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BACKGROUND: Oral submucous fibrosis (OSMF) is a potentially malignant disorder. Although areca nut chewing is an established risk factor, its low prevalence among nut chewers indicates additional factors likely facilitates pathogenesis. We recently demonstrated high fluoride levels in smokeless tobacco products and hypothesized a potential pathological role of fluoride in OSMF. Further exploring this novel role, this study compared fluoride levels in tissue, serum, and saliva samples from OSMF patients and healthy controls. METHODS: The ethically approved study included 25 clinically confirmed OSMF patients and 25 healthy matched controls. OSMF cases underwent buccal mucosal incisional biopsy, while controls had buccal mucosa tissue sampling during third molar removal. Fasting venous blood and unstimulated saliva were collected. Fluoride levels were analysed using ion chromatography and expressed as median (IQR). RESULTS: OSMF cases showed significantly higher fluoride concentrations compared with controls in tissue biopsies (30.1 vs. 0 mg/kg, p < 0.0001), serum (0.4 vs. 0 mg/L, p = 0.005) and saliva (1.3 vs. 0 mg/L, p < 0.0001). Majority (68%) of controls had undetectable fluoride levels across all samples. Tissue fluoride weakly correlated with OSMF severity (r = -0.158, p = 0.334). CONCLUSION: The preliminary findings demonstrated increased tissue fluoride levels in OSMF patients compared with healthy controls. Along with a previous study showing high fluoride content in smokeless tobacco products, these findings provided early evidence suggesting fluoride could play a contributory role in OSMF pathogenesis. Further large-scale investigation is warranted to definitively establish whether the association between fluoride exposure and OSMF is indicative of causation.
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Fibrosis de la Submucosa Bucal , Tabaco sin Humo , Humanos , Fibrosis de la Submucosa Bucal/patología , Fluoruros/efectos adversos , Proyectos Piloto , Mucosa Bucal/patología , Tabaco sin Humo/efectos adversosRESUMEN
BACKGROUND: Long-term follow-ups after receiving lycopene therapy for management of oral submucous fibrosis (OSMF) are scarce. The study aimed to assess the long-term efficacy of lycopene for management of OSMF symptoms. METHODS: In this prospective clinical study, 400 clinically diagnosed early OSMF patients were assessed for the efficacy of lycopene in alleviation of burning sensation (BS) and reduced mouth opening (MO) symptoms in comparison to placebo. After 1-year follow-up, group A (lycopene group) was divided equally into group A1 and group A2. group A1 patients were retreated with lycopene and the A2 group was followed without retreatment. After 2-year follow-up, the Group A2 patients were advised retreatment but not followed as most of the patient did not agree for follow-up. However, group A1 patients were continued to follow-up every 6 months for a total three years. Statistical analysis was by independent sample t-test and P-value <.05 were considered as significant. RESULTS: A statistically significant difference (P < .05) in BS and MO was found between group A and B with lycopene showing better results. At one-year follow-up, a statistically significant recurrence in the symptoms was found (P < .05) in the lycopene group (group A). After the second intervention, there was a statistically significant difference in the improvement of symptoms between the group A1 and A2 at 6 months and 1 year (P < .05) with group A1 (retreatment) showing better results. CONCLUSIONS: Treatment with lycopene led to improvement in the symptoms of OSMF in the present study. The results highlight the importance of retreatment of lycopene for its long-term effect on alleviation the symptoms of OSMF.
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Fibrosis de la Submucosa Bucal , Estudios de Seguimiento , Humanos , Licopeno , Fibrosis de la Submucosa Bucal/tratamiento farmacológico , Estudios Prospectivos , RecurrenciaRESUMEN
Tumour metastasis is one of the leading cause of cancer-related mortality. Circulating tumour cells (CTCs) have been implicated in loco-regional and distant metastasis and its role is being extensively studied in various malignancies, including those from the head and neck region. The main challenge in understanding their significance lies in the rarity of these cells in the blood. However, newer technologies have attempted to overcome these pitfalls. This review explores the evolution of CTC research and other related areas, including its biological significance, sustainability within the circulating vascular environment and possible clinical implications.
