Treatment Outcomes of Adenoid Cystic Carcinomas of the Head and Neck Region-A Single-Institution Experience.

Malu RafiObjectives This study was undertaken to evaluate the characteristics and treatment outcomes of patients with adenoid cystic carcinomas of the head and neck region treated at a tertiary cancer center in south India. Materials and Methods This was a retrospective study done on patients treated at the institute between 2004 and 2011. Clinicopathological details and treatment outcomes were captured from the treatment records to estimate the treatment outcomes and factors affecting them. Results There were a total of 140 patients with mean age of presentation of 46 years and a median follow-up of 65 months. The most common single site of presentation was the oral cavity. One-hundred eighteen patients (84.3%) underwent primary surgical resection in which 38% had negative surgical margins. Ninety-nine patients were given adjuvant radiotherapy and 18 patients received radical radiotherapy, mostly for surgically inaccessible and inoperable tumors. Median time to recurrence and distant metastasis was 37 and 34 months, respectively. The overall survival and disease-free survival estimate using the Kaplan-Meier method were 92.3 and 71.9%, respectively, at 5 years. Surgical removal of the primary tumor and the nodal stage had the most significant impact on the overall survival outcomes of these patients. Conclusion Surgery remains the most impactful treatment modality in the management of these rare epithelial tumors. The use of adjuvant radiotherapy may help to tackle the issues of perineural spread and inadequate surgical margins in technically difficult sites. Radical radiotherapy also has impressive response rates.

Perspective on oral cancer screening: Time for implementation research and beyond.

Screening aims to detect cancer in asymptomatic populations. In oral cancer, clinical oral examination is the current standard method for screening. Oral cancer screening may be performed by a physician or a healthcare workers and is an affordable and feasible method. There is some evidence that this low-cost method is effective in decreasing mortality from oral cancer in high risk population. The cluster-randomised trial in India that had 15 years of follow-up reported an 81 % mortality reduction in high-risk populations of tobacco and/or alcohol users who adhered to four screening rounds. The observational studies similarly reported 21-22 % reduction in advanced oral cancer and 24-26 % reduction in oral cancer mortality among high risk population. Implementation and evaluation of oral cancer screening programmes in high risk population will support the goals of the World Health Organisation on global oral health.

Outcomes of organ preservation treatment in advanced laryngeal carcinoma: A retrospective analysis from a single institution.

Chemoradiation is the standard treatment for patients with locally advanced laryngeal carcinoma with intact cartilage and functional larynx. The aim of this retrospective study was to assess overall survival (OS) and disease-free survival (DFS) of patients with locally advanced (stage III and stage IV) squamous cell carcinoma of the larynx who have been treated with definitive radical radiotherapy (RT) with or without chemotherapy in a tertiary cancer center in India between January 1, 2006 and December 31, 2015. Data were collected using structured proforma. The patients were treated with RT alone, induction chemotherapy (IC) followed by RT, concurrent chemoradiation therapy (CCRT) or IC followed by CCRT. Response assessment was conducted at 3-4 months post-treatment. Patient-, tumor- and treatment-related factors were documented and were associated with DFS and OS. Survival curves were generated using the Kaplan-Meier method and the statistical significance of survival curves was assessed using the log-rank test. Prognostic factors were assessed using the Cox proportional hazards regression model. A total of 630 patients were included in the present study. The most common age group at presentation was 50-70 years (n=477; 75.7%) and 95.4% (n=601) patients were male. The most common stage at presentation was stage III (n=367, 58.1%). The median follow-up period for the entire group of was 59 months (range, 2-175 months). A complete response after treatment was seen in 549 patients (87.1%). Salvage surgery was performed for 11 patients with residual disease. A total of 134 patients (21.3%) had developed locoregional and distant relapses, and salvage surgery was performed for 31 out of 102 patients with locoregional relapse. The 5-year OS was 48.7% and the 5-year DFS was 45.7%. The stage-wise OS rates were 58.9, 34.9 and 30.4% (P=0.001) and the stage-wise DFS rates were 56.3, 32.0 and 21.7 (P=0.001) for stage III, IVa and IVb, respectively. Results from the present study demonstrated the feasibility of delivery of chemoradiation protocols with good results in a developing country.

Effectiveness of triennial screening with clinical breast examination: 14-years follow-up outcomes of randomized clinical trial in Trivandrum, India.

