Displaying publications 1 - 20 of 97 in total

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  1. Ishigooka J, Nakamura J, Fujii Y, Iwata N, Kishimoto T, Iyo M, et al.
    Schizophr Res, 2015 Feb;161(2-3):421-8.
    PMID: 25556976 DOI: 10.1016/j.schres.2014.12.013
    This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia.
    Matched MeSH terms: Kaplan-Meier Estimate
  2. Tromp J, Tay WT, Ouwerkerk W, Teng TK, Yap J, MacDonald MR, et al.
    PLoS Med, 2018 03;15(3):e1002541.
    PMID: 29584721 DOI: 10.1371/journal.pmed.1002541
    BACKGROUND: Comorbidities are common in patients with heart failure (HF) and complicate treatment and outcomes. We identified patterns of multimorbidity in Asian patients with HF and their association with patients' quality of life (QoL) and health outcomes.

    METHODS AND FINDINGS: We used data on 6,480 patients with chronic HF (1,204 with preserved ejection fraction) enrolled between 1 October 2012 and 6 October 2016 in the Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) registry. The ASIAN-HF registry is a prospective cohort study, with patients prospectively enrolled from in- and outpatient clinics from 11 Asian regions (Hong Kong, Taiwan, China, Japan, Korea, India, Malaysia, Thailand, Singapore, Indonesia, and Philippines). Latent class analysis was used to identify patterns of multimorbidity. The primary outcome was defined as a composite of all-cause mortality or HF hospitalization within 1 year. To assess differences in QoL, we used the Kansas City Cardiomyopathy Questionnaire. We identified 5 distinct multimorbidity groups: elderly/atrial fibrillation (AF) (N = 1,048; oldest, more AF), metabolic (N = 1,129; obesity, diabetes, hypertension), young (N = 1,759; youngest, low comorbidity rates, non-ischemic etiology), ischemic (N = 1,261; ischemic etiology), and lean diabetic (N = 1,283; diabetic, hypertensive, low prevalence of obesity, high prevalence of chronic kidney disease). Patients in the lean diabetic group had the worst QoL, more severe signs and symptoms of HF, and the highest rate of the primary combined outcome within 1 year (29% versus 11% in the young group) (p for all <0.001). Adjusting for confounders (demographics, New York Heart Association class, and medication) the lean diabetic (hazard ratio [HR] 1.79, 95% CI 1.46-2.22), elderly/AF (HR 1.57, 95% CI 1.26-1.96), ischemic (HR 1.51, 95% CI 1.22-1.88), and metabolic (HR 1.28, 95% CI 1.02-1.60) groups had higher rates of the primary combined outcome compared to the young group. Potential limitations include site selection and participation bias.

    CONCLUSIONS: Among Asian patients with HF, comorbidities naturally clustered in 5 distinct patterns, each differentially impacting patients' QoL and health outcomes. These data underscore the importance of studying multimorbidity in HF and the need for more comprehensive approaches in phenotyping patients with HF and multimorbidity.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT01633398.
    Matched MeSH terms: Kaplan-Meier Estimate
  3. Kong CC, Kandasamy R, Haspani S, Idris Z, Abdullah JM
    Malays J Med Sci, 2018 May;25(3):88-102.
    PMID: 30899190 MyJurnal DOI: 10.21315/mjms2018.25.3.9
    Background: Meningiomas are the most common intracranial tumours; they account for 13%-26% of all the primary intracranial tumours. Skull base meningiomas make up 25% of all meningiomas and are one of the most difficult intracranial tumours to be managed surgically. This is due to the fact that it is difficult to approach the lesions which are also close to vital structures such as cranial nerves and major blood vessels. Despite the abundance of these cases in Malaysia, local data on meningiomas is scarce.

    Methods: This is a retrospective study consisting of 199 patients with meningiomas who have been operated at the Kuala Lumpur General Hospital from January 2010-December 2014. They were categorised into skull base and non-skull base groups. Demography, tumour characteristics, and patient outcomes were analysed. Kaplan-Meier survival curves as well as Cox hazard univariable and multivariable regressions for the possible predictors of survival were analysed.