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Productos Biológicos , Neoplasias de Cabeza y Cuello , Células Neoplásicas Circulantes , Recuento de Células , Humanos , Metástasis de la Neoplasia , Células Neoplásicas Circulantes/patologíaRESUMEN
BACKGROUND: Electronic cigarettes (e-cigarettes) and other electronic vaping devices are commonly used as a method to help tobacco smoking cessation. However, the data on their safety and efficacy are currently scarce. The aim of this review was to explore the role of e-cigarettes in tobacco cessation among tobacco users. TYPES OF STUDIES REVIEWED: PubMed, EMBASE, Scopus, Web of Science, and grey literature from January 1990 were searched up to and including September 2018. Two independent reviewers performed the study selection according to eligibility criteria. RESULTS: A total of 13 studies that met the eligibility criteria were included. The majority of studies were done in the USA, and all studies were longitudinal cohort studies. The odds of increased smoking cessation in association with e-cigarette use ranged from onefold to sixfolds. No significant increase in smoking cessation was found among e-cigarette users compared with non-e-cigarette users. Pattern of e-cigarette had positive influence on smoking cessation among users. CONCLUSIONS AND PRACTICAL IMPLICATIONS: E-cigarette use was not significantly associated with increased smoking cessation among cigarette smokers. We also found that pattern of e-cigarette may have significant effect on smoking cessation capability of e-cigarettes. Well-designed randomized controlled clinical trials are needed to assess the clinical efficacy of e-cigarettes in comparison with approved smoking cessation therapies.
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Sistemas Electrónicos de Liberación de Nicotina , Cese del Hábito de Fumar/métodos , Vapeo , Humanos , Estudios Longitudinales , FumadoresAsunto(s)
Neoplasias de la Boca , Industria del Tabaco , Productos de Tabaco , Tabaco sin Humo , Humanos , Control del Tabaco , IndiaRESUMEN
INTRODUCTION: Transcriptomes in saliva can be used as potential biomarkers for both diagnostic and response to treatment in oral squamous cell carcinoma (OSCC). In this review, we explored their application in this increasingly common disease. MATERIALS AND METHODS: PubMed, EMBASE, Scopus, Web of Science and grey literature from January 1990 to May 2017 were searched. Two independent reviewers performed the study selection according to eligibility criteria. RESULTS: A total of nine studies were included. Three studies showed increased expression of DUSP1, IL8, IL1B, OAZ1, SAT1, S100P and two showed increased expression of miRNA-31 among study groups compared to normal healthy controls. The sensitivity ranged from 14% to 100%, while the specificity ranged from 38% to 100%. miRNA-27b had the highest AUC (write in full) of 0.9643 and DUSP1 had the minimum AUC of 0.41. CONCLUSION: Salivary transcriptomics may play an effective role as a robust and non-invasive biomarker sighting tool for the diagnosis and management of OSCC.
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Carcinoma de Células Escamosas/diagnóstico , Neoplasias de la Boca/diagnóstico , Saliva/química , Transcriptoma , Biomarcadores de Tumor/análisis , HumanosRESUMEN
BACKGROUND: Despite much research, there is a lack of a definite protocol or method for documenting oral submucous fibrosis (OSMF) site presentation. In this study, we propose a new potential oral mapping (OM) method and evaluated its use in recording OSMF-affected mucosal sites. METHODS: Fifty OSMF patients were evaluated by 15 primary care dental practitioners using both, a conventional subjective recording method and a new OM method, to document the degree of involvement of affected oral mucosa with a crossover study design. Mann-Whitney test (non-parametric test) was used to make comparison between groups to determine any significant differences between the two identification methods. Wilcoxon tests were used to evaluate any significant differences in the difficulty in identification of two methods. RESULTS: There was a low agreement between the two methods used to detect OSMF in affected mucosal surfaces (P-value < 0.0001). More lesions were identified using the proposed OM method, and less discrepancy was found among dental practitioners. A difference in difficulty of OSMF documentation was found (Wilcoxon z = 3.615, P-value < 0.001), with the proposed OM method found to be easier. CONCLUSION: The proposed OM method appears to be useful for documentation, can easily be adapted in clinical practice, and effectively administered in clinical research. Additionally, it could be a useful tool to helping to maintain an OSMF database.