BACKGROUND: This study presents the preliminary results of a randomized controlled trial (RCT) initiated in January 2006 in India to evaluate the effectiveness of clinical breast examination (CBE) in reducing breast cancer mortality as compared to a no-screening control group reported significant downstaging in the intervention group. The present manuscript reports long-term follow-up outcomes. METHODS: Women 30-69 years old from 133 intervention clusters and 141 control clusters were invited to participate. Women in the intervention arm underwent three rounds of CBE every 3 years. CBE-positive women were reexamined by a physician, and triple-assessment was performed on those confirmed to have abnormalities. All participants were followed through home visits and linkage with population-based cancer registry. RESULTS: Of the 55,843 eligible women in the intervention arm, 95.7% had CBE at least once and 11.5% were CBE-positive. Breast cancers were diagnosed in 335 participants in the intervention group and 273 in the control group (N = 59,447). Age-standardized incidence rate of early cancer was 30.4 of 100,000 in the intervention and 21.9 of 100,000 in the control group, with a rate ratio (RR) of 1.4 (95% confidence interval [CI], 1.1-1.8). The age-standardized breast cancer mortality rates were 11.3 and 11.1 per 100,000 in intervention and control arms, respectively (RR, 1.1; 95% CI, 0.8-1.5) after 15 years. Five-year breast cancer survival rates were 77.0% in the intervention and 71.2% in the control groups (overall p value = .043). CONCLUSIONS: Triennial CBE screening failed to demonstrate any mortality benefit despite achieving a shift toward earlier stage at detection and improved survival in the intervention arm. CBE is a valuable tool for diagnosis of breast cancer in symptomatic women especially in areas where mammography and/or breast cancer screening programs are not widely available.

Epstein-Barr virus dynamics and its prognostic impact on nasopharyngeal cancers in a non-endemic region.

Background: Epstein-Barr virus (EBV) DNA quantification in nasopharyngeal cancer (NPC) is an indicator of the tumour burden, stage and survival. Although EBV dynamics in endemic regions has been extensively studied and reported, the data from non-endemic regions is sparse. This study attempts to investigate the EBV dynamics in NPC patients from a non-endemic region and also to identify the factors impacting the outcomes. Materials and methods: This was a prospective observational study conducted at a tertiary care centre in South India and enrolled patients with non-metastatic, biopsy proven NPC, who were suitable for radical chemo-radiotherapy with or without induction chemotherapy. Two blood samples, one prior to initiation of any anticancer treatment, and second at 6 weeks post treatment, were collected to quantify EBV DNA using real-time quantitative polymerase chain reaction. Antibodies against EBV viral capsid antigen (EBV VCA IgM), EBV Early Antigen (EBV EA IgG) and EBV Nuclear Antigen (EBV EBNA IgG) were also measured in the sample. The impact of EBV dynamics on the outcomes was then analysed. Results: The study included a total of 35 patients. Thirty-three had identifiable EBV DNA (94.3%) and a histological diagnosis of non-keratinising undifferentiated type of squamous cell carcinoma. There was no correlation between the EBV DNA and anti-EBV antibodies. There was a significant association between composite stage and pre-treatment DNA titre (p = 0.030). The mean EBV DNA titre was lower for patients with no clinically demonstrable disease at last follow-up and the reduction in EBV DNA titres was significant (p = 0.020) for those patients who remained disease free. Conclusion: Plasma EBV DNA is an accurate and reliable biomarker for NPC for WHO type 2 and 3 tumours even in non-endemic regions.

Stage migration and treatment outcome in carcinoma tongue - A comparison of seventh and eighth AJCC pathological staging systems.

