Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.
The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.
The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.
The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).
by Ashwini Arunachalam, Sneha Sura, John Murphy, Paul Conkling, Jerome Goldschmidt
BackgroundIn 2018, the treatment options for unresectable stage III non-small cell lung cancer (NSCLC) changed with durvalumab, an immune checkpoint inhibitor (ICI), which was approved for consolidation therapy following concurrent chemoradiotherapy (cCRT) without disease progression. Despite durvalumab’s clinical benefit, many patients receiving this therapy developed progression. This study evaluated treatment patterns and clinical outcomes in real-world community oncology practices for patients with unresectable stage III NSCLC who received cCRT.
MethodsThis study used The US Oncology Network’s (iKnowMed) electronic health record database supplemented by chart review and included adults diagnosed with unresectable stage III NSCLC initiating cCRT between 11/01/2017 and 10/31/2019, with follow-up through 04/30/2022. cCRT included concurrent treatment with platinum-based chemotherapy and radiation therapy (+/-14 days). Real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) were estimated from cCRT initiation using the Kaplan–Meier method.
ResultsAmong 426 patients, 61.5% received durvalumab post-cCRT (cCRT+durvalumab) and 38.5% did not (cCRT alone). Death (28.3%) and disease progression (22.2%) were the most common reasons for not initiating durvalumab. The median age for the cCRT+durvalumab and cCRT alone cohorts were 70 and 71 years, and 71.8% and 61.6% had Eastern Cooperative Oncology Group performance status of 0–1, respectively. 51.5% of cCRT+durvalumab discontinued durvalumab, primarily due to adverse events (35.8%) and disease progression (28.4%). Median rwOS was 50.2 (95% confidence interval [CI]:41.4, not reached) and 11.6 (95% CI:6.5,15.9) months for cCRT+durvalumab and cCRT alone, respectively. Median rwPFS was 28.5 (95% CI:23.3,36.4) months for cCRT+durvalumab and 6.3 (95% CI:4.3,9.3) months for cCRT alone, respectively. 23.7% (cCRT+durvalumab) and 26.2% (cCRT alone) received subsequent treatment, of which, 59.7% (cCRT+durvalumab) and 46.5% (cCRT alone) received ICI.
ConclusionFour out of ten patients did not receive consolidation durvalumab mainly due to disease progression. Even among patients who initiated durvalumab, many patients relapsed and were retreated with ICIs. These findings underscore the need to refine treatment strategies for better outcomes in stage III unresectable NSCLC.