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Mucosa Bucal/patología , Fibrosis de la Submucosa Bucal/diagnóstico , Estudios Cruzados , Humanos , Estudios ProspectivosRESUMEN
PURPOSE: To understand the role played by the immediate family in treatment decision and support in patients diagnosed with breast cancer, the influence of demographic factors on psychosocial roles of women within the family. METHODS: A mixed method design used for data collection on family support, financial arrangement and psychosocial impact of cancer from 378 women with breast cancer recruited at first diagnosis between 2008 and 2012, during multiple counseling sessions. The median follow-up is 7 years with only 2% lost to follow-up. RESULTS: Most patients (99%) had support from family members. 57% of patients met the costs of treatment through personal savings and health insurance. The rest (43%) had difficulty and had to resort to desperate measures such as selling their property or taking on high-interest personal loans. Patients with higher education and urban settings had better financial management. A male member of the family (husband or son) was the main decision maker in half of the cases. Concerns over women's responsibilities within the family varied by the age of the patient. The vast majority of women (90%) experienced social embarrassment in dealing with the disease and its aftermath. CONCLUSION: In India, it is the family that provides crucial support to a woman with breast cancer during her ordeal with the disease and its treatment. This study has implications on the psychosocial support beyond the cancer patients alone, to include the immediate family and consider aspects of finance and social adjustments as critical in addition to the routine medical aspects of the disease.
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Oral submucous fibrosis (OSMF) is a debilitating condition of oral cavity which has significant potential for malignant transformation. In spite of over 20 years of research, the pathogenesis of the condition is still obscure and no single management modality is effective. Many OSMF treatment protocols have been proposed to alleviate the signs and symptoms of the disorder and there is overwhelming evidence that as areca nut is primary cause, stopping its use may have a considerable effect on symptoms rather than reversing pre-existing fibrosis. We present a review of the current protocols for managing OSMF.
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Fibrosis de la Submucosa Bucal/terapia , Lesiones Precancerosas/terapia , Areca/efectos adversos , Tratamiento Conservador , Humanos , Fibrosis de la Submucosa Bucal/patología , Procedimientos Quirúrgicos Orales , Modalidades de Fisioterapia , Lesiones Precancerosas/patología , Terapia TrombolíticaRESUMEN
Oral submucous fibrosis (OSMF) is a potentially malignant condition associated with areca nut chewing. Formerly confined to the Indian subcontinent, it is now often seen in Asian populations of the United Kingdom, USA and other developed countries, and is therefore a serious problem for global health. What makes it more sinister is the malignant transformation rate, which has been reported to be around 7.6% over a 17-year period. In this concise article, we review the current trends in the pathophysiology of malignant transformation of OSMF.
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Carcinoma de Células Escamosas/patología , Transformación Celular Neoplásica/patología , Neoplasias de la Boca/patología , Fibrosis de la Submucosa Bucal/patología , Lesiones Precancerosas , Areca/efectos adversos , HumanosRESUMEN
AIM: To compare the effects of yoga program with supportive therapy on self-reported symptoms of depression in breast cancer patients undergoing conventional treatment. PATIENTS AND METHODS: Ninety-eight breast cancer patients with stage II and III disease from a cancer center were randomly assigned to receive yoga (n = 45) and supportive therapy (n = 53) over a 24-week period during which they underwent surgery followed by adjuvant radiotherapy (RT) or chemotherapy (CT) or both. The study stoppage criteria was progressive disease rendering the patient bedridden or any physical musculoskeletal injury resulting from intervention or less than 60% attendance to yoga intervention. Subjects underwent yoga intervention for 60 min daily with control group undergoing supportive therapy during their hospital visits. Beck's Depression Inventory (BDI) and symptom checklist were assessed at baseline, after surgery, before, during, and after RT and six cycles of CT. We used analysis of covariance (intent-to-treat) to study the effects of intervention on depression scores and Pearson correlation analyses to evaluate the bivariate relationships. RESULTS: A total of 69 participants contributed data to the current analysis (yoga, n = 33, and controls, n = 36). There was 29% attrition in this study. The results suggest an overall decrease in self-reported depression with time in both the groups. There was a significant decrease in depression scores in the yoga group as compared to controls following surgery, RT, and CT (P < 0.01). There was a positive correlation (P < 0.001) between depression scores with symptom severity and distress during surgery, RT, and CT. CONCLUSION: The results suggest possible antidepressant effects with yoga intervention in breast cancer patients undergoing conventional treatment.