Background: The eighth edition of the American Joint Committee on Cancer (AJCC) for oral cancer has incorporated additional pathological features like depth of invasion (DOI) and extranodal extension (ENE) into T and N staging. The incorporation of these two factors will impact the staging and, hence, the treatment decisions. The aim of the study was to clinically validate the new staging system in predicting the outcome in patients treated for carcinoma oral tongue. The study also examined the correlation of pathological risk factors with survival. Methods: We studied 70 patients with squamous cell carcinoma of the oral tongue who underwent primary surgical treatment at a tertiary care center in the year 2012. All these patients were restaged pathologically according to the new AJCC eighth staging system. The 5-year overall survival (OS) and disease-free survival (DFS) were calculated using the Kaplan-Meier method. Akaike information criterion and concordance index were calculated between both staging systems to identify a better predictive model. Log-rank test and univariate Cox regression analysis were conducted to find out the significance of different pathological factors on outcome. Results: Incorporation of DOI and ENE resulted in 47.2% and 12.8% stage migration, respectively. DOI less than 5 mm was associated with a 5-year OS and DFS of 100% and 92.9%, respectively, compared to 88.7% and 85.1%, respectively, when the DOI was more than 5 mm. Presence of lymph node involvement, ENE, and perineural invasion (PNI) were associated with inferior survival. The eighth edition had lower Akaike information criterion and improved concordance index values compared with the seventh edition. Conclusion: The eighth edition of AJCC allows better risk stratification. Restaging of cases based on the eighth edition AJCC staging manual resulted in significant upstaging with difference in survival.

Risk-Based Selection of Individuals for Oral Cancer Screening.

PURPOSE: We evaluated proof of principle for resource-efficient, risk-based screening through reanalysis of the Kerala Oral Cancer Screening Trial. METHODS: The cluster-randomized trial included three triennial rounds of visual inspection (seven clusters, n = 96,516) versus standard of care (six clusters, n = 95,354) and up to 9 years of follow-up. We developed a Cox regression-based risk prediction model for oral cancer incidence. Using this risk prediction model to adjust for the oral cancer risk imbalance between arms, through intention-to-treat (ITT) analyses that accounted for cluster randomization, we calculated the relative (hazard ratios [HRs]) and absolute (rate differences [RDs]) screening efficacy on oral cancer mortality and compared screening efficiency across risk thresholds. RESULTS: Oral cancer mortality was reduced by 27% in the screening versus control arms (HR = 0.73; 95% CI, 0.54 to 0.98), including a 29% reduction in ever-tobacco and/or ever-alcohol users (HR = 0.71; 95% CI, 0.51 to 0.99). This relative efficacy was similar across oral cancer risk quartiles (P interaction = .59); consequently, the absolute efficacy increased with increasing model-predicted risk-overall trial: RD in the lowest risk quartile (Q1) = 0.5/100,000 versus 13.4/100,000 in the highest quartile (Q4), P trend = .059 and ever-tobacco and/or ever-alcohol users: Q1 RD = 1.0/100,000 versus Q4 = 22.5/100,000; P trend = .026. In a population akin to the Kerala trial, screening of 100% of individuals would provide 27.1% oral cancer mortality reduction at number needed to screen (NNS) = 2,043. Restriction of screening to ever-tobacco and/or ever-alcohol users with no additional risk stratification would substantially enhance efficiency (43.4% screened for 23.3% oral cancer mortality reduction at NNS = 1,029), whereas risk prediction model-based screening of 50% of ever-tobacco and/or ever-alcohol users at highest risk would further enhance efficiency with little loss in program sensitivity (21.7% screened for 19.7% oral cancer mortality reduction at NNS = 610). CONCLUSION: In the Kerala trial, the efficacy of oral cancer screening was greatest in individuals at highest oral cancer risk. These results provide proof of principle that risk-based oral cancer screening could substantially enhance the efficiency of screening programs.

Sociodemographic Factors and Stage of Cancer at Diagnosis: A Population-Based Study in South India.

PURPOSE: Lower socioeconomic status is associated with inferior cancer survival in high-income countries, but whether this applies to low- and middle-income countries is not well described. Here, we use a population-based cancer registry to explore the association between educational level and stage of cancer at diagnosis in South India. METHODS: We used the Trivandrum District population-based cancer registry to identify all cases of breast and cervical cancer (women) and oral cavity (OC) and lung cancer (men) who were diagnosed from 2012 to 2014. Educational status-classified as illiterate/primary school, middle school, or secondary school or higher-was the primary exposure of interest. Primary outcome was the proportion of patients with advanced stage disease at diagnosis defined as stage III and IV (breast, cervix, or OC) or regional/metastatic (lung). RESULTS: The study population included 4,547 patients with breast (n = 2,283), cervix (n = 481), OC (n = 797), and lung (n = 986) cancer. Educational status was 22%, 19%, and 26% for illiterate/primary, middle, and secondary school or higher, respectively. Educational status was missing for 33% of patients. The proportion of all patients with advanced stage disease was 37% (breast), 39% (cervix), 67% (OC), and 88% (lung). Patients with illiterate/primary school educational status were considerably more likely to have advanced breast cancer (50% v 39% v 36%; P < .001), cervix cancer (46% v 43% v 24%; P = .002), and OC cancer (77% v 76% v 59%; P < .001) compared with patients with higher educational levels. The proportion of patients with advanced lung cancer did not vary across educational levels (89% v 84% v 88%; P = .350). CONCLUSION: A substantial proportion of patients in South India have advanced cancer at the time of diagnosis. This is particularly true among those with the lowest levels of education. Future health awareness and preventive interventions must target less-educated communities to reduce delays in seeking medical care for cancer.

