before randomization, and no other anticancer therapy; Karnofsky performance status ≥ 80%; and centrally confirmed measurable, non-enhancing disease evaluable by magnetic resonance imaging. Crossover from placebo to the vorasidenib arm is permitted upon centrally confirmed radiographic progression per RANO-LGG criteria. Primary endpoint: progression-free survival assessed by independent review. Secondary endpoints: safety and tolerability, tumor growth rate assessed by volume, ORR, overall survival, and quality of life. Clinical data will be reviewed regularly by an independent data monitoring committee. The study is currently enrolling patients in the US, with additional countries planned (NCT04164901).

eMonarcHER: A phase 3 study of abemaciclib plus standard adjuvant endocrine therapy in patients with HR+, HER2+, node-positive, high-risk early breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS596-TPS596
Author(s):  
Sara M. Tolaney ◽  
Lesley Fallowfield ◽  
Peter A. Kaufman ◽  
Eva M. Ciruelos ◽  
Mary Corona Gainford ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Primary Breast Tumor ◽  
Phase 3 ◽  
Free Survival ◽  
Node Positive ◽  
High Risk Disease ◽  
Definitive Surgery

TPS596 Background: Hormone receptor positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with high-risk characteristics has a high risk of disease recurrence. Novel therapeutic options for this population are urgently needed. Abemaciclib is an oral, selective, and potent CDK4 & 6 inhibitor administered on a continuous schedule which is approved for HR+, HER2- advanced BC (ABC) as monotherapy and in combination with endocrine therapy (ET). Abemaciclib combined with ET demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) in participants (pt) with HR+, HER2-, node-positive, high risk early breast cancer (EBC) and also clinical activity in HR+, HER2+ ABC. The eMonarcHER trial investigates whether abemaciclib plus ET will improve IDFS in pts with HR+, HER2+, node-positive, high risk EBC. Methods: eMonarcHER is a phase 3 global, randomized, double-blinded, placebo (PB)-controlled trial in participants with HR+, HER2+, node-positive, high risk EBC who have completed adjuvant HER2-targeted therapy (tx). Eligible participants are randomized 1:1 to receive either abemaciclib 150 mg twice daily or PB, plus standard ET. Study intervention period will be ≤26 cycles (approximately 2 years) followed by ≤8 years of ET as medically indicated. Participants must have undergone definitive surgery of the primary breast tumor and have high-risk disease. High-risk disease is defined as (i) detection of residual axillary nodal disease at the time of definitive surgery in participants with prior neoadjuvant (neoadj) tx; or (ii) in patients not receiving neoadj tx, must have either ≥4 pathologically positive axillary lymph nodes (pALNs), or 1-3 pathological pALNs and either: histologic Grade 2-3 and/or primary invasive tumor size ≥5 cm. Participants must have received either adjuvant pertuzumab plus trastuzumab with chemotherapy or adjuvant T-DM1. Stratification factors include treatment with neoadj tx, menopausal status, and region. The study is powered at approximately 80% to detect the superiority of abemaciclib plus ET over PB plus ET in terms of IDFS (as defined by the STEEP system) at a 1-sided α =.025 using a log-rank test. Assuming a hazard ratio of 0.73, this requires approximately 324 events at final IDFS analysis. Key secondary objectives include overall survival, distant relapse free survival, safety, pharmacokinetics, and patient-reported outcomes. The study is planned to start in March 2021. Approximately 525 centers in 23 countries plan to enroll ̃2450 participants. Clinical trial information: NCT04752332.

scholarly journals Overexpression of the OCT-1 Gene Is a Biomarker Associated with Poor Outcomes in Diffuse Large B-Cell Lymphoma (DLBCL) - Data from a Retrospective Cohort from Latin America: Defining a Very High-Risk Clinical-Molecular Subgroup

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 41-42
Author(s):  
Luis Alberto de Padua Covas Lage ◽  
Gisele Rodrigues Gouveia ◽  
Suzete Cleusa Ferreira ◽  
Sheila Aparecida Coelho de Siqueira ◽  
Abrahão Elias Hallack Neto ◽  
...  
Keyword(s):  
Gene Expression ◽  
High Risk ◽  
B Cell ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Prognostic Impact ◽  
Molecular Subgroup ◽  
Free Survival ◽  
Very High

