The aim of this study was to assess incidence and risk factors for acute kidney injury (AKI) in patients with dengue fever (DF). A total of 223 patients (males, 130; females, 93; mean age, 26.2 ± 18.2 years) from a tertiary care centre in southern India were retrospectively analysed. Acute renal failure (ARF) developed in 24 (10.8%) patients. Based on the Acute Kidney Injury Network (AKIN) criteria, the results revealed that: 12 (5.4%) had mild AKI; seven (3.1%) had moderate AKI; and five (2.2%) had severe AKI. A further 54 (24%) were diagnosed with dengue haemorrhagic fever (DHF); 11 (5%) were co-infected with leptospirosis; thrombocytopenia was present in 157 (70%); and 64 (29%) were hypotensive. Patients were divided into either group A (with AKI) or group B (without AKI), and group A was divided into mild (A1), moderate (A2) and severe (A3) subgroups. We recorded: a higher total white count (A = 9824; B = 6706; P = 0.01); serum glutamic pyruvic transaminase (SGPT; A = 450; B = 144; P = 0.001); alkaline phosphatase (ALP) levels (A = 207; B = 42; P = 0.001); lower albumin (A = 2.65; B = 3.09; P < 0.001); and serum bicarbonate (A = 20.57; B = 23.21; P = 0.009). Hypotension (P = 0.01), coexisting viral hepatitis (P < 0.001), sepsis (P < 0.001), multiple organ dysfunction syndrome (MODS; P < 0.001) and the need for inotropes (P < 0.001) were associated with DF. Total white count (P = 0.038), glomerular filtration rate (GFR) on discharge (P = 0.034), specific gravity of urine (P = 0.006), ALP (P = 0.013), SGPT (P = 0.042), MODS (P = 0.05) and use of platelet fresh frozen plasma (FFP; P = 0.007) were significantly different between mild, moderate and severe AKI subgroups. Twenty-two (9%) died. AKI is associated with an increased mortality in DF (P = 0.005).
Background Breakthrough chemotherapy–induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open‐label, single‐center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV. Procedure Children aged 5‐18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy were randomly assigned to the metoclopramide or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or metoclopramide for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms. Results Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm). CR rates were significantly higher in the olanzapine arm compared with the metoclopramide arm for vomiting (72% vs 39%, P = 0.003) and nausea (59% vs 34%, P = 0.026). Seven patients in the metoclopramide arm crossed over to the olanzapine arm and none crossed over in the olanzapine arm (P < 0.001). The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01). Hyperglycemia and drowsiness were more commonly seen in the olanzapine arm. Conclusion Olanzapine is superior to metoclopramide for the treatment of breakthrough CIV in children. Drowsiness and hyperglycemia need to be monitored closely in children receiving olanzapine for breakthrough CIV.
Adolescent and young adult (AYA) patients with acute lymphoblastic leukaemia (ALL) have inferior survival when compared to children. The causes are multiple and include bad biology, differences in treatment approaches, and other complex social, economic and psychological factors that affect therapy adherence. 1 Intensive 'paediatric' regimens improve outcomes, but these come with the cost of higher toxicity, which may even negate these benefit of reduced relapse. 2-5 To understand the real-world data from India, we analysed the outcomes of AYA ALL (aged 15-29 years, treated between 2012 and 2017) from a retrospective database maintained by the Hematology Cancer Consortium (HCC). Baseline data of all patients (including those who were not treated) diagnosed within the period stipulated by a particular centre were captured, including reasons for not availing treatment. Survival outcomes were estimated for treated patients (censored on 31 July 2019). For this analysis, 'high risk' was defined based on white blood cell count (WBC) at diagnosis (B cell >30 9 10 9 /l, T cell >100 9 10 9 /l). Protocols such as Multicentre protocol 841 (MCP-841), Berlin-Frankfurt-M€ unster 95 (BFM-95), BFM-90, and Children's Oncology Group (COG) were considered 'paediatric type', whereas German Multicentre ALL (GMALL), hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (Hyper-CVAD), and UKALL were considered 'adult type'. Minimal residual disease (MRD) >0Á01% (when assessed by flow cytometry) was considered positive. Of the 1383 patients registered, 1141(82Á5%) underwent treatment (Supplementary Table S1 and S2, baseline characteristics), and 242 did not start treatment (Fig 1). The inability to afford treatment was the commonest cause for not initiating treatment (105/1383, 7Á6%). There were no Fig 1. Flowchart depicting the outcomes of patients who were included in the registry. Of the 1383 patients, only 1141 started therapy (induction) and 863 (76%) achieved complete remission (CR). At last follow-up, 574 were in CR and on follow-up. A total of 336/1383 (24%) patients either did not start therapy (N = 242), or abandoned therapy after starting induction (N = 94) (A). (B) Comparison of induction outcomes between those treated with 'paediatric' and 'adult' protocols. There were no differences in terms of achievement of CR (76% vs. 73%, P = 0Á509), induction mortality (4Á7% vs. 3Á2%, P = 0Á842), or minimal residual disease (MRD) positivity rate (36% vs. 42%, P = 0Á382). (C) The commonest cause of induction mortality was infection (56%) followed by progressive disease (23%).