    Results: 97.5% of the patients (n = 194) had WHO grade I meningioma and only five patients had WHO grade II meningioma. There was a female predominance (n = 134; 67.3%), with a male-to-female ratio of 1:2. Some 27.1 % patients had skull base meningiomas. Patients with skull base meningiomas had poorer outcomes and discharge conditions (n = 23; 42.6% P < 0.01), in addition to higher risk of incomplete resections (n = 34; 63% P < 0.01). Multivariate cox hazard regressions showed that the skull base meningioma group had four times the risk of death of the non-skull base group.

    Conclusions: Symptomatic meningiomas can be curative if the tumour is completely removed. Our study has revealed that skull base meningiomas which were operated locally had higher rates of incomplete resection and poorer surgical outcomes as compared to the non-skull base group. Patients with skull base meningiomas had four times the risk of death vis-à-vis non-skull base ones. More local studies are needed to look into skull base meningiomas for the improvement of its surgical outcomes.

    Matched MeSH terms: Kaplan-Meier Estimate
  4. Chua HH, Tuan Sharif SE, Wan Ismail WFN, Zawawi MSF, Abdullah S
    Asian Pac J Cancer Prev, 2021 Mar 01;22(3):741-747.
    PMID: 33773537 DOI: 10.31557/APJCP.2021.22.3.741
    BACKGROUND: The receptor activator of nuclear factor kappa B ligand (RANKL) is one of the key regulators of bone remodelling in bone oncology, including osteosarcoma. We assessed RANKL immunohistochemical expression in osteosarcoma, its association, and disease-free survival with the patients' clinicopathological characteristics.

    METHODS:   One hundred osteosarcoma cases from 2003 to 2018 in Hospital Universiti Sains Malaysia were retrieved. The tissue samples were stained for RANKL, and the association with the clinicopathological characteristics was evaluated. Staining was interpreted in a semiquantitative scoring system and classified into negative and positive expressions.  Results: Eighty-two cases had a positive expression of RANKL in which 56 and 26 patients were classified as low expression and high expression, respectively. The positive expression of RANKL did not show a significant association with clinicopathological characteristics. However, Kaplan Meier survival analysis showed a significant improvement in the disease-free survival patients who underwent limb salvage surgery (LSS) than amputated patients (p-value 0.002), whereas poorer survival was observed among conventional osteosarcomas compared to non-conventional osteosarcoma (p-value 0.01).

    CONCLUSION: Limb salvage surgery had proven to improve osteosarcoma patients' survival compared to amputation, which could improve overall quality of life in osteosarcoma patients. However, our data did not show a significant association between positive RANKL immunohistochemistry with any of the clinicopathological characteristics and patients' final survival. Further studies may be acquired to understand the suitability of using RANKL immunohistochemistry as prognostication in the management of osteosarcoma patients.