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Oral submucous fibrosis (OSMF) is a premalignant condition associated with chewing areca nut and tobacco products. We observed increased fluoride levels in some OSMF-endemic regions,and the observation suggested that fluoride exposure may contribute to its pathogenesis. This study aimed to assess the fluoride content of various smokeless tobacco items as a potential influencing source. Fluoride concentration was analysed in commercial areca nut products, including gutkha, pan masala, and raw areca nut, along with tobacco, slaked lime, and catechu samples from Karnataka, India. Fluoride was measured using alkali fusion and the ion selective electrode method. All products showed high fluoride, with catechu having the highest mean concentration at 51.20 mg/kg, followed by tobacco, gutkha, pan masala, processed areca nut, and raw areca nut. Fluoride was also elevated in soil, but not in water. The findings demonstrate substantial fluoride levels in popular types of smokeless tobacco, and highlight an overlooked source of exposure among consumers of gutkha, pan masala and similar oral tobacco-products. The fluoride content warrants an investigation of potential links with the occurrence and severity of OSMF.
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Fibrosis de la Submucosa Bucal , Tabaco sin Humo , Humanos , Fluoruros , Areca , Proyectos Piloto , Nueces , IndiaRESUMEN
Background: Lorlatinib, an anaplastic lymphoma kinase (ALK)-inhibitor, is approved as frontline as well as subsequent line of therapy in ALK-rearranged advanced non-small cell lung cancer (NSCLC). There is limited literature about safety and efficacy of lorlatinib in Indian patients. Materials and methods: This was a retrospective multicentre study on patients with ALK-rearranged advanced NSCLC received lorlatinib as second line and beyond between May 2017 and December 2021. ALK was tested either by immunohistochemistry or fluorescent in-situ hybridisation. Clinicopathologic features, treatment details, toxicity and outcomes were analysed. Results: A total of 38 patients were enrolled with a median age of 54 years (range: 30-72) and male: female ratio of 20:18. Fifteen (44%) patients had brain metastases at baseline. Lorlatinib use was - second line in 11 (29%), third line in 21 (55%) and fourth line in 4 (11%) of patients, respectively. The best radiologic response to lorlatinib was - complete response in 9 (24%), partial response in 17 (46%), stable disease in 9 (24%) and progressive disease in 2 (5%) of patients, respectively. After a median follow-up of 76.6 months (95% CI: 68.9-100), the median progression-free survival (PFS) of lorlatinib was not reached (95% CI: 24.3-not reached) and median overall survival (OS) of the whole cohort was 93.1 months (95% CI: 62-not reached). Both median PFS (p = 0.48) and median OS (p = 0.74) was similar between second line and later line use of lorlatinib. Thirty-three (87%) patients experienced treatment-related toxicity and six (16%) patients required dose modification. Conclusion: Lorlatinib was highly efficacious in terms of overall response rate, median PFS and median OS in this small real-world cohort of advanced ALK+ve NSCLC with a manageable safety profile.
