Assessing the Prevalence of Financial Toxicity, its Predictors and Association with Health- Related Quality of Life Among Radiation Oncology Patients in India: A Cross-Sectional Patient Reported Outcome Study.

PURPOSE: Financial toxicity has been associated with several clinical outcomes such as early mortality and poor quality of life. The aim of this study was to evaluate the magnitude of financial toxicity among radiation oncology patients and its association with health-related quality of life (HRQOL) in Indian health care settings. METHODS AND MATERIALS: This cross-sectional study was conducted among patients with cancer who had completed radiation therapy, either standalone or as part of a multimodal treatment. Financial toxicity and HRQOL were assessed using the Comprehensive Score for Financial Toxicity (COST) and Functional Assessment of Cancer Therapy: General (FACT-G) measures, respectively. Associations between financial toxicity and HRQOL were assessed using Pearson correlation. Univariate and multivariate regression analyses were conducted to identify the factors associated with financial toxicity. RESULTS: A total of 350 patients were included in this study. Of the 350 participants, 57.7% were male, 95.7% had no health insurance, and 61% were diagnosed with Head & Neck cancers. The average COST score was 15.38 ± 9.18 (range, 2-35), and the average FACT-G score was 69.63 ± 12.25 (range, 33-99). Based on the total COST score, 7.4% of participants reported grade 3 and 44.9% reported grade 2 financial toxicity. A significant positive correlation was observed between the COST and FACT-G scores, with a correlation coefficient of 0.58 (P < .001), indicating a large effect size. The COST score also significantly predicted the FACT-G score (ß = 0.77; 95% confidence interval [CI], 0.66-0.88; P < .001). The results of multivariate linear regression identified annual household income (ß = 3.9; 95% CI, 3.29-4.57; P < .001) and cancer type (ß = 3.74; 95% CI, 2.33-5.14; P < .001) as significant predictors of the COST score. CONCLUSIONS: More than 80% of the participants experienced financial toxicity in this study. The results highlight the need for interventions to alleviate the growing financial toxicity among cancer survivors in India.

Designing of Peptide Based Multi-Epitope Vaccine Construct against Gallbladder Cancer Using Immunoinformatics and Computational Approaches.

Gallbladder cancer (GBC) is an aggressive and difficult to treat biliary tract carcinoma with a poor survival rate. The aim of this study was to design a peptide-based multi-epitope vaccine construct against GBC using immunoinformatics approaches. Three proteins implicated in the progression of GBC were selected for B and T cell epitope prediction and the designing of the potential vaccine construct. Seven CTL, four HTL and six Bcell epitopes along with a suitable adjuvant were selected and connected using linkers for designing the vaccine construct. The secondary and tertiary models of the designed vaccine were generated and satisfactorily validated. A Ramachandran plot of the final 3D model showed more than 90% of the residues in allowed regions and only 0.4% in disallowed regions. The binding affinity of a vaccine construct with TLR 2, 3 and 4 receptors was assessed through molecular docking and simulation. The average numbers of hydrogen bonds for vaccine-TLR 2, 3 and 4 complexes in the simulation were 15.36, 16.45, and 11.98, respectively, and remained consistent over a 100 ns simulation period, which is critical for their function. The results of this study provide a strong basis for further evaluation through in vitro/in vivo experimental validation of the safety and efficacy of the designed vaccine construct.

A Study of Head and Neck Cancer Patients with Reference to Tobacco Use, Gender, and Subsite Distribution.

Richa ChauhanContext Head and neck cancer (HNC) is very common in India, constituting 30% of all the cancers because of the widespread use of tobacco across India. The prevalence and pattern of tobacco use vary in different regions and states of the country. Although predominantly seen in males, studies have reported that the male-to-female ratio varies worldwide and also by anatomical subsite. Aims This study was done with an aim to determine the difference in pattern and prevalence of tobacco use in male and female patients with HNCs and compare them with different subsites' involvement in our region. Methods and Materials This is a retrospective analysis of 500 consecutive biopsy-proven HNC patients from a large comprehensive cancer hospital from Bihar during the period of January 2019 to June 2019. Data collected for the study included age, gender, site of the disease, and use of tobacco. The categorical data were analyzed by a chi-square test using SPSS (version 16). Results Our study showed a male-to-female ratio of 8.43:1 with tobacco addiction in 84.40% patients. Smokeless tobacco was used by 52.20%, combustible form by 12.80%, and both by 19.40% of the patients. Tobacco use was seen in 87.25% of male patients as compared with only 60.38% of female patients ( p -value = 0.0001). Oral cavity cancer was seen in 60.85% of male patients and 37.74% of female patients ( p -value = 0.0012), whereas oropharyngeal cancer was seen in only 11.63% of male patients as compared with 25.83% of female patients ( p -value = 0.0008). The subsite analysis showed that in patients with oral cavity cancers, no addiction was found in only 10.29% of male patients as compared with 30% of the female patients ( p -value = 0.008). Conclusions Our study confirms a high prevalence of tobacco use among HNC patients. So, we need to continue our efforts to create awareness against tobacco use. Besides, there is also a need for more studies to look into other etiological factors among nontobacco users.

