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Introduction: Autologous stem cell transplant (ASCT) remains the backbone therapeutic modality with the highest progression-free survival (PFS) and overall survival (OS) benefit even in the era of the novel agents in newly diagnosed multiple myeloma (NDMM). The survival post-transplant can be prolonged using maintenance therapies. The regimen with maximum benefit is still debated, with bortezomib showing PFS benefit even in the high-risk myeloma. Aims & Objectives: This randomized phase II trial is aimed at studying the efficacy (as measured by overall survival (OS), progression- free survival (PFS)), and safety of post-ASCT different maintenance regimens in patients with NDMM. Material(s) and Method(s): Multicentric open-label interventional study with randomized allocation, parallel assignment, with intention-totreat analysis. Recruitment was prospective starting 01 Jan 2017, including all NDMM patients eligible for the study. Remission status was evaluated at D100 and every 6 months for 2y post-ASCT, including MRD analysis by multicolor flow cytometry (MFC) and PET/CT. The four arms included (Arm-A) bortezomib alone (V), (Arm-B) bortezomib in combination with cyclophosphamide and dexamethasone (VCD), (Arm-C) bortezomib in combination with lenalidomide (VR), and (Arm-D) Lenalidomide starting D100 till 2y post-ASCT. Adverse events with CTACE grade<2 were defined as non-serious and the rest as serious. JMP ver. 13 was used for statistical analysis and p<0.05 was considered significant. Kaplan Meier statistics was used for survival analysis. Result(s): A total of 123 patients have enrolled of which 92 patients completed the study protocol and the rest 31 patients were excluded because of protocol deviation due to the COVID pandemic. The median age of the study population was 54.5y (35-76y) with a male preponderance (67%). There was no statistically significant difference between the four arms on the log-rank test in the OS (p-0.99), clinical PFS (p-0.65), biochemical PFS (p-0.6), or MFC-based PFS (p-0.83). There was a statistically significant difference between the four arms on the log-rank test (p-0.0185) on PET/CT-based PFS (PFS being in a descending order VCD>V>VR>R regimen). The all-cause mortality of the study participants was 19.57% (n-18) and the difference in deaths among the various groups was not statistically significant (p-0.85). The tolerability, serious and non-serious adverse were significantly higher amongst Arm D patients. Conclusion(s): We conclude that there was no difference in OS between the different regimens. Patients on Lenalidomide-only therapy had significantly inferior Imaging-PFS.
ABSTRACT
Introduction: Infertility is a clinically common disease, occurring in approximately 10% of women of childbearing age. There is a paucity of studies investigating hematological parameters among infertile women and the association of anemia with infertility. Aims & Objectives: To estimate the prevalence of anemia and the haematological profile among women undergoing infertility treatment. Material(s) and Method(s): This is a cross-sectional single centre descriptive study from Western India. Patients visiting artificial reproductive (ART) centre aged between 18-50 years and were cohabitating with husband for at least six months during the study period (Jan 2021 to Sep 2022) were screened for inclusion. Patients with chronic kidney disease, chronic liver disease, malignancy, on chemotherapy for any malignancy, taking drugs interfering with Iron/ Vitamin B12/Folic acid metabolism and diabetes mellitus were excluded from the study. All included patients were subjected to CBC using 7-part coulter and those with any haematological abnormality were further assessed by haematologist for establishing firm diagnosis. Those patients who didn't give consent for detailed evaluation or those who were lost to follow up because of COVID were excluded from the study. Data was analysed using JMP ver 16.0.0. Result(s): Study population included 108 patients with a mean age of 28.30 +/- 4.14y. Eighty percent of the study population were home makers. Average annual family income was 7.55 +/- 1.47 lakhs per year. The mean duration of infertility being 5.95 +/- 3.52 years with most of them having primary infertility (81%). RBC characteristics of study population being, Hb- 12.12 +/- 1.07 g/dL, MCV- 81.57 +/- 7.12fL, PCV-36.72 +/- 2.88%, RBCs-4.52 +/- 0.45million/ lL, MCH-26.99 +/- 2.86 pg, MCHC-33.02 +/- 1.11 g/L, and RDW- 14.96 +/- 2.17. Other hematological profiles of the infertility patients revealed a total leukocyte count of 7439 +/- 1897/muL, Platelets- 2.53 +/- 0.90/lL. Of all the patients 43% had anemia at presentation to the infertility clinic. Among those who had anemia 52% had microcytic hypochromic whereas 46% had normocytic normochromic with 2% having macrocytic anemia. Among those with microcytic hypochromic anaemia, the mean Mentzer index was 15.53 +/- 2.40. Irrespective of anemia status, 30% of patients had microcytosis. Most of the patients with microcytic hypochromic anemia had Iron deficiency with one two patients having BTT. The prevalent anemia was not higher than the background prevalence. None of the patients had any leukocyte or platelet disorders. Conclusion(s): There is no predominant haematological association with female infertility.