    Matched MeSH terms: Kaplan-Meier Estimate
  5. Balasundram S, Salekan K, Ahmad Shariffuddin FN, Taib NA, Adnan TH
    Asian Pac J Cancer Prev, 2018 Sep 26;19(9):2409-2415.
    PMID: 30255693
    Objective: To gauge surgical outcome in breast cancer patients with particular reference to overall survival and
    recurrence free survival among breast cancer patients in Hospital Sultanah Nora Ismail Batu Pahat, Johor, Malaysia.
    Methods: Patients undergoing ablative breast cancer surgery were identified and clinical records were assessed.
    Inclusion criteria for enrolment were stage I-IV breast malignancy necessitating resection with or without radiotherapy/
    chemotherapy from 2007 to 2013. All individuals had a pre-operative assessment. The post operative assessment period
    ranged from 1 year to 5 years. Survival distributions were analyzed using Kaplan-Meier curves. Results: A total of
    121 patients were included in this study, with an age range of 28-78 years. Some 98% had undergone local excision/
    lumpectomy/ mastectomy with axillary clearance. While 81% of patients underwent chemotherapy, only 69% had
    radiotherapy. Tumours were oestrogen receptor positive in 58% of cases and progesterone receptor positive in 62%.
    Local recurrence was detected in 10%. The mean age at diagnosis was 51.3 + 10.4 years. The overall survival analysis
    was based on 22 deaths among the 121 patients (18.2%). Three-year and five-year survival rates were 87.6% and 78.4%,
    respectively. Analysis of recurrence-free-survival (RFS) was based on 12 events among 121 patients. The Kaplan-Meier
    RFS analysis revealed that in 90% of the patients with recurrence, it occurred within 45 months. The five year RFS
    rate was 84.5%. The median time taken from diagnosis to ablative surgery was 51 days (upper limit of 791 days).
    Only distant metastasis was a significant factor that impacted on both overall survival and recurrence-free survival
    (p<0.001). Conclusion: Overall survival among our breast cancer patients in our facility is comparable to other in
    other tertiary centres in the country. A trend for earlier detection was noted.
    Matched MeSH terms: Kaplan-Meier Estimate
  6. Chet LS, Hamid SAA, Bachok N, Chidambaram SK, Adnan WNAW
    Saudi J Med Med Sci, 2021 04 29;9(2):135-144.
    PMID: 34084104 DOI: 10.4103/sjmms.sjmms_72_20
    Background: Antiretroviral therapy (ART) has transformed the management of human immunodeficiency virus (HIV) infection and significantly improved survival rates, but there is lack of such survival data from Malaysia.

    Objective: The objective was to determine the survival rates and prognostic factors of survival in HIV-infected adults treated with ART in Malaysia.

    Materials and Methods: This retrospective cohort study considered all HIV-positive adult patients registered in Sungai Buloh Hospital, a major referral center in Malaysia, between January 1, 2007 and December 31, 2016. Then, patients were selected through a systematic sampling method. Demographic, clinical, and treatment data were extracted from electronic medical records. Person-years at risk and incidence of mortality rate per 100 person-years were calculated. The Kaplan-Meier survival curve and log-rank test were used to compare the overall survival rates. Cox proportional hazards regression was applied to determine the prognostic factors for survival.

    Results: A total of 339 patients were included. The estimated overall survival rates were 93.8%, 90.4%, 84.9%, and 72.8% at 1, 3, 5, and 10 years, respectively, from ART initiation. The results of multiple Cox proportional hazard regression indicated that anemic patients were at a 3.76 times higher risk of mortality (95% confidence interval [CI]: 1.97-7.18; P < 0.001). The hazard risk was 2.09 times higher for HIV patients co-infected with tuberculosis (95% CI: 1.10, 3.96; P = 0.024).

    Conclusion: The overall survival rates among HIV-infected adults in this study are higher than that from low-income countries but lower than that from high-income countries. Low baseline hemoglobin levels of <11 g/dL and tuberculosis co-infection were strong prognostic factors for survival.

    Matched MeSH terms: Kaplan-Meier Estimate
  7. Ch'ng CC, Ong LM, Beh KKM, Md Yusuf WS, Chew TF, Lee ML, et al.
    Nephrology (Carlton), 2020 Aug;25(8):644-651.
    PMID: 31900988 DOI: 10.1111/nep.13689
    AIM: Many patients, especially the elderly, who require renal replacement therapies (RRT) have delayed or rejected dialysis for various reasons. Current dialysis guidelines may not be relevant for the elderly or frail patients. We aim to determine survival advantage of initiating dialysis in patients deemed to require RRT.

    METHODS: This was an observational cohort on incident end-stage kidney disease (ESKD) patients from January 1, 2007 to December 31, 2008. The primary outcome was all-cause mortality. Patients contributed person-time from the date of ESKD diagnosis until death, transplant or end of study on December 31, 2014, whichever occurred first. An extended Cox regression model with time-varying exposure to dialysis was used to account for immortal time bias.

