Browsing by Author "Huang X."

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    Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC
    (2024-08-15) Lu S.; Kato T.; Dong X.; Ahn M.J.; Quang L.V.; Soparattanapaisarn N.; Inoue T.; Wang C.L.; Huang M.; Yang J.C.H.; Cobo M.; Özgüroǧlu M.; Casarini I.; Khiem D.V.; Sriuranpong V.; Cronemberger E.; Takahashi T.; Runglodvatana Y.; Chen M.; Huang X.; Grainger E.; Ghiorghiu D.; Van Der Gronde T.; Ramalingam S.S.; Lu S.; Mahidol University
    Background Osimertinib is a recommended treatment for advanced non-small-cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation and as adjuvant treatment for resected EGFR-mutated NSCLC. EGFR tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR-mutated NSCLC. Methods In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR-mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review. Results A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75 to 89) and 74% with placebo (95% CI, 57 to 85), with a hazard ratio for death of 0.81 (95% CI, 0.42 to 1.56; P=0.53). The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1 to 2) was reported in 48% and 38%, respectively. No new safety concerns emerged. Conclusions Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC.
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    Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study
    (2025-04-01) Garassino M.C.; He Y.; Ahn M.J.; Orlov S.V.; Potter V.; Kato T.; Laskin J.; Voon P.J.; Reungwetwattana T.; Ramalingam S.S.; Wu Y.L.; Albayaty M.; Cross S.L.; Huang X.; Kulkarni D.; Cho B.C.; Garassino M.C.; Mahidol University
    Introduction: This post-hoc analysis of the registrational FLAURA study and AURA program reports long-term safety data in epidermal growth factor receptor-mutated (EGFRm), advanced non–small cell lung cancer (NSCLC) treated with osimertinib for ≥ 36 months. Methods: Patients from FLAURA who received first-line osimertinib and from the AURA program (AURA, AURA2, AURA3) who received ≥ second-line osimertinib were included. Patients received osimertinib 80 mg once daily. Safety data were analyzed in patients who remained on treatment for ≥ 36 months. The post-study global safety database captured investigator-reported serious adverse events (SAEs) in patients who continued osimertinib beyond final data cut-off (DCO) of the studies. Best response data were analyzed in patients on treatment for ≥ 54 months (FLAURA) or ≥ 36 months (AURA program). Results: In FLAURA, 76 (28 %) and 36 (13 %) of 267 patients received first-line osimertinib for ≥ 36 and ≥ 54 months, respectively; median exposure: 52.5 and 64.5 months, respectively. Across the AURA program,124 (16 %) of 799 patients received ≥ second-line osimertinib for ≥ 36 months; median exposure: 44.7 months. Investigators reported on-study SAEs in 17 % (FLAURA) and 35 % (AURA program) of patients who continued treatment for ≥ 36 months. Post-study incidences of SAEs were 11 % (FLAURA) and 21 % (AURA program). On-study, adverse events (AEs) of cardiac effects (indicative of cardiac failure; grouped term) occurred in 7 % (FLAURA) and 5 % (AURA program) of patients; AEs of interstitial lung disease (ILD; grouped term) occurred in 0 (FLAURA) and 1 (AURA program) patient. No post-study SAEs were reported for the grouped terms cardiac effects and ILD. Most patients treated for ≥ 54 months (FLAURA) and ≥ 36 months (AURA program) had a best on-study response of partial response. Conclusion: This analysis demonstrated that long-term treatment with osimertinib of ≥ 36 months was well tolerated in patients with EGFRm advanced NSCLC.