A comparative analysis of the clinicopathological profile of early-onset versus late-onset rectal cancer patients.

Introduction: Colorectal cancer has been primarily considered a disease of the elderly, but recent data have shown an alarming rise among young people. It has been also suggested that young age is associated with aggressive histopathological characteristics and advanced stages of the disease at diagnosis. As there are few studies and none from our part of the country evaluating the clinicopathological profile of early-onset versus late-onset rectal cancer patients, this analysis was conducted to assess and compare the clinical and pathological characteristics of patients with rectal cancer diagnosed with ages over and below 50 years. Materials and method: The relevant details of all biopsy proven rectal cancer patients undergoing radiotherapy at a tertiary cancer hospital, from January 2017 to December 2019, were collected. All the data were categorised into two groups, an early-onset group (age <50 years) and a late-onset group (age ≥50 years), and comparison of the clinicopathological characteristics between the two groups was made. Results: A total of 224 patients with rectal cancer, 150 male and 74 female, were included in the study. About two-thirds of the patients were less than 50 years of age, with an average age of 42 years. The comparative analysis showed a significantly higher number of young patients presenting with bleeding and pain. Patients below 50 years also had a significantly higher number of adenocarcinoma grade III and clinical stage III than those in the late-onset group. Conclusion: Our study revealed a significant number of early-onset rectal cancer patients. There should be a high index of suspicion in any young patient presenting with symptoms suggestive of rectal malignancy and they should be evaluated promptly.

Pre-treatment hematological parameters as a cost effective predictive marker for response to concurrent chemo radiation in locally advanced cervical cancer.

INTRODUCTION: Locally advanced cervical cancer is still a major cause of mortality in developing countries. Recently, personalized medicine has changed the treatment paradigm for many solid cancers but no robust biomarkers has yet been validated for predicting response to chemo radiation in cervical cancer patients. AIM: To assess the role of hematological parameters as a cost-effective predictive marker of response to concurrent chemo radiation in cervical cancer patients. MATERIALS AND METHOD: This is a retrospective analysis of 90 cervical cancer patients treated with concurrent chemo radiation in a tertiary cancer center. Clinical details of the patients were extracted from the case records. For end point evaluation, the pre-treatment levels of hemoglobin, neutrophil, lymphocyte, platelet, platelet lymphocyte ratio (PLR) and neutrophil lymphocyte ratio (NLR) were compared and statistically analyzed between responders and non-responders. The optimal cutoff values of hematological parameters were estimated by the receiver operating characteristics (ROC) curve. RESULT: Out of 90 patients, 60 (66.66%) were complete responders and remaining 30 (33.33%) were non-responders. The mean value of platelet, NLR, and PLR was significantly higher in the non-responder group. ROC curve analysis showed the optimal cut-off value of pre-treatment Hb, PLT, NLR and PLR to be 11 gm/dl, 3, 177 × 109/L, and 70 respectively. CONCLUSION: Our study suggests that simple hematological markers like NLR, PLT count and PLR could be used as a cost effective pretreatment predictive marker for response to chemo radiation in cervical cancer patients.

Assessing the reliability and validity of comprehensive score for financial toxicity (COST) among radiation oncology patients in India: a cross-sectional pilot study.