    RESULTS: Of 3990 incident ESKD patients included, 70.2% patients initiated dialysis; 78.8% with haemodialysis (HD) while the remaining 21.2% with peritoneal dialysis (PD). Dialysis reduced hazard of death in both elderly and non-elderly patients even after controlling for comorbidities (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.50, 0.68 and HR 0.76, 95% CI 0.69, 0.85, respectively). HD was protective in both the elderly and non-elderly (HR 0.53, 95% CI 0.45, 0.63 and HR 0.71, 95% CI 0.64, 0.80, respectively). PD significantly reduced risk of death compared to no dialysis in the elderly but not in the non-elderly.

    CONCLUSION: Dialysis improved survival in all incident ESKD patients. The findings suggested a larger protection offered by HD. Although improvement in survival from initiating dialysis was large, its true benefit should take overall quality of life into account. SUMMARY AT A GLANCE This observational study showed that initiation of dialysis improves the survival of end-stage kidney disease (ESKD) patients of all age groups, but the quality of life is an important aspect that has not been explored.

    Matched MeSH terms: Kaplan-Meier Estimate
  8. Gomaa W, Al-Ahwal M, Al-Maghrabi H, Buhmeida A, Al-Qahtani M, Al-Maghrabi B, et al.
    Malays J Pathol, 2017 Dec;39(3):243-250.
    PMID: 29279586
    BACKGROUND/AIM: Colorectal carcinoma (CRC) carries a high incidence of morbidity and mortality. Prognosis is related to nodal metastasis and stage. Clusterin is a widely distributed glycoprotein with not yet fully understood functions. Clusterin may be overexpressed in some tumours or under expressed in other tumours. The aim behind this study is to examine the relation of clusterin cytoplasmic immunostaining to tumour characteristics, disease relapse, and survival in CRC.

    MATERIALS AND METHODS: Paraffin blocks of 133 CRCs were retrieved from the Department of Pathology, King Abdulaziz University, Jeddah, Saudi Arabia. Immunostaining was done using antibody to clusterin. Staining expression in 10% of malignant cells was used as a cut-off to determine low immunostaining and high immunostaining. Statistical tests were used to evaluate the association of clusterin immunostaining with clinicopathological parameters.

    RESULTS: Immunohistochemical results showed clusterin low immunostaining in CRC and nodal metastases. No association was found between clusterin immunostaining and tumour grade, age, tumour invasiveness, distant metastases, vascular invasion, nodal metastases, relapse, and survival.

    CONCLUSION: Our study showed low clusterin immunostaining in CRC with lack of association with prognostic indicators in CRC. These results raise the controversy of understanding the role of clusterin in CRC. Further molecular studies are required to explore more about possible mechanisms of clusterin association with tumorigenicity, apoptosis, tumour growth progression, local and vascular invasion, and metastasis of CRC.

    Matched MeSH terms: Kaplan-Meier Estimate
  9. Rahman FA, Naidu J, Ngiu CS, Yaakob Y, Mohamed Z, Othman H, et al.
    Asian Pac J Cancer Prev, 2016;17(8):4037-41.
    PMID: 27644658
    BACKGROUND: Hepatocellular carcinoma (HCC) is a common cancer that is frequently diagnosed at an advanced stage. Transarterial chemoembolisation (TACE) is an effective palliative treatment for patients who are not eligible for curative treatment. The two main methods for performing TACE are conventional (c-TACE) or with drug eluting beads (DEB-TACE). We sought to compare survival rates and tumour response between patients undergoing c-TACE and DEB-TACE at our centre.

    MATERIALS AND METHODS: A retrospective cohort study of patients undergoing either treatment was carried out from January 2009 to December 2014. Tumour response to the procedures was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Kaplan-Meier analysis was used to assess and compare the overall survival in the two groups.