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    Pharmacokinetics and Safety of Bictegravir in Pregnant and Postpartum Persons With HIV and Their Infants
    (2025-03-01) Powis K.M.; Pinilla M.; McMorrow F.; Stek A.; Brooks K.M.; Shapiro D.E.; Knowles K.; Eke A.C.; Greene E.; Agwu A.; Topete L.; Browning R.; Chakhtoura N.; Arora P.; Huang X.; Best B.M.; Mirochnick M.; Momper J.D.; Deville J.G.; Carter M.F.; Nielsen-Saines K.; Floyd R.; Thomas-Seaton L.T.; Jordan-Thompson S.; Moore R.M.; Mills M.; Rosenberg M.G.; Haines A.; Anderson T.; Collinson-Streng A.; Jao J.; Lartey E.; Cehic R.; Gomez N.; Alverez G.A.; Mitchell C.D.; Aziz M.; Cejtin H.; McNichols M.; Rungmaitree S.; Phatharadom P.; Morales Y.; Spector S.A.; Deutsch K.; Loughran M.; Powis K.M.; Mahidol University
    Background: Limited data exist on bictegravir pharmacokinetics in pregnancy among persons with HIV (PWH) and infant washout. Setting: Nonrandomized, open-label, multicenter phase-IV prospective study of bictegravir pharmacokinetics and safety in pregnant PWH and their infants. Methods: Steady-state 24-hour pharmacokinetic sampling of oral bictegravir 50 mg once daily (a component of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide) during the second and third trimesters and postpartum was performed. Cord blood and infant washout samples were collected. Total and free bictegravir concentrations were measured by validated liquid chromatography with tandem mass spectrometry methods. Within-participant geometric mean ratios (GMR) with 90% confidence intervals (CI) were calculated to compare pharmacokinetics between second and third trimester versus postpartum. Infant HIV testing results were obtained. Results: Twenty-seven maternal–infant pairs were enrolled. Bictegravir area under the concentration–time curve from time 0 through 24 hours post-dose was 46% lower in the second trimester (n = 12; P = 0.002; GMR 0.54; 90% CI: 0.43 to 0.69) and 52% lower in the third trimester (n = 24; P, 0.0001; GMR 0.48; 90% CI: 0.43 to 0.55), compared with postpartum. C24 concentrations were above the estimated bictegravir protein-adjusted 95% effective concentration of 0.162 mg/mL. The median ratio of cord-to-maternal blood concentration was 1.38 (n = 17; quartiles: 1.17–1.63). Median T1/2 for infant bictegravir washout was 33.2 hours (quartiles: 25.7–45.9) with a Cmax of 2.06 mg/mL (quartiles: 1.37–2.72). Overall, 88%–92% of participants maintained suppression, 40 copies/mL throughout pregnancy and postpartum. All available infant HIV testing results were negative. The safety profile for pregnant PWH and infants was acceptable. Conclusions: Bictegravir exposure was lower during pregnancy compared with postpartum, yet C24 concentrations were greater than the bictegravir protein-adjusted 95% effective concentration.
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    Recent advances in membrane and electrochemical hybrid technologies for emerging contaminants removal
    (2025-01-01) Xue W.; Tabucanon A.S.; Amarakoon A.M.S.N.; Xiao K.; Huang X.; Xue W.; Mahidol University
    Emerging contaminants (ECs) pose significant risks to environmental and human health, necessitating advanced treatment technologies. Integrating electrochemical processes with membrane filtration has emerged as a promising solution for preventing the leakage of various ECs in water and wastewater treatment. This review critically evaluates recent applications of hybrid membrane and electrochemical technologies for EC removal, systematically examining various configurations such as two-stage processes, one-pot systems with reactive electrochemical membranes, and electrochemical membrane bioreactors (EMBRs). The review highlights their working mechanisms, performance, and energy efficiencies in removing ECs. It analyzes the potentials and challenges of each hybrid configuration: two-stage processes, while easily integrated into existing systems, face energy efficiency limitations; one-pot systems offer promise in enhancing energy efficiency and membrane self-cleaning but need further research for scalability and long-term effectiveness; and EMBRs, which integrate physical, chemical, and biological processes, require additional studies to optimize performance and address complex interactions. Future research should also focus on understanding the degradation mechanisms and toxicity pathways of ECs, as well as on developing cost-effective and scalable membrane-electrochemical hybrid technologies for newly identified contaminants.
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    Unraveling the Impact of Widowhood Duration on Depression: Does Time Heal All Wounds?
    (2024-01-01) Huang X.; Tey N.P.; Lai S.L.; Huang X.; Mahidol University
    China’s aging population has witnessed a surge in widowed older adults, raising concerns about their mental health. Losing a spouse is a profoundly distressing experience with enduring effects on well-being. Despite the proverbial belief in time’s healing power, existing studies often neglect the potential decline in depressive symptoms during widowhood. Drawing data from the 2015 and 2018 China Health and Retirement Longitudinal Study, this study delves into the impact of widowhood duration on depression among 8370 older adults and uncovered significantly higher depression scores among widowed individuals, particularly in the initial 3 years. The research reveals that widowhood contributes to heightened depression levels even after accounting for sociodemographic factors. Although the depressive impact lessens over time, it persists beyond 3 years, underscoring the need for heightened awareness and support for this vulnerable population.