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Background: The genetic profiling of non-small cell lung cancer (NSCLC) has contributed to the discovery of actionable targetable mutations, which have significantly improved outcomes in disease with poor prognosis. Molecular epidemiological data of driver mutations in Indian populations have not been extensively elaborated compared to western and eastern Asian NSCLC populations. This study assessed the prevalence and clinical outcomes of EGFR (epidermal growth factor receptor) mutations among the Indian NSCLC cohort in South India. Patients and Methods: Retrospective analysis of 2,003 NSCLC patients who had undergone EGFR mutational analysis from 2013 to 2020 was performed. Clinical analysis was performed for 141 patients from 2013 to 2017 using Kaplan-Meier and Chi-square methods. Descriptive and survival statistics were performed using IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Results: EGFR-sensitizing mutations were detected in 41.6% (834/2003) in the study cohort with compound mutations detected in 7.55% (63/834) of EGFR-positive cases. A significant relationship with regard to female gender and EGFR mutation status (P <.001) was observed. Exon 18 G719X (8.7%) mutations and exon 20 T790M point mutation (3.1%) were the most frequently isolated uncommon EGFR mutations. In the clinical cohort, EGFR mutations were detected at a significantly higher prevalence in females (P =0.002) and never-smokers (P < 0.001). EGFR mutation demonstrated a significant relationship with regard to brain metastasis (P = 0.011). EGFR mutated individuals had significantly longer median overall survival compared to EGFR wild type (26 months vs. 12 months, P = 0.044). Conclusion: We reports the highest number of EGFR mutation analysis performed from India and mutational analysis indicated a loco-regional variation in India with regard to EGFR mutation frequency and its subtypes.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Femenino , Humanos , Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Receptores ErbB/genética , India/epidemiología , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Epidemiología Molecular , Mutación , Inhibidores de Proteínas Quinasas , Estudios RetrospectivosRESUMEN
BACKGROUND: Cardiotoxicity is a commonly observed adverse effect seen in breast cancer (BC) patients undergoing chemotherapy with attributes toward cardiac autonomic dysfunction (CAD). Yoga, a mind-body system of medicine that has been shown to improve cardiac autonomic nervous system (ANS) activity in various health conditions, could be an effective adjuvant approach in addressing CAD. OBJECTIVE: This study aims to investigate the protective effects of Integrated Yoga Therapy (IYT) on ANS functioning, assessed using Heart rate variability (HRV) in breast cancer patients undergoing chemotherapy. METHODS: A total of 68 (stage I-III) BC patients were randomly assigned into 2 groups: Treatment as Usual group (TAU) and TAU with Yoga Therapy group (TAUYT). All patients underwent anthracycline-based adjuvant chemotherapy for a total of 6 cycles with 21 days/cycle. During chemotherapy, the TAUYT group received IYT 5 days a week for 18 weeks, compared with usual care alone in the TAU group. Resting heart rate (RHR) and HRV, measured in both the time and frequency domains, were used to assess the cardiac ANS function of each patient before and after 6 cycles of chemotherapy. RESULTS: A total of 30 subjects in the TAU group and 29 subjects in the TAUYT group were included in the analysis. At baseline (before chemotherapy), there were no significant differences between the TAU and TAUYT groups in terms of RHR and HRV indices. However, after chemotherapy, patients in the TAU group had a significantly higher average RHR (P < .02) and lower HRV indices with reduced parasympathetic indices: RMSSD (P < .01), pNN50% (P < .04), high-frequency power (P < .001) and increased sympathetic indices: low-frequency power (P < .001) with sympathovagal imbalance: LF/HF (P < .001) compared with patients in the TAUYT group. CONCLUSION: The study showed the protective effects of yoga therapy on CAD in patients receiving anthracycline-based chemotherapy for BC, proposing yoga as a potential adjuvant intervention in improving cardiac health and preventing cardiovascular-related morbidities. TRIAL REGISTRATION: This trial is registered with the Clinical Trials Registry-India (CTRI) database (CTRI/2020/10/028446; October 16, 2020).