    RESULTS: A total of 79 patients were analysed (34 had c-TACE, 45 had DEB-TACE) with a median follow-up of 11.8 months. A total of 20 patients in the c-TACE group (80%) and 12 patients in the DEB-TACE group (44%) died during the follow up period. The median survival durations in the c-TACE and DEB-TACE groups were 4.9 ± 3.2 months and 8.3 ± 2.0 months respectively (p=0.008). There was no statistically significant difference noted among the two groups with respect to mRECIST criteria.

    CONCLUSIONS: DEB-TACE demonstrated a significant improvement in overall survival rates for patients with unresectable HCC when compared to c-TACE. It is a safe and promising approach and should potentially be considered as a standard of care in the management of unresectable HCC.

    Matched MeSH terms: Kaplan-Meier Estimate
  10. Wickersham JA, Zahari MM, Azar MM, Kamarulzaman A, Altice FL
    Drug Alcohol Depend, 2013 Sep 1;132(1-2):378-82.
    PMID: 23414931 DOI: 10.1016/j.drugalcdep.2013.01.005
    To evaluate the impact of methadone dose on post-release retention in treatment among HIV-infected prisoners initiating methadone maintenance treatment (MMT) within prison.
    Matched MeSH terms: Kaplan-Meier Estimate
  11. Syadwa AS, Anita ZB
    Med J Malaysia, 2018 08;73(4):190-196.
    PMID: 30121680 MyJurnal
    AIM: Symptomatic relief following palliative radiotherapy for advanced cancers may take a few weeks up to a few months to achieve. Thus, accurate prognostication is important to avoid harm to these patients with limited lifespan. We conducted a retrospective cohort study to determine the median survival and 30-day mortality (30-DM) and factors associated with these parameters in our centre.

    METHODS: Data from 585 eligible patients who received palliative radiotherapy between January 2012 and December 2014 were analysed. Median overall survival was calculated from the commencement of first fraction of the last course of radiotherapy to date of death or when censored. 30-DM was calculated as the proportion of patients who died within 30 days from treatment start date. Kaplan-Meier survival analysis was used to estimate survival. Chi-square test and logistic regression was used to assess the impact of potential prognostic factors on median survival and 30-DM.

    RESULTS: The most common diagnoses were lung and breast cancers and most common irradiated sites were bone and brain. Median survival and 30-DM were 97 days and 22.7% respectively. Primary cancer, age, treatment course, performance status, systemic treatment post radiotherapy and intended radiotherapy treatment completed had an impact on median survival whereas mainly the latter three factors had an impact on 30-DM.

    CONCLUSION: Median survival and factors affecting both survival and 30-DM in our study are comparable to others. However, a 30-DM rate of 22.7% is significantly higher compared to the literature. We need to better select patients who will benefit from palliative radiotherapy in our centre.