IntroductionThe rising economic burden of cancer on healthcare system and patients in India has led to the increased demand for evidence in order to inform policy decisions such as drug price regulation, setting reimbursement package rates under publicly financed health insurance schemes and prioritising available resources to maximise value of investments in health. Economic evaluations are an integral component of this important evidence. Lack of existing evidence on healthcare costs and health-related quality of life (HRQOL) makes conducting economic evaluations a very challenging task. Therefore, it is imperative to develop a national database for health expenditure and HRQOL for cancer.Methods and analysisThe present study proposes to develop a National Cancer Database for Cost and Quality of Life (CaDCQoL) in India. The healthcare costs will be estimated using a patient perspective. A cross-sectional study will be conducted to assess the direct out-of-pocket expenditure (OOPE), indirect cost and HRQOL among cancer patients who will be recruited at seven leading cancer centres from six states in India. Mean OOPE and HRQOL scores will be estimated by cancer site, stage of disease and type of treatment. Economic impact of cancer care on household financial risk protection will be assessed by estimating prevalence of catastrophic health expenditures and impoverishment. The national database would serve as a unique open access data repository to derive estimates of cancer-related OOPE and HRQOL. These estimates would be useful in conducting future cost-effectiveness analyses of management strategies for value-based cancer care.Ethics and disseminationApproval was granted by Institutional Ethics Committee vide letter no. PGI/IEC-03/2020-1565 of Post Graduate Institute of Medical Education and Research, Chandigarh, India. The study results will be published in peer-reviewed journals and presented to the policymakers at national level.
Recent reports suggest that in the TKI era, the survival of chronic myeloid leukemia approaches that of general population. The real-world situation may be different. We analyzed patients (C 18 years) with chronic phase (CP) CML enrolled over a 7-year period (2002-2008) in an imatinib access program. Event was defined as non-achievement/loss of complete hematological response (CHR), loss of cytogenetic response or progression to accelerated (AP)/blast phase (BC). Progression was defined as development of AP/BC. Any delay of C 1 week in reporting for drug refills was categorized as non-adherence. Of the 443 patients with CP-CML who started imatinib [median age: 36 years (18-70); High risk: 32% (Sokal) and 14% (Hasford/EUTOS)], 162 (37%) had received prior therapy [mostly hydroxyurea (N = 153]. CHR was achieved by 430 (97%). After a median follow up of 109.5 months (3.4-184.3), the EFS, PFS and OS at 10 years was 43%, 75% and 76% respectively. Superior EFS was predicted by low-risk Hasford score and adherence to therapy. Adherence to therapy was the only factor which predicted EFS on multivariate analysis (HR 0.64, 95% CI 0.50-0.83, P = 0.001). Long-term follow up of patients with CP-CML reflects poorer survival than those reported from clinical trials and reflects multiple issues that affect ''real-world'' patients. The continued drop in EFS, noted during long-term follow up, might take time to impact the PFS and OS due to the chronic nature of the disease. Sustained adherence to therapy is important for optimum long-term outcomes.
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