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Neoplasias de la Mama , Yoga , Femenino , Humanos , Antraciclinas/uso terapéutico , Antibióticos Antineoplásicos , Neoplasias de la Mama/tratamiento farmacológico , Corazón , Cardiopatías/tratamiento farmacológico , Frecuencia Cardíaca/fisiología , MeditaciónRESUMEN
BACKGROUND & OBJECTIVES: Age adjusted incidence rate of lung cancer in India ranges from 7.4 to 13.1 per 100,000 among males and 3.9 to 5.8 per 100,000 among females. The factors affecting survival in lung cancer patients in India are not fully understood. The current study was undertaken to evaluate the factors affecting survival in patients diagnosed with lung cancer attending a tertiary care cancer institute in Bangalore, Karnataka, India. METHODS: Consecutive patients with primary lung cancer attending Bangalore Institute of Oncology, a tertiary care centre at Bangalore, between 2006 and 2009 were included. Demographic, clinical, radiological data were collected retrospectively from the medical records. RESULTS: A total of 170 consecutive subjects (128 males, 42 females) diagnosed to have lung cancer; 151 non-small cell lung cancer (NSCLC) and 19 small cell lung cancer (SCLC) were included. A higher proportion of never-smokers (54.1%) were observed, mostly presenting below the age of 60 yr. Most subjects were in stage IV and III at the time of diagnosis. More than 50 per cent of patients presented with late stage lung cancer even though the duration of symptoms is less than 2 months. The 30-month overall survival rates for smokers and never-smokers were 32 and 49 per cent, respectively. No significant differences were observed in 30 month survival based on age at presentation, gender and type of lung cancer. Cox proportional hazards model identified never-smokers and duration of symptoms less than 1 month as factors adversely affecting survival. INTERPRETATION & CONCLUSIONS: Our results showed that lung cancer in Indians involved younger subjects and associated with poorer survival as compared to other ethnic population. Studies on large sample need to be done to evaluate risk factors in lung cancer patients.
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Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Fumar/efectos adversos , Factores de Edad , Femenino , Humanos , Incidencia , India/epidemiología , Neoplasias Pulmonares/etiología , Masculino , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Tasa de SupervivenciaRESUMEN
Del(5)(q) is a common chromosomal abnormality with favourable prognosis in Myelodysplastic Syndrome (MDS) and Acute myeloid leukemia (AML). However, del(5)(q) is also seen rarely in Acute lymphoblastic leukemia (ALL) and its significance remains poorly understood. We present here, a case report of diagnosis of an adult 75 year old patient of ALL with a cytogenetic abnormality of del(5)(q32). His clinical features, morphology and immunophenotyping findings were suggestive of T-ALL. Relevant literature has been reviewed and discussed.
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Despite a better understanding of the pathophysiology and development of newer therapeutic options, cancer remains an area with several unmet needs. Although overall survival (OS) remains a gold standard endpoint for all cancer therapies, it poses challenges such as the requirement of a long-term follow-up, a higher number of patients, and a higher financial burden. Therefore, surrogate endpoints such as progression-free survival, time to progression, duration of response, and objective response rate are being investigated and used in oncology studies. Patient-related outcomes that measure the patient's overall health, quality of life, and satisfaction in the long term are crucial surrogate endpoints considered for drug approval. Surrogate endpoints shorten oncology clinical studies and accelerate the evaluation and implementation of newer therapies. Emerging surrogate endpoints such as biomarkers, immune-related response criteria, minimal residual disease, and pathological complete response are increasingly being considered in oncology trials. Validation of surrogate endpoints enables their substitution for OS and gain market approval. The selection of surrogate endpoints for an oncology trial depends on cancer type and stage, the purpose of treatment, and expected duration of survival for the relevant disease. With the advent of individualized approach and complex study designs, the field of oncology is currently undergoing a paradigm shift. The use of newer surrogate endpoints will aid in accelerating the drug development process, making patient care for oncology more accessible.