ABSTRACT
Background: Patients with inadequate amounts of copper often present with cytopenias and exhibit dysplasia on bone marrow, mimicking myelodysplastic syndrome (MDS) and pose diagnostic difficulties. Method(s): This cross-sectional observational study was performed from January 2020 to June 2021. Patients diagnosed with MDS were included in the study and serum copper levels were measured by the Inductively Coupled Plasma Mass Spectrometry (ICPMS) method. Copper supplementation with intravenous copper chloride 2.5mg daily for the first two weeks, followed by oral 3mg copper sulfate thrice daily for the next three months, was given for copper-deficient patients. Response assessment was performed with repeat hemogram and serum copper levels. Result(s): A total of 57 patients were diagnosed with MDS, of these, 33 (57.89%) were males and 24 (42.10%) were females. The mean age was 54.3+/-14.6 years (13-81). The distribution of patients in different types of MDS was MDS-SLD in 15, MDS-MLD in 18, MDS-EB1 in 7, MDS-EB2 in 8, and MDS-U in 9 patients. Anemia was seen in (87.71%) of patients, with mean hemoglobin 7.6+/-2.1g/dL (4.6-14.5g/dL). Neutropenia was seen in 31 (54.38%) with a mean absolute neutrophil count(ANC) of 2073+/-2139/muL (211-10,952/muL). Thirty seven (64.91%) patients had thrombocytopenia with a mean platelet count of 1,05,298+/-1,21,769/muL (9,000-6,74,000/muL). The mean serum copper levels were 146.69+/-42.36mug/dL (54.2-254.0mug/dL). Only three (5.26%) patients out of 57 were found to have copper deficiency. All three patients with low copper levels were found to have anemia, thrombocytopenia, and mildly raised serum erythropoietin levels. All three patients had dyserythropoiesis on bone marrow examination, and only one patient each had cytoplasmic vacuolations in erythroid precursors and dysmegakaryopoiesis. Among the three patients with copper deficiency, two patients had significant improvement in cytopenias after copper supplementation, and one had lost follow-up due to COVID-19. Conclusion(s): This study is the first from India to evaluate the role of copper in patients presenting with predominantly hematological manifestations. For patients presenting with cytopenias or marrow dysplasia resembling MDS, copper deficiency should be considered in the differential diagnosis. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest. Copyright © 2022
ABSTRACT
Background: The impact of COVID-19 pandemic has been highly heterogeneous across the globe and different regions within the country. The differences in the outcome of these patients is related to their demographic profile, genetics, socio-economic conditions, and government health policies. Prior to the COVID-19 pandemic, the Healthcare Access and Quality (HAQ) Index for hematological malignancies (HAQ index <30) in a low-middle socio-demographic index(SDI) country like India was less than the mean HAQ index for all other diseases (HAQ index 41) with a significant regional disparity.(1)Several national and international registries from high socio-demographic Index (SDI) countries have reported worse short-term outcomes of coronavirus disease (COVID-19) in patients with hematologic as compared to other solid cancers. The outcomes of COVID-19 in patients with hematologic malignancies from a low-middle SDI country are yet unknown. The COVID-19 Hematologic Cancer registry of India reports these outcomes from India. Methods: Ten tertiary referral hospitals across India reported the demographic, clinical, laboratory, treatment, and outcomes of COVID-19 infection in patients with hematological malignancies. The registry was retrospective from March 21, 2020, and prospective from November 1, 2020, till March 20, 2021. Risk factors associated with severity and mortality were evaluated using the penalised logistic regression and Cox proportional hazards model. Findings: Data from 565 patients was included in this study. Among these, 429 (76%) patients were hospitalized, 186 (33%) patients had moderate/severe COVID-19.There were 116 (20.5%) non-survivors at a mean follow up of 147 (95% CI : 142-153) days. Age >60 years (HR 2·55, 1·23 - 5·27), diagnosis of acute myeloid leukemia (HR 2·85, 1·58 - 5·13), interruption or alteration of anticancer therapy (HR 2·78, 1·65 - 4·68), and post hematopoietic cell transplant status (HR 3·68, 1·82 - 7·45) predicted mortality. In contrast, increasing age [20-40 years (OR 2·54, 1·32 - 4·90), 41-60 years (OR 3·51, 1·84 - 6·71), >60 years (OR 6·04, 3·01 - 12·10), comorbidities such as diabetes mellitus (OR 1·89, 1·18 - 3·04), hypertension (OR 1·94, 1·17 - 3·19), diagnosis of AML (OR 3·70, 2·06 - 6·67), indolent non-hodgkin lymphoma (OR 3·20, 1·68 - 6·09), multiple myeloma (OR 2·88, 1·64 - 5·05), malignancy not being in remission (OR 1·71, 1·12 - 2·60)were significantly associated with severe COVID-19 on univariate analysis. Of these, only increasing age [20-40 years (OR 2·60 (1·31 - 5·15), 40-60 years (OR 3·44, 1.60 - 7·41), more than 60 years (OR 5·70, 2·43 - 13·35)], AML (OR 2·73, 1·45 - 5·12), and malignancy not being in remission (OR 1·85, 1·18 - 2·89) were significantly associated with severe COVID-19 on multivariable analysis Conclusion: The overall mortality from COVID-19 infection of the entire cohort was 20.5%;the mortality was 46.2% in patients who had moderate to severe disease COVID-19 illness. Similar to previous studies, age, diagnosis of acute myeloid leukemia and a post stem cell transplant status was associated with mortality. In addition, interruption or de-escalation of anticancer therapy during Covid-19 infection was identified as an important factor associated with higher mortality on follow up in the current study. References 1. Measuring performance on the Healthcare Access and Quality Index for 195 countries and territories and selected subnational locations: a systematic analysis from the Global Burden of Disease Study 2016. Lancet (London, England)2018;391(10136): 2236-71.Lee AJX, Purshouse K. COVID-19 and cancer registries: learning from the first peak of the SARS-CoV-2 pandemic. Br J Cancer 2021;124(11): 1777-84. [Formula presented] Disclosures: No relevant conflicts of interest to declare.