Setup uncertainties and PTV margins at different anatomical levels in intensity modulated radiotherapy for nasopharyngeal cancer.

AIM: To determine the systematic error (∑), random error (σ) and derive PTV margin at different levels of the target volumes in Nasopharyngeal Cancer (NPC). MATERIALS AND METHODS: A retrospective offline review was done for patients who underwent IMRT for NPC from June 2015 to May 2016 at our institution. Alternate day kV images were matched with digitally reconstructed radiographs to know the setup errors. All radiographs were matched at three levels - the clivus, third cervical (C3) and sixth cervical (C6) vertebra. The shifts in positions along the vertical, longitudinal and lateral axes were noted and the ∑ and σ at three levels were calculated. PTV margins were derived using van Herk's formula. RESULTS: Twenty patients and 300 pairs of orthogonal portal films were reviewed. The ∑ for the clivus, C3 and C6 along vertical, longitudinal and lateral directions were 1.6 vs. 1.8 vs. 2 mm; 1.2 vs. 1.4 vs. 1.4 mm and 0.9 vs. 1.6 and 2.3 mm, respectively. Similarly, the random errors were 1.1 vs. 1.4 vs. 1.8 mm; 1.1 vs. 1.2 vs. 1.2 mm and 1.2 vs. 1.3 vs. 1.6 mm. The PTV margin at the clivus was 4.4 mm along the vertical, 4 mm along the longitudinal direction and 3.2 m in the lateral direction. At the C3 level, it was 5.5 mm in the vertical, 5 mm in the lateral direction and 4.4 mm in the longitudinal direction. At the C6 level, it was 6.4 mm in the vertical, 6.9 mm in the lateral direction and 4.4 mm in the longitudinal direction. CONCLUSION: A differential margin along different levels of target may be necessary to adequately cover the target.

Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer.

BACKGROUND: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m2) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. OBJECTIVES: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m2) with weekly cisplatin (40 mg/m2) concurrently with radiation in patients with locally advanced head and neck cancer. PATIENTS AND METHODS: This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m2 3 weekly and Arm B received cisplatin 40 mg/m2 weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan-Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment. RESULTS: The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively (P = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively (P = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms. CONCLUSION: This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in).

Associations of body mass index, smoking, and alcohol consumption with prostate cancer mortality in the Asia Cohort Consortium.

Many potentially modifiable risk factors for prostate cancer are also associated with prostate cancer screening, which may induce a bias in epidemiologic studies. We investigated the associations of body mass index (weight (kg)/height (m)(2)), smoking, and alcohol consumption with risk of fatal prostate cancer in Asian countries where prostate cancer screening is not widely utilized. Analysis included 18 prospective cohort studies conducted during 1963-2006 across 6 countries in southern and eastern Asia that are part of the Asia Cohort Consortium. Body mass index, smoking, and alcohol intake were determined by questionnaire at baseline, and cause of death was ascertained through death certificates. Analysis included 522,736 men aged 54 years, on average, at baseline. During 4.8 million person-years of follow-up, there were 634 prostate cancer deaths (367 prostate cancer deaths across the 11 cohorts with alcohol data). In Cox proportional hazards analyses of all cohorts in the Asia Cohort Consortium, prostate cancer mortality was not significantly associated with obesity (body mass index >25: hazard ratio (HR) = 1.08, 95% confidence interval (CI): 0.85, 1.36), ever smoking (HR = 1.00, 95% CI: 0.84, 1.21), or heavy alcohol intake (HR = 1.00, 95% CI: 0.74, 1.35). Differences in prostate cancer screening and detection probably contribute to differences in the association of obesity, smoking, or alcohol intake with prostate cancer risk and mortality between Asian and Western populations and thus require further investigation.