Introduction: Diffuse large B-cell lymphoma (DLBCL) is the most frequent lymphoid malignancy, representing 30-40% of all non-Hodgkin's lymphomas (NHLs). They comprise a group of aggressive and heterogeneous neoplasms in terms of clinical presentation, response to therapy and prognosis. The OCT-1 gene is a member of the homodomain-POU family of transcriptional regulators of B-lymphoid differentiation. OCT-1 acts by controlling the expression of specific B-cell genes, such as BCL-2, a potent inhibitor of apoptosis that is essential for the differentiation of B-cells in the germinal center. These genes can be expressed in DLBCL, but the role of BCL-2 in its prognosis has been contradictory and the prognostic impact of the OCT-1 gene has not yet been tested in this lymphoma. Methods: In this observational, retrospective, single-center study, we investigated the prognostic impact of BCL-2 and OCT-1 gene expression in Brazilian patients with DLCBL treated with immunopolychemotherapy R-CHOP in a real-world context. The BCL-2 and OCT-1 genes were assessed in 78.5% (77/98) DLBCL patients, and the RNA for quantitative real-time PCR (qRT-PCR) was isolated from formalin-fixed and paraffin-embedded (FFPE) samples. The values obtained for gene expression were transformed into categorical variables according to their medians (6.27 for BCL-2 and 24.5 for OCT-1). The association between clinical and laboratory variables and results of gene expression was verified by the Fischer test. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Univariate analysis was performed using Cox's bivariate regression method and multivariate analysis using Cox multiple regression methodology. Results: The median age of the cohort was 54.5 years (15-84), 50% (49/98) were male, 49.4% (38/77) and 51.4% (40/77) showed expression of OCT-1 and BCL- 2 ≥ median, respectively. The clinical characteristics of the 98 Brazilian patients with DLBCL that comprised our cohort are summarized in Table 1. The overall response rate (ORR) in all patients was 68.4% (67/98), 65.3% (64/98) showed a complete response (CR), and 3.1% (3/98) showed partial response (PR), while 6.1% (6/98) were primary refractory. With a median follow-up of 3.77 years (95% CI: 3.2-4.1), the median overall survival (OS) was 5.43 years (95% CI: 2.2-NR) and the median progression-free survival (PFS) was 5.15 years (95% CI: 2.9-NR). The 5-year OS and PFS was 54.2% (42.2% -64.8%) and 52.0% (40.1-62.6%), respectively. In the univariate analysis OCT-1 ≥ median was associated with shortened OS (HR: 2.45, 95% CI: 1.21-4.96, p = 0.013) and PFS (HR: 2.27, 95% CI: 1.14-4.51, p = 0.019). Overexpression of BCL-2 was associated with worse PFS (HR: 2.00, 95% CI: 1.02-3.95, p = 0.043). Subgroup analysis showed that OCT-1 overexpression predominated in elderly individuals (≥ 60 years) in a statistically significant mode (29/38 cases - 76.3%, p = 0.029). It was also observed that overexpression of OCT-1 was associated with worse OS in the high-risk adjusted International Prognostic Index (aIPI) subgroup (p = 0.048) - Figure 1, and worse PFS in patients ≥ 60 years old (p = 0.025) - Figure 2. In the multivariate analysis, overexpression of OCT-1 was associated with poor PFS (HR: 2.22, 95% CI: 1.06-4.76, p = 0.035). Conclusion: In this study, we demonstrated that overexpression of the OCT-1 gene was an independent prognostic factor associated with adverse outcomes in Brazilian patients with DLCBL. We also show that in patients with unfavorable risk, such as the elderly and those with intermediate-high and high-risk IPI, overexpression of OCT-1 contributed to the identification of a very high-risk clinical-molecular subgroup, where the results with standard R-CHOP therapy are unsatisfactory, and they may benefit from intensified therapeutic strategies. Our results are preliminary and need to be validated in subsequent studies of prospective nature and with an expanded sample. Disclosures No relevant conflicts of interest to declare.

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