    Matched MeSH terms: Kaplan-Meier Estimate
  12. Nik Hisamuddin NAR, Azlan K
    Med J Malaysia, 2012 Jun;67(3):259-64.
    PMID: 23082413 MyJurnal
    In this study, we sought to determine whether laboratory and physiological parameters can be useful in predicting mortality in patients with sepsis-induced hypotension and septic shock.
    Matched MeSH terms: Kaplan-Meier Estimate
  13. Park SJ, Ahn JM, Kim YH, Park DW, Yun SC, Lee JY, et al.
    N Engl J Med, 2015 Mar 26;372(13):1204-12.
    PMID: 25774645 DOI: 10.1056/NEJMoa1415447
    BACKGROUND: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents.
    METHODS: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups.
    RESULTS: After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG.
    CONCLUSIONS: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).
    Matched MeSH terms: Kaplan-Meier Estimate
  14. Wong KK, Gascoyne DM, Soilleux EJ, Lyne L, Spearman H, Roncador G, et al.
    Oncotarget, 2016 Aug 16;7(33):52940-52956.
    PMID: 27224915 DOI: 10.18632/oncotarget.9507
    FOXP2 shares partially overlapping normal tissue expression and functionality with FOXP1; an established diffuse large B-cell lymphoma (DLBCL) oncogene and marker of poor prognosis. FOXP2 is expressed in the plasma cell malignancy multiple myeloma but has not been studied in DLBCL, where a poor prognosis activated B-cell (ABC)-like subtype display partially blocked plasma cell differentiation. FOXP2 protein expression was detected in ABC-DLBCL cell lines, and in primary DLBCL samples tumoral FOXP2 protein expression was detected in both germinal center B-cell-like (GCB) and non-GCB DLBCL. In biopsies from DLBCL patients treated with immunochemotherapy (R-CHOP), ≥ 20% nuclear tumoral FOXP2-positivity (n = 24/158) correlated with significantly inferior overall survival (OS: P = 0.0017) and progression-free survival (PFS: P = 0.0096). This remained significant in multivariate analysis against either the international prognostic index score or the non-GCB DLBCL phenotype (P < 0.05 for both OS and PFS). Expression of BLIMP1, a marker of plasmacytic differentiation that is commonly inactivated in ABC-DLBCL, did not correlate with patient outcome or FOXP2 expression in this series. Increased frequency of FOXP2 expression significantly correlated with FOXP1-positivity (P = 0.0187), and FOXP1 co-immunoprecipitated FOXP2 from ABC-DLBCL cells indicating that these proteins can co-localize in a multi-protein complex. FOXP2-positive DLBCL had reduced expression of HIP1R (P = 0.0348), which is directly repressed by FOXP1, and exhibited distinct patterns of gene expression. Specifically in ABC-DLBCL these were associated with lower expression of immune response and T-cell receptor signaling pathways. Further studies are warranted to investigate the potential functional cooperativity between FOXP1 and FOXP2 in repressing immune responses during the pathogenesis of high-risk DLBCL.
    Matched MeSH terms: Kaplan-Meier Estimate
  15. Miao H, Hartman M, Verkooijen HM, Taib NA, Wong HS, Subramaniam S, et al.
    BMC Cancer, 2016 10 21;16(1):820.
    PMID: 27769212
    BACKGROUND: CancerMath is a set of web-based prognostic tools which predict nodal status and survival up to 15 years after diagnosis of breast cancer. This study validated its performance in a Southeast Asian setting.

    METHODS: Using Singapore Malaysia Hospital-Based Breast Cancer Registry, clinical information was retrieved from 7064 stage I to III breast cancer patients who were diagnosed between 1990 and 2011 and underwent surgery. Predicted and observed probabilities of positive nodes and survival were compared for each subgroup. Calibration was assessed by plotting observed value against predicted value for each decile of the predicted value. Discrimination was evaluated by area under a receiver operating characteristic curve (AUC) with 95 % confidence interval (CI).

    RESULTS: The median predicted probability of positive lymph nodes is 40.6 % which was lower than the observed 43.6 % (95 % CI, 42.5 %-44.8 %). The calibration plot showed underestimation for most of the groups. The AUC was 0.71 (95 % CI, 0.70-0.72). Cancermath predicted and observed overall survival probabilities were 87.3 % vs 83.4 % at 5 years after diagnosis and 75.3 % vs 70.4 % at 10 years after diagnosis. The difference was smaller for patients from Singapore, patients diagnosed more recently and patients with favorable tumor characteristics. Calibration plot also illustrated overprediction of survival for patients with poor prognosis. The AUC for 5-year and 10-year overall survival was 0.77 (95 % CI: 0.75-0.79) and 0.74 (95 % CI: 0.71-0.76).

    CONCLUSIONS: The discrimination and calibration of CancerMath were modest. The results suggest that clinical application of CancerMath should be limited to patients with better prognostic profile.