Burden of total and cause-specific mortality related to tobacco smoking among adults aged ≥ 45 years in Asia: a pooled analysis of 21 cohorts.

BACKGROUND: Tobacco smoking is a major risk factor for many diseases. We sought to quantify the burden of tobacco-smoking-related deaths in Asia, in parts of which men's smoking prevalence is among the world's highest. METHODS AND FINDINGS: We performed pooled analyses of data from 1,049,929 participants in 21 cohorts in Asia to quantify the risks of total and cause-specific mortality associated with tobacco smoking using adjusted hazard ratios and their 95% confidence intervals. We then estimated smoking-related deaths among adults aged ≥45 y in 2004 in Bangladesh, India, mainland China, Japan, Republic of Korea, Singapore, and Taiwan-accounting for ∼71% of Asia's total population. An approximately 1.44-fold (95% CI = 1.37-1.51) and 1.48-fold (1.38-1.58) elevated risk of death from any cause was found in male and female ever-smokers, respectively. In 2004, active tobacco smoking accounted for approximately 15.8% (95% CI = 14.3%-17.2%) and 3.3% (2.6%-4.0%) of deaths, respectively, in men and women aged ≥45 y in the seven countries/regions combined, with a total number of estimated deaths of ∼1,575,500 (95% CI = 1,398,000-1,744,700). Among men, approximately 11.4%, 30.5%, and 19.8% of deaths due to cardiovascular diseases, cancer, and respiratory diseases, respectively, were attributable to tobacco smoking. Corresponding proportions for East Asian women were 3.7%, 4.6%, and 1.7%, respectively. The strongest association with tobacco smoking was found for lung cancer: a 3- to 4-fold elevated risk, accounting for 60.5% and 16.7% of lung cancer deaths, respectively, in Asian men and East Asian women aged ≥45 y. CONCLUSIONS: Tobacco smoking is associated with a substantially elevated risk of mortality, accounting for approximately 2 million deaths in adults aged ≥45 y throughout Asia in 2004. It is likely that smoking-related deaths in Asia will continue to rise over the next few decades if no effective smoking control programs are implemented. Please see later in the article for the Editors' Summary.

Managing the changing burden of cancer in Asia.

Asia accounts for 60% of the world population and half the global burden of cancer. The incidence of cancer cases is estimated to increase from 6.1 million in 2008 to 10.6 million in 2030, due to ageing and growing populations, lifestyle and socioeconomic changes. Striking variations in ethnicity, sociocultural practices, human development index, habits and dietary patterns are reflected in the burden and pattern of cancer in different regions. The existing and emerging cancer patterns and burden in different regions of Asia call for political recognition of cancer as an important public health problem and for balanced investments in public and professional awareness. Prevention as well as early detection of cancers leads to both better health outcomes and considerable savings in treatment costs. Cancer health services are still evolving, and require substantial investment to ensure equitable access to cancer care for all sections of the population. In this review, we discuss the changing burden of cancer in Asia, along with appropriate management strategies. Strategies should promote healthy ageing via healthy lifestyles, tobacco and alcohol control measures, hepatitis B virus (HBV) and human papillomavirus (HPV) vaccination, cancer screening services, and vertical investments in strengthening cancer healthcare infrastructure to improve equitable access to services.

Efficacy of Varunadi Ghritha (polyherbal compound) in treated head and neck cancer cases as a biological response modifier.

BACKGROUND: Persistent immune suppression is reported in Head and Neck Cancers (HNC) even after treatment and a higher recurrence rate was observed in patients with poor CD3 count. Loco regional recurrences and second primary tumours are the common forms of failure in head and neck cancers. Several agents have been tried to overcome this problem without much benefit. In Ayurveda, several plant based products have been reported to have anti-tumour and immunomodulatory properties. AIM: To test the role of Varunadi Ghritha, as an immunomodulator in apparently healthy, treated and controlled HNC patients and to evaluate its effectiveness in preventing locoregional relapses and development of second primary tumours. MATERIALS AND METHODS: Total 78 patients of treated head and neck cancers were randomly selected for intervention and control group. Patients in the intervention group (n = 38) received Varunadi Ghritha, 5gms twice daily for one year and followed up to two years. Patients in the control group (n = 40) were followed up at regular intervals. Immune parameters were assessed in the peripheral blood at base line and at the end of administration of the study compound. RESULTS: In the intervention group, mean percentage increase in CD3, CD19 and CD16 positive cells were significantly higher after the administration of the study compound compared to the control group indicating an immunomodulatory effect of the study compound. A non-significant improvement in disease control was observed in patients with advanced stage of disease in the intervention group. CONCLUSION: Administration of Varunadi Ghritha resulted in an increase in T cell counts in patients with treated HNC.

Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India.

OBJECTIVES: We studied oral cancer incidence and mortality and the impact of compliance to repeat screening rounds during a 15-year follow-up in a cluster-randomized controlled trial in Trivandrum district, Kerala, India. METHODS: Healthy individuals aged 35 and above in seven clusters randomized to the intervention arm received four rounds of oral visual inspection by trained health workers at 3-year intervals, and those in six clusters randomized to the control arm received routine care during 1996-2005 and one round of visual screening during 2006-2009. Screen-positive persons were referred for diagnosis and treatment. Oral cancer incidence and mortality were compared between the study arms by intention to treat analysis. RESULTS: Of the 96,517 eligible subjects in the intervention arm, 25,144 (26.1%) had one, 22,382 (23.2%) had two, 22,008 (22.8%) had three and 19,288 (20.0%) had four rounds of screening. Of the 95,356 eligible subjects in the control group 43,992 (46.1%) received one round of screening. Although the 12% reduction in oral cancer mortality in all individuals did not reach statistical significance, there was a 24% reduction in oral cancer mortality (95% CI 3-40%) in users of tobacco and/or alcohol in the intervention arm after 4-rounds of screening; there was 38% reduction in oral cancer incidence (95% CI 8-59%) and 81% reduction in oral cancer mortality (95% CI 69-89%) in tobacco and/or alcohol users adhering to four screening rounds. CONCLUSION: Sustained reduction in oral cancer mortality during the 15-year follow-up, with larger reductions in those adhering to repeated screening rounds support the introduction of population-based screening programs targeting users of smoking or chewing tobacco or alcohol or both in high-incidence countries.

Association of body mass index and risk of death from pancreas cancer in Asians: findings from the Asia Cohort Consortium.

We aimed to examine the association between BMI and the risk of death from pancreas cancer in a pooled analysis of data from the Asia Cohort Consortium. The data for this pooled analysis included 883 529 men and women from 16 cohort studies in Asian countries. Cox proportional-hazards models were used to estimate the hazard ratios and 95% confidence intervals for pancreas cancer mortality in relation to BMI. Seven predefined BMI categories (<18.5, 18.5-19.9, 20.0-22.4, 22.5-24.9, 25.0-27.4, 27.5-29.9, ≥ 30) were used in the analysis, with BMI of 22.5-24.9 serving as the reference group. The multivariable analyses were adjusted for known risk factors, including age, smoking, and a history of diabetes. We found no statistically significant overall association between each BMI category and the risk of death from pancreas cancer in all Asians, and obesity was unrelated to the risk of mortality in both East Asians and South Asians. Age, smoking, and a history of diabetes did not modify the association between BMI and the risk of death from pancreas cancer. In planned subgroup analyses among East Asians, an increased risk of death from pancreas cancer among those with a BMI less than 18.5 was observed for individuals with a history of diabetes; hazard ratio=2.01 (95% confidence interval: 1.01-4.00) (P for interaction=0.07). The data do not support an association between BMI and the risk of death from pancreas cancer in these Asian populations.

Determinants of participation in a breast cancer screening trial in trivandrum district, India.

BACKGROUND: Conspicuous differences in participation rates for breast self-examination (BSE), clinical breast examination (CBE), and referral for further investigations have been observed indicating involvement of a number of different factors. This study analysed determinants for participation in different levels of the breast cancer screening process in Indian females. MATERIALS AND METHODS: An intervention group of 52,011 women was interviewed in a breast cancer screening trial in Trivandrum district, India. In order to assess demographic, socio-economic, reproductive, and cancer-related determinants of participation in BSE, CBE, and referral, uni- and multi-variate logistic regression was employed. RESULTS: Of the interviewed women, 23.2% reported practicing BSE, 96.8% had attended CBE, and 49.1% of 2,880 screen-positives attended referral. Results showed an influence of various determinants on participation; women who were currently not married or who had no family history of cancer were significantly less likely to attend the screening process at any level. CONCLUSIONS: Increasing awareness about breast cancer, early detection methods, and the advantages of early diagnoses among women, and their families, as well as health care workers offering social support, could help to increase participation over the entire screening process in India.