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Neoplasias , Calidad de Vida , Humanos , Oncología Médica , Neoplasias/tratamiento farmacológico , Supervivencia sin Progresión , Proyectos de InvestigaciónRESUMEN
Background: Chemotherapy-related cognitive impairment (CRCI) and cardiac dysfunction (CRCD) are common adverse effects seen in breast cancer patients undergoing chemotherapy. Even though these effects significantly influence daily functioning and overall quality of life, effective strategies to avoid and/or mitigate these adverse effects remain elusive. Yoga as a Mind-body intervention has been used increasingly by cancer patients and has undergone empirical investigations as a potential intervention for patients with cancer. Furthermore, yoga is associated with improved cognition and cardiac functioning in healthy older adults and subjects with cognitive and cardiac impairments. Accordingly, in the current study, yoga holds promise as an intervention to prevent/manage CRCI and CRCD with improved overall QOL in women receiving chemotherapy for breast cancer. Methods: The study is a two-arm, randomized controlled trial. Women diagnosed with stage I-III breast cancer and awaiting neo-adjuvant or adjuvant chemotherapy will be recruited from a tertiary care center in Bangalore, India. Following recruitment, subjects are randomized to the intervention group (integrated yoga therapy intervention during chemotherapy) or the control group (standard care during chemotherapy). The study's primary outcome is to measure the quality of life (cognitive domain) using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The other primary objectives will include cognitive functioning using neuropsychological test battery and cardiac autonomic function testing using heart rate variability. Secondary outcomes are Brain-derived neurotrophic factor (BDNF), brain function (functional MRI), Echocardiography, serum cortisol, Functional assessment of cancer therapy-cognition (FACT-Cog V3), perceived stress scale and Ryff Scales of Psychological Well-Being. Assessments take place before, during and after chemotherapy; 16-weeks post chemotherapy and 1-year post-baseline. Discussion: Yoga is a promising intervention for preventing and/or managing chemotherapy-related adverse effects (CRAE) and enhancing the quality of life among breast cancer patients. The findings from this study may also help understand the inner mechanisms involved in the protective and restorative effects of yoga on CRAE and support the use of yoga prophylactically for breast cancer patients. In addition, the results of this study could help chemotherapy-exposed individuals with other solid cancer types who have cognitive and cardiac issues. Ethics and Dissemination: The study is approved by the ethics committee of the HealthCare Global Enterprises Ltd. Hospital (EC/434/19/01) and National Institute of Mental Health and Neurosciences (NIMH/DO/ETHICS SUB-COMMITTEE (BS&NS) 9th MEETING/2018). Clinical Trial Registration: http://ctri.nic.in/Clinicaltrials/advancesearchmain.php, identifier CTRI/2020/10/028446.
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Vikas OstwalBackground Ramucirumab is considered a standard of care as second-line therapy (CT2) in advanced gastric cancers (AGCs). The aim of this study was to assess practice patterns and outcomes with ramucirumab among Indian patients with AGCs. Materials and Methods A computerized clinical data entry form was formulated by the coordinating center's (Tata Memorial Hospital) medical oncologists and disseminated through personal contacts at academic conferences as well as via email for anonymized patient data entry. The data was analyzed for clinical characteristics, response rates, and survival outcomes. Results A total of 26 physicians contributed data, resulting in 55 patients receiving ramucirumab and being available for analysis. Median age was 53 years (range: 26-78), 69.1% of patients had greater than two sites of disease, and baseline Eastern Cooperative Oncology Group's performance score (ECOG PS) ≥ 2 was seen in 61.8% of patients. Ramucirumab was used as monotherapy in 10.9% of patients, while the remaining 89.1% received ramucirumab combined with chemotherapy. Median event-free survival (EFS) and median overall survival (OS) with ramucirumab were3.53 months (95% CI: 2.5-4.57) and 5.7 months (95% CI: 2.39-9.0), respectively. Common class specific grade adverse events seen with ramucirumab included gastrointestinal (GI) hemorrhage (9.1% - all grades) and uncontrolled hypertension (Grade 3/4 - 3.6%). Conclusions Ramucirumab appears to have similar efficacy in Indian AGC patients when compared with real-world data from other countries in terms of median EFS, but OS appears inferior due to more patients having borderline ECOG PS and high metastatic disease burden. GI hemorrhages appear more common than published data, although not unequivocally related to ramucirumab.