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).
METHODS: A cross-sectional study was conducted in Hospital Universiti Sains Malaysia, Kelantan from November 2013 till May 2016 among Type 2 DM patients (DM with no DR and DM with NPDR). The patients were evaluated for anterior ocular segment biometry [central corneal thickness (CCT), anterior chamber width (ACW), angle opening distance (AOD) and anterior chamber angle (ACA)] by using Anterior Segment Optical Coherence Tomography (AS-OCT). Three ml venous blood was taken for the measurement of HbA1c.
RESULTS: A total of 150 patients were included in this study (DM with no DR: 50 patients, DM with NPDR: 50 patients, non DM: 50 patients as a control group). The mean CCT and ACW showed significant difference among the three groups (p < 0.001 and p = 0.015 respectively). Based on post hoc result, there were significant mean difference of CCT between non DM and DM with NPDR (mean difference 36.14 μm, p < 0.001) and also between non DM and DM with no DR (mean difference 31.48 μm, p = 0.003). The ACW was significantly narrower in DM with NPDR (11.39 mm SD 0.62) compared to DM with no DR (11.76 mm SD 0.53) (p = 0.012). There were no significant correlation between HbA1c and all the anterior ocular segment biometry.
CONCLUSION: Diabetic patients have significantly thicker CCT regardless of retinopathy status whereas ACW was significantly narrower in DM with NPDR group compared to DM with no DR. There was no significant correlations between HbA1c and all anterior ocular segment biometry in diabetic patients regardless of DR status.
METHODS: Cross-sectional study involving a retrospective record review of diabetic macular oedema patients who received an induction treatment of three monthly 0.5 mg intravitreal ranibizumab injections between 2016 and 2019. Central macular thickness was measured at baseline and 3 months post-treatment. Linear regression was applied to identify the factors associated with the changes of central macular thickness.
RESULTS: A total of 153 diabetic macular oedema patients were involved in this study. Their mean age was 57.5 ± 7.7 years, 54.9% were female. The mean change of central macular thickness from baseline to 3 months after completed induction treatment of intravitreal ranibizumab was 155.5 ± 137.8 μm. Factors significantly associated with changes of central macular thickness were baseline central macular thickness [b = 0.73; 95% (CI): 0.63, 0.84; p = <0.001] and presence of subretinal fluid [b = 35.43; 95% CI: 3.70, 67.16; p = 0.029].
CONCLUSION: Thicker baseline central macular thickness and presence of subretinal fluid were the factors significantly associated with greater changes of central macular thickness in diabetic macular oedema patients after receiving three injections of intravitreal ranibizumab.