Association between body mass index and cardiovascular disease mortality in east Asians and south Asians: pooled analysis of prospective data from the Asia Cohort Consortium.

OBJECTIVE: To evaluate the association between body mass index and mortality from overall cardiovascular disease and specific subtypes of cardiovascular disease in east and south Asians. DESIGN: Pooled analyses of 20 prospective cohorts in Asia, including data from 835,082 east Asians and 289,815 south Asians. Cohorts were identified through a systematic search of the literature in early 2008, followed by a survey that was sent to each cohort to assess data availability. SETTING: General populations in east Asia (China, Taiwan, Singapore, Japan, and Korea) and south Asia (India and Bangladesh). PARTICIPANTS: 1,124,897 men and women (mean age 53.4 years at baseline). MAIN OUTCOME MEASURES: Risk of death from overall cardiovascular disease, coronary heart disease, stroke, and (in east Asians only) stroke subtypes. RESULTS: 49,184 cardiovascular deaths (40,791 in east Asians and 8393 in south Asians) were identified during a mean follow-up of 9.7 years. East Asians with a body mass index of 25 or above had a raised risk of death from overall cardiovascular disease, compared with the reference range of body mass index (values 22.5-24.9; hazard ratio 1.09 (95% confidence interval 1.03 to 1.15), 1.27 (1.20 to 1.35), 1.59 (1.43 to 1.76), 1.74 (1.47 to 2.06), and 1.97 (1.44 to 2.71) for body mass index ranges 25.0-27.4, 27.5-29.9, 30.0-32.4, 32.5-34.9, and 35.0-50.0, respectively). This association was similar for risk of death from coronary heart disease and ischaemic stroke; for haemorrhagic stroke, the risk of death was higher at body mass index values of 27.5 and above. Elevated risk of death from cardiovascular disease was also observed at lower categories of body mass index (hazard ratio 1.19 (95% confidence interval 1.02 to 1.39) and 2.16 (1.37 to 3.40) for body mass index ranges 15.0-17.4 and <15.0, respectively), compared with the reference range. In south Asians, the association between body mass index and mortality from cardiovascular disease was less pronounced than that in east Asians. South Asians had an increased risk of death observed for coronary heart disease only in individuals with a body mass index greater than 35 (hazard ratio 1.90, 95% confidence interval 1.15 to 3.12). CONCLUSIONS: Body mass index shows a U shaped association with death from overall cardiovascular disease among east Asians: increased risk of death from cardiovascular disease is observed at lower and higher ranges of body mass index. A high body mass index is a risk factor for mortality from overall cardiovascular disease and for specific diseases, including coronary heart disease, ischaemic stroke, and haemorrhagic stroke in east Asians. Higher body mass index is a weak risk factor for mortality from cardiovascular disease in south Asians.

Clinical breast examination: preliminary results from a cluster randomized controlled trial in India.

A cluster randomized controlled trial was initiated in the Trivandrum district (Kerala, India) on January 1, 2006, to evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced disease incidence and breast cancer mortality. A total of 275 clusters that included 115,652 healthy women, aged 30-69 years, were randomly allocated to intervention (CBE; 133 clusters; 55,844 women) or control (no screening; 142 clusters; 59,808 women) groups. Performance characteristics (sensitivity, specificity, false-positive rate, and positive predictive value) of CBE were evaluated. An intention-to-treat analysis was performed for comparison of incidence rates between the intervention and control groups. Preliminary results for incidence are based on follow-up until May 31, 2009, when the first round of screening was completed. Of the 50,366 women who underwent CBE, 30 breast cancers were detected among 2880 women with suspicious findings in CBE screening that warranted further investigations. Sensitivity, specificity, false-positive rate, and positive predictive value of CBE were 51.7% (95% confidence interval [CI] = 38.2% to 65.0%), 94.3% (95% CI = 94.1% to 94.5%), 5.7% (95% CI = 5.5% to 5.9%), and 1.0% (95% CI = 0.7% to 1.5%), respectively. The age-standardized incidence rates for early-stage (stage IIA or lower) breast cancer were 18.8 and 8.1 per 100,000 women and for advanced-stage (stage IIB or higher) breast cancer were 19.6 and 21.7 per 100,000 women, in the intervention and control groups, respectively.