to demonstrated futility vs nab-paclitaxel monotherapy upon completion of a protocol-specified interim analysis. Overall, 161 patients were randomized (nab-paclitaxel+CC-486, 81; nab-paclitaxel, 80). Baseline characteristics were balanced between arms. The median number of cycles was 4 for each arm, and the median nab-paclitaxel cumulative dose was 600 mg/m 2 and 800 mg/m 2 in the nab-paclitaxel+CC-486 and nab-paclitaxel arms, respectively. Rates of grade 3/4 (G3/4) treatmentemergent AEs were 59.5% and 54.4% for the combination and monotherapy arms, respectively. The most frequent hematologic G3/4 AEs were neutropenia (16.5% vs 10.1%) and anemia (1.3% vs 7.6%). G3/4 peripheral neuropathy was reported in 2.5% and 7.6% of patients, respectively. The addition of CC-486 to nab-paclitaxel did not improve ORR, DCR, PFS, or OS (Table). When assessed by Lung Cancer Symptom Scale, nab-paclitaxel monotherapy was associated with improvement in the global QoL, average symptom burden index, and lung cancer symptoms except for hemoptysis. Conclusion: The addition of CC-486 to nab-paclitaxel did not clinically benefit patients with previously treated NSCLC. However, single-agent nab-paclitaxel appears to be a promising therapy based on safety, efficacy, and QoL data. Updated efficacy and safety data will be presented. NCT02250326.
Introduction: Preeclampsia (PE) is one of the leading obstetric diseases with significant morbidity and mortality in both mother and foetus. The etiology of preeclampsia is unknown. It may result from several reasons with imbalance between angiogenic regulatory factors in maternal circulation as one of the factor. High circulatory levels of Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) are detectable several weeks before clinical presentation of preeclampsia. Aim: To determine association of serum levels of sFlt-1 with preeclampsia in second and third trimester of pregnancy. Materials and Methods: A prospective cohort study was conducted in the Department of Biochemistry in collaboration with the Department of Obstetrics and Gynaecology in a tertiary care hospital (Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India), from November 2018 to March 2021. The study participants were divided into two groups i.e, normotensive (group 1) and preeclamptic (group 2). The enrollment of participants was done during second trimester. Serum sFlt-1 concentration was measured in second trimester (24-28 weeks) and in third trimester (beyond 28 weeks) using Enzyme Linked Immunoassay (ELISA) kits. Receiver Operating Characteristics (ROC) curve analysis was done for evaluation of Area Under Curve (AUC), sensitivity and specificity using software defined cut-off values. Results: Total 60 participants were there in each group with maternal mean age of 25.8±3.2 years in group 1 and 30.6±5.5 years in group 2 (p-value <0.001). sFlt-1 levels were significantly higher in preeclampsia group both in second and third trimesters when compared with normotensive group with median 313.07 versus 65.150 (p-value <0.001) and 337.875 versus 76.925 (p-value <0.001), respectively. The ROC curve analysis using 190.5 ng/mL as cut-off point in second trimester showed sensitivity 90%, specificity 85%, AUC was 0.832, 95% CI (0.745-0.918) and in third trimester at cut-off point 271.5 ng/mL showed sensitivity 90%, specificity 90%, AUC was 0.884, 95% CI (0.817-0.951). Conclusion: The soluble Fms-Like Tyrosine Kinase-1-1 (sFlt-1), may serve as biomarker for early diagnosis and can improve prediction of preeclampsia.
Introduction: Fine-needle aspiration cytology (FNAC) breast is generally considered a reliable diagnostic tool to distinguish non-proliferative from proliferative breast lesions. Nevertheless, differentiating these breast lesions on FNAC poses a diagnostic challenge. Modified Masood Scoring System (MMSS) based on cytomorphological examination has been used to help in differentiating these lesions.Material and methods: A total of 67 patients were included in this prospective study done from November 2012 to May 2014 and the breast lesions were cytologically categorized by conventional and as per MMSS criteria, followed by comparison to a histopathological examination, which was taken as a gold standard. Relevant frequencies and proportions were calculated along with the sensitivity and specificity of the MMSS.Results: The age of the patients ranged from 15 to 85 years with a mean age of 44.3 ± 14.8 years. Females predominated in the study and right-sided breast lesions were more common compared to the left side. Overall diagnostic specificity (100%) and accuracy (97%) were higher using MMSS as compared to conventional cytology in which case specificity was 83.6% and accuracy was 82.1%.Conclusions: Cytological grading system based on MMSS allowed accurate and reproducible diagnosis compared to the standard histopathological diagnosis. It is essential to differentiate non-proliferative lesions from proliferative lesions as the line of treatment and prognosis varies.
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