Assessment of novel prognostic biomarkers to predict pathological complete response in patients with non-metastatic triple-negative breast cancer using a window of opportunity design.

Background: Triple-negative breast cancer (TNBC) includes approximately 20% of all breast cancer and is characterized by its aggressive nature, high recurrence rates, and visceral metastasis. Pathological complete response (pCR) is an established surrogate endpoint for survival. The window of opportunity studies provide valuable information on the disease biology prior to definitive treatment. Objectives: To study the association of dynamic change in pathological, imagining, and genomic biomarkers that can prognosticate pCR. The study aims to develop a composite prognostic score. Design: Clinical, interventional, and prognostic biomarker study using the novel window of opportunity design. Methods: The study aims to enroll 80 treatment-naïve, pathologically confirmed TNBC patients, administering a single dose of paclitaxel and carboplatin during the window period before neoadjuvant chemotherapy (NACT). Tumor tissue will be obtained through a tru-cut biopsy, and positron emission tomography and computed tomography scans will be performed for each patient at two time points aiming to evaluate biomarker alterations. This will be followed by the administration of standard dose-dense NACT containing anthracyclines and taxanes, with the study culminating in surgery to assess pCR. Results: The study would develop a composite prognostic risk score derived from the dynamic change in the Ki-67, tumor-infiltrating lymphocytes, Standardized Uptake Value (SUV max), Standardized Uptake Value for lean body mass (SUL max), and gene expression level pre- and post-intervention during the window period prior to the start of definitive treatment. This outcome will aid in categorizing the disease biology into risk categories. Trial registration: The current study is approved by the Institutional Ethics Committee [Ethics: Protocol. no. JIP/IEC/2020/019]. This study was registered with ClinicalTrials.gov [CTRI Registration: CTRI/2022/06/043109]. Conclusion: The validated biomarker score will help to personalize NACT protocols in patients in TNBC planned for definitive treatment.

Precision in action: unveiling predictive biomarkers for enhanced TNBC treatment We are investigating new ways to predict how well a particular treatment will work in patients with a specific type of breast cancer called triple-negative breast cancer. The study goal is to find biomarkers that change in response to drugs to predict the complete elimination of cancer in patients before it spreads to other parts of the body. To do this, we are using a special research approach called a 'window of opportunity design.' This information could be valuable in personalizing and improving cancer treatments.

Clinicopathological profile and its association with peritoneal disease among gastric cancer patients.

BACKGROUND: There are no clinicopathological criteria or test to predict peritoneal metastasis either in primary or recurrent gastric cancer. The early prediction will help in altering or adding other adjuvant potential therapy modalities like HIPEC and maintenance chemotherapy. METHODS: Paraffin based blocks of 110 gastric tumor specimens were subjected to IHC staining to assess VEGF, Her 2 neu, E cadherin, bcl 2 and p 53 expression and its association with peritoneal disease evaluated. RESULTS: Her 2 neu uptake was present in 17.3%, bcl-2 expression in 19.1%, P53 expression in 40.9%, VEGF in 41.8% and E cadherin expression in 49.1% patients. On univariate analysis, a younger age(p = .029), female sex(p = .026), positive VEGF expression (p = .001) and p53 expression(p = .015) were significantly associated with peritoneal disease. A binomial logistic regression was performed to ascertain the effects of independent variables evaluated on univariate analysis. Of the 10 predictors variables, only three were statistically significant: tumor type, P53, and VEGF. Positive VEGF expression had 48.7, E cadherin 2.6 and Her2neu 1.5 times higher odds of exhibiting peritoneal disease. CONCLUSION: A younger age, female sex, distal 2/3rd, diffuse variant, VEGF staining in >10% cells and decrease p53 expression were associated with peritoneal disease.

Hypothermia detection in low birth weight neonates using a novel bracelet device.

OBJECTIVE: The objective of this study is to assess the diagnostic accuracy of a novel hypothermia monitoring and alert bracelet device (BEMPU Bracelet) in low birth weight (LBW) neonates weighing less than 2000 g. DESIGN: This was a controlled prospective study. SETTING: This study was done in the step-down nursery of a tertiary level newborn unit of a major teaching hospital in India. METHODS: Eligible cases fulfilling inclusion criteria were given BEMPU Bracelets for a period of 24 h. A comparison was made between skin temperatures taken at the axilla by a mercury thermometer and skin temperatures taken at the wrist by the BEMPU Bracelet. Temperatures were taken every 6 h and every time the BEMPU Bracelet alarmed. Trained nurses obtained temperature measurements on newborns during their 24-h stay in the hospital step-down nursery. RESULTS: A total of 461 neonates were screened for hypothermia, giving 2428 temperature readings. Three hundred and eleven of 461 babies experienced hypothermia at some point. The 461 babies studied experienced 495 episodes of hypothermia in total. The sensitivity and the specificity of the bracelet in diagnosing hypothermia were 98.6% and 95% respectively. The positive and negative predictive values of the bracelet were 83.6% and 99.6%, respectively. The accuracy of the bracelet in diagnosing hypothermia was 95.8%. CONCLUSION: The BEMPU Bracelet is an accurate screening tool to detect and alert for neonatal hypothermia, thereby facilitating prompt management, which could prevent complications.

Healthcare Associated Infections in a Resource Limited Setting.

INTRODUCTION: Health Care associated Infections (HAI) are the most common complications affecting the hospitalized patients. HAI are more common in developing and under developed countries. However, there are no systematic surveillance programs in these countries. AIM: To find out the burden, predisposing factors and multidrug resistant organisms causing HAI in a resource limited setting. MATERIALS AND METHODS: This prospective observational study was done at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). Patients aged 13 years or more with stay of more than 48 hours in a 16 bedded Medical Intensive Care Unit (MICU) between November 2011 and April 2013 were included in the study. Patients were prospectively followed up till discharge or death for the development of HAI. Device associated HAI like Ventilator Associated Pneumonia (VAP), Catheter Related-Blood Stream Infection (CR-BSI) and Catheter Associated-Urinary Tract Infections (CA-UTI) were studied. Standard laboratory methods were used for identification of microorganisms causing HAI and to test their antibiotic sensitivity. RESULTS: A total of 346 patients were included in the study with median age of 38 years. Common indications for admission to Medical Intensive Care Unit (MICU) were poisoning (31.5%); neurological illness (23.4%) like Guillian-Barre syndrome, tetanus, meningitis, encephalitis; respiratory illness (14.5%) like pneumonia, acute respiratory distress syndrome and tropical infections (7.2%) like malaria, scrub typhus, leptospirosis. Fifty percent (174/346) patients developed one or more HAI with VAP being the most common. The rates of HAI per 1000 device days for VAP, CR-BSI, CA-UTI were 72.56, 3.98 and 12.4, respectively. Acinetobacter baumannii was the most common organism associated with HAI. Multidrug resistance was seen in 74% of the isolates. CONCLUSION: The burden of HAI, especially with MDR organisms, in resource constrained setting like ours is alarming. There is urgent need for infection control and monitoring system to reduce HAI.