PATIENTS AND METHODS: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety.
RESULTS: A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade ≥3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP.
CONCLUSION: These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients with EGFR mutation-positive NSCLC (NCT01342965).
MATERIALS AND METHODS: This was a retrospective descriptive study. We identified 1041 patients (810 Chinese, 139 Malays, 92 Indians) without previous history of cardiovascular disease who underwent cardiac computed tomography for atypical chest pain evaluation. A cardiologist, who was blinded to the patients' clinical demographics, reviewed all scans. We retrospectively analysed all their case records.
RESULTS: Overall, Malays were most likely to be active smokers (P = 0.02), Indians had the highest prevalence of diabetes mellitus (P = 0.01) and Chinese had the highest mean age (P <0.0001). The overall prevalence of patients with non-calcified plaques as the only manifestation of sub-clinical coronary artery disease was 2.1%. There was no significant difference in the prevalence of CAC, mean CAC score or prevalence of non-calcified plaques among the 3 ethnic groups. Active smoking, age and hypertension were independent predictors of CAC. Non-calcified plaques were positively associated with male gender, age, dyslipidaemia and diabetes mellitus.
CONCLUSION: The higher MI rates in Malays and Indians in Singapore cannot be explained by any difference in CAC or non-calcified plaque. More research with prospective follow-up of larger patient populations is necessary to establish if ethnic-specific calibration of CAC measures is needed to adjust for differences among ethnic groups.
MATERIALS AND METHODS: The Singapore Cardiovascular Cohort Study is a longitudinal follow-up study on a general population cohort of 5920 persons drawn from 3 previous cross-sectional surveys. Morbidity and mortality from IHD and stroke were ascertained by record linkage using a unique identification number with the death registry, Singapore Myocardial Infarct Registry and in-patient discharge databases.
RESULTS: There were 193 first IHD events and 97 first strokes during 52,806 person-years of observation. The overall incidence of IHD was 3.8/1000 person-years and that of stroke was 1.8/1000 person-years. In both males and females, Indians had the highest IHD incidence, followed by Malays and then Chinese. For males after adjusting for age, Indians were 2.78 times (95% CI 1.86, 4.17; P < 0.0001) and 2.28 times (95% CI 1.34, 3.88; P = 0.002) more likely to get IHD than Chinese and Malays respectively. For females after adjusting for age, Indians were 1.97 times (95% CI 1.07, 3.63; P = 0.03) and 1.37 times (95% CI 0.67, 2.80; P = 0.39) more likely to get IHD than Chinese and Malays respectively. For stroke, male Chinese and Indians had higher incidence than Malays (though not statistically significant). However, in females, Malays had the highest incidence of stroke, being 2.57 times (95% CI 1.31, 5.05; P = 0.008) more likely to get stroke than Chinese after adjustment for age.
CONCLUSIONS: This prospective study of both mortality and morbidity has confirmed the higher risk of IHD in Indians. It has also found that Malay females have a higher incidence of stroke, which deserves further study because of its potential public health importance.