    Matched MeSH terms: Kaplan-Meier Estimate
  16. Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, et al.
    N Engl J Med, 2015 Sep 24;373(13):1195-206.
    PMID: 26214039 DOI: 10.1056/NEJMoa1506223
    BACKGROUND: A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.
    METHODS: We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57. We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15.
    RESULTS: Follow-up data were available for 10,165 of 10,275 participants (99%) in CYD14 and 19,898 of 20,869 participants (95%) in CYD15. Data were available for 3203 of the 4002 participants (80%) in the CYD23 trial included in CYD57. During year 3 in the CYD14, CYD15, and CYD57 trials combined, hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group. Pooled relative risks of hospitalization for dengue were 0.84 (95% confidence interval [CI], 0.56 to 1.24) among all participants, 1.58 (95% CI, 0.83 to 3.02) among those under the age of 9 years, and 0.50 (95% CI, 0.29 to 0.86) among those 9 years of age or older. During year 3, hospitalization for severe dengue, as defined by the independent data monitoring committee criteria, occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group. Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3% (95% CI, 55.7 to 64.5) for all participants, 65.6% (95% CI, 60.7 to 69.9) for those 9 years of age or older, and 44.6% (95% CI, 31.6 to 55.0) for those younger than 9 years of age.
    CONCLUSIONS: Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up, the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group. (Funded by Sanofi Pasteur; ClinicalTrials.gov numbers, NCT00842530, NCT01983553, NCT01373281, and NCT01374516.).
    Matched MeSH terms: Kaplan-Meier Estimate
  17. Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, et al.
    Lancet, 2014 Oct 11;384(9951):1358-65.
    PMID: 25018116 DOI: 10.1016/S0140-6736(14)61060-6
    An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children.
    Matched MeSH terms: Kaplan-Meier Estimate
  18. Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, et al.
    Future Oncol, 2019 Jul;15(21):2489-2501.
    PMID: 31140297 DOI: 10.2217/fon-2019-0143
    Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240 mg/day or placebo for 1 year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n = 165; placebo, n = 176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31-1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27-1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: Clinicaltrials.gov NCT00878709.
    Matched MeSH terms: Kaplan-Meier Estimate
  19. Zanaruddin SN, Saleh A, Yang YH, Hamid S, Mustafa WM, Khairul Bariah AA, et al.
    Hum Pathol, 2013 Mar;44(3):417-26.
    PMID: 23026198 DOI: 10.1016/j.humpath.2012.06.007
    The presence of lymph node (LN) metastasis significantly affects the survival of patients with oral squamous cell carcinoma (OSCC). Successful detection and removal of positive LNs are crucial in the treatment of this disease. Current evaluation methods still have their limitations in detecting the presence of tumor cells in the LNs, where up to a third of clinically diagnosed metastasis-negative (N0) patients actually have metastasis-positive LNs in the neck. We developed a molecular signature in the primary tumor that could predict LN metastasis in OSCC. A total of 211 cores from 55 individuals were included in the study. Eleven proteins were evaluated using immunohistochemical analysis in a tissue microarray. Of the 11 biomarkers evaluated using receiver operating curve analysis, epidermal growth factor receptor (EGFR), v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 (HER-2/neu), laminin, gamma 2 (LAMC2), and ras homolog family member C (RHOC) were found to be significantly associated with the presence of LN metastasis. Unsupervised hierarchical clustering-demonstrated expression patterns of these 4 proteins could be used to differentiate specimens that have positive LN metastasis from those that are negative for LN metastasis. Collectively, EGFR, HER-2/neu, LAMC2, and RHOC have a specificity of 87.5% and a sensitivity of 70%, with a prognostic accuracy of 83.4% for LN metastasis. We also demonstrated that the LN signature could independently predict disease-specific survival (P = .036). The 4-protein LN signature validated in an independent set of samples strongly suggests that it could reliably distinguish patients with LN metastasis from those who were metastasis-free and therefore could be a prognostic tool for the management of patients with OSCC.
    Matched MeSH terms: Kaplan-Meier Estimate
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