BACKGROUND: Besides physical toxicity, cancer care imposes significant financial distress referred to as financial toxicity (FT). FT has become a growing concern among cancer patients. Researchers have associated FT among cancer patients with clinical outcomes like mortality, poor quality of life and non-adherence. Currently, no reliable tools are available for assessing FT among cancer patients in India. The aim of this pilot study was to test the reliability and validity of the Comprehensive Score for Financial Toxicity (COST) questionnaire among patients undergoing radiotherapy in India. MATERIAL AND METHODS: This cross-sectional pilot study was conducted among head and neck cancer patients on follow-up in radiation oncology department. The reliability of COST measure was assessed using Cronbach's α. The underlying construct of COST was verified by Exploratory Factor Analysis (EFA). EFA was performed using parallel analysis technique. RESULTS: Based on inclusion and exclusion criteria, the COST questionnaire was administered to 29 patients using the interview method after written informed consent. The COST measure demonstrated excellent reliability with Cronbach's α of 0.92. A Kaiser-Meyer-Olkin of 0.87 verified the sample adequacy and a p-value of ˂0.001on Bartlett's sphericity test indicated that the strength of the correlation between 11 COST items was good to perform the EFA. Parallel analysis technique identified one factor on scree plot with eigenvalue of 6.21 explaining 56.5% of the variance by non-rotated solution. All the factor loadings in one factor model were ˃0.3 (range 0.35-0.97). The factor loadings indicated that the underlying construct can be considered as one factor domain as intended by the original COST development study. However, Chi-square goodness of fit test revealed the one factor model did not adequately depict the data. However, the results were consistent with the construct obtained in the original scale development study. CONCLUSION: This pilot study demonstrated excellent reliability of COST for measuring FT among radiation oncology patients. Further studies are warranted to study the clinical implications of FT in the Indian population for making better strategies and policies to ease the financial burden on cancer patients.

Development and Validation of Subjective Financial Distress Questionnaire (SFDQ): A Patient Reported Outcome Measure for Assessment of Financial Toxicity Among Radiation Oncology Patients.

BACKGROUND: Financial toxicity is a consequence of subjective financial distress experienced by cancer patients as a result of treatment expenditures. Financial toxicity has been associated with poor quality of life, early mortality, and non-adherence. It is evident from the literature that the currently available instruments for the assessment of financial toxicity do not measure coping and support seeking domains. The aim of this study was to develop an instrument for the assessment of financial toxicity among radiation oncology patients that captures and integrates all the relevant domains of subjective financial distress. MATERIALS AND METHODS: The study was conducted among Head & Neck cancer (HNC) patients (age ≥18 years) who have completed the radiotherapy either as stand-alone or part of a multimodal treatment. Literature review, expert opinion, and patient interviews were used for scale item generation. The validity and underlying factor structure were evaluated by Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA). The reliability and internal consistency of the final scale was assessed using Cronbach's alpha coefficient. RESULTS: A total of 17 items were identified for scale development. The preliminary 17-item instrument was administered to 142 HNC patients. Among 142 participants, 85.9% were male and 98.6% were from rural areas. EFA was performed on 17 items and three items were removed (factor loadings <0.5). The remaining 14 items loaded onto three factors (eigenvalue >1) explaining 62.0% of the total variance. The Chi-square goodness of fit test in CFA and the values of other model fit indices, namely, RMSEA = 0.045, SRMR = 0.014, GFI = 0.92, CFI = 0.98, and TLI=0.97 indicate a good model fit suggesting the three-factor model adequately fits the data. The Cronbach's α for the final 14-item scale was 0.87 indicating excellent reliability and the Cronbach's α coefficient of all the individual 14 items was ≥0.85 (range 0.85-0.88). CONCLUSION: The SFDQ showed excellent validity and reliability. SFDQ captures and integrates all the relevant domains of financial toxicity. However, the provisional SFDQ instrument warrants further larger sample studies for validation and psychometric evaluation in different primary cancer subsites and treatment modalities from multiple cancer centers to improve the generalizability of this instrument.

A Comparative Analysis of Body Mass Index with Estrogen Receptor, Progesterone Receptor and Human Epidermal Growth Factor Receptor 2 Status in Pre- and Postmenopausal Breast Cancer Patients.

BACKGROUND: Breast cancer is now the most common cancer among Indian women. Recent studies have suggested a possible link between risk factors like high BMI and molecular subtypes of breast cancer. Studies from Western and Asian population have shown varying relationship between post- menopausal obesity and expression of ER, PR, Her2-neu receptors in breast cancer patients. AIM: This study was done with an aim to explore if overweight or obesity as defined by BMI and status of ER, PR and Her2-neu receptors differ in Indian pre-menopausal and post-menopausal breast cancer patients. METHODS AND MATERIAL: This is a retrospective analysis of 446 breast cancer patients treated at Mahavir Cancer Sansthan, Patna from July to December 2019. Their case records were evaluated and data regarding age, menopausal status, height, weight and ER, PR & HER2-neu receptor status were extracted for analyses. STATISTICAL ANALYSIS: Chi-square test was used to compare categorical variables between the pre-menopausal and post-menopausal group. RESULTS: The prevalence of obesity in the post-menopausal group was 2.3% more than the pre-menopausal group (P-value = 0.24). As compared to the pre-menopausal group, there was an increase in the ER/PR positivity in the postmenopausal group by 3.41% (P-value = 0.47) and in the Her2-neu positivity by 6.38% (P-value = 0.15). As compared to the pre-menopausal group, there was further increase in the ER/PR positivity in the post-menopausal group by 6.85% (P-value = 0.40) in sub-group of patients with BMI ≥ 25kg/m2. CONCLUSIONS: Our study showed slightly increased incidence of obesity in post-menopausal breast cancer patients. Overweight post-menopausal patients also had a higher percentage of ER/PR receptor positivity and lower percentage of Triple negative breast cancer. The percentage of Her2-neu receptor positivity was more in post-menopausal patients. A high BMI was found to be associated with a lower Her2neu positivity.

Inflammatory markers in cancer: Potential resources.

Cancer is a leading cause of death worldwide and a major burden on developing and less developed countries of the world with limited resources for prevention and effective treatment of cancer. Although cancer is multifactorial in origin, various epidemiological and experimental studies suggest that chronic inflammation has an important role in all stages of cancer, from initiation to progression and even survival of the patient. Inflammatory products like cytokines, chemokines, leucocytes, prostaglandins, cyclooxygenase, reactive oxygen and nitrogen species, metalloproteinase induce genetic and epigenetic changes in normal cells damaging its DNA, inhibiting its repair, altering transcription factors, preventing apoptosis, and stimulating angiogenesis, and thus resulting in carcinogenesis. Thus, these inflammatory mediators have a potential role to become cancer biomarkers for all stages of cancer as many of them can be measured in a cost-effective manner. However, large scale prospective trials are required to validate these potential cancer biomarkers. Nonetheless, a transition from potential to practical utilization of these markers will be an effective tool for the amelioration of cancer burden and mortality in a resource limited setting.

Metaplastic Carcinoma Breast: A Clinical Analysis of Nine Cases.

Metaplastic Breast Carcinoma (MBC) is a rare heterogeneous group of primary breast malignancies with different subgroups; exhibits a variety of histopathologic patterns and appears to be both epithelial and mesenchymal in origin. The ideal treatment for MBC remains unknown, due to its low incidence and pathological variability. Owing to its rarity, MBC has been treated as a variant of Invasive Duct Carcinoma (IDC). But it has poorer prognosis as compared to IDC. This is a case series to evaluate clinicopathologic characteristics and the multi-disciplinary treatment of nine MBC patients treated in a single institute.

Leiomyosarcoma of Penis: An Aggressive and Exceptionally Rare Entity.

Penile leiomyosarcoma is a very rare disease of penile mesenchymal tissue, most of them are of vascular origin and pathologically classified into the superficial and deep type. Because of the small number of cases reported so far, the conclusions about treatment and prognosis are equivocal. Here we report a case of 40-year old patient who presented with leiomyosracoma of penis; despite adequate surgery patient developed local recurrence and distant metastasis indicating aggressive nature of leiomyosarcoma entity of penis.

Arsenic Exposure and Haematological Derangement in Cervical Cancer Cases in India.

Cervical cancer is the second most common gynecological malignancy worldwide. According to HPV Information Centre, Spain (Aug'2014), in India approximately 1,22,844 women are diagnosed with the disease every year and of them 67,477 die due to the disease. CaCx is said to be mediated by HPV but recent data published reveal the role of Oxidative Stress in different Cancers. Arsenic is also one of the agents for causing Oxidative Stress. Arsenic has been linked with different types of cancer. Arsenic is considered responsible for generation of free radicals and eventually for apoptosis. Early diagnosis of CaCx is presently a matter of concern and clinical presentation in advanced stages become difficult for complete clinical response. For determination of oxidative stress, Malondialdehyde (MDA) was taken as an identifier and arsenic estimation was performed with the help of Atomic Absorption Spectrometer (AAS). RBC count and Haemoglobin levels were performed according to standard protocol. MDA was in direct proportion with arsenic concentration and inversely proportional to RBC and Haemoglobin in CaCx patients. Arsenic is one of the major causative agents for oxidative stress and hence may be a risk factor leading to cancer including CaCx.